FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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).