(136 days)
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with both the 3M™ Attest™ Auto-reader 490 or the Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of:
- · 3 minutes at 270°F (132°C)
- · 4 minutes at 270°F (132°C)
- · 3 minutes at 275°F (135°C)
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater) to qualify or routinely challenge dynamic-air-removal steam sterilization cycles at 132°C and 135°C.
The 1492V BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1492V BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of the 1492V BI in the 490 Auto-reader or the 490H Auto-reader (software version 4.0.0 or greater) indicates a sterilization failure.
The provided text describes the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H. This is a Class II medical device used for monitoring steam sterilization cycles.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Biological Indicator 1492V Performance: | |
| Positive Control Test | Passed |
| Survival Time (132°C) | ≥ 2.07 minutes |
| Survival Time (135°C) | ≥ 1.82 minutes |
| Kill Time (132°C) calculated per ISO 11138-1:2017, Annex E | ≤ 5.07 minutes |
| Kill Time (135°C) calculated per ISO 11138-1:2017, Annex E | ≤ 4.45 minutes |
| Reduced Incubation Time (>97% alignment with 7-day conventional incubation) - Fluorescent result in 24 minutes | Passed |
| Reduced Incubation Time (>97% alignment with 7-day conventional incubation) - Optional visual pH color change result in 48 hours | Passed |
| D-Value (at 132°C) | ≥ 24 seconds (Acceptance criteria: ≥ 10 seconds) |
| D-Value (at 135°C) | ≥ 21 seconds (Acceptance criteria: ≥ 8 seconds) |
| Population (Total Viable Spore Count) | ≥ 10^6 spores (Acceptance criteria: ≥ 10^6 spores) |
| Component Inhibition Studies (no impact on recovery of 10-100 organisms) | Passed |
| Hold Time Assessment (D-value does not change when activated 7 days post sterilization) | Passed |
| Simulated Use (Verification of performance in claimed cycles) | Passed |
| Auto-reader 490/490H Performance: | |
| Incubation Temperature Maintenance (60 ± 2°C over 7 days) | Passed |
| Compliance to IEC 61010-1 (2010), IEC 61010-2-010 (2014) | Verified by Underwriters Laboratory |
| Compliance to FCC Part 15, Subpart B, Class A | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" sample size in terms of number of biological indicators or cycles tested for all the non-clinical tests. However, it indicates that testing was conducted following FDA guidance and relevant ISO/ANSI standards, which typically specify minimum sample sizes for such evaluations.
Regarding data provenance: The studies are non-clinical bench and laboratory tests, meaning the data was generated in a controlled testing environment, not from patient populations. There is no information about country of origin of the data provided, but the submission is to the U.S. FDA by 3M Health Care, St. Paul, MN, USA. The data is prospective in the sense that it was generated specifically for this submission to demonstrate compliance with performance and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the device is a biological indicator system, not an AI or diagnostic device that relies on expert human interpretation for establishing ground truth for test sets. The "ground truth" for these tests is based on objective, quantifiable biological and physical parameters (e.g., spore kill, fluorescence detection, temperature stability) governed by established international standards like ISO 11138-1 and ISO 11138-3.
4. Adjudication Method for the Test Set:
This is not applicable for the reasons stated above. The tests performed are objective and do not involve human interpretation requiring 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:
This is not applicable. The device is an automated biological indicator system, not a device intended for interpretation by human readers, nor does it incorporate AI for diagnostic or interpretive purposes in the context of human "reading." Therefore, no MRMC study was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device (3M™ Attest™ Auto-reader 490/490H) is inherently a standalone automated system for reading the biological indicators. The "algorithm" (software version 4.0.0 or greater) in the auto-reader automatically detects fluorescence and provides a result (positive/negative) at 24 minutes without human intervention in the reading process itself. The non-clinical tests described demonstrate the performance of this system (biological indicator + auto-reader) in a standalone capacity.
7. The Type of Ground Truth Used:
The ground truth used for proving the device performance relies on:
- Biological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization cycles, as determined by growth and metabolic activity leading to fluorescence. This is the fundamental "ground truth" for biological indicators.
- Physical Measurements: Precisely controlled temperature and time exposures during resistance testing to establish D-values, survival times, and kill times according to ISO standards.
- Established Standards: Adherence to defined parameters and methodologies dictated by ISO 11138 series, USP chapters, and FDA guidance for biological indicators.
8. The Sample Size for the Training Set:
This information is not explicitly provided in the document. However, "training set" is typically a term used for machine learning or AI models. Given that this device is a biological indicator system and auto-reader, its underlying principles are based on biological and chemical reactions and established parameters, not on machine learning requiring a training set in the conventional sense. The "training" of the system would be its design and calibration based on known biological and chemical properties of Geobacillus stearothermophilus and its interaction with the growth medium and the auto-reader's detection mechanism.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" in the context of AI/ML is not directly applicable here. The "ground truth" for the development and validation of the biological indicator and auto-reader system would be established through extensive foundational research in microbiology, sterilization science, and optical detection technology. This would involve:
- Microbiological Standards: Using certified strains of Geobacillus stearothermophilus (traceable to ATCC™ 7953) with known resistance characteristics.
- Controlled Sterilization Cycles: Running precisely controlled steam sterilization cycles with varying conditions to determine spore survival and kill rates.
- Fluorescence Detection Principles: Understanding the biochemical reactions that lead to fluorescence in the presence of viable spores and designing the auto-reader's optics to reliably detect this signal.
- Calibration: Calibrating the auto-reader's detection threshold and timing based on these established biological and chemical principles to accurately differentiate between sterile and non-sterile conditions.
§ 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).