(84 days)
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX® | Standard |
| Advanced | |
| STERRAD® 100NX® | Flex |
| EXPRESS |
The STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained standalone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 1x10° 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.
Here's a breakdown of the acceptance criteria and study information for the STERRAD® CYCLESURE® 24 Biological Indicator, based on the provided 510(k) summary:
Device: STERRAD® CYCLESURE® 24 Biological Indicator
1. Acceptance Criteria and Reported Device Performance:
The document describes several studies performed to confirm the biological indicator performs as intended. The acceptance criteria for these tests are implicitly "Passed," indicating that the device met the required performance standards.
| Study Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Evaporation | Passed | Passed |
| Verification of Positive BI Color | Passed | Passed |
| Bacteriostasis | Passed | Passed |
| BI Validation in STERRAD® Systems (Dose Response) | Passed | Passed |
| Verification of Minimum Incubation Time | Passed | Passed |
| Growth Promotion | Passed | Passed |
| Spore Resistance Testing | Passed | Passed |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes used for each test. It mentions that "Testing was conducted" and "Performance testing demonstrated," but no specific numbers of biological indicators tested are provided.
The data provenance is implied to be prospective testing conducted by the applicant (Advanced Sterilization Products) as part of their submission for clearance of the modified device. The country of origin for the data is not specified, but the applicant's address is in Irvine, CA, USA.
3. Number and Qualifications of Experts for Ground Truth:
This information is not applicable to this type of device (biological indicator) and study. Biological indicators are designed to provide a direct readout (growth or no growth of spores) to indicate sterility. There is no human interpretation of images or complex data involved that would require expert consensus.
4. Adjudication Method:
Not applicable. See point 3. The results of the biological indicator (growth or no growth) are objective and do not require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output with and without AI assistance to assess changes in accuracy or efficiency. A biological indicator functions as a direct sterility monitor and does not involve human interpretation in the same way.
6. Standalone Performance Study (Algorithm Only):
Yes, a standalone performance study was done in the sense that the biological indicator itself (the "algorithm" in this context) was tested independently to verify its function. The listed studies (Evaporation, Verification of Positive BI Color, Bacteriostasis, BI Validation, Minimum Incubation Time, Growth Promotion, Spore Resistance Testing) all assess the intrinsic performance of the biological indicator without human intervention or interpretation beyond observing the final growth result.
7. Type of Ground Truth Used:
The ground truth used for this device is based on microbiological principles and refers to the known outcome of spore killing under specific sterilization conditions.
- Positive Controls: Unsterilized or partially sterilized biological indicators are expected to show spore growth.
- Negative Controls: Properly sterilized biological indicators are expected to show no spore growth.
- D-value and Z-value parameters: For spore resistance testing, the ground truth relates to the known resistance of Geobacillus stearothermophilus spores to hydrogen peroxide under defined conditions.
- Growth Promotion: The ground truth is the ability of the medium to support the growth of the target microorganism.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that learns from a training set. It is a physical biological indicator.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
§ 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).