(89 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:
- STERRAD® 100S
- STERRAD® 50
- STERRAD® 200
- STERRAD® NX®
- STERRAD® 100NX® (Standard, Flex and Express Cycles)
- For STERRAD® 100NX® DUO Cycle in the United States, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).
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 1x10^6 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 provided text describes a 510(k) summary for a biological indicator, the STERRAD® CYCLESURE® 24 Biological Indicator. This device is a self-contained biological monitor used to verify the effectiveness of STERRAD® sterilization processes.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Evaporation | Pass (meets performance standards) | Passed |
| Verification of Positive BI Color | Pass (correctly indicates positive growth) | Passed |
| Bacteriostasis | Pass (no inhibition of microbial growth by indicator components) | Passed |
| BI Validation in the STERRAD® Sterilization Systems (Dose Response) | Pass (demonstrates appropriate response to varying sterilant exposure in specific systems) | Passed |
| Verification of Minimum Incubation Time | Pass (growth detectable within specified time) | Passed |
| Growth Promotion | Pass (supports growth of target organism) | Passed |
| Spore Resistance Testing | Pass (acceptable resistance to sterilant) | Passed |
Note: The document states "Passed" for all studies, implying that the device met the pre-defined acceptance criteria for each test. The specific quantitative acceptance criteria are not explicitly detailed in this summary for each test, but are inherent in the "Passed" designation for regulatory submissions of this type.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the nonclinical tests. The testing methodology for biological indicators typically involves a statistically significant number of replicates, but the exact numbers are not provided in this summary.
Regarding data provenance: The tests were conducted to confirm the performance of the STERRAD® CYCLESURE® 24 Biological Indicator when used with STERRAD® Sterilization Systems. This indicates that the data was generated specifically for the device in question, likely in a controlled laboratory or testing environment. The country of origin of the data is implicitly the country where Advanced Sterilization Products (Irvine, CA, USA) conducted its research and development, but this is not explicitly stated. The studies are prospective in nature, as they are designed to evaluate the performance of a new or modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For a biological indicator, the "ground truth" is established through standardized microbiological and sterilization efficacy testing methods. This does not involve human expert consensus in the same way an image interpretation study would. Instead, the ground truth is determined by:
- Microbiological assays: Confirming the presence and viability of spores.
- Sterilization efficacy: Determining if the sterilization process effectively inactivates the spores under controlled conditions.
- Colorimetric changes: Observing the chemical or biological indicator's color change as designed.
Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in this context is not directly applicable as it would be for, for example, a diagnostic imaging device. The "experts" would be qualified microbiologists and engineers overseeing the test procedures, rather than a panel of clinicians.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used for studies involving subjective human interpretation, such as medical image reading where discrepancies between readers need to be resolved. This is not applicable to the nonclinical performance testing of a biological indicator, where results are generally objective (e.g., growth/no growth, specific color change, quantitative measurements). The "adjudication" is inherent in the validation protocols and quality control measures of the testing procedures.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not applicable here. This type of study assesses how human performance (e.g., diagnostic accuracy of radiologists) changes with or without the assistance of an AI-powered device. The STERRAD® CYCLESURE® 24 Biological Indicator is a standalone device for monitoring sterilization, not a diagnostic aid for human interpretation.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was done. The nonclinical tests listed (Evaporation, Verification of Positive BI Color, Bacteriostasis, BI Validation, Verification of Minimum Incubation Time, Growth Promotion, Spore Resistance Testing) all represent the performance of the biological indicator itself, without human intervention in its function. The device is a "self-contained standalone biological monitor."
7. Type of Ground Truth Used
The ground truth used for evaluating the biological indicator is based on:
- Microbiological viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to varying levels of sterilant, typically confirmed through incubation and observation of growth.
- Chemical indicator response: The expected color change of the chemical indicator on the cap, confirming exposure to hydrogen peroxide.
- Growth media efficacy: The ability of the nutrient growth medium to support microbial growth.
- Standardized sterilization cycles: The defined parameters of the STERRAD® Sterilization Systems represent the "truth" of the sterilization conditions.
Essentially, the ground truth is established by objective microbiological and physical measurements under controlled conditions.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or artificial intelligence algorithms. This device is a biological indicator that functions based on microbiological principles, not a machine learning algorithm. Therefore, there is no "training set" in the AI sense. The development of such a device involves extensive R&D and validation, but not statistical machine learning training on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML algorithm for this biological indicator, this question is not applicable. The development of the device's performance characteristics is based on established sterilization science, microbiology, and materials science principles, and its effectiveness is validated through the nonclinical studies listed in the summary.
§ 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).