The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 60 Sterilizer's Lumen Cycle can sterilize:

Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:
- single or dual lumen devices with stainless steel lumens that are ≥ 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length
- triple lumen devices with stainless steel lumens that are
  - ≥ 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

The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize

Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO 60 Sterilizer's Flexible Cycle can sterilize:

One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any 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

Device Description

The V-PRO 60 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 Amsco V-PRO 1, Amsco V-PRO 1 Plus and Amsco V-PRO maX Sterilizers. As with the predicate device (K102330), the V-PRO 60 Sterilizer has three preprogrammed cycles: the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle. The V-PRO 60 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities. The V-PRO 60 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed 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

This document describes the V-PRO® 60 Low Temperature Sterilization System, a vaporized hydrogen peroxide sterilizer. The acceptance criteria are based on achieving sterility and maintaining material compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization Efficacy
AOAC Sporicidal Test	All carriers processed should be sterile.	All 720 carriers processed using 3 lots of EOSL sterilant were sterile.
Determination of D-value and Total Kill Endpoint	Greater than a 12 log reduction of the most resistant organism.	Greater than a 12 log reduction of the most resistant organism is achieved within all cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) of the V-PRO 60 Sterilizer.
½ Cycle Modified Total Kill Endpoint Verification	All sterile results within the validation load.	Modified total kill end point analysis was demonstrated for all three V-PRO 60 Sterilizer cycles. The standard injection weight of 1.1 g and at least one lower injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. Partial positives or all survive results were seen at lower injection weights.
½ Cycle Sterilization Verification of Cycle Claims	Reproducible sterilization of specified devices/lumens.	• The Lumen Cycle reproducibly sterilizes single, dual and triple lumen devices under worst case conditions in ½ Cycle. • The Flexible Cycle reproducibly sterilizes 1 x 990 mm flexible endoscope lumens under worst case conditions in ½ Cycle. • The Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in ½ Cycle.
½ Cycle Verification of Mated Surfaces	Sterile efficacy for mated surfaces under worst case conditions.	Sterile efficacy was demonstrated for mated surfaces under worst case conditions.
Simulated Use Test	Sterilization of medical devices under worst case conditions.	Simulated use testing verified the ability of the V-PRO 60 Sterilizer cycles to sterilize medical devices under worst case processing conditions.
In Use Test	Sterilization of patient-soiled, clinically-cleaned instruments.	The in use investigation demonstrated the ability of the V-PRO 60 Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments.
Device Compatibility & Integrity
Biocompatibility	Biocompatibility after processing.	Cytotoxicity and residue analysis of 23 materials have demonstrated biocompatibility after processing in the V-PRO 60 Sterilizer.
Medical Device Material Compatibility	Compatibility with materials of construction after multiple cycles.	Evaluation of medical devices after multiple cycles in the V-PRO 60 Sterilizer has demonstrated compatibility with 23 materials of construction.
Process Control & Verification
Final Process Qualification	Successful qualification for all cycles.	The V-PRO 60 Sterilizer final process qualification was successful for all three (3) sterilizer cycles. All three lots of CI exhibited complete color change. All three SCBI PIs exhibited a passing color change and all SCBIs were negative for growth. Manual inspection of the process parameter data confirmed that all cycle specifications were met.
Conformity to Standards (Safety and EMC)	Compliance with EN 61010-1:2001 and EN61326-1:2006.	The V-PRO 60 Low Temperature Sterilization System has been tested for conformity and is certified to EN 61010-1:2001 and EN61326-1:2006.

Study Proving Device Meets Acceptance Criteria:

The document summarizes the "Summary of Nonclinical Tests" performed on the V-PRO 60 Low Temperature Sterilization System to demonstrate its substantial equivalence to the predicate device, the V-PRO maX Low Temperature Sterilization System. The studies aim to prove the device's ability to sterilize various medical devices effectively and safely.

2. Sample Size Used for the Test Set and Data Provenance:

The document provides specific sample sizes for particular tests:

AOAC Sporicidal Test: "All 720 carriers processed using 3 lots of EOSL sterilant."
Validation Loads:
- Lumen Cycle: "a maximum of twelve (12) lumens per load... consisting of one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg)."
- Non Lumen Cycle: "a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg)."
- Flexible Cycle: "one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load."
Biocompatibility and Material Compatibility: "23 materials" were analyzed.

Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. However, based on the nature of medical device clearance submissions to the FDA (United States Food and Drug Administration), these are typically prospective laboratory and simulated-use studies conducted by the manufacturer or authorized testing facilities, aiming to meet regulatory requirements prior to market entry.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the "number of experts" or their "qualifications" used to establish ground truth. The studies involve standardized microbiological and engineering tests rather than expert interpretation of results in a clinical setting. For sterilization studies, the ground truth is typically established by laboratory methods such as growth/no growth of biological indicators (e.g., Geobacillus stearothermophilus) following exposure to the sterilization process.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective performance evaluations (e.g., sterility, log reduction, material compatibility) rather than interpretation-based assessments that would require an adjudication method like 2+1 or 3+1.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The device is a sterilizer, and its performance is evaluated through objective physical and biological tests, not through human reader interpretation of cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies described are standalone performance evaluations of the sterilization device. There is no "human-in-the-loop" interaction in the output or interpretation of the sterilization cycle results beyond operating the device and reading standard indicators. The device itself is the "algorithm only" in the context of its function.

7. The Type of Ground Truth Used:

The primary type of ground truth used would be:

Microbiological Negativity/Positivity: For sterilization efficacy tests (AOAC Sporicidal, D-value/Total Kill, ½ Cycle Modified Total Kill Endpoint, ½ Cycle Sterilization Verification, Simulated Use, In Use), the ground truth is established by culturing biological indicators or test organisms and observing the presence or absence of growth. "Sterile" or "no growth" is the ground truth for effective sterilization.
Physical/Chemical Analysis: For biocompatibility and material compatibility, the ground truth is established through laboratory analyses (e.g., cytotoxicity assays, residue analysis, visual inspection for degradation) and quantitative measurements.
Process Parameter Verification: For Final Process Qualification, the ground truth is established by objective measurements of process parameters (time, temperature, pressure, sterilant injection weight) and the observed color change of chemical indicators.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device (sterilizer) and not an AI/machine learning model that would require a 'training set' of data in the conventional sense. The development of the sterilizer's cycles and parameters is based on engineering principles and iterative testing, not on data training in the way an algorithm learns from a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The physical and biological principles governing sterilization, along with extensive engineering development and testing, define the performance of the sterilizer.

Summary

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Image /page/0/Picture/0 description: The image shows the word "STERIS" in a large, bold font, with the registered trademark symbol next to it. Above the word "STERIS" is the code "K140498". Below the word "STERIS" is a graphic of several horizontal wavy lines stacked on top of each other.

JUL 2 4 2014

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

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

Bill Brodbeck Contact: Director, Regulatory Affairs

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

July 24, 2014 Summary Date:

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

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1. Device Name

Trade Name:	V-PRO® 60 Low Temperature Sterilization System
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas21 CFR 880.6860Product Code MLR
Device Class:	Class II

Predicate Devices 2.

Amsco V-PRO maX Low Temperature Stetilization System (K131120). Please note that the predicate device was originally cleared under K102330.

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

Feature	V-PRO 60 Low TemperatureSterilization System(Proposed Device)	V-PRO maX Low Temperature Sterilization System(Predicate Device/K131120)
Indications for Use	The V-PRO 60 Low TemperatureSterilization System, with VAPROX® HCSterilant, is a vaporized hydrogenperoxide sterilizer intended for use in theterminal sterilization of cleaned, rinsedand dried reusable metal and nonmetalmedical devices used in healthcarefacilities. The pre-programmedsterilization cycles (Lumen Cycle, NonLumen Cycle, and Flexible Cycle)operate at low pressure and lowtemperature and are thus suitable forprocessing medical devices sensitive toheat and moisture.	The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature SterilizationSystems, with VAPROX® HC Sterilant, arevaporized hydrogen peroxide sterilizersintended for use in the terminal sterilization ofcleaned, rinsed and dried reusable metal andnonmetal medical devices used in healthcarefacilities. The three pre-programmedsterilization cycles (Lumen Cycle, Non LumenCycle, and Flexible Cycle) operate at lowpressure and low temperature and are thussuitable for processing medical devicessensitive to heat and moisture.
	The V-PRO 60 Sterilizer's Lumen Cyclecan sterilize:a Instruments with diffusion-restrictedspaces such as the hinged portion offorceps and scissors Non-lumened devices including non-lumened rigid and semi-rigidendoscopes Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes, with thefollowing configurations: a	The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature SterilizationSystem's Lumen Cycle, can sterilize:a Lumened and non-lumened instrumentswith diffusion-restricted spaces such asthe hinged portion of forceps andscissors Medical devices, including single, dualand triple channeled rigid and semi-rigidendoscopes, with the followingconfigurations: a single channeled devices with astainless steel lumen that is ≥ 0.77mm internal diameter (ID) and <
Feature	V-PRO 60 Low TemperatureSterilization System(Proposed Device)	V-PRO maX Low Temperature SterlizationSystem(Predicate Device/K131120)
	o single or dual lumen devices withstainless lumens that are■ ≥ 0.77 mm (~1/32") internaldiameter (ID) and ≤ 410 mm(16-9/64") in lengtho triple lumen devices withstainless steel lumens that are■ ≥ 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	500 mm in lengtho dual lumen devices with stainlesslumens that are ≥ 0.77 mm ID and≤ 527 mm in lengtho triple lumen devices with stainlesssteel lumens that are■ ≥ 1.2 mm ID and ≤ 275 mm inlength■ ≥ 1.8 mm ID and ≤ 310 mm inlengthor■ ≥ 2.8 mm ID and ≤ 317 mm inlength
a	The validation studies for all lumenconfigurations were conducted usinga maximum of twelve (12) lumensper load. Hospital loads should notexceed the maximum number oflumens validated by this testing. Thevalidation studies were performedusing a validation load consisting ofone instrument tray with instrumentorganizers and mat and two pouchesfor a total weight of 11 lbs (5.0 kg).	a The validation studies for all channel/lumen configurations were conductedusing a maximum of twenty (20)lumens per load. Hospital loadsshould not exceed the maximumnumber of lumens validated by thistesting. The validation studies wereperformed using a validation loadconsisting of two instrument trays andtwo pouches for a total weight of19.65 lbs.
	The V-PRO 60 Sterilizer's Non LumenCycle can sterilize: b• Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith stainless steel or titaniumdiffusion-restricted spaces such as thehinged portion of forceps andscissors.	The Amsco V-PRO 1 Plus and V-PRO maXLow Temperature Sterilization Systems' NonLumen Cycle, cleared under K083097,K102394 and K111810, can sterilize:b• Non-lumened instruments including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumenedinstruments with stainless steeldiffusion-restricted areas such as thehinged portion of forceps or scissors.
	b The validation studies wereperformed using a validation loadconsisting of one instrument traywith instrument organizers and matand one pouch for a total weight of12 lbs (5.4 kg).	b The validation studies were conductedusing a validation load consisting of twoinstrument trays and two pouches for atotal weight of 19.65 lbs.
	The V-PRO 60 Sterilizer's FlexibleCycle can sterilize: c• One flexible surgical endoscope orbronchoscope with a light cord (if not	The Amsco V-PRO maX Low TemperatureSterilization System's Flexible Cycle, clearedunder K102330 and K112760, can sterilizesingle or dual lumen surgical flexibleendoscopes (such as those used in ENT,Urology and Surgical Care) andbronchoscopes in either of two loadconfigurations:1.Two flexible endoscopes with a light cord(if not integral to endoscope) and matwith no additional load.c
Feature	V-PRO 60 Low TemperatureSterilization System(Proposed Device)	V-PRO maX Low Temperature SterlizationSystem(Predicate Device/K131120)
	integral to endoscope) and matwithout any additional load. Theflexible endoscope may be a:o single or dual lumen device withlumens that are ≥ 1 mm (~3/64")ID and ≤ 990 mm (38-63/64") inlengthc The validation studies wereconducted with one flexibleendoscope, packaged into a tray withsilicone mat, instrument organizersand light cord (if not integral toscope) and no additional load.	The flexible endoscopes may containeither:o a single lumen that is ≥ 1 mm ID and≤ 1050 mm in lengtho or two lumens with:one lumen that is ≥ 1 mm ID and ≤998 mm in length and the otherlumen that is ≥ 1 mm ID and ≤ 850mm in lengthc The validation studies were conductedwith two flexible endoscopes, each packaged intoa tray with silicone mat and light cord (if notintegral to endoscope).2. One flexible endoscope with a light cord(if not integral to endoscope) and mat andadditional non-lumened instrumentsincluding instruments with diffusion-restricted areas such as the hinged portionof forceps or scissors.dThe flexible endoscope can contain either:• a single lumen that is ≥ 1 mm ID and≤ 1050 mm in length• or two lumens with:a single lumen that is ≥ 1 mm ID and≤ 998 mm in length and the otherlumen that is ≥ 1 mm and ≤ 850 mmin lengthd The validation studies were conductedwith a flexible endoscope in a tray with siliconemat and light cord (if not integral to endoscope).Also included in the load were an additionalinstrument tray and one pouch for a total loadweight of 24.0 lbs.

	The critical process parameters are:	The critical process parameters are:
ProcessParameters	• Time	• Time
	• Chamber Temperature	• Chamber Temperature
	• Vaporizer Temperature	• Vaporizer Temperature
	• Chamber Pressure Prior to Injection	• Chamber Pressure Prior to Injection
	• Sterilant Injection Weight	• Sterilant Injection Weight
Feature	V-PRO 60 Low TemperatureSterilization System(Proposed Device)	V-PRO maX Low Temperature SterilizationSystem(Predicate Device/K131120)
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 informationindefinitely.The software allows user selection ofeither the Lumen, Non Lumen, orFlexible pre-programmed cycle.	Programmable Logic Control (PLC). Thesoftware allows user selection of either theLumen, Non Lumen, or Flexible pre-programmed cycle.
TotalCycleTime	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutes	Lumen Cycle - 55 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutes
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).The same amount of sterilant is injectedfor each of the sterilization pulses for allthree cycles.	VAPROX HC Sterilant (59% HydrogenPeroxide).The same amount of sterilant is injected foreach of the sterilization pulses for all threecycles.
Accessories	Accessories were submitted underseparate, individual, concurrent 510(k)sand cover the following:Self-contained biological indicatorand biological indicator challengepack Chemical indicator Trays & Tray Accessories Pouches	The following accessories are available for theV-PRO maX Low Temperature SterilizationSystemSelf-contained biological indicator Biological indicator challenge pack Chemical indicator Trays & Tray Accessories Pouches

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. . .

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The proposed device has an intended use similar to the predicate with the same technological characteristics. Although, the devices slightly differ, the provided descriptive characteristics and performance data demonstrate equivalence. Therefore, the proposed V-PRO 60 Low Temperature Sterilization System is substantially equivalent to the predicate device, the V-PRO maX Low Temperature Sterilization System.

3. Description of Device

As with the predicate device (K102330), the V-PRO 60 Sterilizer has three preprogrammed cycles: the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle. The V-PRO 60 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.

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The V-PRO 60 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed 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 cvcle.

4. Intended Use

The V-PRO 60 Low Temperature Sterilization System, with VAPROX HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 60 Sterilizer's Lumen Cycle can sterilize: 4

· Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
· Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
· Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: 3
- single or dual lumen devices with stainless steel lumens that are o
  - = > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length triple lumen devices with stainless steel lumens that are
  - . ≥ 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

4 The validation studies for all lumen configurations were 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 with instrument organizers and mat and two pouches for a total weight of 11 1bs (5.0 kg).

The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize °

· Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusionrestricted spaces such as the hinged portion of forceps and scissors.

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b The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg).
The V-PRO 60 Sterilizer's Flexible Cycle can sterilize: 6
One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 . O mm (38-63/64") in length
- C The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load.

5. Summary of Nonclinical Tests

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
AOAC SporicidalTest	All 720 carriers processed using 3 lots of EOSLsterilant were sterile.	PASS
Determination of D-value and Total KillEndpoint	Greater than a 12 log reduction of the most resistantorganism is achieved within all cycle (LumenCycle, Non Lumen Cycle and Flexible Cycle) ofthe V-PRO 60 Sterilizer.	PASS
½ Cycle ModifiedTotal Kill EndpointVerification	Modified total kill end point analysis wasdemonstrated for all three V-PRO 60 Sterilizercycles. The standard injection weight of 1.1 g andat least one lower injection weight resulted in allsterile results within the validation load used toqualify each sterilizer cycle. Partial positives or allsurvive results were seen at lower injectionweights.	PASS
½ Cycle SterilizationVerification of CycleClaims	• The Lumen Cycle reproducibly sterilizes single,dual and triple lumen devices under worst caseconditions in ½ Cycle• The Flexible Cycle reproducibly sterilizes 1 x990 mm flexible endoscope lumens under worstcase conditions in ½ Cycle• The Non Lumen Cycle reproducibly sterilizesnon-lumened devices under worst caseconditions in ½ Cycle	PASS

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Test	Result	Conclusion
½ Cycle Verificationof Mated Surfaces	Sterile efficacy was demonstrated for matedsurfaces under worst case conditions	PASS
Simulated Use Test	Simulated use testing verified the ability of theV-PRO 60 Sterilizer cycles to sterilize medicaldevices under worst case processing conditions.	PASS
In Use Test	The in use investigation demonstrated the ability ofthe V-PRO 60 Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments.	PASS
Biocompatibility	Cytotoxicity and residue analysis of 23 materialshave demonstrated biocompatibility afterprocessing in the V-PRO 60 Sterilizer.	PASS
Medical DeviceMaterialCompatibility	Evaluation of medical devices after multiple cyclesin the V-PRO 60 Sterilizer has demonstratedcompatibility with 23 materials of construction.	PASS
Final ProcessQualification	The V-PRO 60 Sterilizer final process qualificationwas successful for all three (3) sterilizer cycles. Allthree lots of CI exhibited complete color change.All three SCBI PIs exhibited a passing color changeand all SCBIs were negative for growth. Manualinspection of the process parameter data confirmedthat all cycle specifications were met.	PASS

The V-PRO 60 Low Temperature Sterilization System has been tested for conformity and is certified to the following standards:

. EN 61010-1:2001 Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements; Part 1: General Requirements
. EN61326-1:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

ર્. Conclusion

The V-PRO 60 Low Temperature Sterilization System's Lumen, Non Lumen and Flexible Cycles have been validated to meet the established performance criteria. The results of the V-PRO 60 Low Temperature Sterilization System verification studies demonstrate that the sterilizer performs as intended and the proposed device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

July 24, 2014

STERIS Corporation Dr. William Brodbeck Director, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060

Re: K140498

Trade/Device Name: V-Pro 60 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: II Product Code: MLR Dated: June 24, 2014 Received: June 25, 2014

Dear Dr. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

・・

Teiashri Purohi FOR

Erin I. Keith, M.S. 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): K140498

Device Name:

V-PRO® 60 Low Temperature Sterilization System

Indications For Use:

The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 60 Sterilizer's Lumen Cycle can sterilize: 4

· Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
· Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
· Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: 4
- single or dual lumen devices with stainless steel lumens that are o ■ ≥ 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length
- triple lumen devices with stainless steel lumens that are o
  - ≥ 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 1 or
  - ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length 사
- a The validation studies for all lumen configurations were 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 with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg).

The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize °

· Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.
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b The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg).
The V-PRO 60 Sterilizer's Flexible Cycle can sterilize: 6
· One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
- single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 o mm (38-63/64") in length
- E The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/11/Picture/11 description: The image shows a digital signature of Sreekanth Gutala. The signature includes the name "Sreekanth Gutala -S" in a large font on the left side of the image. On the right side, there is information about the digital signature, including the date and time: 2014:07:24 12:48:52 -04'00'.

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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).