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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Propper PASS/FAIL Challenge Pack, a biological/chemical indicator for steam sterilizers. It serves as a premarket notification for a Class II medical device, indicating that its approval is based on substantial equivalence to existing legally marketed devices, rather than comprehensive clinical trial data.

Therefore, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the way a clinical trial report would. Instead, it focuses on demonstrating substantial equivalence.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of "acceptance criteria" with numerical targets and then list "reported device performance" against those targets in the manner of a clinical study report.

Instead, the closest equivalent is the statement under "Substantial Equivalence":
"Composite results from comparative testing of these products are given in the two figures which accompany this summary."

Acceptance Criteria (Implied): The implied acceptance criterion is that the performance of the Propper PASS/FAIL Challenge Pack should be "substantially equivalent" to predicate devices. This means it should demonstrate similar performance characteristics as established, legally marketed biological test packs for steam sterilization.
Reported Device Performance: The document states that "Composite results from comparative testing of these products are given in the two figures which accompany this summary." These figures (which are not included in the provided text) would presumably show the comparative performance data, allowing for an assessment of substantial equivalence.

Without those figures, specific performance metrics cannot be reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated in the provided text. The phrase "comparative testing of these products" suggests tests were conducted, but the number of units tested (sample size) is not given.
Data Provenance: Not specified. It's unclear if the testing was prospective or retrospective, or the country of origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not relevant or applicable to this device. As a biological/chemical indicator, its "ground truth" is determined by its physical and chemical response to specific sterilization conditions (temperature, time, steam penetration) rather than expert interpretation of images or patient outcomes. The performance is assessed by observing a color change or growth/no-growth of microorganisms.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept is not applicable to the evaluation of a biological/chemical indicator. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth from multiple expert interpretations, often in diagnostic imaging, which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done, and is not applicable to this device. MRMC studies are used for evaluating diagnostic devices that involve human interpretation (like AI-assisted imaging). The Propper PASS/FAIL Challenge Pack is a physical indicator, not a diagnostic aid requiring human interpretation in that sense. Its function is to provide a direct readout of sterilization conditions.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: This concept also does not apply to the Propper PASS/FAIL Challenge Pack. It's not an algorithm or software. It is a physical device that responds to environmental conditions. Its "standalone performance" would be its inherent response to steam sterilization conditions, which would have been tested, but it's not described in terms of an algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for a biological/chemical indicator like this is the known, controlled conditions of the steam sterilizer.

For example, if testing at 121°C gravity displacement, the ground truth is that the sterilizer did reach and maintain 121°C for the specified time. The indicator is then observed to see if it correctly registers this (e.g., color change or no growth).
Similarly for prevacuum sterilizers at 134°C.

Essentially, the "ground truth" is established by the physical parameters of the sterilization cycle itself, as measured by calibrated equipment, and verifying if the indicator responds as expected.

8. The sample size for the training set

Training Set Sample Size: Not applicable. The Propper PASS/FAIL Challenge Pack is not an AI/ML device, so it doesn't have a "training set" in the computational sense. Its design and manufacturing are based on chemical and biological principles, not machine learning.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary:

The provided 510(k) summary is for a physical biological/chemical indicator. Many of the questions (experts, adjudication, MRMC, AI, training sets) are designed for evaluating AI/ML-driven diagnostic devices or those requiring complex human interpretation, and therefore do not apply to this submission. The core of this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices through comparative performance testing. The specifics of that comparative testing, including exact acceptance criteria and the detailed data, are referenced as being in accompanying figures, which are not included in the text provided.

Summary

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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 (301) 594-4692. 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 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 (800) 638-2041 or (301) 443-6597 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.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use	X
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		(Optional Format 1-2-96)
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	Qum S. Lin (Division Sign-Off) Division of Dental, Infection Control,and General Hospital Devices 510(k) Number K991276
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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).