← Product Code [NVE](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NVE) · K222849

# AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System,  RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222849)

_Steris · NVE · Sep 30, 2022 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/NVE/K222849

## Device Facts

- **Applicant:** Steris
- **Product Code:** [NVE](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NVE.md)
- **Decision Date:** Sep 30, 2022
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Intended Use

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles: Prevac, Prevac, Prevac, Prevac, Prevac, Prevac-IUSS, Gravity, Warm-Up, DART, Leak Test. The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

## Device Story

Device suite includes AMSCO 600 Steam Sterilizer, V-PRO Low Temperature Sterilization Systems (maX 2, s2, 60), and RAS Racks for washer-disinfectors. Steam sterilizer uses saturated steam (gravity or vacuum) to sterilize heat-stable loads. V-PRO systems use vaporized hydrogen peroxide (VAPROX HC) for terminal sterilization of heat-sensitive, cleaned, and dried medical devices (lumened/non-lumened). RAS Racks enable automated cleaning/disinfection of robotic instruments in compatible washer-disinfectors. Operated by technicians in sterile processing departments or surgical suites. Modifications address component obsolescence (oscillator, coin cell battery replaced by super capacitor, flash memory updates). Output includes sterilized instruments ready for use. Benefits include effective sterilization/disinfection of complex surgical instrumentation, ensuring patient safety by reducing infection risk.

## Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including 1/2 cycle sterility assurance tests (biological indicators showing no growth) and software verification tests confirming proper operation of the modified controller boards and RTC circuits.

## Technological Characteristics

Sterilization systems utilize saturated steam or vaporized hydrogen peroxide (VAPROX HC). Chamber materials include 316L stainless steel. Systems feature embedded controllers, RTD temperature sensors, and pressure transducers. Connectivity includes USB/printer for cycle data. Software updates support new flash memory components. Sterilization cycles are pre-programmed and validated per ANSI/AAMI standards.

## Regulatory Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

## Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

## Predicate Devices

- AMSCO 600 Steam Sterilizer, V-PRO maX 2 and s2 Low Temperature Sterilization Systems, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector ([K222543](/device/K222543.md))
- V-PRO 60 Low Temperature Sterilization Systems, V-PRO s2 Low Temperature Sterilization Systems ([K190917](/device/K190917.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 30, 2022

Anthony Piotrkowski Director, Regulatory Affairs Steris Inc. 5960 Heislev Rd Mentor, Ohio 44060

#### Re: K222849

Trade/Device Name: AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector Regulation Number: 21 CFR 880.6880; 21 CFR 880.6860; 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FLE,PEC, MLR, NVE Dated: September 19, 2022 Received: September 21, 2022

Dear Anthony Piotrkowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K222849

Device Name

AMSCO 600 Steam Sterilizer

Indications for Use (Describe)

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):

| Cycles          | Sterilize<br>Temperature | Sterilize Time | Dry Time   | Maximum Recommended Load                                                                                                                          |
|-----------------|--------------------------|----------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac          | 270°F (132°C)            | 4 minutes      | 20 minutes | Fabric Packs. Refer to Table 2 for<br>recommended quantities.                                                                                     |
| Prevac          | 270°F (132°C)            | 4 minutes      | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg)<br>each and Fabric Packs. Refer to<br>Table 2 for recommended<br>quantities. |
| Prevac          | 270°F (132°C)            | 10 minutes     | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3<br>kg) each . Refer to Table 2 for<br>recommended quantities.                    |
| Prevac          | 270°F (132°C)            | 4 minutes      | 5 minutes  | Single Fabric Pack.                                                                                                                               |
| Prevac          | 275°F (135°C)            | 3 minutes      | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg)<br>each. Refer to Table 2 for<br>recommended quantities.                     |
| Prevac-<br>IUSS | 270°F (132°C)            | 4 minutes      | 1 minutes  | Immediate use – single<br>unwrapped tray                                                                                                          |
| Gravity         | 250°F (121°C)            | 30 minutes     | 30 minutes | Double wrapped instrument trays,<br>maximum weight 25 lbs. (11.3 kg)<br>each. Refer to Table 2 for<br>recommended quantities.                     |
| Warm-Up         | 270°F (132°C)            | 3 minutes      | 1 minute   | N/A                                                                                                                                               |
| DART            | 270°F (132°C)            | 3.5 minutes    | 1 minute   | Bowie-Dick Test Pack, DART                                                                                                                        |
| Leak<br>Test    | N/A                      | N/A            | N/A        | N/A                                                                                                                                               |

Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cvcles and cvcle values

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| Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer s |                          |              |
|---------------------------------------------------------------|--------------------------|--------------|
| Sterilizer Size                                               | Wrapped Instrument Trays | Fabric Packs |
| 26" x 26" x 39"                                               | 9                        | 12           |
| 26" x 26" x 51"                                               | 12                       | 16           |
| 26" x 26" x 63"                                               | 15                       | 20           |

ize

The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## Indications for Use

510(k) Number (if known)

K222849

#### Device Name

V-PRO maX 2 Low Temperature Sterilization Systems

Indications for Use (Describe)

The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and Fast Non Lumen Cycle.

The Non Lumen Cycle can sterilize:

t Non-lumened instruments including non-luments, non-lumened rigid, semi-rigid, semi-rigid and flexible endoscopes.

* The validation studies were conducted using a validation load consisting of two instrument travs for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize:

*Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

* The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.* The flexible endoscopes may contain either:

- · A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
- Or two lumens with:
	- One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
	- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

* The validation studies were conducted with two flexible endoscopes, each packaged into a tray with sillicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. †† The flexible endoscope may contain either:

- · A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
- Or two lumens with:
	- One lumen that is > 1 mm ID and ≤ 990 mm in length

- And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

f The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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The Lumen Cvcle can sterilize:

+Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

- Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length
- · Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length
- · Dual channeled devices with stainless lumens that are > 0.77 mm ID and < 527 mm in length
- · Triple channeled devices with stainless lumens that are either:

≥ 1.2 mm ID and ≤ 275 mm in length

≥ 1.8 mm ID and ≤ 310 mm in length

or

- ≥ 2.8 mm ID and ≤ 317 mm in length
* Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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## Indications for Use

510(k) Number (if known)

#### K222849

#### Device Name

V-PRO® s2 Low Temperature Sterilization System

#### Indications for Use (Describe)

The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.

* The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).

#### The V-PRO s2 Sterilizer Fast Cycle can sterilize: t

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

- · Single or dual channeled devices with stainless steel lumens that are
- > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
- ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length

· Triple channeled devices with stainless steel lumens that are either:

- ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length
- or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.

* Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

The V-PRO s2 Sterilizer Flexible Cycle can sterilize: @

One surgical flexible endoscope (such as those used in ENT. Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

- · The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length
- · Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
- ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
- ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21-5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second

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tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 1bs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

- · Single or dual channeled devices with stainless steel lumens that are
- ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length
- ≥ 1.8 mm (~5/64) ID x ≤ 542 mm (~21-5/16") in length
- · Triple channeled devices with stainless steel lumens that are either:
- ≥ 1.2 mm (~3/64") ID and < 275 mm (~10-53/64") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length

or

- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 Ibs (5.0 kg).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

#### 510(k) Number (if known)

#### K222849

#### Device Name

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector

#### Indications for Use (Describe)

The RAS Racks are used in the RAS Cycle of the AMSCO 7052HP Single-Chamber Washer/Disinfector and the AMSCO 7053HP Single-Chamber Washer/Disinfector for the effective cleaning, intermediate level disinfection and drying of reusable da Vinci® X/Xi and S/Si EndoWrist® instruments.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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## Indications for Use

510(k) Number (if known)

#### K222849

#### Device Name

V-PRO® 60 Low Temperature Sterilization System

#### Indications for Use (Describe)

The V-PRO® 60 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize: t

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes.

* The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).

#### The V-PRO 60 Sterilizer Flexible Cycle can sterilize: @

One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

- The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") internal diameter (ID) and ≤ 990 mm (38-63/64'') in length
- · Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
- ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9-11/64") in length
- ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
- ≥ 1.8mm (~5/64") ID and ≤ 542 mm (~21-5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel load weight of 11 1bs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO 60 Sterilizer Lumen Cycle can sterilize: ^

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

- · Single or dual channeled devices with stainless steel lumens that are
	- ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length
	- ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") length
- · Triple channeled devices with stainless steel lumens that are either:
- ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length

or

- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless seel lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 Ibs (5.0 kg).

{10}------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

- X Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(k) Summary For AMSCO 600 Steam Sterilizer

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact: Tony Piotrkowski Director, Regulatory Affairs

> Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: Tony_Piotrkowski@steris.com

September 28, 2022 Summary Date:

Premarket Notification Number: K222849

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

{12}------------------------------------------------

#### 1. Device Name

| Trade Name:            | AMSCO 600 Steam Sterilizer |
|------------------------|----------------------------|
| Device Class:          | Class II                   |
| Common/usual Name:     | Steam Sterilizer           |
| Classification Name:   | Sterilizer, Steam          |
| Classification Number: | 21 CFR 880.6880            |
| Product Code:          | FLE, PEC                   |

#### 2. Predicate Device

- K222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 and s2 Low Temperature Sterilization Systems, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
#### 3. Description of Device

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.

The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.

The sterilizers are generally operated by technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite to allow for Immediate Use Steam Sterilization (IUSS) for instances where an instrument is needed immediately for a procedure (e.g. after an instrument has been dropped and there is no replacement readily available). Standard practices for use of sterilizers in health care facilities are provided by various organizations (e.g. ANSI/AAMI ST79).

The ALUS is used with the AMSCO 600 Steam Sterilizer's existing transfer carriages and loading carts. It consists of a conveyor system which attaches to the load and/or unload ends of the steam sterilizer. It has a series of barcode labels which correspond to pre-programmed cycles and an optional scanner which when fitted to the system will communicate to the sterilizer which cycle to initiate.

{13}------------------------------------------------

#### 4. Intended Use/Indications for Use

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture- stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles:

| Cycles          | Sterilize<br>Temperature | Sterilize<br>Time | Dry Time   | Maximum Recommended Load                                                                                                                       |
|-----------------|--------------------------|-------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac          | 270°F (132°C)            | 4 minutes         | 20 minutes | Fabric Packs. Refer to Table 2<br>for recommended quantities.                                                                                  |
| Prevac          | 270°F (132°C)            | 4 minutes         | 30 minutes | Double wrapped instrument trays, maximum<br>weight 25 lbs. (11.3 kg) each and Fabric<br>Packs. Refer to Table 2 for<br>recommended quantities. |
| Prevac          | 270°F (132°C)            | 10 minutes        | 30 minutes | Double wrapped instrument trays, maximum<br>weight 25 lbs. (11.3 kg) each. Refer to Table<br>2 for recommended quantities.                     |
| Prevac          | 270°F (132°C)            | 4 minutes         | 5 minutes  | Single Fabric Pack.                                                                                                                            |
| Prevac          | 275°F (135°C)            | 3 minutes         | 30 minutes | Double wrapped instrument trays, maximum<br>weight 25 lbs. (11.3 kg) each. Refer to Table 2<br>for recommended quantities.                     |
| Prevac-<br>IUSS | 270°F (132°C)            | 4 minutes         | 1 minutes  | Immediate use - single<br>unwrapped tray                                                                                                       |
| Gravity         | 250°F (121°C)            | 30 minutes        | 30 minutes | Double wrapped instrument trays, maximum<br>weight 25 lbs. (11.3 kg) each. Refer to Table 2<br>for recommended quantities.                     |
| Warm-Up         | 270°F (132°C)            | 3 minutes         | 1 minute   | N/A                                                                                                                                            |
| DART            | 270°F (132°C)            | 3.5 minutes       | 1 minute   | Bowie-Dick Test Pack, DART                                                                                                                     |
| Leak Test       | N/A                      | N/A               | N/A        | N/A                                                                                                                                            |

AMSCO 600 Steam Sterilizer factory-validated sterilization cvcles and cycle values

#### AMSCO 600 Steam Sterilizer full load per sterilizer size

| Sterilizer Size | Wrapped Instrument<br>Trays | Fabric Packs |
|-----------------|-----------------------------|--------------|
| 26" x 26" x 39" | 9                           | 12           |
| 26" x 26" x 51" | 12                          | 16           |
| 26" x 26" x 63" | 15                          | 20           |

The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

{14}------------------------------------------------

| Feature                        | AMSCO 600 Steam Sterilizer<br>(Modified Device)                                                                                                                                                           | AMSCO 600 Steam Sterilizer<br>(Predicate Device/K222543)                                                                                                                                                  | Comparison                                            |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Intended Use                   | The AMSCO 600 Steam Sterilizer is<br>designed for sterilization of heat and<br>moisture-stable materials used in healthcare<br>facilities.                                                                | The AMSCO 600 Steam Sterilizer is<br>designed for sterilization of heat and<br>moisture-stable materials used in healthcare<br>facilities.                                                                | Same                                                  |
| Critical Process<br>Parameters | Time Chamber Temperature Pressure                                                                                                                                                                         | Time Chamber Temperature Pressure                                                                                                                                                                         | Same                                                  |
| Control                        | Embedded Controller                                                                                                                                                                                       | Embedded Controller                                                                                                                                                                                       | Same control but<br>using slightly<br>modified boards |
| SAL                            | 10-6                                                                                                                                                                                                      | 10-6                                                                                                                                                                                                      | Same                                                  |
| Sterilant                      | Saturated Steam                                                                                                                                                                                           | Saturated Steam                                                                                                                                                                                           | Same                                                  |
| Utilities                      | Steam, Water, Electricity, Air                                                                                                                                                                            | Steam, Water, Electricity, Air                                                                                                                                                                            | Same                                                  |
| Chamber<br>Material            | 316L Stainless Steel                                                                                                                                                                                      | 316L Stainless Steel                                                                                                                                                                                      | Same                                                  |
| Nominal<br>Chamber Size        | 26" w x 26" h x 39" d 26" w x 26" h x 51" d 26" w x 26" h x 63" d                                                                                                                                         | 26" w x 26" h x 39" d 26" w x 26" h x 51" d 26" w x 26" h x 63" d                                                                                                                                         | Same                                                  |
| Door                           | 304L Stainless Steel<br>26" x 26" Power vertical sliding                                                                                                                                                  | 304L Stainless Steel<br>26" x 26" Power vertical sliding                                                                                                                                                  | Same                                                  |
| Chamber<br>Pressure Rating     | 45 psig, 300°F                                                                                                                                                                                            | 45 psig, 300°F                                                                                                                                                                                            | Same                                                  |
| Door Seal                      | Steam activated door seal                                                                                                                                                                                 | Steam activated door seal                                                                                                                                                                                 | Same                                                  |
| External Process<br>Monitors   | Electronic Control Printer                                                                                                                                                                                | Electronic Control Printer                                                                                                                                                                                | Same                                                  |
| Accessories                    | BI, CI, Pouches, Trays, Wraps, Tape,<br>Containers, Shelves, Loading Equipment,<br>automated loading system                                                                                               | BI, CI, Pouches, Trays, Wraps, Tape,<br>Containers, Shelves, Loading Equipment,<br>automated loading system                                                                                               | Same                                                  |
| Test Cycles                    | Warm Up, Leak Test, DART (Bowie Dick)<br>Test                                                                                                                                                             | Warm Up, Leak Test, DART (Bowie Dick)<br>Test                                                                                                                                                             | Same                                                  |
| Internal Process<br>Monitors   | Temperature<br>-Dual element RTD located in chamber drain<br>- RTD located in the jacket drain<br>- RTD located in heat exchanger<br>Pressure<br>-Pressure transducer in chamber                          | Temperature<br>-Dual element RTD located in chamber drain<br>- RTD located in the jacket drain<br>- RTD located in heat exchanger<br>Pressure<br>-Pressure transducer in chamber                          | Same                                                  |
| Performance                    | Meets ANSI/AAMI ST8:2013                                                                                                                                                                                  | Meets ANSI/AAMI ST8:2013                                                                                                                                                                                  | Same                                                  |
| Cycles                         | 270F, Prevac, 4' Full fabric pack 270F, Prevac, 4' Full tray 270F, Prevac, 4' One fabric pack 270F, Prevac, 4' IUSS 275F, Prevac, 3' Full fabric 250F, Gravity, 30' Full tray 270F, Prevac, 10' Full tray | 270F, Prevac, 4' Full fabric pack 270F, Prevac, 4' Full tray 270F, Prevac, 4' One fabric pack 270F, Prevac, 4' IUSS 275F, Prevac, 3' Full fabric 250F, Gravity, 30' Full tray 270F, Prevac, 10' Full tray | Same                                                  |
| Full Loads                     | 39": 9, 25-lb double wrapped trays or 12, fabric packs 51": 12, 25-lb double wrapped trays or 16, fabric packs 63": 15, 25-lb double wrapped trays or 20, fabric packs                                    | 39": 9, 25-lb double wrapped trays or 12, fabric packs 51": 12, 25-lb double wrapped trays or 16, fabric packs 63": 15, 25-lb double wrapped trays or 20, fabric packs                                    | Same                                                  |

## Technological Characteristics Comparison Table

{15}------------------------------------------------

The proposed device has the same intended use as the predicate with the same technological characteristics. The modifications, subject of this submission, are to address the obsolescence of an oscillator and to replace the coin cell battery with a super capacitor in the RTC (Real Time Clock) circuit. The modification also includes alternates for Flash memory components and associated software updates to allow the flash memory to interact with the current software.

#### ನ. Summary of Nonclinical Tests

Non-clinical performance test was performed according to the test methodology listed below and is the same methods used to verify the original design. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.

| Test                                 | Criterion                                                                                                                                                     | Conclusion |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 1½ Cycle sterility<br>assurance Test | All biological indicators must show no growth after a ½<br>Cycle exposure with a worst-case load.                                                             | Pass       |
| Software test                        | Verify sterilizer can set and read RTC, bootloader<br>can load and run software application and verify<br>proper operation of applications using serial flash | Pass       |

#### 6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device K222543, Class II (21 CFR 880.6860), product code FLE and the use of slightly modified boards has no impact on the device performance.

{16}------------------------------------------------

# STERIS®

# 510(k) Summary For V-PRO® maX 2 Low Temperature Sterilization System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 tony piotrkowski@steris.com

Email:

Summary Date: September 28, 2022

Premarket Notification Number: K222849

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

{17}------------------------------------------------

#### 1. Device Name

| Trade Name:            | V-PRO® maX 2 Low Temperature Sterilization System |
|------------------------|---------------------------------------------------|
| Device Class:          | Class II                                          |
| Common/usual Name:     | Vapor Phase Hydrogen Peroxide Sterilizer          |
| Classification Name:   | Sterilizer, Ethylene Oxide Gas                    |
| Classification Number: | 21 CFR 880.6860                                   |
| Product Code:          | MLR                                               |

#### 2. Predicate Device

K222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 and s2 Low Temperature Sterilization Systems, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector

#### Descrintion of Device 3.

The V-PRO Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer. It has the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.

The V-PRO Sterilizers uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. Packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.

#### 4. Intended Use / Indications for Use

The maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and the Fast Non Lumen Cycle.

#### The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

{18}------------------------------------------------

#### STERIS SPECIAL 510(k) PREMARKET NOTIFICATION K222849 Modification to V-PRO maX 2 Low Temperature

‡ The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

### The Fast Non Lumen Cycle can sterilize:*

Non-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

* The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

## The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT,

Urology and Surgical Care) and bronchoscopes in either of the two configurations:

- 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain either:
- · A single lumen that is > 1 mm internal diameter (ID) and < 1050 mm in length
- Or two lumens with:
- One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

* The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain either:

· A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

- Or two lumens with:
- One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
- · And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

†† The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).

## The Lumen Cycle can sterilize: †

Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length

• Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length

• Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length

· Triple channeled devices with stainless lumens that are either:

≥ 1.2 mm ID and ≤ 275 mm in length

≥ 1.8 mm ID and ≤ 310 mm in length

or

≥ 2.8 mm ID and ≤ 317 mm in length

† Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

{19}------------------------------------------------

#### 5. Technological Characteristics

The proposed and predicate devices are identical in all technological characteristics including but not limited to: fundamental scientific technology, composition, mechanism of action, components and accessories. No physical changes were made to the devices for this modification other than the those described.

| Feature                             | V-PRO maX 2 Low Temperature<br>Sterilization System (Modified Device)                                                                                                                                                                                                                                                                                                                                          | V-PRO maX 2 Low Temperature<br>Sterilization System (Predicate -<br>K222543)                                                                                                                                                                                                                                                                                                                                   | Comparison                                            |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Intended Use                        | The maX 2 Low Temperature<br>Sterilization System using VAPROX HC<br>Sterilant is intended for use in the terminal<br>sterilization of properly prepared (cleaned,<br>rinsed and dried) medical devices in<br>Healthcare Facilities. The preprogrammed<br>sterilization cycles operate at low pressure<br>and temperature, suitable for processing<br>medical devices without leaving toxic<br>residues        | The maX 2 Low Temperature<br>Sterilization System using VAPROX HC<br>Sterilant is intended for use in the terminal<br>sterilization of properly prepared (cleaned,<br>rinsed and dried) medical devices in<br>Healthcare Facilities. The preprogrammed<br>sterilization cycles operate at low pressure<br>and temperature, suitable for processing<br>medical devices without leaving toxic<br>residues        | Same                                                  |
| Process Parameters                  | The critical process parameters are:<br>• Time<br>• Chamber Temperature<br>• Vaporizer Temperature<br>• Chamber Pressure Prior toInjection<br>• Sterilant Injection Weight                                                                                                                                                                                                                                     | The critical process parameters are:<br>• Time<br>• Chamber Temperature<br>• Vaporizer Temperature<br>• Chamber Pressure Prior to Injection<br>• Sterilant Injection Weight                                                                                                                                                                                                                                    | Same                                                  |
| Software/<br>Firmware<br>Controlled | Control system consists of a proprietary<br>microcomputer control board and<br>peripheral function circuit boards, located<br>within the control housing. A memory<br>backup system maintains user settings and<br>calibration data indefinitely. Up to 300<br>cycle data files can be stored for review or<br>downloading by the user.<br>The software allows user selection of the<br>pre- programmed cycle. | Control system consists of a proprietary<br>microcomputer control board and<br>peripheral function circuit boards, located<br>within the control housing. A memory<br>backup system maintains user settings and<br>calibration data indefinitely. Up to 300<br>cycle data files can be stored for review or<br>downloading by the user.<br>The software allows user selection of the<br>pre- programmed cycle. | Same control but<br>using slightly<br>modified boards |
| Sterilant                           | VAPROX HC Sterilant (59% Hydrogen<br>Peroxide).                                                                                                                                                                                                                                                                                                                                                                | VAPROX HC Sterilant (59% Hydrogen<br>Peroxide).                                                                                                                                                                                                                                                                                                                                                                | Same                                                  |
| Accessories                         | Accessories were submitted under<br>separate, individual, concurrent 510(k)s<br>and cover the following:<br>• Self-contained biological indicator<br>• Biological indicator challenge pack<br>• Fast Acting Biological Indicator<br>• Chemical indicator<br>• Trays & Tray Accessories<br>• Pouches<br>• Tape                                                                                                  | Accessories were submitted under<br>separate, individual, concurrent 510(k)s<br>and cover the following:<br>• Self-contained biological indicator<br>• Biological indicator challenge pack<br>• Fast Acting Biological Indicator<br>• Chemical indicator<br>• Trays & Tray Accessories<br>• Pouches<br>• Tape                                                                                                  | Same                                                  |

#### Technological Characteristics Comparison Table

The modifications, subject of this submission, are to address the obsolescence of an oscillator and to replace the coin cell battery with a super capacitor in the RTC (Real Time Clock) circuit. The modification also includes alternates for Flash memory components and associated software updates to allow the flash memory to interact with the current software.

{20}------------------------------------------------

#### 6. Summary of Non-Clinical Testing

Non-clinical performance test was performed according to the test methodology listed below and is the same methods used to verify the original design. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.

| Test                                           | Criterion                                                                                                                                                     | Conclusion |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 1         /2 Cycle sterility<br>assurance Test | All biological indicators must show no growth after a ½<br>Cycle exposure with a worst-case load.                                                             | Pass       |
| Software test                                  | Verify sterilizer can set and read RTC, bootloader<br>can load and run software application and verify<br>proper operation of applications using serial flash | Pass       |

## 7. Conclusions

Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO maX 2 Low Temperature Sterilization System is as safe, as effective and performs as well as or better than the legally marketed predicate device K222543, Class II (21 CFR 880.6860), product code MLR and the use of slightly modified boards has no impact on the device performance.

{21}------------------------------------------------

# STERIS®

## 510(k) Summary For V-PRO® s2 Low Temperature Sterilization System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 Email: tony piotrkowski@steris.com

Summary Date: September 28, 2022

Premarket Notification Number: K222849

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

{22}------------------------------------------------

#### Device Name 2.

| Trade Name:            | V-PRO® s2 Low Temperature Sterilization Systems |
|------------------------|-------------------------------------------------|
| Device Class:          | Class II                                        |
| Common/usual Name:     | Vapor Phase Hydrogen Peroxide Sterilizer        |
| Classification Name:   | Sterilizer, Ethylene Oxide Gas                  |
| Classification Number: | 21 CFR 880.6860                                 |
| Product Code:          | MLR                                             |

#### 3. Predicate Device

- K222543 AMSCO 600 Steam Sterilizer. V-PRO maX 2 and s2 Low Temperature Sterilization Systems, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
#### Description of Device 4.

The V-PRO s2 Sterilizer executes four sterilization cycles (the Lumen, Non Lumen, Flexible Cycles and Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing.

The V-PRO s2 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.

#### 5. Intended Use / Indications for Use

#### The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC

Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusionrestricted spaces such as the hinged portion of forceps and scissors.

#### The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

: The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).

#### The Fast Cycle can sterilize: t

Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

{23}------------------------------------------------

#### STERIS SPECIAL 510(k) PREMARKET NOTIFICATION K222849 Modification to V-PRO s2 Low Temperature

• Single or dual channeled devices with stainless steel lumens that are

> 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length

> 1.8 mm (~5/64") ID x < 542 mm (~21-5/16") in length

· Triple channeled devices with stainless steel lumens that are either:

> 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length

≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length

Or

≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

: Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

## The Flexible Cycle can sterilize: 0

One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

· The flexible endoscope may be a single or dual lumen device with lumens that are > 1 mm ID and ≤ 990 mm in length

· Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions

≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length

> 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length

> 1.8 mm (~5/64") ID and < 542 mm (~21-5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

## The Lumen Cycle can sterilize: ^

Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

· Single or dual channeled devices with stainless steel lumens that are

≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length

≥ 1.8 mm (~5/64) ID x ≤ 542 mm (~21-5/16") in length

· Triple channeled devices with stainless steel lumens that are either:

> 1.2 mm (~3/64") ID and < 275 mm (~10-53/64") in length

> 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length

or

≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument trav and two pouches for a total weight of 11 lbs (5.0 kg).

{24}------------------------------------------------

## STERIS SPECIAL 510(k) PREMARKET NOTIFICATION K222849 Modification to V-PRO s2 Low Temperature

| Feature                             | V-PRO s2 Low Temperature<br>Sterilization System<br>(Modified Device)                                                                                                                                                                                                                                                                              | V-PRO s2 Low Temperature<br>Sterilization System<br>(Predicate Device K222543)                                                                                                                                                                                                                                                                     | Comparison                                               |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Indications<br>for Use              | See completed indications for use below. No changes are being proposed to the<br>device's intended use or indications for use                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                    | Identical                                                |
| Process<br>Parameters               | The critical process parameters are:<br>• Time<br>• Chamber Temperature<br>• Vaporizer Temperature<br>• Chamber Pressure Prior to Injection<br>• Sterilant Injection Weight                                                                                                                                                                        | The critical process parameters are:<br>• Time<br>• Chamber Temperature<br>• Vaporizer Temperature<br>• Chamber Pressure Prior to Injection<br>• Sterilant Injection Weight                                                                                                                                                                        | Identical                                                |
| Software/<br>Firmware<br>Controlled | Control system consists of a microcomputer<br>control board and peripheral function circuit<br>boards, located within the control housing.<br>A memory backup system maintains cycle<br>settings and current cycle information.<br>The software allows user selection of either<br>the Lumen, Non Lumen, Flexible or Fast<br>pre-programmed cycle. | Control system consists of a microcomputer<br>control board and peripheral function circuit<br>boards, located within the control housing.<br>A memory backup system maintains cycle<br>settings and current cycle information.<br>The software allows user selection of either<br>the Lumen, Non Lumen, Flexible or Fast<br>pre-programmed cycle. | Same control<br>but using<br>slightly<br>modified boards |
| Total Cycle<br>Time                 | Lumen Cycle - 60 minutes<br>Non Lumen Cycle - 28 minutes<br>Flexible Cycle - 38 minutes<br>Fast Cycle - 19 minutes                                                                                                                                                                                                                                 | Lumen Cycle - 60 minutes<br>Non Lumen Cycle - 28 minutes<br>Flexible Cycle - 38 minutes<br>Fast Cycle - 19 minutes                                                                                                                                                                                                                                 | Identical                                                |
| Sterilant                           | VAPROX HC Sterilant (59% Hydrogen<br>Peroxide).                                                                                                                                                                                                                                                                                                    | VAPROX HC Sterilant (59% Hydrogen<br>Peroxide).                                                                                                                                                                                                                                                                                                    | Identical                                                |
| Accessories                         | Accessories include:<br>• Self-contained biological indicator<br>• Biological indicator challenge pack<br>• Fast Acting Biological Indicator<br>• Chemical indicator<br>• Trays & Tray Accessories<br>• Pouches<br>• Tape                                                                                                                          | Accessories include:<br>• Self-contained biological indicator<br>• Biological indicator challenge pack<br>• Fast Acting Biological Indicator<br>• Chemical indicator<br>• Trays & Tray Accessories<br>• Pouches<br>• Tape                                                                                                                          | Identical                                                |

## Technological Characteristics Comparison Table

The proposed device has the same intended use as the predicate with the same technological characteristics. The modifications, subject of this submission, are to address the obsolescence of an oscillator and to replace the coin cell battery with a super capacitor in the RTC (Real Time Clock) circuit. The modification also includes alternates for Flash memory components and associated software updates to allow the flash memory to interact with the current software.

#### Summary of Non-Clinical Testing 6.

Non-clinical performance test was performed according to the test methodology listed below and is the same methods used to verify the original design. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.

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| Test                                  | Criterion                                                                                                                                                     | Conclusion |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 1/2 Cycle sterility<br>assurance Test | All biological indicators must show no growth after a ½<br>Cycle exposure with a worst-case load.                                                             | Pass       |
| Software test                         | Verify sterilizer can set and read RTC, bootloader<br>can load and run software application and verify<br>proper operation of applications using serial flash | Pass       |

## 7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO s2 Low Temperature Sterilization System is as safe, as effective and performs as well as or better than the legally marketed predicate device K222543, Class II (21 CFR 880.6860), product code MLR and the use of slightly modified boards has no impact on the device performance.

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# STERIS®

## 510(k) Summary For V-PRO® 60 Low Temperature Sterilization System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 Email: tony piotrkowski@steris.com

Summary Date: September 28, 2022

Premarket Notification Number: K222849

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

{27}------------------------------------------------

#### Device Name 8.

| Trade Name:            | V-PRO® 60 Low Temperature Sterilization Systems |
|------------------------|-------------------------------------------------|
| Device Class:          | Class II                                        |
| Common/usual Name:     | Vapor Phase Hydrogen Peroxide Sterilizer        |
| Classification Name:   | Sterilizer, Ethylene Oxide Gas                  |
| Classification Number: | 21 CFR 880.6860                                 |
| Product Code:          | MLR                                             |

#### 9. Predicate Device

K190917 V-PRO 60 Low Temperature Sterilization Systems, V-PRO s2 Low Temperature Sterilization Systems

#### 10. Descrintion of Device

The V-PRO s2 Sterilizer executes four sterilization cycles (the Lumen, Non Lumen, Flexible Cycles and Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing.

The V-PRO s2 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cvcle, no cool down or aeration period is required following completion of the cycle.

#### 11. Intended Use / Indications for Use

The V-PRO® 60 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

* The validation studies were conducted using a validation load consisting of one instrument trav for a total weight of 25 lbs (11.3 kg).

The V-PRO 60 Sterilizer Flexible Cycle can sterilize:@

One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

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#### STERIS SPECIAL 510(k) PREMARKET NOTIFICATION K222849 Modification to V-PRO 60 Low Temperature

- The flexible endoscope may be a single or dual lumen device with lumens that are > 1 mm (~3/64") internal diameter (ID) and ≤ 990 mm (38-63/64") in length
- · Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
	- > 0.76 mm (~1/32") ID and ≤ 233 mm (~9-11/64") in length
	- ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
	- ≥ 1.8mm (~5/64") ID and ≤ 542 mm (~21-5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing. The V…

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/NVE/K222849](https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/NVE/K222849)

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