V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems

K190917 · STERIS Corporation · MLR · May 9, 2019 · General Hospital

Device Facts

• Record ID: K190917
• Device Name: V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
• Applicant: STERIS Corporation
• Product Code: MLR · General Hospital
• Decision Date: May 9, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

V-PRO s2 and V-PRO 60 are vaporized hydrogen peroxide (VHP) sterilizers using VAPROX HC Sterilant (59% H2O2). Systems operate via pre-programmed cycles (Lumen, Non-Lumen, Flexible, Fast) involving conditioning, sterilization, and aeration phases at low pressure/temperature. Input: cleaned, rinsed, dried, and packaged surgical instruments. Output: terminally sterilized devices ready for immediate use. Used in healthcare facilities by clinical staff. Microcomputer control system manages cycle parameters (time, temperature, pressure, sterilant injection). Benefits include rapid turnaround without aeration/cool-down periods and compatibility with heat/moisture-sensitive instruments.

Clinical Evidence

Bench testing only. No clinical data. Validation included 1/2 cycle modified total kill endpoint verification and simulated use testing under worst-case conditions to confirm sterilization efficacy for specified lumen configurations.

Technological Characteristics

Vaporized hydrogen peroxide sterilizer; VAPROX HC (59% H2O2) sterilant. Microcomputer-controlled with peripheral circuit boards. Features include conditioning, sterilization, and aeration phases. V-PRO s2 is free-standing; V-PRO 60 is cart-mounted. Connectivity includes memory backup for cycle settings. Sterilization cycles operate at low pressure/temperature. Software-controlled cycle selection.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried medical devices in healthcare facilities. Includes non-lumened instruments, rigid/semi-rigid/flexible endoscopes, and stainless steel lumened devices (single, dual, triple channeled) with specific ID and length configurations. Contraindicated for devices not properly cleaned, rinsed, or dried.

Regulatory Classification

Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Predicate Devices

• V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems (K182568)

Reference Devices

• V-PRO 1 (K190103)
• V-PRO 1 Plus (K190103)
• V-PRO maX (K190103)
• V-PRO maX 2 (K190103)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 9, 2019

STERIS Corporation Anthony Piotrkowski Director Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K190917

Trade/Device Name: V-PRO 60 Low Temperature Sterilization Systems, V-PRO s2 Low Temperature Sterilization Systems Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: April 8, 2019 Received: April 9, 2019

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For David Krause, PhD Acting 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)

### 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)

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# Indications for Use

510(k) Number (if known)

### 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).

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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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# 510(k) Summary For

# V-PRO® 60 Low Temperature Sterilization Systems and V-PRO®s2 Low Temperature Sterilization Systems

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Tony Piotrkowski Contact: Director, Regulatory Affairs

Telephone: [phone] Fax No: [phone]

Summary Date: May 8, 2019

Premarket Notification Number: K190917

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

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#### 1. Device Name

2.

| Trade Name: | V-PRO® 60 Low Temperature Sterilization<br>Systems and V-PRO® s2 Low Temperature<br>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 |
| Predicate Devices | |
| Primary Predicate: K182568 | V-PRO® s2 and V-PRO® 60 Low Temperature<br>Sterilization Systems |
| Reference Device: K190103 | V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V- |

#### Description of Devices 3.

The V-PRO s2 Sterilizer contains the same three sterilization cycles as V-PRO 60 Sterilizer (the Lumen. Non Lumen and Flexible Cycles) with one additional cycle (the Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing as opposed to the cart-mounted V-PRO 60 Sterilizer.

Systems

PRO® maX 2 Low Temperature Sterilization

The V-PRO 60 Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer model that currently exists in the STERIS V-PRO family of sterilizers. The current proposed device claims are intended to modify the indications for use statement.

The V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems are 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 pre-programmed cycles all utilize 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.

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

# V-PRO s2 Low Temperature Sterilization System

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 diffusionrestricted 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-lumened general medical instruments, 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:*

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") 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 (12-31/64") mm in length

Non-lumened instruments including non-lumened general medical instruments, 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. 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 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 (~3/64") 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

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≥ 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 travs. 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-PRO s2 Sterilizer 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 and ≥ 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 tray and two pouches for a total weight of 11 lbs (5.0 kg).

# V-PRO 60 Low Temperature Sterilization System

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 diffusionrestricted 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-lumened general medical instruments, 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 60 Sterilizer Flexible Cycle can sterilize: @

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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.
- 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 V-PRO 60 Sterilizer 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 tray and two pouches for a total weight of 11 lbs (5.0 kg).

#### 5. Technological Characteristics

# Shown below is a comparison between the modified V-PRO s2 Low Temperature Sterilization System to the predicate device.

| Feature | V-PRO s2 Low Temperature<br>Sterilization System<br>(Modified Device)/K190917 | V-PRO s2 Low Temperature<br>Sterilization System<br>(Predicate Device/K182568) |
|---------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
|---------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------|

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# STERIS Corporation Special Premarket Notification [510(k)] Modifications to V-PRO® s2 and V-PRO® 60 Low Temperature Sterilization Systems

| Indications<br>for Use | The V-PRO® s2 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 pre-programmed<br>sterilization cycles operate at low pressure<br>and low temperature, suitable for processing<br>medical devices without leaving toxic<br>residues. | The V-PRO® s2 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 pre-programmed<br>sterilization cycles operate at low pressure<br>and low temperature, suitable for processing<br>medical devices without leaving toxic<br>residues. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Each Cycle can sterilize non-lumened<br>instruments and instruments with diffusion-<br>restricted spaces such as the hinged portion<br>of forceps and scissors. | Each Cycle can sterilize non-lumened<br>instruments and instruments with diffusion-<br>restricted spaces such as the hinged portion<br>of forceps and scissors. |
| | The V-PRO s2 Sterilizer Non Lumen Cycle<br>can sterilize:‡<br>Non-lumened instruments including non-<br>lumened general medical instruments, non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes. | The V-PRO s2 Sterilizer Non Lumen Cycle<br>can sterilize:‡<br>Non-lumened instruments including non-<br>lumened general medical instruments, non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes. |

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| | V-PRO s2 Low Temperature | V-PRO s2 Low Temperature |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Sterilization System<br>(Modified Device/K190917) | Sterilization System<br>(Predicate Device/K182568) |
| | ‡ The validation studies were conducted using<br>a validation load consisting of one instrument | ‡ The validation studies were conducted using<br>a validation load consisting of one instrument |
| | tray for a total weight of 25 lbs (11.3 kg). | tray for a total weight of 25 lbs (11.3 kg). |
| | | |
| | The V-PRO s2 Sterilizer Fast Cycle can | The V-PRO s2 Sterilizer Fast Cycle can |
| | sterilize:‡ | sterilize:‡ |
| | Medical devices (including single, dual and | Medical devices (including single, dual and |
| | triple channeled rigid and semi-rigid | triple channeled rigid and semi-rigid |
| | endoscopes) with the following | endoscopes) with the following |
| | configurations: | configurations: |
| | • Single or dual channeled devices with<br>stainless steel lumens that are | • Single or dual channeled devices with<br>stainless steel lumens that are ≥ 0.77 |
| | ≥ 0.77 mm (~1/32") internal diameter<br>(ID) and ≤ 410 mm (~16-9/64") in<br>length | mm (~1/32") internal diameter (ID)<br>and ≤ 410 mm (~16-9/64") in length |
| | • ≥ 1.8 mm (~5/64) ID x ≤ 542 mm<br>(~21 5/16") in length | • Triple channeled devices with stainless<br>steel lumens that are either: |
| | • Triple channeled devices with stainless<br>steel lumens that are either:<br>≥ 1.2 mm (~3/64") ID and ≤ 275 mm<br>(~10-53/64") in length | ≥ 1.2 mm (~3/64") ID and ≤ 275 mm<br>(~10-53/64") in length |
| | ≥ 1.8 mm (~5/64") ID and ≤ 310 mm<br>(~12-13/64") in length | ≥ 1.8 mm (~5/64") ID and ≤ 310 mm<br>(~12-13/64") in length |
| | or<br>≥ 2.8 mm (~7/64") ID and ≤ 317 mm<br>(12-31/64") in length | or<br>≥ 2.8 mm (~7/64") ID and ≤ 317 mm<br>(12-31/64") in length |
| | Non-lumened instruments including non-<br>lumened general medical instruments, non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes. | Non-lumened instruments including non-<br>lumened general medical instruments, non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes. |
| | ‡ Validation testing for all lumen sizes was<br>conducted using a maximum of eight (8)<br>lumens per load. Hospital loads should not<br>exceed the maximum number of lumens<br>validated by this testing. Validation testing<br>was conducted using a validation load<br>consisting of one pouched instrument tray and<br>two pouched devices outside of the tray with a<br>total weight of 4.0 lbs (~1.8kg). | ‡ Validation testing for all lumen sizes was<br>conducted using a maximum of eight (8)<br>lumens per load. Hospital loads should not<br>exceed the maximum number of lumens<br>validated by this testing. Validation testing<br>was conducted using a validation load<br>consisting of one pouched instrument tray and<br>two pouched devices outside of the tray with a<br>total weight of 4.0 lbs (~1.8kg). |
| | The V-PRO s2 Sterilizer Flexible Cycle can<br>sterilize: @<br>One surgical flexible endoscope (such as<br>those used in ENT, Urology and Surgical<br>Care) or bronchoscope with light cord (if<br>not integral to endoscope), mat, and<br>additional load. | The V-PRO s2 Sterilizer Flexible Cycle can<br>sterilize: @<br>One surgical flexible endoscope (such as<br>those used in ENT, Urology and Surgical<br>Care) or bronchoscope with light cord (if<br>not integral to endoscope), mat, and<br>additional load. |
| | • The flexible endoscope may be a<br>single or dual lumen device with<br>lumens that are ≥ 1 mm (~3/64") ID<br>and ≤ 990 mm (38-63/64") in length. | • The flexible endoscope may be a<br>single or dual lumen device with<br>lumens that are ≥ 1 mm (~3/64") ID<br>and ≤ 990 mm (38-63/64") in length. |
| | • Additional load, up to 11 lb (5 kg) can<br>include stainless steel lumens with the<br>following dimensions | • Additional load, up to 11 lb (5 kg) can<br>include stainless steel lumens with the<br>following dimensions |
| | | ○ ≥ 2 mm (~5/64") ID and ≤ 400<br>mm (~15 3/4") in length |
| | | ○ ≥ 0.76 mm (~1/32") ID and ≤ 233…