The Prior BI O.K." EO Gas Biological Test-Pak is intended for use as a disposable device for the biological monitoring of ethylene oxide sterilizers in health care facilities. Its construction closely duplicates that described for such testing by AAMI/ANSI ST41-1992.

The Propper BI-O.K. Gas Biological Test Pack is indicated for use as an aid or adjunct for use in biological monitoring of ethylene oxide sterilizers only. Its performance was verified versus the standard AAMI pack under the conditions of 600 mg/L ethylene oxide, 60% RH, 54.4 C in a Joslyn BIER vessel using a 10% ethylene oxide, 90% HCFC gas mixture.

Device Description

The BI-O.K. EO Gas Biological Test-Pak consists of a BI-O.K. EO Gas Biological Indicator placed inside a plastic syringe. The syringe along with a Record Card and absorbent towel are enclosed in a paper/plastic peel pouch suitable for use in ethylene oxide sterilizers.

AI/ML Overview

Here's an analysis of the provided text, extracting the requested information about the device's acceptance criteria and studies:

Acceptance Criteria and Study for Propper BI-O.K. EO Gas Biological Test-Pak

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Performance characteristics similar to existing devices for monitoring ethylene oxide sterilization.	Tested in-house in a Joslyn BIER vessel under controlled conditions (60% RH, 600 mg/L ethylene oxide, 54.4°C). The results obtained are similar to those reported for similar devices.
Suitable for its intended use as a disposable device for biological monitoring of ethylene oxide sterilizers in health care facilities.	Based upon indications for use, construction, and performance, deemed "suitable for its intended use" and "substantially equivalent" to established devices like the standard AAMI pack and commercially available test packs from 3M and ATI. Performance was verified versus the standard AAMI pack under specified conditions.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "Performance studies" were done "in-house." This indicates the data was retrospective and likely originated from the manufacturer's own testing facility. Specific country of origin is not explicitly stated beyond "in-house," but given the manufacturer's address in Long Island City, New York, the data likely originates from the United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The "Performance studies" section describes in-house testing in a BIER vessel as the basis for performance evaluation.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Performance was evaluated through direct testing in a controlled environment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biological indicator for a sterilization process, not an imaging device or diagnostic tool that typically involves human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The "Performance studies" describe the device being tested "in-house in a Joslyn BIER vessel to determine the performance characteristics of the system under controlled, reproducible conditions." This indicates algorithm-only performance testing as the device functions independently of human interpretation in its initial role.

7. Type of Ground Truth Used

The ground truth used was direct experimental outcome (sterilization efficacy in a controlled environment). The device's performance was compared to "similar devices" and "the standard AAMI pack," implying a benchmark based on established scientific principles and industry standards for biological indicators.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI component. The device is a biological indicator, which operates on a deterministic biological reaction, not a learned algorithm.

9. How Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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Summary of Safety and Effectiveness

JAN - 9 1998

510(k) Submission K97 _2747

Propper BI-O.K. EO Gas Biological Test-Pak

General Information:

Submitters Name/Address:

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

Common Name of the Device:

Biological/Chemical Indicator

Trade Name of the Device:

BI-O.K.Th Ethylene Oxide Gas Biological Test-Pak

Classification Information:

Class II

Sterilization Process Indicator

Indications for Use:

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Device Description:

。

Substantial Equivalence:

The Propper BI-O.K. EO Gas Biological Test-Pak is substantially equivalent to the standard pack described by AAMI as well as commercially available test packs marketed by 3M and ATI which employ biological indicators for monitoring ethylene oxide sterilization in health care facilities.

Performance studies:

The Propper BI-O.K. EO Gas Biological Test-Pak was tested in-house in a Joslyn BIER vessel to determine the performance characteristics of the system under controlled, reproducible conditions consisting of 60% RH, 600 mg/L ethylene oxide and 54.4°C. The results obtained are similar to those reported for similar devices.

Conclusion:

Based upon the indications for use, construction, and performance, the Propper BI-O.K. EO Gas Biological Test-Pak has been shown to be suitable for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with arms outstretched, embracing a stylized cross.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 1998

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

K972747 Re : BI-0.K.™ EO Gas Biological Test-Pak Trade Name: (269305,269310,269320) Requlatory Class: II Product Code: FRC November 17, 1997 Dated: Received: November 20, 1997

Dear Dr. Dyekman:

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 aqainst 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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Paqe 2 - Dr. Dyekman

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 requlations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Clifford

v A. 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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510(k) Number (if known):

Device Name:_

Indications For Use:

INDICATIONS FOR USE

Page

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chim S. Lim

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number: K972747

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use X

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).