(105 days)
The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent montoring of the following STERRAD Sterlization Systems and has been validated for use in health care facilities:
- . STERRAD 100S
- o STERRAD 50
- . STERRAD 200
- o STERRAD NX®
- . STERRAD 100NX® (Standard, Flex and Express Cycles)
- For STERRAD 100NX DUO Cycle in the United States, the STERRAD CYCLESURE 24 Biological 0 Indicator should only be used in a test pack configuration (REF 20243).
The STERRAD CYCLESURE 24 Biological Indicator (BI) is a self-contained stand- alone biological monitor intended for the routine monitoring of the STERRAD Sterilization Process. It consists of a glass fiber disc containing a minimum of 1x106 Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion.
The document describes a 510(k) premarket notification for the STERRAD® CYCLESURE® 24 Biological Indicator. The primary modification being sought is an extension of the labeled shelf life from 6 months to 9 months. The information provided focuses on demonstrating that this shelf life extension does not impact the device's performance or safety.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Specifications Maintained) | Reported Device Performance |
|---|---|
| Spore Population | Passed |
| Resistance Characteristics (D-value) | Passed |
| Resistance Characteristics (Survival Time) | Passed |
| Resistance Characteristics (Kill Time) | Passed |
| Positive BI color test | Passed |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes for the stability studies. It mentions "Stability studies were conducted" in the plural, implying multiple tests were performed.
The data provenance is not specified in terms of country of origin, but it is explicitly prospective as the studies were conducted to verify the device's stability over an extended shelf life.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this submission. The device is a biological indicator designed to monitor sterilization processes, and its performance is evaluated against predefined biological and chemical metrics (spore population, D-value, color change), not against expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
This question is not applicable, as the evaluation is based on objective scientific measurements and laboratory testing, not human interpretation requiring 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
This question is not applicable. The device is a biological indicator, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent to its design and biological components, and it functions standalone in the sense that it indicates sterilization failure or success without human intervention beyond observing the color change or culture results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is established by well-defined scientific and microbiological specifications. These include:
- Minimum viable spore population: 1 x 10⁶ Geobacillus stearothermophilus spores/BI (as per the device description).
- Resistance characteristics: D-value at 2.5 mg/L of hydrogen peroxide (≥ ~1 second), calculated survival time, and a kill time of 60 seconds.
- Positive BI color test: The indicator should demonstrate the expected color change (from red to golden yellow or bronze) when exposed to hydrogen peroxide.
These are objective, quantitative measures for a biological indicator.
8. The sample size for the training set
This question is not applicable. The device is not an AI/ML model that requires a "training set." Its performance is based on its inherent physical and biological properties.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this type of 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).