The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) are Class 1 vaporized hydrogen peroxide sterilization process indicators that conform to ANSI/AAMI/ISO 11140-1: 2005. They are designed to distinguish between processed and unprocessed units when placed within (Version 1A) or affixed to (Version 2A) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to yellow, when the device (Version 1A) or pack (Version 2A) has been exposed to a V-PRO 1 Low Temperature sterilization process (Lumen Cycle) or V-PRO 1 Plus Low Temperature sterilization process (Lumen or Non-Lumen cycle). This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization System and Amsco V-PRO 1 Plus Low Temperature Sterilization System at 50 °C using Vaprox™ HC Sterilant.

The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) intended for use in vaporized hydrogen peroxide sterilization processes. The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) change color from magenta to yellow when exposed to the appropriate cycle conditions of temperature, sterilant concentration and duration, as shown in the table below:

Model	Temperature	SterilantConcentration	Cycle Type	ExposureTime
VerifyVersion 1A	50 °C	2.1 g H2O2 x 4injections	Lumen	32 minutes
VerifyVersion 2A	50 °C	2.1 g H2O2 x 4injections	Lumen	32 minutes
VerifyVersion 1A	50 °C	2.1 g H2O2 x 4injections	Non-Lumen	12 minutes
VerifyVersion 2A	50 °C	2.1 g H2O2 x 4injections	Non-Lumen	12 minutes

Device Description

The Verify® V-PRO Chemical Indicator is provided as two formats:

Version 1A: Verify® V-PRO Chemical Indicator .
Version 2A: Verify® V-PRO Chemical Indicator Adhesive Label .

The Version 1A: Verify® V-PRO Chemical Indicator is a Class 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2005 which consists of the chemical indicator applied to an inert polymeric substrate; the indicator spot is laminated with a transparent laminate.

The Version 2A: Verify® V-PRO Chemical Indicator Adhesive Label is a Class 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the STERIS Verify® V-PRO Chemical Indicators, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Verify® V-PRO Chemical Indicator – Version 1A and Version 2A are based on their classification as Class 1 process indicators conforming to ANSI/AAMI/ISO 11140-1:2005. The primary performance metric is a visible color change from magenta to yellow when exposed to appropriate cycle conditions and no color change when not sufficiently exposed.

Performance Metric / Acceptance Criteria	Reported Device Performance
Color Change after Exposure to Sterilization Conditions:	The device (CI) changes color from magenta to yellow when exposed to the appropriate cycle conditions.
- Lumen Cycle:	Change from magenta to yellow after exposure to 50 °C, 2.1 g H2O2 x 4 injections, for 32 minutes.
- Non-Lumen Cycle:	Change from magenta to yellow after exposure to 50 °C, 2.1 g H2O2 x 4 injections, for 12 minutes.
No Color Change (or insufficient change) in Ineffective Exposure:	(Not explicitly detailed in the provided text, but implied by the function of a chemical indicator to distinguish between processed and unprocessed units.)
Conformance to ANSI/AAMI/ISO 11140-1:2005 (Class 1 indicator):	The device meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2005.
Durability / Stability:	Testing was performed to investigate the effects of exposure to UV, visible light, and aggressive chemicals. (Results not detailed in the summary.)
Simulated In-Use Applications:	Additional testing was completed to simulate typical in-use applications. (Results not detailed in the summary.)

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

Sample Size for Test Set: The exact sample size (number of indicators or runs) used for performance testing is not specified in the provided 510(k) summary. The document generally states "Performance testing was conducted."
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly probable the testing was conducted in a controlled lab environment (likely in the US or a country with recognized standards), but details are absent.

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

This information is not applicable / not provided in the context of this device. Chemical indicators rely on a physical, observable color change, not subjective expert interpretation like diagnostic imaging. The "ground truth" is typically established by physical parameters of the sterilization cycle (temperature, sterilant concentration, exposure time) and a reference standard (e.g., biological indicator or validated sterilization cycle).

4. Adjudication Method for the Test Set

This information is not applicable / not provided. Adjudication typically refers to resolving discrepancies between multiple human readers or interpretations. For a chemical indicator with a clear color change, the "adjudication" is inherent in the objective chemical reaction.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. This device is a chemical indicator that provides a direct visual change, not interpreted by multiple readers in an MRMC setting.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not applicable to a chemical indicator. The device is the "standalone" indicator; its performance is based on its chemical reaction and visible color change, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by controlled sterilization cycle parameters (temperature, sterilant concentration, and duration as specified in the table on page 2), in adherence to the requirements of the ANSI/AAMI/ISO 11140-1:2005 standard for chemical indicators. The expected outcome is a specific color change (magenta to yellow) under these defined conditions, and either no change or an insufficient change under inadequate conditions.

8. The Sample Size for the Training Set

This information is not applicable / not provided. Chemical indicators are not "trained" in the way AI algorithms are. Their performance is inherent in their chemical composition and manufacturing.

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

This information is not applicable / not provided for the same reasons as point 8.

Summary

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STERIS

OCT 2 7 2009 510(k) Summary For Verify® V-PRO Chemical Indicator – Version 1A and Version 2A

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Robert F. Sullivan Senior Director STERIS FDA Regulatory Affairs Telephone: (440) 392-7695 Fax No: (440) 357-9198

Submission Date:

October 26, 2009

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

October 26, 2009

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Device Name 1.

Trade Name:	Verify® V-PRO Chemical Indicator
Models:	Version 1A: Verify® V-PRO Chemical Indicator.Version 2A: Verify® V-PRO Chemical Indicator Adhesive Label.
Common Name:	Chemical Indicator.
Classification Name:	Physical/chemical sterilization process indicator (21 CFR880.2800 (b), Product Code JOJ).

Predicate Device 2.

Verify® V-PRO Chemical Indicator - Version 1 and 2 (K072510)

Device Description 3.

The Verify® V-PRO Chemical Indicator is provided as two formats:

Version 1A: Verify® V-PRO Chemical Indicator .
Version 2A: Verify® V-PRO Chemical Indicator Adhesive Label .

Indication for Use: 4.

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designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization System and Amsco V-PRO 1 Plus Low Temperature Sterilization System at 50 °C using Vaprox™ HC Sterilant.

Model	Temperature	SterilantConcentration	Cycle Type	ExposureTime
VerifyVersion 1A	50 °C	2.1 g H2O2 x 4injections	Lumen	32 minutes
VerifyVersion 2A	50 °C	2.1 g H2O2 x 4injections	Lumen	32 minutes
VerifyVersion 1A	50 °C	2.1 g H2O2 x 4injections	Non-Lumen	12 minutes
VerifyVersion 2A	50 °C	2.1 g H2O2 x 4injections	Non-Lumen	12 minutes

Description of Safety and Substantial Equivalence 5.

The proposed and predicate devices are single use process indicators for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The differences between the proposed Verify® V-PRO Chemical Indicator - Version IA and Version 2A and the predicate Verify® V-PRO Chemical Indicator - Version 1 and 2 device are limited to differences in the chemical composition of the indicator ink. These differences do not raise any new issues of safety and efficacy.

Performance Testing 6.

Performance testing was conducted to verify that the proposed Verify® V-PRO Chemical Indicator - Version 1A and Version 2A meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ ISO 11140-1:2005. Additional testing was completed to simulate typical in-use applications and testing was also performed to investigate the effects of exposure to UV, visible light and aggressive chemicals to the performance of the Verify® V-PRO Chemical Indicator.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. John R. (Jack) Scoville, Jr. Fellow, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

OCT 2 7 2009

Re: K091174

Trade/Device Name: Verify® V-PRO Chemical Indicator - Version 1A and Verision 2A Regulation Number: 21 CFR 880. 2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: October 21, 2009 Received: October 22, 2009

Dear Mr. Scoville:

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.

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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Page 2 - Mr. Scoville

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthem D. m
B.B.S., M.A.

Susan Runner, D.D.S., M Acting Division Director Division of Anesthesiology, General Hospital, 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): K091174

Device Name:

Verify® V-PRO Chemical-Indicator - Version 1A and Version 2A

Indications For Use:

Model	Temperature	SterilantConcentration	Cycle Type	ExposureTime
VerifyVersion 1A	50 °C	2.1 g H2O2 x 4injections	Lumen	32 minutes
VerifyVersion 2A	50 °C	2.1 g H2O2 x 4injections	Lumen	32 minutes
VerifyVersion 1A	50 °C	2.1 g H2O2 x 4injections	Non-Lumen	12 minutes
VerifyVersion 2A	50 °C	2.1 g H2O2 x 4injections	Non-Lumen	12 minutes

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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 In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety 510(k)

Shule A Murphy MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K091174

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).