SPOR-TEST PA BIOLOGICAL INDICATOR KIT

K050664 · Getinge USA, Inc. · FRC · Apr 7, 2005 · General Hospital

Device Facts

• Record ID: K050664
• Device Name: SPOR-TEST PA BIOLOGICAL INDICATOR KIT
• Applicant: Getinge USA, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Apr 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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

Device Story

Biological indicator kit used to monitor efficacy of Steris System 1 liquid chemical sterilization process. Contains chromatography strips inoculated with Geobacillus stearothermophilus spores and tubes of culture media. Device placed in sterilizer; after cycle, indicator is incubated to determine if spores were killed. Provides visual confirmation of sterilization success. Used in healthcare facilities to ensure equipment safety. Reduces incubation time to 48 hours compared to previous versions.

Clinical Evidence

Bench testing only. Samples from at least 3 lots tested per CDRH guidance for biological indicators. Results demonstrated >97% assurance for 48-hour incubation time.

Technological Characteristics

Biological indicator consisting of chromatography strips inoculated with Geobacillus stearothermophilus spores and modified soybean casein digest broth. Designed for use with Steris System 1 liquid chemical sterilization (peracetic acid).

Indications for Use

Indicated for monitoring the Steris System 1 liquid chemical sterilization system using Steris 20 sterilant. Contraindicated for use in monitoring 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

• Castle SPOR-TEST PA Biological Indicator Kit
• SPOR-TEST PA Biological Indicator Kit (K020205)

Submission Summary (Full Text)

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Getinge USA, Inc.

APR 7 -2005 SPOR-TEST PA Bilogical Indicator Kit

# Attachment 4 510(k) Summary

K050664

# Prepared on February 7, 2005

| Submitter: | Getinge USA, Inc.<br>1777 East Henrietta Rd.<br>Rochester, NY 14623 USA |
|-------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Barb Smith, Operations Manager Consumable Products<br>Telephone: [phone] FAX: [phone] |
| Trade Name: | SPOR-TEST PA Biological Indicator Kit |
| Classification: | Biological Sterilization Process Indicator – 21 CFR 880.2800 (a) Class II |
| Predicate Device: | Castle® SPOR-TEST PA Biological Indicator Kit |

## Device Description:

The SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the Steries System 1 The SPOR-IEST PA Bloogical Indication At is oxcidently interior contains chromatography
and sterilization process, with Steris 20 sterilant. The product negations of 40 peracetic aclu stemization process, with Geobacillus spores at a nominal population of 10
strips that are inoculated with Geobacillus stearothermophilus spores at a licenstic stifps that are inoculated with Geobacilias stearomerified soybean casein digest broth) and a fransfer per strip. Stehle lubes of Gellige Media (modifical manner as the Steris® Process Biological Indicator Kit.

## Intended Use:

The SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liguid The SPOR-TEST FA Blooglear Indicator Title only Internationing other sterilization processes is
chemical sterilization system, with Steris 20 sterilant. Use in monitoring oth Chemical Stehlization System, with Oteno Eventual Second Getinge Culture Media.
contraindicated. SPOR-TEST PA Biological Indicators are qualified using Getinge Cul Contraindicated. SPOR-TEST TTT Biological Indicators and States PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

## Comparison to Unmodified Device:

The SPOR-TEST PA Biological Indicator Kit's manufacturing material, manufacturing methods and The SPOR-TEST PA Diological Indicator TR. STREET PA Biological Indicator Kit (K020205). The storage concilions are the same as the Sacks or 3 days (72 hours) to 2 days (48 hours). Testing per in the in only change is to reduce the mododion time intended to Monitor Sterilizers Used in Health
Premarket Notifications [510(k)] for Biological indicators Intended to Monitor Steri Premaired Notifcations [310(k)] for Blogical Hundton Microsoft H found greater than 97% assurance for a 48 hour readout.

## Description of Testing:

Samples from a minimum of 3 different lots of SPOR-TEST PA were tested according to the Samples Trom a Thinhum of S uncrent loto '6r or Srtended to Monitor Sterilizers Used in Health Premailted Notifications for brokers and FDA Reviewers Appendix H. Results provided greater Care Facilities, Drait Guidanee for Masting time for all lots tested per CDRH Guidelines.

## Conclusion:

The SPOR-TEST PA Biological Indicator Kit is equivalent to the Castle SPOR-TEST PA Biological THE SI OR-1 LOT TTA Blogiour manaker is System 1 peracetic acid sterilization process with Steris 20 Sterilant with the improvement of results available in 48 hours.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, symbolizing care and protection. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 7 2005

Ms. Barb Smith Operations Manager Getingc USA, Incorporated 1777 East Henrietta Road Rochester, New Jersey 14623-3133

Re: K050664

K050004
Trade/Device Name: SPOR-TEST PA Biological Indicator Kit Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: March 11, 2005 Received: March 15, 2005

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(t) promised is substantially equivalent (for the referenced above and have determined the do receile marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predicate and indications for use stated in the chelosarof to togally as and of the Medical Device interstate commerce prior to May 20, 1 7 7 0, the end environment with the provisions of
Amendments, or to devices that have been recordance epprovel of a premarket Amendments, or to devices that have been fees and require approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act that dout subject to the general the Federal Food, Drug, and Cosmetic Free (rice, market the device, subject to the general approval application (I MA). Tou may, includes of the Act include controls provisions of the Act. The general of the estably and manufacturing practice, a requirements for anifall regionst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
n affect If your device is classified (see above) into chirolas Existing major regulations affecting
(PMA), it may be subject to such additional controls. Title 21, Ports 800 to 898 (PMA), it may be subject to such adultional volutions. Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, The Federal your device can be found in the Code of Peachards on the Federal Register.

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# Page 2 - Ms. Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualice of a substantials with other requirements
mean that FDA has made a determination that your device Fodorol agencies mean that FDA has made a decemination that Journalisms administered by other Federal agencies. of the Act or any rederal statutes and regirements, including, but not limited to: registration in You must comply with an the Act 3 requirements and 01); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gray 830'; and i and listing (21 CFR Part 807), laboling (21 OF North (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act);
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) This letter will anow you to begin malicomig your antial equivalence of your device to a premarket notification. The PDA midnig of backanner of 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), a If you desire specific advice for your device at [phone]. Also, please note the regulation please contact the Office of Comphanes at (210) = 11 = 1 Part 8 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = entitled, "Ivisoranding by reference to premation on your responsibilities under the Act its tall f may obtain offer general mionmation on your and Consumer Assistance at its toll-free Division of Simal 2011 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suette H. Michie Oms.

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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SPOR-TEST PA Bilogical Indicator Kit

Getinge USA, Inc.

## Attachment 2 Indications for Use Statement

510(k) Number: _K050664

Device Name: SPOR-TEST PA Biological Indicator Kit

Indications for Use:

The 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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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)

Shuli P. Murphy, 152 Hill B 4/7/65

Tision Sign-Off) ivision of Anesthesiology, General Hospital, Intection Control, Dental Devices

K Number: K050464