(177 days)
The Verify® Self-Contained Biological Indicator may be used for installation testing and routine monitoring of the following steam sterilization cycle:
- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle . for packaged items
The proposed Verify® Self-Contained Biological Indicator (SCBI) is identical in components, design, materials, and manufacturing specifications to the predicate Verify® Self-Contained Biological Indicator (cleared in K855101 as the Assert™ Biological/Chemical Indicator). The SCBI consists of a plastic vial that contains a disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and an ampoule of culture media.
This is a 510(k) summary for a biological indicator and not an AI/ML device per se. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC study, sample sizes for training/test sets) are not applicable or cannot be extracted from the provided text. The document focuses on performance testing to expand the indications for use of the biological indicator.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Validation of SCBI for use in the Express abbreviated prevacuum steam sterilization cycle. | Performance testing confirmed that the SCBI meets current requirements of FDA guidance and relevant industry standards for monitoring the 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle for packaged items. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The document refers to "Performance testing was conducted," implying a controlled study, but details are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/specified. For a biological indicator, the "ground truth" is determined by whether the indicator correctly registers sterilization or growth, which is a direct biological outcome, not an expert interpretation.
- Qualifications: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The performance of a biological indicator is typically assessed through direct observation of growth or lack thereof in the culture medium, not through expert adjudication in the manner of diagnostic image interpretation.
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
- MRMC Study: Not applicable. This is a biological indicator, not an AI/ML diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: While the "device" (biological indicator) operates independently to indicate sterilization effectiveness, it's not an "algorithm" in the typical sense of AI/ML. Its performance is inherent in its biological response. The study was essentially a standalone performance validation for a specific sterilization cycle.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for a biological indicator's performance is typically established by:
- Microbiological viability: Determining the survival or inactivation of the inoculated Geobacillus stearothermophilus and/or Bacillus atrophaeus spores after exposure to sterilization conditions.
- Sterilization Cycle Parameters: The efficacy of the sterilization cycle itself, under controlled conditions.
The document states, "Performance testing was conducted to validate the SCBI for use in the Express abbreviated prevacuum steam sterilization cycle," implying direct biological/physical validation against established sterilization efficacy.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that undergoes a training phase.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. This is not an AI/ML device that undergoes a training phase.
§ 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).