CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT

K020205 · Getinge/Castle, Inc. · FRC · Jun 24, 2002 · General Hospital

Device Facts

• Record ID: K020205
• Device Name: CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT
• Applicant: Getinge/Castle, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Jun 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Castle ® SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated. Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

Device Story

Biological indicator kit for monitoring Steris System 1 liquid chemical sterilization efficacy. Input: chromatography paper strips inoculated with 10^5 G. stearothermophilus spores. Operation: strips placed in sterilizer, processed with 1000 ppm peracetic acid at 50°C, then recovered in Castle Culture Media (modified soybean casein broth) containing phenol red indicator. Output: color change in media indicating presence or absence of viable spores. Used in clinical settings by healthcare personnel to verify sterilization of exterior surfaces of loads. Benefits: provides confirmation of sterilization process efficacy.

Clinical Evidence

Bench testing only. Performance validated by survival/kill time testing: indicator survives 41 seconds and is killed at 6 minutes when exposed to 1,000 ppm peracetic acid at 50°C.

Technological Characteristics

Chromatography paper carrier inoculated with 10^5 G. stearothermophilus spores. Recovery medium: modified soybean casein broth with phenol red indicator. Processing: tension clamp. Sterilization monitoring: liquid chemical (peracetic acid).

Indications for Use

Indicated for monitoring the Steris System 1 liquid chemical sterilization system using Steris 20 sterilant. Contraindicated for monitoring any other sterilization processes.

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

• Steris® Process Biological Indicator Kit (K960570)
• MDT Unispore® and Spor-Test Biological Indicator (K960777)

Submission Summary (Full Text)

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K020205

## 510(k) Summary Statement

| Date Prepared: | June 12, 2002 |
|---------------------------|------------------------------------------------------------------------------------------------------------------|
| Submitter's Name/Address: | Getinge/Castle Inc.<br>1777 East Henrietta Road<br>Rochester, NY 14623 |
| Contact Person: | Karla Byrne, Operations Director, Consumable Products Dept.<br>Telephone: [phone] |
| Trade Name: | Castle® SPOR-TEST PA Biological Indicator Kit (K020205) |
| Classification: | Sterilization Process Indicator - 21 CFR 880.2800 (a)<br>Class II |
| Predicate Devices: | Steris® Process Biological Indicator Kit (K960570)<br>MDT Unispore® and Spor-Test Biological Indicator (K960777) |

### Device Description:

The Castle® SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the Steris® System 1 peracetic acid sterilization process, with Steris 20 sterilant. The product contains chromatography paper strips that are inoculated with Bacillus stearothermophilus (or G. stearothermophilus) spores at a nominal population of 105 per strip. Sterile tubes of Castle Culture Media (modified soybean casein broth) and a transfer clip are included. The materials of construction are equivalent to the Unispore® product. The product is intended to be used in an identical manner as the Steris® Process Biological Indicator Kit.

### Intended Use:

The Castle® SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated. Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid. 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

### Comparison to the Predicate Device: Steris® Process Biological Indicator Kit

- Both devices are exclusively used to monitor the Steris® peracetic acid process. ●
- Both devices are assessed in process conditions of 1000 parts per million peracetic acid at 50°C. ●
- Both devices use a chromatography paper carrier inoculated with 10° B. stearothermophilus ● spores.
- Both devices are processed in the Sterilizer when held by a tension clamp. .
- Both devices are open-loop biological indicators that are recovered in tubes of sterile growth ● medium that uses phenol red as a color change indicator.
- . Both devices may only monitor sterilization efficacy on exterior surfaces to loads processed in the Steris® peracetic acid process.

### Conclusion:

The Castle® SPOR-TEST PA Biological Indicator Kit is substantially equivalent the Steris® Process Biological Indicator Kit for monitoring the Steris ® System 1 peracetic acid process.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2002

Mr. Mark N. Smith Director, Corporate QA/RA Getinge/Castle. Incorporated 1777 East Henrietta Road Rochester, New York 14623-3133

Re: K020205

Trade/Device Name: Castle ® SPOR-TEST PA Biological Indicator Kit Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FRC Dated: April 8, 2002 Received: April 10, 2002

Dear Mr. Smith:

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.

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.

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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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

06/17/02 Date:

K020205 510(k) Number:

Castle® SPOR-TEST PA Biological Indicator Kit Device Name:

Indications for Use:

The Castle ® SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated.

Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
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OR

| Over-The-Counter Use | |
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(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

K020205510(k) Number ---------