(177 days)
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert Self-Contained Biolgoical Indicator in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
The document describes the VERIFY Assert Self-Contained Biological Indicator (SCBI) for monitoring steam sterilization processes. The acceptance criteria and testing are detailed for this device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Reduced Incubation Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the 40-minute results with the conventional incubation time of 7 days | PASS |
| Viable spore population | 1.0 - 4.0 x 10^6 spore/SCBI | 1.6 - 1.9 x 10^6 spore/SCBI |
| Resistance | D121 ≥ 1.5 min | |
| D132 ≥ 10 s | ||
| D135 ≥ 8 s | D121 ≥ 2.29 min | |
| D132 ≥ 49 s | ||
| D135 ≥ 40 s | ||
| Survival Time | Meets the longer of FDA and ISO 11138-3 requirements | 121 C ≥ 9.81 min |
| 132 C ≥ 3.51 min | ||
| 135 C ≥ 2.83 min | ||
| Kill Time | Meets the shorter of FDA and ISO 11138-3 requirements | 121 C ≤ 25.57 min |
| 132 C ≤ 9.21 min | ||
| 135 C ≤ 7.73 min | ||
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst-case steam exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to steam sterilization | PASS |
| Simulated Use | Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle | Abbreviated cycle - growth |
| Full cycle - no growth | ||
| Process indicator | Meets requirements for a “Class 1” process indicator of ISO 11140-1:2005 | PASS (Testing provided in K112256) |
The provided document is a 510(k) summary for a medical device (Biological Indicator) and lacks specific information regarding studies involving AI, human readers, or image analysis. Therefore, the following sections will indicate that the information is not applicable based on the content.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes performance testing for biological indicators used in sterilization. It does not refer to "test sets" in the context of AI/machine learning or human reader studies. The data provenance is laboratory testing related to the performance of biological indicators under specific conditions rather than patient data. Specific sample sizes for each test are not explicitly detailed in the summary, but the resistance and population values are quantitative measurements of the device itself rather than data collected from a large number of 'samples' in the sense of a clinical trial. The testing is likely prospective and conducted in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a biological indicator, and its performance is determined through standardized laboratory tests (e.g., spore count, D-value determination, growth/no growth observation) rather than interpretation by human experts.
4. Adjudication Method for the Test Set:
Not applicable. The determination of device performance (e.g., whether spores are killed, whether a fluorescent signal is produced) is based on objective laboratory measurements and biological principles, not expert 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:
Not applicable. This document pertains to a biological indicator for sterilization monitoring, not an AI-powered diagnostic or interpretive device involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device itself is a biological indicator. Its "performance" involves a chemical/biological reaction monitored by a specific reader, but this is not an "algorithm" in the context of standalone AI performance. The reader provides a fluorescent result.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is established by:
- Biological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
- Fluorescent Signal: The detection of a fluorescent moiety produced by the organism's enzyme reacting with a substrate, indicating viability.
- Standardized Test Methods: Adherence to established standards like ISO 11138 and FDA guidance for biological indicators.
- Quantitative Measurements: D-values (decimal reduction time), survival time, kill time, and spore population counts based on microbiological assays.
8. The Sample Size for the Training Set:
Not applicable. This document does not describe an AI/machine learning model that requires a training set. The device is a physical biological indicator.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as no training set for an AI model is described.
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