STERIS RESERT XL TEST STRIP

K081600 · STERIS Corporation · JOJ · Aug 22, 2008 · General Hospital

Device Facts

• Record ID: K081600
• Device Name: STERIS RESERT XL TEST STRIP
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Aug 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERIS Resert XL Test Strip is a high level disinfectant concentration monitor dedicated for use with Resert® XL HLD High-Level Disinfectant. The purpose of the STERIS Resert XL Test Strip is to determine whether the concentration of a Resert XL HLD High-Level Disinfectant solution is above the minimum recommended concentration (MRC) of 1.5%. The STERIS Resert XL Test Strip only indicates hydrogen peroxide concentration and does not confirm disinfection.

Device Story

The STERIS Resert XL Test Strip is a single-use chemical indicator designed to monitor the concentration of Resert XL HLD High-Level Disinfectant. The device consists of an absorbent paper pad impregnated with reactive chemicals, adhesively bonded to a polymer film. The user dips the strip into the disinfectant solution; the strip provides a visual indication of whether the hydrogen peroxide concentration is above the 1.5% minimum recommended concentration (MRC). It does not confirm the efficacy of the disinfection process itself. It is intended for use in clinical settings where Resert XL HLD is utilized.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use chemical indicator strip; absorbent paper pad impregnated with reactive chemicals; adhesively bonded to a polymer film; monitors hydrogen peroxide concentration.

Indications for Use

Indicated for monitoring the concentration of Resert XL HLD High-Level Disinfectant to ensure it remains above the minimum recommended concentration (MRC) of 1.5%.

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

• SPOROX™ Test Strips (K972035)
• Browne Metrex 1.8% Glutaraldehyde Indicator (K012335)

Submission Summary (Full Text)

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AUG 2 2 2008

# 510(k) Summary For STERIS Resert XL Test Strip

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STERIS Corporation 5960 Heisley Road Mentor OH 44060-1834

Contact:

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

Summary Date:

August 08, 2008

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

CONFIDENTIAL

August 08, 2008

B-2

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#### 1. Device Name

| Trade Name: | STERIS Resert XL Test Strip |
|----------------------|-----------------------------------------------------------------------------------------------|
| Common/Usual Name: | Resert XL Test Strip |
| Classification Name: | Physical/chemical sterilization process indicator<br>(21 CFR 880.2800 (b), Product Code JOJ). |

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### 2. Predicate Devices

- . K972035 - SPOROX™ Test Strips
- . K012335 - Browne Metrex 1.8% Glutaraldehyde Indicator

### 3. Description of Device

The STERIS Resert XL Test Strip 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 STERIS Resert XL Test Strip has been developed to monitor the Resert® XL HLD High-Level Disinfectant (K080420) that has an MRC of 1.5%.

### 4. Intended Use

The STERIS Resert XL Test Strip is a high level disinfectant concentration monitor dedicated for use with Resert XL HLD High-Level Disinfectant. The purpose of the STERIS Resert XL Test Strip is to determine whether the concentration of a Resert XL HLD High-Level Disinfectant solution is above the minimum recommended concentration (MRC) of 1.5%.

The STERIS Resert XL Test Strip only indicates hydrogen peroxide concentration and does not confirm disinfection.

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

The proposed and predicate devices are all single use indicators used to monitor either hydrogen peroxide or glutaraldehyde concentration in specific solutions. The differences between the proposed STERIS Resert XL Test Strip and predicate devices are limited to differences in the device design, materials and concentration range being monitored. These differences do not raise any new issues of safety and efficacy.

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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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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 its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2008

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

Re: K081600

Trade/Device Name: STERIS Resert XL Test Strip Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 6, 2008 Received: June 6, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contant the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Sreall 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 vours.

Chiu S. Lin, Ph. D.

Chiu S. Lin, Ph. D 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): K081600

Device Name:

STERIS Resert XL Test Strip

Indications for Use:

The STERIS Resert XL Test Strip is a high level disinfectant concentration monitor dedicated for use with Resert® XL HLD High-Level Disinfectant. The purpose of the STERIS Resert XL Test Strip is to determine whether the concentration of a Resert XL HLD High-Level Disinfectant solution is above the minimum recommended concentration (MRC) of 1.5%.

The STERIS Resert XL Test Strip only indicates hydrogen peroxide concentration and does not confirm disinfection.

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)

Shule A Murphy
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K081600

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CONFIDENTIAL