PASS/FAIL CHALLENGE PACK

K991276 · Propper Mfg. Co., Inc. · JOJ · Jul 12, 1999 · General Hospital

Device Facts

• Record ID: K991276
• Device Name: PASS/FAIL CHALLENGE PACK
• Applicant: Propper Mfg. Co., Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Propper PASS/FAIL Challenge Pack is indicated for use in testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.

Device Story

The PASS/FAIL Challenge Pack is a sterilization process indicator used to monitor steam sterilizer performance. It consists of a Propper Vapor Line steam sterilization integrator housed within a test pack, designed to simulate the construction of the Propper BI-O.K. steam sterilization test pack. The device is placed inside a sterilizer during a cycle; the integrator undergoes a chemical change in response to steam, temperature, and time. Healthcare personnel observe the integrator output to determine if the sterilization cycle parameters were met. This provides a visual pass/fail result, assisting in the verification of sterilizer efficacy.

Clinical Evidence

Bench testing only. Comparative performance testing against existing biological test packs was conducted to validate the device's ability to monitor steam sterilization cycles.

Technological Characteristics

Consists of a chemical steam sterilization integrator (Vapor Line) enclosed in a test pack. The test pack construction mimics the Propper BI-O.K. test pack. Operates via chemical indicator response to steam sterilization parameters (time, temperature, steam).

Indications for Use

Indicated for testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.

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.

Reference Devices

• Propper BI-O.K. steam sterilization test pack

Submission Summary (Full Text)

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JUL 12 1939

# SUMMARY OF SAFETY AND EFFECTIVENESS

510 (k) Submission K99 [2]

# Propper PASS/FAIL Challenge Pack

General Information:

Submitter's Name/Address:

Propper Manufacturing Co., Inc. 36-04 Skillman Avenue Long Island City, NY 11101 Attn: John D. Dyckman, Ph.D.

Common Name of the Device:

Biological/Chemical Indicator

Trade Name of the Device:

PASS/FAIL Challenge Pack

Classification Information:

Class II, Sterilization Process Indicator

#### Indications for Use:

The Propper PASS/FATL Challenge Pack is indicated for use in testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.

Device Description:

The PASS/FAIL Challenge Pack consists of a Propper Vapor Line steam sterilization integrator placed inside a test pack similar in construction to the Propper BT- O.K. M steam sterilization test pack.

### Substantial Equivalence:

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The PASS/FAIL Challenge Pack consists of a Propper Vapor Line steam sterilization integrator placed inside a test pack similar in construction to the Propper BI- O.K.™ steam sterilization test pack.

# Substantial Equivalence:

The Propper PASS/FAIL Challenge Pack is substantially equivalent to several biological test packs marketed for testing steam sterilization at 121° C in gravity displacement sterilizers or at 132-134°C in prevacuum sterilizers. Composite results from comparative testing of these products are given in the two figures which accompany this summary.

# Conclusion:

Based upon the indications for use and documented performance, the Propper PASS/F AIL Challenge Pack has been shown to be both safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1.2 1999

John D. Dyckman, Ph.D. Vice President Product Research Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101 USA

Re : K991276 PASS/FAIL™ Challenge Pack Trade Name: II Requlatory Class: Product Code: JOJ Dated: May 20, 1999 Received: May 21, 1999

Dear Dr. Dyckman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Dyckman

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 requlation entitled, "Misbranding by reference to ene regaration chercloud "hisbranding by other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Simon Kummer

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

Enclosure

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510(k) Number (if known):

. Device Name:________________________________________________________________________________________________________________________________________________________________ PASS/FAIL Challenge Pack

Indications For Usc:

The Propper PASS/FAIL Challenge Pack is indicated for use in testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use | X |
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| | | (Optional Format 1-2-96) |
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| | <div align="left"> <p><u>Qum S. Lin</u></p> <p>(Division Sign-Off)</p> <p>Division of Dental, Infection Control,<br/>and General Hospital Devices</p> <p>510(k) Number <u>K991276</u></p> </div> |
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