VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL

K091174 · STERIS Corporation · JOJ · Oct 27, 2009 · General Hospital

Device Facts

• Record ID: K091174
• Device Name: VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Oct 27, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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:

Device Story

Verify® V-PRO Chemical Indicators (Version 1A and 2A) serve as visual process indicators for vaporized hydrogen peroxide sterilization. Version 1A consists of an indicator spot on an inert polymeric substrate; Version 2A is an adhesive label on a spun bonded polyolefin substrate. Indicators are placed within or affixed to sterilization packs. Upon exposure to specific cycle conditions (50°C, Vaprox™ HC sterilant, defined exposure times), the indicator undergoes a chemical reaction causing a visible color change from magenta to yellow. This provides immediate visual confirmation to healthcare personnel that the pack has been exposed to the sterilization process. The device does not indicate sterility, but distinguishes processed from unprocessed units.

Clinical Evidence

Bench testing only. Testing verified compliance with ANSI/AAMI/ISO 11140-1:2005 for Class 1 indicators. Additional testing simulated in-use applications and evaluated performance stability under exposure to UV, visible light, and aggressive chemicals.

Technological Characteristics

Class 1 chemical indicator. Version 1A: inert polymeric substrate with transparent laminate. Version 2A: spun bonded polyolefin substrate with adhesive backing. Sensing principle: chemical ink color change (magenta to yellow) triggered by temperature, sterilant concentration, and duration. Conforms to ANSI/AAMI/ISO 11140-1:2005.

Indications for Use

Indicated for use as a Class 1 vaporized hydrogen peroxide sterilization process indicator to distinguish between processed and unprocessed units in Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems. Applicable to sterilization wraps, trays, or pouches.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

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

Submission Summary (Full Text)

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# STERIS

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

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STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact:

Robert F. Sullivan Senior Director STERIS FDA Regulatory Affairs Telephone: [phone] Fax No: [phone]

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.<br>Version 2A: Verify® V-PRO Chemical Indicator Adhesive Label. |
| Common Name: | Chemical Indicator. |
| Classification Name: | Physical/chemical sterilization process indicator (21 CFR<br>880.2800 (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 .

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.

#### Indication for Use: 4.

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

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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.

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 | Sterilant<br>Concentration | Cycle Type | Exposure<br>Time |
|----------------------|-------------|------------------------------|------------|------------------|
| Verify<br>Version 1A | 50 °C | 2.1 g H2O2 x 4<br>injections | Lumen | 32 minutes |
| Verify<br>Version 2A | 50 °C | 2.1 g H2O2 x 4<br>injections | Lumen | 32 minutes |
| Verify<br>Version 1A | 50 °C | 2.1 g H2O2 x 4<br>injections | Non-Lumen | 12 minutes |
| Verify<br>Version 2A | 50 °C | 2.1 g H2O2 x 4<br>injections | 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 [phone] or [phone] 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:

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 | Sterilant<br>Concentration | Cycle Type | Exposure<br>Time |
|----------------------|-------------|------------------------------|------------|------------------|
| Verify<br>Version 1A | 50 °C | 2.1 g H2O2 x 4<br>injections | Lumen | 32 minutes |
| Verify<br>Version 2A | 50 °C | 2.1 g H2O2 x 4<br>injections | Lumen | 32 minutes |
| Verify<br>Version 1A | 50 °C | 2.1 g H2O2 x 4<br>injections | Non-Lumen | 12 minutes |
| Verify<br>Version 2A | 50 °C | 2.1 g H2O2 x 4<br>injections | 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