(99 days)
The Celerity™ HP Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
The Celerity™ HP Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for multivariable indicator claims.
The provided text describes the acceptance criteria and study results for the CELERITY HP Chemical Indicator, a medical device used to monitor sterilization cycles. Here's a breakdown of the information requested:
Acceptance Criteria and Device Performance
1. Table of acceptance criteria and the reported device performance:
| Testing | Purpose | Acceptance Criteria | Study Result |
|---|---|---|---|
| Multivariable CI Performance Testing | Demonstrates that the indicator reacts to all critical variables (time, temperature, and sterilant concentration) of the sterilization process. | Pass testing per Table 8 of ISO 11140-1:2014 (complete color change) | Pass. All CI show a complete color change. |
| Fail testing per Table 8 of ISO 11140-1:2014 (incomplete color change) | Pass. All CI show an incomplete color change. | ||
| Endpoint color stability | Demonstrates that the processed indicator color does not significantly change over the labeled time period. | Color remains stable | Pass. Color stable up to 15 months. |
| Simulated Use Testing (Leveraged from K192020) | Demonstrates that the indicator performs as expected in a commercial sterilizer with worst-case load. | Complete color change in a full cycle. Incomplete color change in an abbreviated cycle. | Pass. Complete color change in a full cycle. Incomplete color change in an abbreviated cycle. |
Regarding the other information, the provided text does NOT contain details about the following aspects, which are typically relevant for AI/ML-based medical devices or studies involving human readers:
2. Sample size used for the test set and the data provenance: This information is not explicitly stated. The study refers to "All CI" for the multivariable performance, implying a batch of Chemical Indicators were tested. The provenance (country of origin, retrospective/prospective) is also not detailed, though the manufacturing facility is in the United Kingdom.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This device is a chemical indicator that shows a color change, not an AI/ML system requiring expert interpretation of images. Therefore, expert consensus on ground truth in that context is not applicable. The "ground truth" here is the physical reaction of the chemical indicator to specific sterilization parameters as defined by ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a chemical indicator.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical chemical indicator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical chemical indicator.
7. The type of ground truth used: The ground truth for this device's performance is established by ISO 11140-1:2014 standards for chemical indicators and verified by subjecting the indicators to controlled sterilization conditions with specified time, temperature, and sterilant concentration. The "complete color change" and "incomplete color change" are the physical manifestations defining the ground truth.
8. The sample size for the training set: Not applicable. This is an engineered chemical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 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).