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

Device Description

The Verify® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to an Amsco V-PRO 1 Low Temperature Sterilizer cycle. When exposed, the indicator exhibits a visible color change from magenta to yellow.

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

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

The Version 1: Verify® V-PRO Chemical Indicator is a Class 1 process indicator in accordance with 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 2: Verify® V-PRO Chemical Indicator Adhesive Label is a Class 1 process indicator in accordance with 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 an analysis of the acceptance criteria and study information for the STERIS® Verify® V-PRO Chemical Indicator, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meets requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI ISO 11140-1:2005.	"Performance testing was conducted to verify that the proposed Verify® V-PRO Chemical Indicator meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSVAAMI ISO 11140-1:2005." (The document states that it meets these requirements, implying successful performance.)
Exhibits a visible color change from magenta to yellow when exposed to an Amsco V-PRO 1 Low Temperature Sterilizer cycle.	"When exposed, the indicator exhibits a visible color change from magenta to yellow." and "indicate, through a visible change from magenta to yellow, when the device (Version 1) or pack (Version 2) has been exposed to a V-PRO 1 sterilization process." (The description of the device's function directly states this is its performance.)
Performance in typical in-use applications.	"Additional testing was completed to simulate typical in-use applications." (The document states this testing was done but does not provide specific performance metrics beyond the implication that it was successful.)
Resistance to effects of exposure to UV, visible light, and aggressive chemicals.	"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." (The document states this testing was done but does not provide specific performance metrics beyond the implication that it was successful.)

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

Sample Size for Test Set: The document does not explicitly state the sample size used for the performance tests. It mentions "Performance testing was conducted to verify..." but does not quantify the number of indicators or cycles tested.
Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a submission to the FDA (U.S. Department of Health and Human Services), it's highly likely the testing was either conducted in the USA or under protocols accepted by US regulatory standards. The data provenance is retrospective, as the testing was completed prior to the 510(k) submission.

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

The document does not provide this information. Chemical indicators are typically assessed objectively based on a chemical reaction producing a color change, rather than subjective expert interpretation requiring a "ground truth" established by multiple human experts. The color change is a physical/chemical phenomenon.

4. Adjudication Method for the Test Set

Not applicable for this device. The assessment of a chemical indicator's performance (color change) is objective and typically determined by visual inspection against a reference, not through a human reader adjudication process.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can potentially improve their performance. This chemical indicator is an objective indicator of sterilization process exposure, not a diagnostic tool requiring human interpretation improvement.

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

No. This device is a passive chemical indicator, not an algorithm. Its performance is inherent in its chemical properties and design, observed directly by a human. There is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

The ground truth for the chemical indicator's performance is the objective outcome of exposure to the specified sterilization cycle parameters. That is, whether the indicator was actually exposed to a V-PRO 1 sterilization process that met certain conditions (temperature, sterilant concentration, time). The expected outcome (color change to yellow) is then compared to this objective 'ground truth' of actual exposure.

8. Sample Size for the Training Set

Not applicable. This device is a chemical indicator, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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K072510 STERIS®

510(k) Summary For Verify® V-PRO Chemical Indicator -Versions 1 and 2-

DEC 1 1 2007

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

Contact:

Jack Scoville. Fellow Regulatory Affairs Telephone: (440) 392-7330 Fax No: (440) 357-9198

September 05, 2007 Submission Date:

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

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1. Device Name

Trade Name:	Verify® V-PRO Chemical Indicator.
Models:	Version 1: Verify® V-PRO Chemical Indicator.Version 2: 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).

2. Predicate Device

Chemical Indicator Component of the STERRAD® CycleSure™ Biological Indicator (K994055)

3. Device Description

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

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

4. Intended Use:

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processed and unprocessed units when placed within (Version 1) or affixed to (Version 2) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to yellow, when the device (Version 1) or pack (Version 2) has been exposed to a V-PRO 1 sterilization process. This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization system at 50°C using Vaprox™ HC Sterilant.

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 and the predicate device are limited to differences in design, material, and parameters of the sterilization cycles these indicators are designed to monitor. 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 meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSVAAMI 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 logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, arranged in a cascading manner.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2007

Mr. Jack Scoville Fellow, Regulatory Affairs STERIS. Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

Re: K072510

Trade/Device Name: Verify® V-PRO Chemical Indicator (Versions 1 and 2) Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: November 20, 2007 Received: November 21, 2007

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 such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Judite y. Michau Cais

Chiu Lin, Ph.D. 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): K072510

Device Name: Verify® V-PRO Chemical Indicator (Versions 1 and 2).

Indications For Use:

The Verify® V-PRO Chemical Indicator (Version 1) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2) are Class 1 vaporized hydrogen peroxide sterilization process indicators. They are designed to distinguish between processed and unprocessed units when placed within (Version 1) or affixed to (Version 2) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to vellow, when the device (Version 1) or pack (Version 2) has been exposed to a V-PRO 1 sterilization process. This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization system at 50 °C using Vaprox™ HC Sterilant.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula R. Murphey, MD

K 072510

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).