The V-PRO 1, 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 and semi-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-lumened general medical instruments, 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 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 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).

One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-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 (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 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 nonmetal medical devices used in Healthcare facilities. The pre-programmed sterilization cycles (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 60 Sterilizer's Lumen Cycle can sterilize: (a)

· 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: (a)
- 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

(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 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 (b)

· 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 or scissors.
(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: (c)

One flexible surgical endoscope 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

(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.

Device Description

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 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 Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The packaged sterilized devices are ready for use at the completion of the cycle; no cool down or aeration period is required following completion of the cycle.

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

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 metal and nonmetal medical devices used in healthcare facilities. The three 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.

AI/ML Overview

The STERIS V-PRO Low Temperature Sterilization Systems were studied to verify two modifications: the removal of eye-contacting limitations and the addition of polyurethane as a compatible material for the Lumen Cycle.

Here's a breakdown of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

Device Modification	Verification / Validation Activity	Acceptance Criteria (Implied)	Reported Device Performance
Removal of Eye-Contacting Limitations
	Compare the residual hydrogen peroxide level for materials after processing under worst-case conditions in the V-PRO Sterilizers and the STERRAD 100NX Sterilizer.	Residual hydrogen peroxide levels in V-PRO processed samples should be statistically less than or equal to materials similarly processed in the predicate device (STERRAD 100NX Sterilizer).	Pass: "V-PRO 60 Sterilizer (worst-case) processed samples hydrogen peroxide residues were statistically less than or equal to materials similarly processed in the STERRAD 100NX Sterilizer."
	Compare the dilution required to achieve non-cytotoxic results for materials after processing under worst-case conditions in the V-PRO Sterilizers and the STERRAD 100NX Sterilizer.	The cytotoxic response for materials processed in the V-PRO Sterilizer cycles (worst-case) should be equivalent to or less than the cytotoxic response for the same materials processed in the predicate device (STERRAD 100NX Sterilizer Cycles).	Pass: "The cytotoxic response for all materials processed in the V-PRO 60 Sterilizer cycles (worst-case) was equivalent to or less than the cytotoxic response for the same materials processed in STERRAD 100NX Sterilizer Cycles."
	Confirm that the cytotoxic component present in each extract (if the neat sample is cytotoxic) is hydrogen peroxide (H2O2) by the addition of catalase to the extracts.	The cytotoxic component should be identified as hydrogen peroxide (H2O2).	"The cytotoxic component for all V-PRO 60 Sterilizer (worst-case) processed materials was identified as hydrogen peroxide (H2O2)." (This is an observation supporting the mechanism, not a pass/fail criteria itself, but confirms understanding of the cytotoxic agent).
	Determine the cytotoxicity for medical devices after processing in three (3) back-to-back V-PRO 60 Sterilizer (worst-case) Lumen Cycles.	Following exposure to three (3) back-to-back cycles, devices should be non-cytotoxic at the neat dilution.	Pass: "Following exposure to three (3) back-to-back cycles, devices are non-cytotoxic at the neat dilution."
	Compare the residual hydrogen peroxide level for medical devices after processing in three (3) back-to-back V-PRO 60 Sterilizer (worst-case) Lumen Cycles to hydrogen peroxide levels known to cause eye biocompatibility concerns.	Following exposure to three (3) back-to-back cycles, device hydrogen peroxide residues should be below levels known to cause biocompatibility concerns (specifically eye biocompatibility concerns).	Pass: "Following exposure to three (3) back-to-back cycles, device hydrogen peroxide residues are below levels known to cause biocompatibility concerns."
	Evaluate V-PRO Sterilizer materials processed for 3 consecutive cycles for ocular irritation per ISO 10993-10.	Materials coupons processed for 3 consecutive cycles in the V-PRO maX Lumen (worst-case) Cycle should be non-irritants per ISO 10993-10 evaluation.	Pass: "Materials coupons processed for 3 consecutive cycles in the V-PRO maX Lumen (worst-case) Cycle are non-irritants per ISO 10993-10 evaluation."
Addition of Polyurethane as a compatible material for V-PRO Sterilizers' Lumen Cycle
	Evaluate polyurethane material compatibility after processing the worst-case V-PRO Sterilizer Cycle.	No material degradation or cosmetic changes should be observed for the polyurethane-containing device.	Pass: "No material degradation or cosmetic changes were observed for the polyurethane-containing device."
	Sterilization efficacy for polyurethane in Lumen Cycle is demonstrated by previously completed testing in the V-PRO maX and V-PRO 60 Sterilizers’ (worst-case) Non Lumen Cycle.	Sterilization efficacy for polyurethane should be demonstrated to meet the required sterility assurance level (SAL). (Implied from the "Pass" result, as specific SAL is not stated here but is a standard requirement for sterilization validation.)	Pass: (Specific sterility efficacy data is not provided in this table, but the "Pass" indicates that prior testing supports this. This would typically involve bacterial spore inactivation.)

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the exact "sample size for the test set" in terms of number of unique devices or materials for each specific test. However, it indicates:

For residual hydrogen peroxide and cytotoxicity comparison: "materials" were processed.
For in-device cytotoxicity and tissue residue: "medical devices" were processed.
For ocular irritation: "Materials coupons" were processed.
For polyurethane compatibility: "polyurethane-containing device" and "polyurethane material" were evaluated.

Data Provenance: The studies were conducted by STERIS Corporation for a 510(k) premarket notification. This implies the data is prospective for the purpose of demonstrating the safety and effectiveness of the proposed changes. The country of origin of the data is not specified but is presumably the USA, where STERIS Corporation is based.

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

This information is not provided in the document. The tests described are primarily laboratory-based evaluations of chemical residues, cytotoxicity, material compatibility, and biological irritation, rather than assessments requiring interpretation by clinical experts. For biocompatibility tests like ocular irritation per ISO 10993-10, trained toxicologists or evaluators would interpret the results.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are laboratory-based experimental validations, not clinical studies requiring independent interpretation or adjudication of outcomes by multiple experts.

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

A MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic accuracy of imaging or other interpretive devices, often with and without AI assistance to human readers. The STERIS V-PRO System is a sterilizer, and its performance is evaluated through physical, chemical, and biological efficacy studies, not reader interpretation.

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

A standalone study was not done because the device itself is a sterilizer, not an algorithm. Its performance is inherent in its operation (sterilization efficacy, material compatibility, residue levels), not in an algorithmic output.

7. Type of Ground Truth Used

The ground truth used in these studies is based on:

Quantitative measurements: Residual hydrogen peroxide levels (chemical analysis).
Biological assays: Cytotoxicity tests (e.g., using live cells to detect toxic effects), ocular irritation tests (per ISO 10993-10 guidelines, likely involving animal models or in vitro alternatives).
Visual assessment: Material degradation or cosmetic changes.
Sterilization efficacy: Implied to be based on inactivation of biological indicators with a known sterility assurance level (SAL).

8. Sample Size for the Training Set

This information is not applicable as the V-PRO Sterilization System is a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device type.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile, arranged in a cascading manner. The figures are depicted in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

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

March 31, 2017

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

Re: K162413

Trade/Device Name: Amsco® V-PRO™ 1 Low Temperature Sterilization System Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System V-PRO™ Max Low Temperature Sterilization System V-PRO 60 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: February 21, 2017 Received: February 22, 2017

Dear Bill Brodbeck:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Michael J. Ryan -S

for Tina Kiang, Ph.D.

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

Enclosure

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Indications for Use

510(k) Number (if known) K162413

Device Name

V-PRO® 1, 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, 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 and semi-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-lumened general medical instruments, 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 for a total weight of 50 lbs.

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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One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-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 (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.

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)

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

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K162413

Device Name

V-PRO® 60 Low Temperature Sterilization System

Indications for Use (Describe)

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

· 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: (a)
- 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 (b)

· 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.
(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: (c)

One flexible surgical endoscope 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

(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.

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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)

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

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/6/Picture/0 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

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

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

Contact:

Bill Brodbeck Director, Regulatory Affairs Tel: 440-392-7690 Fax: 440-357-9198

Summary Date: March 31, 2017

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

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

Device Class:	Class II
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas
Classification Number:	21 CFR 880.6860
Product Code:	MLR

2. Predicate Device

The claimed primary predicate device is the V-PRO maX Low Temperature Sterilization System, cleared most recently under K160433.

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

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

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

V-PRO 60 Low Temperature Sterilization System, cleared most recently under K140498.

The purpose of this submission is to remove labeling restrictions of processing evecontacting devices which contain certain materials and to include polyurethane as a material compatible while being processed in the devices' Lumen Cycle.

3. Description of Device

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exposure to vaporized hydrogen peroxide (VHP). The packaged sterilized devices are ready for use at the completion of the cycle; no cool down or aeration period is required following completion of the cycle.

The V-PRO 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 metal and nonmetal medical devices used in healthcare facilities. The three 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.

4. Intended Use

The V-PRO 1, 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 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:(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 and semi-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.

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K162413: TRADITIONAL PREMARKET NOTIFICATION for V-PRO 1, V-PRO 1 Plus, V-PRO maX, and V-PRO 60 Low Temperature Sterilization Systems

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle can sterilize: (b) Non-lumened instruments including non-lumened general medical instruments, 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.

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

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).

One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-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 (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 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 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: (a)

· 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

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

(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 (b)

· 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.

(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: (c)

· 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

(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.

ട. Description of Safety and Substantial Equivalence

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Sterilizers are the same as the predicate devices except for the specific requested changes to labeling as described in this submission. There are no differences in the indications for use or technology (including features, materials, and principles of operation) between the proposed and predicate devices. Therefore, the differences between the proposed and predicate devices are limited to the proposed changes to labeling to remove

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eye-contacting materials restrictions and add polyurethane as a compatible material for processing in the devices' Lumen Cycle.

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

DeviceModification	Verification / Validation Activity	Results
Removal ofEye-ContactingLimitationsfrom theV-PRO LowTemperatureSterilizationSystems	Compare the residual hydrogenperoxide level for materials afterprocessing under worst caseconditions in the V-PRO Sterilizersand the STERRAD 100NXSterilizer	PassV-PRO 60 Sterilizer (worst-case)processed samples hydrogen peroxideresidues were statistically less than orequal to materials similarly processedin the STERRAD 100NX Sterilizer.
	Compare the dilution required toachieve non-cytotoxic results formaterials after processing underworst case conditions in the V-PROSterilizers and the STERRAD100NX Sterilizer.	PassThe cytotoxic response for all materialsprocessed in the V-PRO 60 Sterilizercycles (worst-case) was equivalent toor less than the cytotoxic response forthe same materials processed inSTERRAD 100NX Sterilizer Cycles.
	Confirm that the cytotoxiccomponent present in each extract(if the neat sample is cytotoxic) ishydrogen peroxide (H2O2) by theaddition of catalase to the extracts.	The cytotoxic component for all V-PRO 60 Sterilizer (worst-case)processed materials was identified ashydrogen peroxide (H2O2).
	Determine the cytotoxicity formedical devices after processing inthree (3) back-to-back V-PRO 60Sterilizer (worst-case) LumenCycles.	PassFollowing exposure to three (3) back-to-back cycles, devices are non-cytotoxic at the neat dilution.
	Compare the residual hydrogenperoxide level for medical devicesafter processing in three (3) back-to-back V-PRO 60 Sterilizer (worst-case) Lumen Cycles to hydrogenperoxide levels known to cause eyebiocompatibility concerns.	PassFollowing exposure to three (3) back-to-back cycles, device hydrogenperoxide residues are below levelsknown to cause biocompatibilityconcerns.
	biocompatibility concerns.	concerns.
	Evaluate V-PRO Sterilizer materialsprocessed for 3 consecutive cyclesfor ocular irritation per ISO 10993-10.	PassMaterials coupons processed for 3consecutive cycles in the V-PRO maXLumen (worst-case) Cycle are non-irritants per ISO 10993-10 evaluation.

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K162413: TRADITIONAL PREMARKET NOTIFICATION for V-PRO 1, V-PRO 1 Plus, V-PRO maX, and V-PRO 60 Low Temperature Sterilization Systems

DeviceModification	Verification / Validation Activity	Results
Addition ofpolyurethaneas acompatiblematerial forV-PROSterilizers'Lumen Cycle	Evaluate polyurethane materialcompatibility after processing theworst case V-PRO Sterilizer Cycle.	PassNo material degradation or cosmeticchanges were observed for thepolyurethane-containing device.
	Sterilization efficacy forpolyurethane in Lumen Cycle isdemonstrated by previouslycompleted testing in the V-PROmaX and V PRO 60 Sterilizers'(worst-case) Non Lumen Cycle	Pass

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and perform at least as safely and effectively as the legally marketed predicate device (K160433), 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).