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

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

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 ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length ≥ 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

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”) 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 (~10-53/64") 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

The V-PRO® s 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 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”) 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 ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length ≥ 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

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”) 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 (~10-53/64") 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

Device Description

The V-PRO s2 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of sterilizers. The V-PRO product line currently consists of the V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Sterilizers.

The V-PRO s2 Sterilizer contains the same three sterilization cycles as the predicate device (K172319), the Lumen, Non Lumen and Flexible Cycles, with a new cycle, the Fast Cycle. In addition, compared to the claimed predicate device, the proposed device contains a cabinetry modification, adds additional claims for devices that may be processed in the Flexible Cycle, and increases the maximum claimed load weight for the Non Lumen Cycle.

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.

As with the predicate device (K172319), the V-PRO 60 Sterilizer has three preprogrammed cycles: the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle, none of which are being altered. The V-PRO 60 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities.

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence of the STERIS V-PRO s2 Low Temperature Sterilization System and modifications to the V-PRO 60 Low Temperature Sterilization System to a legally marketed predicate device. This document describes the acceptance criteria and the study that proves a medical device (sterilizer) meets these criteria, rather than an AI/ML powered device.

Therefore, the requested information points related to AI/ML device studies (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, etc.) do not apply to this document as it pertains to a physical sterilization device and not a diagnostic AI/ML system.

However, I can extract the acceptance criteria for the sterilization device and the reported performance based on the provided text.

Acceptance Criteria and Reported Device Performance (for a Sterilization Device)

The "acceptance criteria" for a sterilizer device are typically demonstrated through various validation studies to ensure the device effectively sterilizes medical instruments. The "reported device performance" is the conclusion that these studies meet the established criteria.

Here's a table based on the "Summary of Nonclinical Tests" section (Page 17-18) which outlines the tests conducted (functioning as acceptance criteria) and their successful results (reported performance):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Name)	Reported Device Performance (Result and Conclusion)
Determination of D-value and Total Kill Endpoint	Result: Greater than a 12 log reduction of the most resistant organism is achieved within Fast, Non Lumen and Flexible Cycles of the V-PRO s2 Sterilizer. Conclusion: PASS
½ Cycle Modified Total Kill Endpoint Verification	Result: Modified total kill end point analysis was demonstrated for Non Lumen and Flexible V-PRO s2 and V-PRO 60 Sterilizer cycles and for the Fast V-PRO s2 Sterilizer cycle. The standard injection weight of 1.1 g and at least one lower injection weight resulted in all sterile results for all cycles. Conclusion: PASS
½ Cycle Sterilization Verification of Surfaces	Result: Verified surface sterilization efficacy for the most resistant material for VHP within a worst-case validation load in the V-PRO s2 Sterilizer Fast ½ Cycle and the V-PRO 60 Non Lumen Cycle. Conclusion: PASS
½ Cycle Verification of Mated Surfaces	Result: Sterile efficacy was demonstrated for mated surfaces under worst case conditions in the Fast and Non Lumen V-PRO s2 Sterilizer cycles. Conclusion: PASS
Simulated Use Test	Result: Simulated use testing verified the ability of the Sterilizer cycles to sterilize medical devices under worst case processing conditions in the V-PRO s2 and V-PRO 60 Non Lumen and Flexible Cycles and in the V-PRO s2 Fast Cycle. Conclusion: PASS
In Use Test	Result: The in use investigation demonstrated the ability of the V-PRO s2 and V-PRO 60 Sterilizer Flexible Cycle and the V-PRO s2 Fast Cycle to sterilize patient-soiled, clinically-cleaned, medical instruments. Conclusion: PASS
Biocompatibility	Result: Cytotoxicity and residue analysis of worst case materials have demonstrated biocompatibility after processing in the V-PRO s2 Sterilizer's Fast Cycle. Conclusion: PASS
Final Process Qualification	Result: The V-PRO s2 Sterilizer final process qualification was successful for the Fast Cycle. Conclusion: PASS
Compliance with Safety Standards (IEC 61010-1:2010)	Conclusion: Certified
Compliance with Safety Standards (IEC 61010-2-040: 2015)	Conclusion: Certified
Compliance with Safety Standards (IEC 61326-1:2006/2012 (EMC))	Conclusion: Certified

Regarding the AI/ML-specific questions, as stated previously, this document does not contain information on an AI/ML powered device. Therefore, the following points are not applicable:

Sample size used for the test set and the data provenance: Not applicable. The document discusses "validation studies" and "validation loads" for a sterilizer, which are physical materials and instruments, not data samples for an AI test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer is established through scientific validation (e.g., microbial kill, chemical indicators), not human expert review.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For a sterilizer, the ground truth is the demonstrable absence of viable microorganisms ("sterility") and material compatibility, established through laboratory methods (e.g., biological indicators, chemical indicators, and material analysis) under worst-case conditions, as opposed to expert consensus, pathology, or outcomes data in the context of diagnostic AI.
The sample size for the training set: Not applicable. This refers to a physical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

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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 3, 2019

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

Re: K182568

Trade/Device Name: V-PRO s2 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: November 26, 2018 Received: November 27, 2018

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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Elizabeth F. Claverie -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)

K182568

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, 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
· 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

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
- $[$ 2 mm (~5/64") ID and $[$ 400 mm (~15 3/4") in length
- ≥ 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

@ 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 lbs (5 kg). Hospital loads

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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") 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 (~10-53/64") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length

≥ 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).

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.

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Indications for Use

510(k) Number (if known)

K182568

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, semi-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:(@)

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
- $\≥$ 2 mm (~5/64") ID and $\le$ 400 mm (~15 3/4") in length
- $\ge$ 0.76 mm (~1/32") ID and $\le$ 233 mm (~9 11/64") in length
- $\ge$ 1.0 mm (~3/64") ID and $\le$ 254 mm (~10") in length

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 $\ge$ 0.77 mm (~1/32") internal diameter (ID) and $\le$ 410 mm (16-9/64") in length
· Triple channeled devices with stainless steel lumens that are either:
- $\ge$ 1.2 mm (~3/64") ID and $\le$ 275 mm (~10-53/64") in length
- $\ge$ 1.8 mm (~5/64") ID and $\le$ 310 mm (~12-13/64") in length or

$\ge$ 2.8 mm (~7/64") ID and $\le$ 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).

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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.

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."

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, serif font. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water or waves.

510(k) Summary For V-PRO® s2 and V-PRO 60 Low Temperature Sterilization Systems

K182568

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

Contact: Bill Brodbeck Director, Regulatory Affairs

Telephone: (440) 392-7690 Fax No: (440) 357-9198

Summary Date: November 26, 2018

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

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1. Device Name

K#:	K182568
Trade Name:	V-PRO® s2 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 Devices

V-PRO® 60 Low Temperature Sterilization System (originally cleared under K140498 with additional material compatibility claims cleared under K162413 and most recently, K172319)

	V-PRO s2 Low TemperatureSterlization System(Proposed Device)	V-PRO 60 Low Temperature SterlizationSystem(Predicate Device/K172319)
Feature
Indicationsfor Use	The V-PRO® s2 Low TemperatureSterilization System using VAPROX® HCSterilant is intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The pre-programmed sterilization cycles operate atlow pressure and low temperature, suitablefor processing medical devices withoutleaving toxic residues.Each Cycle can sterilize non-lumenedinstruments and instruments withdiffusion-restricted spaces such as thehinged portion of forceps and scissors.The V-PRO s2 Sterilizer Non LumenCycle can sterilize:‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes.‡ The validation studies were conducted	The V-PRO 60 Low TemperatureSterilization System using VAPROX® HCSterilant is intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The pre-programmedsterilization cycles operate at low pressureand low temperature, suitable for processingmedical devices without leaving toxicresidues.Each Cycle can sterilize non-lumenedinstruments with diffusion-restricted spacessuch as the hinged portion of forceps andscissors. Only stainless steel or titaniumdiffusion restricted spaces should beprocessed in the Non Lumen Cycle.The V-PRO 60 Sterilizer's Non LumenCycle can sterilize:‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible
Feature	V-PRO s2 Low TemperatureSterlization System(Proposed Device)	V-PRO 60 Low Temperature SterlizationSystem(Predicate Device/K172319)
	using a validation load consisting of oneinstrument tray for a total weight of 25 lbs(11.3 kg).	endoscopes.$\ddagger$ The validation studies were conducted usinga validation load consisting of one instrumenttray and one pouch for a total weight of 12 lbs(5.4 kg).
	The V-PRO s2 Sterilizer Fast Cycle cansterilize: $\ddagger$Medical devices (including single, dualand triple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:• Single or dual channeled devices withstainless steel lumens that are ≥ 0.77mm (~1/32") internal diameter (ID)and ≤ 410 mm (~16-9/64") in length• Triple channeled devices withstainless 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 lengthor≥ 2.8 mm (~7/64") ID and ≤ 317 mm(12-31/64") in lengthNon-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes.$\ddagger$ Validation testing for all lumen sizes wasconducted using a maximum of eight (8)lumens per load. Hospital loads should notexceed the maximum number of lumensvalidated by this testing. Validation testingwas conducted using a validation loadconsisting of one pouched instrument trayand two pouched devices outside of the traywith a total weight of 4.0 lbs (~1.8kg).	The V-PRO 60 Sterilizer's Flexible Cyclecan sterilize: @One surgical flexible endoscope (such asthose used in ENT, Urology and SurgicalCare) or bronchoscope with light cord (ifnot integral to endoscope) and mat withoutadditional load. The flexible endoscopemay be a single or dual lumen device withlumens that are > 1 mm (~3/64") ID and <990 mm (38-63/64") in length.@ The validation studies were conductedusing a validation load consisting of oneinstrument tray containing one flexibleendoscope, with silicone mat, instrumentorganizers and light cord (if not integral toscope).
	The V-PRO s2 Sterilizer Flexible Cyclecan sterilize: @One surgical flexible endoscope (such asthose used in ENT, Urology and SurgicalCare) or bronchoscope with light cord (ifnot integral to endoscope), mat, andadditional load.• The flexible endoscope may be asingle or dual lumen device withlumens that are ≥ 1 mm (~3/64") IDand ≤ 990 mm (38-63/64") in length.• Additional load, up to 11 lb (5 kg)can include stainless steel lumenswith the following dimensions○ ≥ 2 mm (~5/64") ID and ≤ 400mm (~15 3/4") in length	The V-PRO 60 Sterilizer's Lumen Cyclecan sterilize: ^Medical devices (including single, dual andtriple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:• Single or dual channeled devices withstainless steel lumens that are ≥ 0.77mm (~1/32") internal diameter (ID) and≤ 410 mm (16-9/64") in length• Triple channeled devices with stainlesssteel 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 lengthor≥ 2.8 mm (~7/64") ID and ≤ 317 mm(12-31/64") in length^ Validation testing for all lumen sizes wasconducted using a maximum of twelve (12)lumens per load. Hospital loads should notexceed the maximum number of lumensvalidated by this testing. The validation studieswere performed using a validation loadconsisting of one instrument tray and twopouches for a total weight of 11 lbs (5.0 kg).
Feature	V-PRO s2 Low TemperatureSterlization System(Proposed Device)	V-PRO 60 Low Temperature SterlizationSystem(Predicate Device/K172319)
	mm (~9 11/64") in length○ ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length@ The validation studies were conductedusing a validation load consisting of twoinstrument trays. One tray contained oneflexible endoscope, with silicone mat,instrument organizers and light cord (if notintegral to scope), and the second traycontained additional load and twelve (12)stainless steel lumens for a total load weightof 11 lbs (5 kg). Hospital loads should notexceed the maximum number of lumensvalidated by this testing.The V-PRO s2 Sterilizer Lumen Cycle cansterilize: ^Medical devices (including single, dualand triple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:• Single or dual channeled devices withstainless steel lumens that are ≥ 0.77mm internal diameter (ID) and ≤ 410mm in length• Triple channeled devices withstainless 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 lengthor≥ 2.8 mm (~7/64") ID and ≤ 317 mm(12-31/64") in length^ Validation testing for all lumensizes was conducted using amaximum of twelve (12) stainlesssteel lumens per load. Hospital loadsshould not exceed the maximumnumber of lumens validated by thistesting. The validation studies wereperformed using a validation loadconsisting of one instrument tray andtwo pouches for a total weight of 11lbs (5.0 kg).
ProcessParameters	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection
Feature	V-PRO s2 Low TemperatureSterilization System(Proposed Device)	V-PRO 60 Low Temperature SterilizationSystem(Predicate Device/K172319)
Software/FirmwareControlled	Control system consists of amicrocomputer control board andperipheral function circuit boards, locatedwithin the control housing. A memorybackup system maintains cycle settingsand current cycle information.	Control system consists of a microcomputercontrol board and peripheral function circuitboards, located within the control housing.A memory backup system maintains cyclesettings and current cycle information.
	The software allows user selection ofeither the Lumen, Non Lumen, Flexible orFast pre-programmed cycle.	The software allows user selection of eitherthe Lumen, Non Lumen, or Flexible pre-programmed cycle.
TotalCycle Time	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutesFast Cycle - 19 minutes	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutes
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).1.1 g of sterilant is used for each sterilantinjection for all four cycles.	VAPROX HC Sterilant (59% HydrogenPeroxide).1.1 g of sterilant is used for each sterilantinjection for all three cycles
Accessories	Accessories are to be submitted underseparate, individual, 510(k)s and cover thefollowing:Self-contained biological indicatorBiological indicator challenge packFast Acting Biological IndicatorChemical indicatorTrays & Tray AccessoriesPouchesTape	Accessories are to be submitted underseparate, individual, 510(k)s and cover thefollowing:Self-contained biological indicatorBiological indicator challenge packFast Acting Biological IndicatorChemical indicatorTrays & Tray AccessoriesPouchesTape

A comparison between the proposed V-PRO s2 Low Temperature Sterilization System to the predicate device is summarized in the table below.

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The proposed device has an intended use similar to the predicate with the same technological characteristics. The indications for use differ between the two devices with the proposed device carrying the additional Fast Cycle, removal of restrictions on claims regarding diffusion-restricted spaces for all cycles, increased maximum load capacity claims for the Non Lumen Cycle and expanded load claims for the Flexible Cycle. Additional convenience features have also been included with the proposed device. Although, the devices slightly differ in their design and additional convenience items and features, the provided descriptive characteristics and performance data demonstrate equivalence. Therefore, the proposed V-PRO s2 Low Temperature Sterilization System is substantially equivalent to the predicate device, the V-PRO 60 Low Temperature Sterilization System.

A comparison between the proposed modifications to the V-PRO 60 Low Temperature Sterilization System to the most recently cleared predicate device is summarized in the table below.

Feature	V-PRO 60 Low Temperature Sterilization System(Proposed Device)	V-PRO 60 Low Temperature Sterilization System(Predicate Device/K172319)
	V-PRO 60 Low TemperatureSterlization System(Proposed Device)	V-PRO 60 Low Temperature SterlizationSystem(Predicate Device/K172319)
Feature
Indicationsfor Use	The V-PRO® s 60 Low TemperatureSterilization System using VAPROX® HCSterilant is intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The pre-programmed sterilization cycles operate atlow pressure and low temperature, suitablefor processing medical devices withoutleaving toxic residues.Each Cycle can sterilize non-lumenedinstruments and instruments withdiffusion-restricted spaces such as thehinged portion of forceps and scissors.The V-PRO 60 Sterilizer Non LumenCycle can sterilize:‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes.‡ The validation studies were conductedusing a validation load consisting of oneinstrument tray for a total weight of 25 lbs(11.3 kg).	The V-PRO 60 Low TemperatureSterilization System using VAPROX® HCSterilant is intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The pre-programmedsterilization cycles operate at low pressureand low temperature, suitable for processingmedical devices without leaving toxicresidues.Each Cycle can sterilize non-lumenedinstruments with diffusion-restricted spacessuch as the hinged portion of forceps andscissors. Only stainless steel or titaniumdiffusion restricted spaces should beprocessed in the Non Lumen Cycle.The V-PRO 60 Sterilizer's Non LumenCycle can sterilize:‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes.‡ The validation studies were conducted usinga validation load consisting of one instrumenttray and one pouch for a total weight of 12 lbs(5.4 kg).
	The V-PRO 60 Sterilizer Flexible Cyclecan sterilize: @One surgical flexible endoscope (such asthose used in ENT, Urology and SurgicalCare) or bronchoscope with light cord (ifnot integral to endoscope), mat, andadditional load.The flexible endoscope may be asingle or dual lumen device withlumens that are ≥ 1 mm (~3/64") IDand ≤ 990 mm (38-63/64") in length. Additional load, up to 11 lb (5 kg) caninclude stainless steel lumens with thefollowing dimensions ≥ 2 mm (~5/64") ID and ≤ 400mm (~15 3/4") in length ≥ 0.76 mm (~1/32") ID and ≤ 233mm (~9 11/64") in length ≥ 1.0 mm (~3/64") ID and ≤ 254mm (~10") in length @ The validation studies were conductedusing a validation load consisting of twoinstrument trays. One tray contained oneflexible endoscope, with silicone mat,instrument organizers and light cord (if not	The V-PRO 60 Sterilizer's Flexible Cyclecan sterilize: @One surgical flexible endoscope (such asthose used in ENT, Urology and SurgicalCare) or bronchoscope with light cord (ifnot integral to endoscope) and mat withoutadditional load. The flexible endoscopemay be a single or dual lumen device withlumens that are > 1 mm (~3/64") ID and < 990 mm (38-63/64") in length.@ The validation studies were conductedusing a validation load consisting of oneinstrument tray containing one flexibleendoscope, with silicone mat, instrumentorganizers and light cord (if not integral toscope).
		The V-PRO 60 Sterilizer's Lumen Cyclecan sterilize: ^Medical devices (including single, dual andtriple channeled rigid and semi-rigidendoscopes) with the followingconfigurations: Single or dual channeled devices withstainless steel lumens that are ≥ 0.77
Feature	V-PRO 60 Low TemperatureSterlization System(Proposed Device)	V-PRO 60 Low Temperature SterlizationSystem(Predicate Device/K172319)
	integral to scope), and the second traycontained additional load and twelve (12)stainless steel lumens for a total load weightof 11 lbs (5 kg). Hospital loads should notexceed the maximum number of lumensvalidated by this testing.The V-PRO 60 Sterilizer Lumen Cycle cansterilize: ^Medical devices (including single, dualand triple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:Single or dual channeled deviceswith stainless steel lumens thatare ≥ 0.77 mm (~1/32") internaldiameter (ID) and ≤ 410 mm (16-9/64") in length Triple channeled devices withstainless steel lumens that areeither:≥ 1.2 mm (~3/64") ID and ≤ 275mm (~10-53/64") in length≥ 1.8 mm (~5/64") ID and ≤ 310mm (~12-13/64") in lengthor≥ 2.8 mm (~7/64") ID and ≤ 317mm (12-31/64") in length ^ Validation testing for all lumen sizeswas conducted using a maximum oftwelve (12) stainless steel lumens perload. Hospital loads should not exceedthe maximum number of lumensvalidated by this testing. The validationstudies were performed using avalidation load consisting of oneinstrument tray and two pouches for atotal weight of 11 lbs (5.0 kg).	mm (~1/32") internal diameter (ID) and≤ 410 mm (16-9/64") in lengthTriple channeled devices with stainlesssteel 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 lengthor≥ 2.8 mm (~7/64") ID and ≤ 317 mm(12-31/64") in length ^ Validation testing for all lumen sizes wasconducted using a maximum of twelve (12)lumens per load. Hospital loads should notexceed the maximum number of lumensvalidated by this testing. The validation studieswere performed using a validation loadconsisting of one instrument tray and twopouches for a total weight of 11 lbs (5.0 kg).
ProcessParameters	The critical process parameters are:Time Chamber Temperature Vaporizer Temperature Chamber Pressure Prior to Injection	The critical process parameters are:Time Chamber Temperature Vaporizer Temperature Chamber Pressure Prior to Injection
Feature	V-PRO 60 Low TemperatureSterilization System(Proposed Device)	V-PRO 60 Low Temperature SterilizationSystem(Predicate Device/K172319)
Software/FirmwareControlled	Control system consists of amicrocomputer control board andperipheral function circuit boards, locatedwithin the control housing. A memorybackup system maintains cycle settingsand current cycle information indefinitely.The software allows user selection ofeither the Lumen, Non Lumen, or Flexiblepre-programmed cycle.	Control system consists of a microcomputercontrol board and peripheral function circuitboards, located within the control housing.A memory backup system maintains cyclesettings and current cycle informationindefinitely.The software allows user selection of eitherthe Lumen, Non Lumen, or Flexible pre-programmed cycle.
TotalCycle Time	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutes	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutes
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).1.1 g of sterilant is used for each sterilantinjection for all three cycles.	VAPROX HC Sterilant (59% HydrogenPeroxide).1.1 g of sterilant is used for each sterilantinjection for all three cycles.
Accessories	Accessories are submitted under separate,individual, concurrent 510(k)s and coverthe following:Self-contained biological indicator Biological indicator challenge pack Fast Acting Biological Indicator Chemical indicator Trays & Tray Accessories Pouches Tape	Accessories were submitted under separate,individual, 510(k)s and cover the following:Self-contained biological indicator Biological indicator challenge pack Fast Acting Biological Indicator Chemical indicator Trays & Tray Accessories Pouches Tape

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The proposed device has an intended use identical to the predicate with the same technological characteristics. The indications for use differ between the two devices with the proposed device's removal of restrictions on claims regarding diffusionrestricted spaces for all cycles, increased maximum load capacity claims for the Non Lumen Cycle and expanded load claims for the Flexible Cycle. Although, the cycle claims slightly differ, the performance data and descriptive characteristics demonstrate equivalence. Therefore, the proposed V-PRO 60 Low Temperature Sterilization System is substantially equivalent to the predicate device.

3. Description of Devices

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device contains a cabinetry modification, adds additional claims for devices that may be processed in the Flexible Cycle, and increases the maximum claimed load weight for the Non Lumen Cycle.

4. Intended Use

V-PRO s2 Low Temperature Sterilization System

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: † 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:

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Single or dual channeled devices with stainless steel lumens that are $\ge$ 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 (~10-53/64”) in length ≥ 1.8 mm (~5/64”) ID and ≤ 310 mm (~12-13/64”) in length or

$$2 \ge 2.8 \text{ mm (-7/64'') ID and} \le 317 \text{ (12-31/64'') mm in length}$$

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
- ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length
- ≥ 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

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”) 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 (~10-53/64”) 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

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V-PRO 60 Low Temperature Sterilization System

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.

t 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”) 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
- ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length
- ≥ 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

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”) internal diameter (ID) and ≤ 410 mm (16-9/64”) in length

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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).

Summary of Nonclinical Tests 5.

The V-PRO s2 Low Temperature Sterilization System has the same intended use and similar but not identical technological characteristics that do not raise different questions of safety and effectiveness as compared to the predicate device. The V-PRO 60 Low Temperature Sterilization System has the same or similar intended use and the same technological characteristics as compared to the predicate device. Performance testing to assess and demonstrate substantial equivalence to the predicate is summarized below.

Test	Result	Conclusion
Determination of D-value and Total KillEndpoint	Greater than a 12 log reduction of the most resistantorganism is achieved within Fast, Non Lumen andFlexible Cycles of the V-PRO s2 Sterilizer.	PASS
½ Cycle ModifiedTotal Kill EndpointVerification	Modified total kill end point analysis wasdemonstrated for Non Lumen and Flexible V-PROs2 and V-PRO 60 Sterilizer cycles and for the FastV-PRO s2 Sterilizer cycle. The standard injectionweight of 1.1 g and at least one lower injectionweight resulted in all sterile results for all cycles.	PASS
½ Cycle SterilizationVerification ofSurfaces	Verified surface sterilization efficacy for the mostresistant material for VHP within a worst-casevalidation load in the V-PRO s2 Sterilizer Fast ½Cycle and the V-PRO 60 Non Lumen Cycle.	PASS
½ Cycle Verificationof Mated Surfaces	Sterile efficacy was demonstrated for matedsurfaces under worst case conditions in the Fast andNon Lumen V-PRO s2 Sterilizer cycles.	PASS
Simulated Use Test	Simulated use testing verified the ability of theSterilizer cycles to sterilize medical devices underworst case processing conditions in the V-PRO s2and V-PRO 60 Non Lumen and Flexible Cyclesand in the V-PRO s2 Fast Cycle.	PASS

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Test	Result	Conclusion
In Use Test	The in use investigation demonstrated the ability ofthe V-PRO s2 and V-PRO 60 Sterilizer FlexibleCycle and the V-PRO s2 Fast Cycle to sterilizepatient-soiled, clinically-cleaned, medicalinstruments.	PASS
Biocompatibility	Cytotoxicity and residue analysis of worst casematerials have demonstrated biocompatibility afterprocessing in the V-PRO s2 Sterilizer's Fast Cycle.	PASS
Final ProcessQualification	The V-PRO s2 Sterilizer final process qualificationwas successful for the Fast Cycle.	PASS

The V-PRO s2 Low Temperature Sterilization System has been tested for conformity and is certified to the following standards:

IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements; Part 1: General Requirements
. IEC 61010-2-040: 2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
IEC 61326-1:2006 (V-PRO 60) or 2012 (V-PRO s2) Safety Requirements ● for Electrical Equipment for Measurement, Control, and Laboratory Use -EMC requirements - Part 1: General Requirements

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject devices are as safe, as effective and performs at least as well as the legally marketed predicate device K172319, Class II (21 CFR 880.6860), product code MLR.

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

(a)
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.(b)
Classification. Class II (performance standards).