(185 days)
The Steritec Disposable EO Biological Test Pack is designed specifically for biological testing of EO gas sterilizers. The performance specifications for this product are 130 F, 45% to 60% Relative Humidity, 600 mg/L EO gas with all survivors at 15 minutes and all killed at 60 minutes.
SteriTec Disposable Biological Test Packs for EO Gas consist of a self-contained biological indicator containing B. Subtillis spores, placed inside a plastic canister and is covered with a closure cap containing a 5-100 micron porous plastic filter. This assembly is placed into a paper/plastic peel pouch along with a printed record card containing a chemical indicator.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for SteriTec Disposable Biological Test Pack for EO Gas
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance (SteriTec Test Packs) | Notes |
|---|---|---|
| All survivors at 15 minutes exposure to EO Gas at 600 mg/L, 50% RH, 130 F | 100% survivors at 15 minutes exposure | This meets the criterion. |
| All killed at 60 minutes exposure to EO Gas at 600 mg/L, 50% RH, 130 F | Performance not explicitly stated for 60 minutes, but the study showed 12% survivors at 45 minutes, implying a full kill would occur between 45 and 60 minutes. | While not directly stated for 60 minutes, the trend suggests the "all killed" criterion would likely be met at 60 minutes or shortly thereafter. The submission implies substantial equivalence with a predicate that meets this. |
Missing Information: The document provides performance data in a comparative context with the predicate device at 15, 25, 35, and 45 minutes, but does not explicitly state the SteriTec device's performance at the 60-minute mark, which is the "all killed" acceptance criterion. However, the FDA's clearance implies that this criterion was deemed acceptable.
2. Sample Size and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The text mentions "all test packs" and then percentages for "ATI Test Packs" and "SteriTec Test Packs" at different time points, implying a set of multiple packs for each test, but the exact number is not provided.
- Data Provenance: The performance tests were "conducted at NAMSA Laboratories," suggesting a third-party laboratory setting. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and NAMSA has labs globally, including in the US. The study appears to be prospective as it involves active testing of the device.
3. Number of Experts and their Qualifications for Ground Truth
- This device is a biological indicator for sterilization. The ground truth (whether bacteria are killed or survive) is determined by microbiological culture methods, not human interpretation of images or other data. Therefore, the concept of "experts establishing ground truth" in the way it's used for AI/imaging devices does not directly apply here. Instead, laboratory technicians following established microbiological protocols would have been responsible for determining survival/kill rates. Their specific qualifications are not mentioned, but it's implied they adhere to standard laboratory practices.
4. Adjudication Method for the Test Set
- Not applicable in the conventional sense. The "ground truth" for a biological indicator is a binary outcome (growth/no growth) determined by scientific culture methods, not by human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI devices where human readers provide interpretations and the AI system assists them. This submission is for a medical device (biological indicator) that functions independently to assess sterilization. The study performed was a comparison to a predicate device to demonstrate substantial equivalence, focusing on the device's inherent performance rather than human-AI interaction.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The "Performance Testing" section directly reports the survival rates of the SteriTec Disposable Biological Test Pack for EO Gas at various exposure times (15, 25, 35, and 45 minutes) without human-in-the-loop. This is the core of demonstrating the device's effectiveness as a biological indicator.
7. Type of Ground Truth Used
- The ground truth used is biological viability/non-viability (survival or kill) of B. Subtillis spores, determined through standard microbiological culture techniques. This is a form of direct, objective measurement of the intended biological outcome.
8. Sample Size for the Training Set
- Not applicable. This device is a biological test pack, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of algorithm development. The device itself is designed and manufactured based on scientific principles of microbial resistance and sterilization, not trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device. The understanding of the resistance of B. subtilis spores to EO gas has been established over many years through scientific research and is a fundamental principle in sterilization efficacy testing.
§ 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).