AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

K172319 · STERIS Corporation · MLR · Jan 18, 2018 · General Hospital

Device Facts

• Record ID: K172319
• Device Name: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
• Applicant: STERIS Corporation
• Product Code: MLR · General Hospital
• Decision Date: Jan 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems 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 temperature, suitable for processing medical devices without leaving toxic residues. 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.

Device Story

Vaporized hydrogen peroxide (VHP) sterilization systems; use VAPROX HC Sterilant to sterilize medical devices. Systems operate via preprogrammed cycles (Lumen, Non-Lumen, Flexible) at low pressure/temperature. Input: cleaned, rinsed, dried medical devices (metal/non-metal). Output: terminally sterilized devices ready for immediate use; no aeration required. Used in healthcare facilities; operated by trained staff. Process eliminates toxic residues. Benefits: enables sterilization of heat/moisture-sensitive instruments (e.g., endoscopes, hinged forceps) without damage or toxic byproduct exposure.

Clinical Evidence

Bench testing only. Validation studies confirmed sterilization efficacy for specified lumen configurations and load weights. Material compatibility testing (50 cycles) showed no structural defects. Cytotoxicity assays confirmed non-cytotoxicity of processed materials. Hydrogen peroxide residual analysis demonstrated levels 2,660 to 13,000-fold lower than tolerable exposure limits for mucosal/internal tissue contact.

Technological Characteristics

Vaporized hydrogen peroxide (VHP) sterilizer; uses VAPROX HC Sterilant. Operates at low pressure/temperature. Compatible with stainless steel, titanium, and various medical device materials. Dimensions/form factor vary by model (V-PRO 1, 1 Plus, maX, 60). Connectivity/software details not specified beyond preprogrammed cycle control.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried medical devices in healthcare facilities. Compatible with stainless steel or titanium diffusion-restricted spaces (hinged instruments). Specific cycles support non-lumened instruments, rigid/semi-rigid/flexible endoscopes, and single/dual/triple channeled rigid endoscopes with defined lumen ID and length constraints.

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 maX Low Temperature Sterilization System (K162413)
• V-PRO 60 Low Temperature Sterilization System (K162413)

Reference Devices

• Amsco V-PRO 1 Low Temperature Sterilization System (K062297)
• Amsco V-PRO 1 Plus Low Temperature Sterilization System (K083097, K102394, K111810, K160433)
• V-PRO maX Low Temperature Sterilization System (K102330, K112760, K112813, K120632, K131120)

Submission Summary (Full Text)

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 18, 2018

STERIS Corporation Bill Brodbeck Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K172319

Trade/Device Name: Amsco V-PRO 1 Low Temperature Sterilization System, Amsco V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: December 8, 2017 Received: December 11, 2017

Dear Bill Brodbeck:

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. 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 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/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,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K172319

### Device Name

AMSCO V-PRO® 1 Low Temperature Sterilization System, AMSCO V-PRO® 1 Plus Low Temperature Sterilization System, V-PRO® maX Low Temperature Sterilization System

### Indications for Use (Describe)

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems 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 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.

The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t

Non-lumened instruments including non-luments, 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 trays for a total weight of 50 lbs (22.7 kg).

The V-PRO maX Sterilizer's 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 V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' Lumen Cycle 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
- 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:

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≥ 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)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

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### Indications for Use

510(k) Number (if known) K172319

### 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 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.

The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize:t

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

t The validation studies were conducted using a validation load consisting of one instrument tray and one pouch for a total weight of 12 lbs (5.4 kg).

The V-PRO 60 Sterilizer's 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) and mat without 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.

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

The V-PRO 60 Sterilizer's 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") internal diameter (ID) and ≤ 410 mm (16-9/64") in length

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

≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") 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) 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).

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

- Prescription Use (Part 21 CFR 801 Subpart D)

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

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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

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Image /page/6/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue. The lines are stacked on top of each other and are slightly offset.

## 510(k) Summary For K172319 Amsco V-PRO 1 Low Temperature Sterilization System Amsco V-PRO 1 Plus Low Temperature Sterilization System V-PRO maX Low Temperature Sterilization System V-PRO 60 Low Temperature Sterilization System

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

Contact:

Bill Brodbeck Director, Regulatory Affairs Tel: [phone] Fax: [phone]

July 31, 2017 Submission Date:

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

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#### 1. Device Name

Amsco® V-PRO™ 1 Low Temperature Sterilization System Trade Name: Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System V-PROTM maX Low Temperature Sterilization System V-PROTM 60 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

The claimed primary predicate device is the V-PRO maX Low Temperature Sterilization System, cleared most recently under K162413.

Reference devices are included in this submission as the V-PRO maX cleared indications for use includes claims for the following proposed reference devices:

- Amsco® V-PROTM 1 Low Temperature Sterilization System (K062297) .
- Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System (K083097, . K102394, K111810 and K160433)

The V-PROTM maX Low Temperature Sterilization System prior clearances include Premarket Submissions K102330, K112760, K112813, K120632 and K131120.

The V-PRO 60 Low Temperature Sterilization System also cleared most recently under K162413.

The purpose of this submission is to describe modifications to labeling of the V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems. The proposed modifications involve (1) addition of compatible materials contained within devices to be processed by the subject devices, and (2) revision of the indications for use statements of the subject devices strictly for clarity and conciseness.

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#### 3. Description of Device

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems, using VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). 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.

The V-PRO 1, V-PRO 1 Plus, and the V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems are programmed to enact one (the Lumen Cycle), two (the Lumen Cycle and the Non Lumen Cycle) or three (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycles, respectively.

#### 4. Intended Use

### V-PRO 1, V-PRO 1 Plus and V-PRO maX

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems 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 temperature, suitable for processing medical devices.

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.

### The V-PRO 1 Plus and V-PRO maX Sterilizers' 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 two instrument trays for a total weight of 50 lbs (22.7 kg).

### The V-PRO maX Sterilizer's 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 load 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

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· 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 V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' Lumen Cycle can sterilize: T

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

• 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).

### V-PRO 60

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-lumened instruments with diffusion-restricted spacessuch as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion restricted spaces should be processed in the Non Lumen Cycle.

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### The V-PRO 60 Sterilizer's 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 and one pouch for a total weight of 12 lbs (5.4 kg).
### The V-PRO 60 Sterilizer's 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) and mat without 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.

- @ The validation studies were conducted using a validation load consisting of one instrument tray containing one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope).
### The V-PRO 60 Sterilizer's Lumen Cycle can sterilize: "

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

- o Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length
- o Triple channeled devices with stainless steel 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 twelve (12) 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).

#### ട്. Description of Safety and Substantial Equivalence

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Sterilizers are the same as the predicate devices except for the specific requested changes to labeling and indications for use statements. There are no differences in technology (including features, materials, and principles of operation) between the proposed and predicate devices. Therefore, the differences between the proposed and predicate devices are limited to the addition of device materials claimed to be compatible for processing in the device and changes to the indications for use statements for the purposes of clarity and conciseness.

The following table summarizes the verification activity that was performed with its respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the V-PRO 1, V-PRO 1 Plus, V-PRO maX or V-PRO 60 Low Temperature Sterilization Systems.

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| Test | Acceptance Criteria | Results |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Determination<br>of Worst Case<br>(Most<br>Resistant)<br>Material for<br>VHP | Test<br>The most resistant material (MRM) is the material that is most difficult to sterilize (the material with the largest number of non-sterile results)<br>Controls<br>Controls shall perform as intended. | Pass<br>As identified within<br>previous V-PRO Sterilizer<br>submissions, the most<br>resistant material (MRM)<br>for surface sterilization is<br>Kraton. |
| Medical<br>Device<br>Material<br>Compatibility | The devices shall be processed for 50 V-PRO 60 Sterilizer Lumen Cycles (worst case) The devices shall show no structural defects (crazing, cracks or chipping). The devices shall function following processing. | Pass<br>This testing verified<br>compatibility of the tested<br>20 materials with the<br>V-PRO Sterilizers. |
| Cytotoxicity<br>Evaluation of<br>Medical<br>Devices | All Worst Case Cycles shall proceed to completion. The cytotoxic endpoint for each medical device shall be determined. Cytotoxicity Assay Controls shall preform as intended | Pass<br>Testing demonstrates that<br>various medical devices<br>containing were determined<br>to be non-cytotoxic<br>following processing in<br>three (3) V-PRO 60<br>Sterilizer Lumen Cycles: |
| Hydrogen<br>Peroxide<br>Residual<br>Analysis of<br>Processed<br>Medical<br>Devices | The residual hydrogen peroxide level for each medical device shall be determined and compared to the allowable hydrogen peroxide limits for mucosal and internal tissue contact. Each device shall demonstrate exhaustive extraction by showing less than a 10% increase for two (2) consecutive sample time points. Hydrogen Peroxide Residual Analysis Controls shall perform as intended. | Pass<br>Testing demonstrates that<br>the hydrogen peroxide<br>residuals from the medical<br>devices composed of the 19<br>proposed compatible<br>materials are from 2660-<br>fold lower to greater than<br>13,000-fold lower than the<br>tolerable exposure limits for<br>mucosal and internal tissue<br>contact when processed in<br>three (3), worst case, back-<br>to-back Lumen Cycles in<br>the V-PRO 60 Sterilizer. |

#### 6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K162413, Class II (21 CFR 880.6860), product code MLR.