(89 days)
The Celerity 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers.
The validated steam sterilization cycles include:
- 250°F (121°C) 30-minute gravity .
- 270°F (132°C) 15-minute gravity .
Celerity 20 Steam Process Challenge Device for Gravity Cycles (PCD), contains a Celerity 20 Steam 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 proposed and predicate are identical except for the BI in the PCD.
The provided text describes the CELERITY 20 Steam Process Challenge Device for Gravity Cycles, a medical device for monitoring steam sterilizers. The document is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use - BI Performance | Performance of the BI (Biological Indicator) in the PCD (Process Challenge Device) is equivalent to the performance of the BI in the AAMI (Association for the Advancement of Medical Instrumentation) reference pack in their respective sterilization processes. | PASS |
| Simulated Use - Chemical Integrator Performance | 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. | PASS |
| Simulated Use - Challenge Level | PCD provides an equivalent or greater challenge than the AAMI standardized test pack. | PASS |
| BI in pack vs BI outside of pack | PCD provides a greater challenge to the process than the BI itself. | PASS |
| CI in pack vs CI outside of pack | PCD provides a greater challenge to the process than the integrator by itself. | PASS |
| Chemical Integrator Timing | 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 mentions "Performance testing" and "nonclinical tests" but does not specify the sample size used for the test set of the device.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that this is a 510(k) submission for a new device claiming substantial equivalence, the testing would typically be prospective, and conducted by the manufacturer (STERIS Corporation, based in Mentor, Ohio, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests seem to rely on established physical/chemical principles and AAMI standards for sterilization challenges, rather than on expert human interpretation of results in the way image-based diagnostics might.
4. Adjudication method for the test set:
This information is not applicable to the type of device and testing described. The "adjudication method" usually refers to how discrepancies in expert ratings are resolved for ground truth in diagnostic studies. Here, the "ground truth" is determined by the failure or success of sterilization (based on BI growth or chemical integrator change) in defined challenge conditions.
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:
This information is not applicable to this device. An MRMC study is relevant for diagnostic devices (especially AI-powered ones) where human interpretation is involved. The CELERITY 20 is a process challenge device, and its performance is assessed by biological and chemical indicators reacting to sterilization conditions, not by human readers interpreting images or data for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable to this device. There is no AI algorithm involved in the function or interpretation of this sterilization process challenge device. Its performance is inherent to its physical and biological components.
7. The type of ground truth used:
The ground truth used for this device's performance evaluation is based on biological inactivation (no growth of the Geobacillus stearothermophilus spores in the biological indicator) and chemical reaction (the appropriate change in the chemical integrator) under specified sterilization conditions, relative to established standards like the AAMI reference pack.
Essentially, the ground truth is:
- AAMI standardized test pack performance: The CELERITY 20 PCD is compared against the performance of the standard 16-towel test pack described in ANSI/AAMI ST79.
- Biological indicator viability: Absence of microbial growth after incubation signifies a successful sterilization cycle and inactivation of the biological indicator. Presence of growth signifies failure.
- Chemical integrator endpoint: The chemical integrator changes visibly to indicate exposure to sterilization conditions.
8. The sample size for the training set:
This information is not applicable as this device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set" for this device.
§ 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).