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510(k) Data Aggregation
(73 days)
The NAMSA SCBI is intended for use in monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are for pre-vacuum and gravity displacement 121°C steam processes. Additional saturated steam sterilization temperatures are also included on the Certificate of Analysis. NAMSA Steam SCBIs are also appropriate for use in saturated steam processes of 132°C, 134°C and 135°C.
The activated SCBI should be incubated at 58-62°C for a minimum of 24 hours. The SCBI should be monitored for visible signs of growth. Growth will be indicated by a color shift from purple to yellow and/or the presence of turbidity. The absence of growth indicates the exposure was effective.
1. Table of acceptance criteria and reported device performance:
The provided document does not explicitly state quantitative acceptance criteria or a dedicated section for "reported device performance." However, based on the testing descriptions and the nature of a biological indicator, the performance is implicitly linked to the successful demonstration of specific resistance characteristics and proper recovery.
| Acceptance Criteria (Implied) | Reported Device Performance/Testing Description |
|---|---|
| Viability of Spores | "Total Viable Spore Count" - This test is conducted to ensure the SCBIs contain a sufficient and consistent number of viable spores (Geobacillus stearothermophilus) to accurately monitor sterilization. Specific counts are generally specified by standards, but not detailed here. |
| Resistance to Sterilization Process | "Resistance Characteristic Studies including D value, z value, Survival/Kill Windows" - This demonstrates the SCBI's ability to resist specific steam sterilization cycles, quantifying its resistance (D-value) and the temperature coefficient (z-value) for demonstrating effectiveness. The survival/kill windows confirm that the SCBI shows growth when conditions are insufficient for sterility and no growth when conditions are sufficient. |
| Material Compatibility/Integrity | "Carrier and Primary Packaging Materials Evaluation" - This ensures the materials housing the spores and growth medium do not interfere with the sterilization process or the indicator's performance. |
| Stability Over Time (Shelf Life) | "Holding Time Assessment" - This likely refers to testing performed over the product's shelf life to ensure the SCBI maintains its performance characteristics. The document also states the device has "the same or similar shelf life" as the predicate. |
| Accurate and Timely Detection of Growth/No Growth | "Recovery Protocols Reduced Incubation Time Studies" & "Medium Suitability" - These tests ensure that surviving spores can be accurately and reliably recovered and grow within the specified incubation time (24 hours in this case), and that the growth medium supports this. The "color shift from purple to yellow and/or the presence of turbidity" indicates growth. |
| Monitoring Efficacy in Various Steam Processes | Stated for "pre-vacuum and gravity displacement 121°C steam processes" and "saturated steam processes of 132°C, 134°C and 135°C." The testing would have evaluated the performance at these specific temperatures and exposure times. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size for each test. It broadly states "multiple lots of NAMSA Steam Self-Contained Biological Indicators over the range of the shelf life" were used for the various tests.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission to the FDA, the testing was likely conducted in accordance with recognized FDA consensus standards and guidance documents, implying prospective studies for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device (biological indicator). The "ground truth" for a biological indicator is established by standard microbiological and sterilization testing methods, not by expert consensus on visual interpretation of results. The ground truth would be the known efficacy of the sterilization cycle itself, determined by validated physical and chemical parameters, against which the BI's performance is measured.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of images or clinical data, where there might be inter-reader variability. For biological indicators, the results (growth/no growth, D-value, Z-value) are objectively measured based on established microbiological and sterilization science principles.
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:
Not applicable. This device is a biological indicator, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a single-use, self-contained biological indicator. Its function is to provide a visual indication of sterilization efficacy (color change and/or turbidity), which is then interpreted by a human. There is no "algorithm only" component to assess.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for a biological indicator's performance is established by standardized microbiological methods and established sterilization parameters.
- For D-value and z-value determination: This involves exposing the BIs to precisely controlled sterilization cycles, often using resistance test equipment, to determine the exact time/temperature required to kill a certain percentage of spores. The "ground truth" is the mathematically derived logarithmic reduction of microorganisms based on kill-time studies.
- For survival/kill windows: The ground truth is determined by running cycles that are known (validated) to achieve sterility and cycles that are known (validated) to fail sterility. The BI's performance (growth/no growth) must align with these known outcomes.
- For total viable spore count: The ground truth is the actual number of viable spores determined by standard plate counting methods.
8. The sample size for the training set:
Not applicable. This device does not involve machine learning or AI, so there is no "training set." The performance is based on the intrinsic biological and physical properties of the indicator.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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