(109 days)
The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.
The validated steam sterilization cycles include:
- · 250°F (121°C) 30-minute gravity
- · 270°F (132°C) 15-minute gravity
The VERIFY Assert Self-Contained Indicator within the Process challenge device must be used with the VERIFY Incubator for Assert Self Contained Biological Indicators. When used in conjunction with the VERIFY Incubator for Assert Self Contained Biological Indicators, the VERIFY Assert Self-Contained Indicator within the Process challenge device provides a fluorescent result within 40 minutes.
The VERIFY"" Assert" |STEAM Process Challenge Device for Gravity Cycles (Gravity PCD), contains a VERIFY Assert Self-Contained Biological Indicator (SCBI) and a steam chemical integrator, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79.
The STERIS VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles does not involve AI or human readers, therefore, many of the requested categories are not applicable.
Here's a summary of the acceptance criteria and study information for this device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | Performance of the BI in the PCD is equivalent to the performance of the BI in the AAMI reference pack in their respective sterilization processes. Performance of the chemical integrator in the PCD is equivalent to the performance of the chemical integrator in AAMI reference pack in their respective processes. PCD provides an equivalent or greater challenge than the AAMI standardized test pack. | PASS |
| BI in pack vs BI outside pack | PCD provides a greater challenge to the process than the BI itself. | PASS |
| CI in pack vs CI outside pack | PCD provides a greater challenge to the process than the integrator by itself. | PASS |
| Chemical Integrator | Chemical integrator does not reach endpoint before BI is inactivated. | PASS |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each test. However, it indicates "Simulated use testing was done side-by-side with the predicate device". The data provenance is derived from these non-clinical tests conducted by STERIS Corporation. The data is prospective as it describes testing specifically designed for the device's clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a sterilization process challenge device, not a diagnostic or AI-powered medical device requiring expert interpretation of results. The "ground truth" is based on the inactivation of biological indicators and the chemical changes in integrators under controlled sterilization conditions, in comparison to an established standard (AAMI reference pack).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The tests involve quantifiable outcomes (e.g., biological indicator inactivation, chemical integrator endpoint attainment) rather than subjective expert adjudication.
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:
Not applicable. This is not an AI-powered device or a device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device's performance is inherently "standalone" in the sense that it functions to indicate sterilization efficacy without human interpretation of complex data or algorithms. Its results (fluorescent or non-fluorescent, chemical change) are read by an automated incubator/reader for the BI and visually for the chemical integrator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth is established based on:
- Biological Inactivation: The complete inactivation of Geobacillus stearothermophilus spores within the biological indicator, as confirmed by the absence of fluorescence after incubation. This aligns with standard microbiological principles for sterilization efficacy.
- Chemical Integrator Response: The visible change in the chemical integrator, indicating exposure to specific sterilization parameters (time, temperature, steam).
- Comparison to AAMI Reference Pack: The performance of the VERIFY™ Assert™ PCD is compared against the "standard 16-towel test pack described in ANSI/AAMI ST79," which serves as a recognized gold standard for validating sterilization processes.
Essentially, the "ground truth" is a set of established physical and biological parameters for effective steam sterilization.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
§ 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).