The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with 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 pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)

Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: (a)
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- o dual channeled devices with stainless steel lumens that are > 0.77 mm ID and < 527 mm in length
- o triple channeled devices with stainless steel lumens that are
  - ≥ 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
(a) The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (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.

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle can sterilize: (0) Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes and non-luments with stainless steel or titanium diffusion-restricted areas such as the hinged portion of forceps or scissors.

(b) The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 50 lbs.

The V-PRO maX Low Temperature Sterilization System'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 two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. (c) The flexible endoscopes 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 that is ≥ 1 mm ID and ≤ 850 mm in length
- (c) 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).
1. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffiusion-restricted areas such as the hinged portion of forceps or scissors.(d) The flexible endoscope can 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 that is ≥ 1 mm and ≤ 850 mm in length
- (d) The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (ff not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

Device Description

The V-PRO 1 Plus and V-PRO maX Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Devices that meet the criteria described within the indications for use and composed of compatible materials are placed within the sterilization chamber and the appropriate cycle selected through the graphic user interface. The preprogrammed cycles all utilize a conditioning phase which prepares the chamber, a sterilize phase in which loaded devices are exposed to the sterilizing agent, VHP, at low pressure and an aeration phase to remove residual hydrogen peroxide. 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 Plus Low Temperature Sterilization System provides two cycle options, Lumen and Non Lumen. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cvcle parameters (injection cylinder, vaporizer, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of stainless steel.

The V-PRO maX Low Temperature Sterilization System provides three cycle options, Lumen, Non Lumen and Flexible. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cycle parameters (injection cylinder, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of plastic.

The purpose of this pre-market notification is to modify the maximum load weight for the Non Lumen Cycle from 19.65 to 50 lbs, to add titanium diffusion-restricted areas to the indications for use of the Non Lumen Cycle, and to remove the term "reusable" from indications for use statement.

AI/ML Overview

The FDA 510(k) summary for the V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems describes performance testing to support the substantial equivalence claim. Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "PASS" result in the context of sterilization, meaning the device successfully sterilized the test articles under specified conditions. The document acts as a summary, so detailed quantitative acceptance criteria (e.g., specific log reduction of microorganisms) are not explicitly stated in this high-level summary but are inherent to sterilization validation.

Test	Acceptance Criteria (Implied)	Reported Device Performance
½ Cycle Modified Total Kill Endpoint Verification	All sterile results within validation load at standard and at least one lower sterilant injection weight. Partial positives/all survive at lower injection weights.	PASS
½ Cycle Sterilization Verification of Cycle Claims	Reproducibly sterilizes non-lumened devices, mated surfaces, and device tray accessories contact sites under worst-case conditions in ½ Cycle.	PASS
Simulated Use Test	Verified ability of Non Lumen Cycle to sterilize medical devices under worst-case processing conditions.	PASS
Final Process Qualification	All cycle specifications met through manual inspection of process parameter data.	PASS
Sterilizer Accessories Performance	Reproducibly sterilizes SCBIs under worst-case ½ cycle conditions; PIs exhibit passing color change; SCBIs negative for growth under full cycle conditions; Chemical indicators show complete color change; Test articles effectively sterilized when packaged as specified.	PASS

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state a numerical sample size for the test set in terms of the number of items sterilized in total. However, it provides details on the load configurations used in the validation studies:

Lumen Cycle: Maximum of twenty (20) lumens per load, using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
Non Lumen Cycle: Validation load consisting of two instrument trays for a total weight of 50 lbs. (This is a modification from the previous 19.65 lbs of two instrument trays and two pouches).
Flexible Cycle (Config 1): Two flexible endoscopes (with light cord/mat) with no additional load.
Flexible Cycle (Config 2): One flexible endoscope (with light cord/mat) and additional non-lumened instruments (instrument tray and one pouch) for a total load weight of 24.0 lbs.

The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin identified for the data. Given it's a pre-market notification for a medical device by the STERIS Corporation (Mentor, OH, USA), it is highly likely the studies were prospective, conducted by the manufacturer, and likely performed in the USA or under relevant international standards.

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

The document does not mention the use of human experts to establish ground truth for the test set. Sterilization validation typically relies on objective measures, primarily biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) and chemical indicators (CIs). The "ground truth" for sterilization is the complete inactivation of these spores, indicated by no growth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth for sterilization is objective (growth/no growth of biological indicators), not based on human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a sterilization system, not an AI-assisted diagnostic or interpretive device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a standalone system. The "algorithm" here is the pre-programmed sterilization cycle, and its performance is assessed directly against the ability to sterilize. There is no human intervention in the sterilization process itself; the human selects the cycle and loads the sterilizer. The performance data presented (e.g., ½ Cycle Modified Total Kill Endpoint Verification, Simulated Use Test) are indeed standalone performance of the device without human interpretation of the sterilization outcome itself.

7. Type of Ground Truth Used

The primary ground truth for sterilization efficacy is the inactivation of biological indicators (BIs). The document explicitly mentions:

"reproducibly sterilized under worst case ½ cycle conditions" for STERIS VERIFY® V24 Self-Contained Biological Indicator (SCBI).
"all SCBIs were negative for growth under worst case full cycle conditions."

Additionally, chemical indicators (CIs) are used to confirm exposure to the sterilant, showing "complete color change."

8. Sample Size for the Training Set

Not applicable. This device is a physical sterilizer and its associated pre-programmed cycles, not a machine learning model that requires a "training set" in the conventional AI sense. The "training" of the cycles would refer to the developmental and engineering process of determining optimal parameters, which involves a different type of experimental design and validation than data-driven machine learning model training.

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

Not applicable, for the same reasons as point 8. The "ground truth" for developing the sterilizer's parameters (e.g., sterilant injection, exposure time, pressure, temperature) would have been established through extensive empirical experimentation and adherence to sterilization standards (e.g., AAMI, ISO) to achieve a validated Sterility Assurance Level (SAL) of 10^-6 or better. This involves progressively testing parameters with biological indicators to determine the minimum conditions required for sterility.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2016

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

Re: K160433

Trade/Device Name: V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems Regulation Number: 21 CFR 880.6860 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: II Product Code: MLR Dated: June 9, 2016 Received: June 10, 2016

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.

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

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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) K160433

Device Name

V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems

Indications for Use (Describe)

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)

Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: (a)
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- o dual channeled devices with stainless steel lumens that are > 0.77 mm ID and < 527 mm in length

o triple channeled devices with stainless steel lumens that are

≥ 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
(a) The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (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.

(b) The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 50 lbs.
The V-PRO maX Low Temperature Sterilization System'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 two load configurations:
1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. (c) The flexible endoscopes 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 that is ≥ 1 mm ID and ≤ 850 mm in length
  - (c) 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).

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1. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffiusion-restricted areas such as the hinged portion of forceps or scissors.(d) The flexible endoscope can 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 that is ≥ 1 mm and ≤ 850 mm in length
  - (d) The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (ff not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

The parameters for the three V-PRO Cycles are as follows:

Table 1: Parameters for V-PRO Cycles
Sterilization Cycle	Sterilantinjection (g)	# of Injections	Sterilant ExposureTime (min)	Chamber PressurePrior to Injection (Torr)	Chamber/VaporizerTemperature (°C)
Lumen	2.1	4	32	0.4	50/60
Non Lumen	2.1	4	12	1	50/60
Flexible	2.1	4	12	0.4	50/60

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all capital letters and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

510(k) Summary For V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems

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

Bill Brodbeck Contact: Director, Regulatory Affairs

Email: William Brodbeck@steris.com Telephone: (440) 392-7690 Fax No: (440) 357-9198

Summary Date: June 9, 2016

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

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1. Device Name

Trade Name:	V-PRO® 1 Plus and V-PRO® maX Low TemperatureSterilization Systems
Device Class:	Class II
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas21 CFR 880.6860Product Code MLR

2. Predicate Devices

Primary predicate claimed is V-PRO 1 Plus/ V-PRO maX Low Temperature Sterilization System cleared under K131120.

V-PRO® 1 Plus Low Temperature Sterilization System was originally cleared under K083097 with modifications cleared under K102394, K111810, K112813 and K120632.

V-PRO® maX Low Temperature Sterilization System was originally cleared under K102330 with modifications cleared under K112760, and K120632.

Comparison between the proposed V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems to the predicate devices is summarized in the table below.

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K160433/ S001 STERIS Response to Request for Additional Information V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems

The proposed devices have an intended use similar to the predicates with the same technological characteristics. Although, the indications differ slightly, the provided performance data demonstrate equivalence. Therefore, the proposed V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are substantially equivalent to the predicate devices, the V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems.

3. Description of Device

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4. Intended Use

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with 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 pre-programmed sterilization cycles [Lumen Cycle, Non Lumen Cycle, and Flexible Cycle (V-PRO maX Sterilizer only)] operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:4

Lumened and non-lumened instruments with diffusion-restricted spaces . such as the hinged portion of forceps and scissors
Medical devices, including single, dual and triple channeled rigid and . semi-rigid endoscopes, with the following configurations: 4
- O single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- dual channeled devices with stainless steel lumens that are ≥ 0.77 O mm ID and ≤ 527 mm in length
- triple channeled devices with stainless steel lumens that are o
  - ≥ 1.2 mm ID and ≤ 275 mm in length

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≥ 1.8 mm ID and ≤ 310 mm in length
or
≥2.8 mm ID and ≤ 317 mm in length
a The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (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.

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, the subject of this submission, can sterilize:'0

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

The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs.

The V-PRO maX Low Temperature Sterilization System'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 two load configurations:

Two flexible endoscopes with a light cord (if not integral to endoscope) and 1. mat with no additional load. °
The flexible endoscopes 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 that is > 1 mm ID and < 850 mm in length .
C 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).
One flexible endoscope with a light cord (if not integral to endoscope) and 2. mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. 4

The flexible endoscope can 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

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and the other lumen that is > 1 mm and ≤ 850 mm in length ●
d 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 load weight of 24.0 lbs.

The parameters for the three V-PRO Cycles are as follows:

SterilizationCycle	Sterilantinjection(g)	# ofInjections	SterilantExposureTime (min)	ChamberPressurePrior toInjection(Torr)	Chamber/VaporizerTemperature(°C)
Lumen	2.1	4	32	0.4	50/60
Non Lumen	2.1	4	12	1	50/60
Flexible	2.1	4	12	0.4	50/60

5. Summary of Nonclinical Tests

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems have the same or similar intended use and the same technological characteristics as compared to the predicate devices. Performance testing to assess and demonstrate substantial

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equivalence to the predicates is summarized below.

		Conclusion
Test	Result	V-PRO 1Plus/V-PROmax LowTemperatureSterilizationSystem(ProposedDevice)	V-PRO 1Plus/V-PROmax LowTemperatureSterilizationSystem(PredicateDevices/K131120)
½ Cycle ModifiedTotal KillEndpointVerification	Modified total kill end point analysis wasdemonstrated for the Non Lumen Cycle.The standard injection weight of 2.1 g andat least one lower injection weight resultedin all sterile results within the validationload. Partial positives or all surviveresults were seen at lower injectionweights.	PASS	PASS
½ CycleSterilizationVerification ofCycle Claims	The Non Lumen Cycle reproduciblysterilizes non-lumened devices, matedsurfaces and device tray accessoriescontact sites under worst case conditionsin ½ Cycle	PASS	PASS
Simulated UseTest	Simulated use testing verified the abilityof the Non Lumen Cycle to sterilizemedical devices under worst caseprocessing conditions.	PASS	PASS
Final ProcessQualification	The Non Lumen Cycle final processqualification was successful. Manualinspection of the process parameter dataconfirmed that all cycle specificationswere met.	PASS	PASS
SterilizerAccessoriesPerformance	Three lots of VERIFY® V24 Self-Contained Biological Indicator (SCBI)were reproducibly sterilized under worstcase ½ cycle conditions. Three lots ofSCBI process indicators (PIs) exhibited apassing color change and all SCBIs werenegative for growth under worst case fullcycle conditions. Three lots of VERIFY®HPU chemical indicator exhibitedcomplete color change under worst casefull cycle conditions. Test articles wereeffectively sterilized under worst case ½cycle conditions when packaged in:• Vis -U-All Low TemperaturePouches or• V-PRO Sterilization Trays	PASS	PASS

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6. Conclusion

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems Non Lumen Cycle has been validated to meet the established performance criteria. The results of the V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle verification studies demonstrate that the sterilizers perform as intended. Based on the intended uses, technological characteristics and non-clinical performance data, the subject devices (V-PRO 1 Plus and V-PRO maX) are as safe, as effective and perform at least as safely and effectively as the legally marketed predicate device (K131120), 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).

Feature	V-PRO 1 Plus/V-PRO maX LowTemperature Sterilization System(Proposed Device)	V-PRO 1 Plus/V-PRO maX LowTemperature Sterilization System(Predicate Devices/K131120)
Indicationsfor Use	The V-PRO 1, V-PRO 1 Plus and V-PROmaX Low Temperature SterilizationSystems, with VAPROX® HC Sterilant, arevaporized hydrogen peroxide sterilizersintended for use in the terminal sterilizationof cleaned, rinsed and dried metal andnonmetal medical devices used in healthcarefacilities. The three pre-programmedsterilization cycles (Lumen Cycle, NonLumen Cycle, and Flexible Cycle) operateat low pressure and low temperature and arethus suitable for processing medical devicessensitive to heat and moisture.The V-PRO 1, V-PRO 1 Plus and V-PRO	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 sterilizationof cleaned, rinsed and dried reusable metaland nonmetal medical devices used inhealthcare facilities. The three pre-programmed sterilization cycles (LumenCycle, Non Lumen Cycle, and FlexibleCycle) operate at low pressure and lowtemperature and are thus suitable forprocessing medical devices sensitive to heatand moisture.The Amsco V-PRO 1, V-PRO 1 Plus and
Feature	V-PRO 1 Plus/V-PRO maX LowTemperature Sterilization System(Proposed Device)	V-PRO 1 Plus/V-PRO maX LowTemperature Sterilization System(Predicate Devices/K131120)
	maX Low Temperature SterilizationSystem's Lumen Cycle, can sterilize:a• Lumened and non-lumenedinstruments with diffusion-restrictedspaces such as the hinged portion offorceps and scissors• Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes, with thefollowing configurations: ao single channeled devices with astainless steel lumen that is >0.77 mm internal diameter (ID)and ≤ 500 mm in lengtho dual lumen devices with stainlesslumens that are ≥ 0.77 mm IDand ≤ 527 mm in lengtho triple lumen devices with stainlesssteel lumens that are• ≥ 1.2 mm ID and ≤ 275 mmin length• ≥ 1.8 mm ID and ≤ 310 mmin lengthor• ≥ 2.8 mm ID and ≤ 317 mmin lengtha The validation studies for allchannel/ lumen configurations wereconducted using a maximum oftwenty (20) lumens per load.Hospital loads should not exceedthe maximum number of lumensvalidated by this testing. Thevalidation studies were performedusing a validation load consistingof two instrument trays and twopouches for a total weight of19.65 lbs.	V-PRO maX Low Temperature SterilizationSystem's Lumen Cycle, can sterilize:a• Lumened and non-lumenedinstruments with diffusion-restrictedspaces such as the hinged portion offorceps and scissors• Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes, with thefollowing configurations: ao single channeled devices with astainless steel lumen that is >0.77 mm internal diameter (ID)and ≤ 500 mm in lengtho dual lumen devices with stainlesslumens that are ≥ 0.77 mm IDand ≤ 527 mm in lengtho triple lumen devices with stainlesssteel lumens that are• > 1.2 mm ID and ≤ 275 mmin length• ≥ 1.8 mm ID and ≤ 310 mmin lengthor• ≥ 2.8 mm ID and ≤ 317 mmin lengtha The validation studies for allchannel/ lumen configurations wereconducted using a maximum oftwenty (20) lumens per load.Hospital loads should not exceedthe maximum number of lumensvalidated by this testing. Thevalidation studies were performedusing a validation load consistingof two instrument trays and twopouches for a total weight of19.65 lbs.
	The V-PRO 1 Plus and V-PRO maX LowTemperature Sterilization Systems' NonLumen Cycle, the subject of thissubmission, can sterilize:b• Non-lumened instruments includingnon-lumened rigid, semi-rigid andflexible endoscopes and non-lumenedinstruments with stainless steel ortitanium diffusion-restricted areas suchas the hinged portion of forceps orscissors.b The validation studies were conductedusing a validation load consisting oftwo instrument trays for a total weight	The Amsco V-PRO 1 Plus and V-PRO maXLow Temperature Sterilization Systems'Non Lumen Cycle, cleared under K083097,K102394 and K111810, can sterilize:b• Non-lumened instruments includingnon-lumened rigid, semi-rigid andflexible endoscopes and non-lumenedinstruments with stainless steeldiffusion-restricted areas such as thehinged portion of forceps or scissors.b The validation studies were conductedusing a validation load consisting oftwo instrument trays and two pouchesfor a total weight of 19.65 lbs.
Feature	V-PRO 1 Plus/V-PRO maX LowTemperature Sterilization System(Proposed Device)of 50.0 lbs.	V-PRO 1 Plus/V-PRO maX LowTemperature Sterilization System(Predicate Devices/K131120)
	The V-PRO maX Low TemperatureSterilization System's Flexible Cycle , cansterilize single or dual lumen surgicalflexible endoscopes (such as those used inENT, Urology and Surgical Care) andbronchoscopes in either of two loadconfigurations:1. Two flexible endoscopes with a lightcord (if not integral to endoscope) andmat with no additional load.cThe flexible endoscopes may containeither:	The Amsco V-PRO maX Low TemperatureSterilization System's Flexible Cycle ,cleared under K102330 and K112760, cansterilize single or dual lumen surgicalflexible endoscopes (such as those used inENT, Urology and Surgical Care) andbronchoscopes in either of two loadconfigurations:1. Two flexible endoscopes with a lightcord (if not integral to endoscope) andmat with no additional load.cThe flexible endoscopes may containeither:
	a single lumen that is ≥ 1 mm IDand ≤ 1050 mm in length or two lumens with:one lumen that is ≥ 1 mm ID and ≤990 mm in length and the otherlumen that is ≥ 1 mm ID and ≤850 mm in length	a single lumen that is ≥ 1 mm IDand ≤ 1050 mm in length 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 ≤850 mm in length
	The validation studies were conductedwith two flexible endoscopes, each packagedinto a tray with silicone mat and light cord (ifnot integral to endoscope).	The validation studies were conductedwith two flexible endoscopes, each packagedinto a tray with silicone mat and light cord (ifnot integral to endoscope).
	2. One flexible endoscope with a lightcord (if not integral to endoscope) andmat and additional non-lumenedinstruments including instruments withdiffusion-restricted areas such as thehinged portion of forceps or scissors.d	2. One flexible endoscope with a lightcord (if not integral to endoscope) andmat and additional non-lumenedinstruments including instruments withdiffusion-restricted areas such as thehinged portion of forceps or scissors.d
	The flexible endoscope can containeither: a single lumen that is ≥ 1 mm IDand ≤ 1050 mm in length or two lumens with:a single lumen that is ≥ 1 mm IDand ≤ 990 mm in length and theother lumen that is ≥ 1 mm and ≤850 mm in length	The flexible endoscope can containeither: a single lumen that is ≥ 1 mm IDand ≤ 1050 mm in length or two lumens with:a single lumen that is ≥ 1 mm IDand ≤ 998 mm in length and theother lumen that is ≥ 1 mm and ≤850 mm in length
	The validation studies were conductedwith a flexible endoscope in a tray with siliconemat and light cord (if not integral toendoscope). Also included in the load were anadditional instrument tray and one pouch for atotal load weight of 24.0 lbs.	The validation studies were conductedwith a flexible endoscope in a tray with siliconemat and light cord (if not integral toendoscope). Also included in the load were anadditional instrument tray and one pouch for atotal load weight of 24.0 lbs.
Feature	V-PRO 1 Plus/V-PRO maX LowTemperature Sterilization System(Proposed Device)	V-PRO 1 Plus/V-PRO maX LowTemperature Sterilization System(Predicate Devices/K131120)
ProcessParameters	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight
Software/FirmwareControlled	Programmable Logic Control (PLC). Thesoftware allows user selection of either theLumen, Non Lumen, or Flexible pre-programmed cycle.	Programmable Logic Control (PLC). Thesoftware allows user selection of either theLumen, Non Lumen, or Flexible pre-programmed cycle.
TotalCycleTime	Lumen Cycle - 55 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutes	Lumen Cycle - 55 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutes
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).The same amount of sterilant is injected foreach of the sterilization pulses for all threecycles.	VAPROX HC Sterilant (59% HydrogenPeroxide).The same amount of sterilant is injected foreach of the sterilization pulses for all threecycles.
Accessories	The following accessories are available forthe V-PRO maX Low TemperatureSterilization System• Self-contained biological indicator• Biological indicator challenge pack• Chemical indicator• Trays & Tray Accessories• Pouches	The following accessories are available forthe V-PRO maX Low TemperatureSterilization System• Self-contained biological indicator• Biological indicator challenge pack• Chemical indicator• Trays & Tray Accessories• Pouches