BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR

K080750 · STERIS Corporation · JOJ · May 12, 2008 · General Hospital

Device Facts

• Record ID: K080750
• Device Name: BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: May 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Browne Rapicide Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Rapicide® High-Level Disinfectant and Sterilant at 35 °C cleared under K993042. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperaturesensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%.

Device Story

Chemical indicator strip for monitoring glutaraldehyde concentration in Rapicide® High-Level Disinfectant and Sterilant. Consists of absorbent paper pad impregnated with reactive chemicals, adhesively bonded to polymer film. Used in clinical settings to verify solution efficacy at 35 °C. Operator dips strip into solution; color change indicates whether glutaraldehyde concentration exceeds 1.5% MRC. Provides immediate visual feedback to healthcare personnel, enabling decision-making regarding reuse of disinfectant solution for instrument reprocessing. Benefits patient by ensuring instruments are reprocessed in solution with adequate disinfectant concentration.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Chemical indicator strip; absorbent paper pad impregnated with reactive chemicals; adhesively bonded to polymer film. Single-use. Designed for use with Rapicide® solution at 35 °C.

Indications for Use

Indicated for monitoring glutaraldehyde concentration in Rapicide® High-Level Disinfectant and Sterilant solutions to ensure levels remain above the 1.5% minimum recommended concentration (MRC) for safe reuse in reprocessing temperature-sensitive and other instruments.

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

• 3M™ ComplyTM Cold Sterilog™ Glutaraldehyde Monitor (K915170)

Reference Devices

• Rapicide® High-Level Disinfectant and Sterilant (K993042)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "K080750" at the top left corner and the phrase "page 1 of 3" at the top right corner. Below that is the word "STERIS" in large, bold letters. At the bottom of the image, there is a graphic of several horizontal wavy lines stacked on top of each other.

MAY 12 2008

# 510(k) Summary For Browne Rapicide Glutaraldehyde Indicator

Albert Browne Ltd., a subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom Phone: [phone] Fax No: [phone]

Contact:

John Robert (Jack) Scoville. Fellow Regulatory Affairs Telephone:[phone] Fax No: [phone]

Summary Date:

March 13, 2008

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

March 13, 2008

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#### 1. Device Name

| Trade Name: | Browne Rapicide Glutaraldehyde Indicator |
|----------------------|-----------------------------------------------------------------------------------------------|
| Common/usual Name: | Browne Rapicide Test Strip |
| Classification Name: | Physical/chemical sterilization process indicator (21<br>CFR 880.2800 (b), Product Code JOJ). |

#### 2. Predicate Device

- K915170 3M™ ComplyTM Cold Sterilog™ Glutaraldehyde Monitor ● 3983MM.
#### 3. Description of Device

The Browne Rapicide Glutaraldehyde Indicator is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The Browne Rapicide Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Rapicide® High-Level Disinfectant (K993042) and Sterilant solution at 35 °C that has an MRC of 1.5% glutaraldehyde.

#### 4. Intended Use

The Browne Rapicide Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Rapicide® High-Level Disinfectant and Sterilant at 35 °C cleared under K993042. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperaturesensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%.

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K080750
page 3 of 3

#### Description of Safety and Substantial Equivalence 5.

The proposed and predicate devices are all single use indicators used to monitor glutaraldehyde concentration in specific solutions. The differences between the proposed Browne Rapicide Glutaraldehyde Indicator and predicate devices are limited to differences in the device design and materials. These differences do not raise any new issues of safety and efficacy.

A summary of the technological characteristics of the new device in comparison to those of the predicate devices is provided in Section 12 of this premarket notification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Scoville Fellow Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

MAY 12 2008

Re: K080750

Trade/Device Name: Browne Rapicide Glutaraldehyde Indicator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: March 13, 2008 Received: March 17, 2008

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sydtie y. Michael Davis

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

KO80750 510(k) Number (if known):

Device Name: Browne Rapicide Glutaraldehyde Indicator

Indications for Use:

The Browne Rapicide Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Rapicide® High-Level Disinfectant and Sterilant. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperature-sensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Shale A. Murphy, 4

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: Kos0730