Propper Vapor Line PCD is a process challenge test device for use in pre-vacuum steam sterilization processes at 273.2°F/134°C. It consists of a capsule with a removable cap and sample holder to permit the positioning and removal of the Propper Vapor Line Integrator. One end of the capsule is connected to a lumen. During the sterilization cycle, the open end of the lumen permits residual air to exit and steam to enter the capsule The integrator display will indicate whether or not sterilization conditions were attained inside the metal capsule.

AI/ML Overview

Acceptance Criteria and Device Performance for Propper Vapor Line PCD Steam Sterilization Process Challenge Test

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal, quantitative acceptance criteria for the Propper Vapor Line PCD Steam Sterilization Process Challenge Test (PCD), beyond the general statement that it "will not indicate acceptable 'PASS' results until after complete spore death has occurred." However, based on the comparative testing against the predicate device (Propper Bio-Challenge Test-Pak, referred to here as Predicate) and the subsequent multiple device equivalency study, we can infer the performance expectations.

The primary inferred acceptance criterion is that the PCD should demonstrate equivalent or better performance in challenging steam sterilization conditions compared to the Predicate, specifically by failing (indicating non-sterilization) when spore death has not occurred and passing (indicating sterilization) when spore death has occurred, under controlled exposure times.

Acceptance Criterion (Inferred)	Reported Device Performance (Propper Vapor Line PCD)
For challenging sterilization conditions: The device should consistently indicate "FAIL" when spore death has not occurred, matching or exceeding the challenge presented by the predicate device.	At 0.25, 0.60, 1.00, and 1.50 minutes exposure (where `Duo-Spore` showed 0% survival, but `BI-O.K.` showed survival up to 0.60 minutes), the `PCD` showed 100% fail. This demonstrates a strong challenge to sterilization conditions. At 1.75 minutes, where `Duo-Spore` and `BI-O.K.` showed 0% survival, `PCD` still showed 15% fail, indicating a more rigorous challenge.
For effective sterilization conditions: The device should consistently indicate "PASS" when complete spore death has occurred, matching or exceeding the predicate device.	At 2.00 minutes exposure, where both `Duo-Spore` and `BI-O.K.` showed 0% survival, the `PCD` showed 0% fail, meaning 100% pass. This aligns with effective sterilization.
Reproducibility across multiple devices: Multiple `PCD` units should exhibit similar performance characteristics under identical challenge conditions.	In the multiple device equivalency study, at 1.50 minutes, all 5 `PCD` units showed 100% fail. At 1.75 minutes, individual `PCD` units showed fail rates ranging from 2/6 (33%) to 4/6 (67%), with an overall average of 47% fail for the `PCD` group. At 2.00 minutes, all `PCD` units showed 0% fail. This indicates comparable performance among the different `PCD` units.

2. Sample Size and Data Provenance

The study utilized two main test sets:

Comparative Testing (PCD vs. Predicate):
- Exposure Time 0.25 min: 5 tests for PCD, 5 for Duo-Spore, 5 for BI-O.K..
- Exposure Time 0.60 min: 20 tests for PCD, 20 for Duo-Spore, 20 for BI-O.K..
- Exposure Time 1.00 min: 20 tests for PCD, 20 for Duo-Spore, 20 for BI-O.K..
- Exposure Time 1.50 min: 5 tests for PCD, 5 for Duo-Spore, 5 for BI-O.K..
- Exposure Time 1.75 min: 20 tests for PCD, 20 for Duo-Spore, 20 for BI-O.K..
- Exposure Time 2.00 min: 20 tests for PCD, 20 for Duo-Spore, 20 for BI-O.K..
- Total number of PCD tests: 90
- Data Provenance: The document does not explicitly state the country of origin. Given the submitter information (Propper Manufacturing Co., Inc., Long Island City, NY) and the FDA 510(k) submission, it is highly probable the data was generated in the United States. The study involved experimental cycles run in a steam sterilizer, indicating a prospective experimental design.
Multiple Device Equivalency Study:
- Exposure Time 1.50 min: 5 tests (1 from each of 5 PCD devices).
- Exposure Time 1.75 min: 30 tests (6 from each of 5 PCD devices).
- Exposure Time 2.00 min: 30 tests (6 from each of 5 PCD devices).
- Total number of PCD tests: 65
- Data Provenance: Similar to the comparative testing, likely United States and prospective experimental data.

3. Number of Experts and Qualifications for Ground Truth

The concept of "experts" in the traditional sense (e.g., radiologists interpreting images) is not directly applicable here. The ground truth for sterilization efficacy is established by biological indicators (BIs), which are scientifically recognized methods for verifying sterilization.

For the comparative testing:

Duo-Spore indicator: A spore strip that is aseptically removed and incubated in trypticase soy broth for seven days. Viable spores (survival) indicate a failure of sterilization.
BI-OK indicator: A vial activated and incubated for 48 hours. Growth indicates a failure of sterilization.

The interpretation of these biological indicators (e.g., checking for growth) would be conducted by trained laboratory personnel following established protocols, rather than "experts" in a diagnostic medical imaging context. The document does not specify the number or qualifications of individuals performing these readings, as it's a standard laboratory procedure.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used for subjective assessments (e.g., expert interpretation disagreements). This study involves objective readings:

PCD: "PASS" or "FAIL" reading based on the integrator display.
Duo-Spore: Growth or no growth after incubation.
BI-OK: Growth or no growth after incubation.

Since these are objective outcomes, an explicit adjudication method for reconciling disagreements between human readers is not mentioned, as it would be unnecessary. Discrepancies would likely point to experimental error or issues with the indicator itself, not subjective interpretation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the context of human readers improving with AI vs. without AI assistance. This device is a process challenge test for steam sterilizers, not an AI-powered diagnostic tool. The "readers" are the devices themselves (PCD, Duo-Spore, BI-OK) or the trained personnel observing their objective outputs.

6. Standalone Performance (Algorithm Only)

Yes, the study primarily assessed the standalone performance of the Propper Vapor Line PCD. The device's "PASS" or "FAIL" reading is an intrinsic characteristic of the device itself, determined by its design and the chemical integrator within it. It acts independently to indicate whether sterilization conditions were met. Its performance was then compared to established biological indicators.

7. Type of Ground Truth Used

The primary ground truth used for establishing the effectiveness of the Propper Vapor Line PCD was biological indicators (BIs), specifically:

Duo-Spore indicator: Represents the "gold standard" for sterility assurance, as it directly assesses the death of highly resistant bacterial spores.
BI-OK indicator: Another type of biological indicator used to confirm sterilization conditions.

These BIs provide an objective measure of whether sterilization was achieved (spore death) or not (spore survival).

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This device is a physical/chemical indicator, not an algorithm that requires training data. Its design and performance are based on physical and chemical principles, not learned from a dataset.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" for this device, the question of how ground truth was established for it is not applicable. The device's function is dictated by its manufacturing and the chemical reaction of its integrator, not by a learning process from data.

Summary

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AUG 1 7 2004

510(k) SUMMARY

Propper Vapor Line PCD Steam Sterilization Process Challenge Test 510(k) Number: K031152

Submitter Information:	Propper Manufacturing Co., Inc.36-04 Skillman AvenueLong Island City, NY 11101Attn: Frank E. Platko, Ph.D.Telephone: (718) 392-6650 Ext. 264
Device Name:	(Trade:) Propper Vapor Line PCD Steam Sterilization Process Challenge Test(Common:) Steam Chemical Indicator(Classification:) Physical/Chemical Sterilization Process Indicator
Substantial EquivalenceDevice:	Propper Bio-Challenge Test-Pak
Device Description:	Propper Vapor Line PCD is a process challenge test device for use in pre-vacuum steam sterilization processes at 273.2°F/134°C. It consists of acapsule with a removable cap and sample holder to permit the positioningand removal of the Propper Vapor Line Integrator. One end of the capsuleis connected to a lumen. During the sterilization cycle, the open end of thelumen permits residual air to exit and steam to enter the capsule Theintegrator display will indicate whether or not sterilization conditions wereattained inside the metal capsule.
Intended UseOf Device:	The Propper Vapor Line PCD is indicated for use in routine challengetesting steam sterilizers in pre-vacuum cycles operating at 273.2°F/134°C.
TechnologicalCharacteristics:	The Propper Vapor Line PCD and Propper Bio-Challenge Test-Pak areboth Steam Process Challenge test devices designed for use in steamsterilization processes. They are similar in function but differ in designand construction.
	The challenge to steam penetration presented by the Propper Vapor LinePCD is controlled by the length, bore and configuration of the lumenwhich is the only opening into the capsule. Whereas the corresponding

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510(k) Summary---continued

	challenge by the Propper Bio-Challenge Test-Pak is determined by a steam-resistant paper load and a rate controlling barrier film.
NonclinicalTests:	The safety and effectiveness of the Propper Vapor Line PCD Steam Sterilization Process Challenge Test were determined by comparing the performance characteristics of this device directly to that of the Propper Bio-Challenge Test-Pak in side-by-side testing in a steam sterilizer.Before each test cycle, a Propper Vapor Line Integrator was placed into the slot of the PCD sample holder which was then inserted into the body of the metal capsule and secured in position with the screw cap. The PCD device was placed inside the sterilizer chamber on the lower rack over the drain, side-by-side with two Propper Bio-Challenge Test-Paks. One pack contained a Duo-Spore indicator and the other a BI-OK indicator. Then, a conventional 4-pulse pre-vacuum steam sterilization cycle was run. Cycle tests were run at 273.2°F/134°C for different exposure times.After each sterilization cycle, the Vapor Line integrator was retrieved and examined to determine the “PASS” or “FAIL” reading. The Duo-Spore strip was aseptically removed from its glassine envelope, transferred to trypticase soy broth and incubated at 56°C. The spore strip was examined for growth on a daily basis for seven days. The BI-OK vial was activated, incubated at 56°C for 48 hours and then examined for growth. A second sterilizer study was conducted to establish multiple device equivalency. Complete test results appear in tabular form at the end of this summary
TestConclusions:	The Propper Vapor Line PCD is a highly reproducible challenge test. It will not indicate acceptable “PASS” results until after complete spore death has occurred. Based on the performance data, the test is safe and effective for its intended use. It is substantially equivalent in performance to commercial biological challenge tests used in pre-vacuum steam sterilizer cycle testing.

challenge by the Propper Bio-Challenge Test-Pak is determined by a steam-resistant paper load and a rate controlling barrier film.

NonclinicalTests:

The safety and effectiveness of the Propper Vapor Line PCD Steam Sterilization Process Challenge Test were determined by comparing the performance characteristics of this device directly to that of the Propper Bio-Challenge Test-Pak in side-by-side testing in a steam sterilizer.Before each test cycle, a Propper Vapor Line Integrator was placed into the slot of the PCD sample holder which was then inserted into the body of the metal capsule and secured in position with the screw cap. The PCD device was placed inside the sterilizer chamber on the lower rack over the drain, side-by-side with two Propper Bio-Challenge Test-Paks. One pack contained a Duo-Spore indicator and the other a BI-OK indicator. Then, a conventional 4-pulse pre-vacuum steam sterilization cycle was run. Cycle tests were run at 273.2°F/134°C for different exposure times.After each sterilization cycle, the Vapor Line integrator was retrieved and examined to determine the “PASS” or “FAIL” reading. The Duo-Spore strip was aseptically removed from its glassine envelope, transferred to trypticase soy broth and incubated at 56°C. The spore strip was examined for growth on a daily basis for seven days. The BI-OK vial was activated, incubated at 56°C for 48 hours and then examined for growth. A second sterilizer study was conducted to establish multiple device equivalency. Complete test results appear in tabular form at the end of this summary

TestConclusions:

The Propper Vapor Line PCD is a highly reproducible challenge test. It will not indicate acceptable “PASS” results until after complete spore death has occurred. Based on the performance data, the test is safe and effective for its intended use. It is substantially equivalent in performance to commercial biological challenge tests used in pre-vacuum steam sterilizer cycle testing.

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VAPOR LINE PCD vs BIO-CHALLENGE TEST-PAK Exposure Time vs % Fail/Survival

273.2F(134C)
Exposure Time (min.)	0.25	0.60	1.00	1.50	1.75	2.00
% Survived (Duo-Spore)*	0	0	0	0	0	0
% Survived (BI-O.K.)	80	40	0	0	0	0
% Fail (Propper Vapor Line PCD)	100	100	100	100	15	0
Total No. of Tests	5	20	20	5	20	20

Complete spore death occurred prior to 0.25 minutes exposure

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PROPPER VAPOR LINE PCD MULTIPLE DEVICE EQUIVALENCY STUDY

Temperature @ 273.2F/134C

Exposure Time (min.)	1.50	1.75	2.00
	Fail/Total	Fail/Total	Fail/Total
PCD 1*	1/1	3/6	0/6
PCD 2	1/1	4/6	0/6
PCD 3	1/1	3/6	0/6
PCD 4	1/1	2/6	0/6
PCD 5	1/1	2/6	0/6
% FAIL (Vapor Line PCD)	100	47	0
Total Number of Tests	5	30	30

PCD # I also used in comparative testing vs Bio-Challenge Test Pak

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Image /page/4/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 a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2004

Dr. John D. Dyckman Vice President, Research and Development Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101

Re: K031152

Trade/Device Name: Propper Vapor Line PCD Steam Sterilization Process Challenge Test Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: May 28, 2004 Received: June 2, 2004

Dear Dr. Dyckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your end have determined the device is substantially equivalent (for the recroniced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinons, or to arretic Act (Act) that do not require approval of a premarket the Federal F 60a; Drag). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 (1 Nr.), it may of such to back of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Dr. Dyckman

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. 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 and ifements as set forth in the quality systems (QS) 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ques

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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K031152 510(k) Number (if known):_

Device Name: Propper Vapor Line PCD Steam Sterilization Process Challenge Test

Indications For Use:

The PROPPER VAPOR LINE PCD is indicated for use as a routine process challenge test for steam sterilizers in pre-vacuum cycles at 273.2°F/134°C.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kai Murray

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental

510(k) Number: K031152

Prescription Use (Pcr 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Formal 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).