(104 days)
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue to pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same fundamental technology that exists in current 3M™ Attest™ Rapid Readout and Super Rapid Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.
This document is a 510(k) Premarket Notification for the 3M™ Attest™ Rapid Readout Biological Indicator 1295. Its purpose is to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, the information provided focuses on the device's technical specifications and performance when used in specific sterilization systems, rather than a clinical study of diagnostic accuracy typically associated with AI/ML-driven medical devices.
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1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated in a quantitative table format suitable for diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are implied through "Pass/Fail" results of various verification tests. The "performance" is the device's ability to demonstrate effective sterilization or sterilization failure.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Verification of performance in full cycles in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | BI must correctly indicate sterilization or failure | Passed |
| Growth promotion ability in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | BI must promote growth of viable spores | Passed |
| Verification of half cycles in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | BI must correctly indicate sterilization failure in partial cycles | Passed |
| Verification of performance in fractional cycles in the Amsco® V-PRO® maX Low Temperature Sterilization System | BI must correctly indicate sterilization failure in fractional cycles | Passed |
| Verification of 4-hour fluorescent readout per FDA's Reduced Incubation Time protocol in the Amsco® V-PRO® maX Low Temperature Sterilization System | BI must provide accurate fluorescent readout within 4 hours | Passed |
| Verification of population and resistance characteristics (D-value, survival, kill) at the end of shelf life in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | BI must maintain specified D-value, survival, and kill characteristics | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (number of biological indicators or sterilization cycles) used for each individual test. The term "test set" is not directly applicable in the context of this device as it refers to a validation process for an AI/ML model. Instead, these are non-clinical verification tests of a biological indicator.
The data provenance is not specified by country of origin, but the testing was conducted to prove the effectiveness of the BI in the Amsco® V-PRO® maX Low Temperature Sterilization System. The studies are non-clinical and likely performed in a laboratory setting. These are prospective tests of the device's performance, not retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The device is a biological indicator designed to detect sterilization failure based on the growth of Geobacillus stearothermophilus spores. The "ground truth" for these tests relates to microbiologic viability and efficacy of sterilization, not expert interpretation of medical images or clinical data. The assessment of "Pass/Failed" for the tests would be based on established scientific protocols for biological indicator evaluation, not expert consensus in the diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving discrepancies in expert interpretations of diagnostic data. The "tests" performed for this biological indicator involve standardized laboratory procedures with objective endpoints (e.g., spore growth/no growth, fluorescence detection).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable, as the device is not an AI-assisted diagnostic tool for human readers. It is a biological indicator for monitoring sterilization processes. Therefore, no MRMC study was conducted, and there is no "human reader improvement with AI" to report.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable in the context of an "algorithm only" performance. The device itself (the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H) operates autonomously to detect sterilization failure. Its performance is evaluated directly through the non-clinical tests listed. There is no human involved in the interpretation of the biological indicator's direct result (fluorescence as detected by the auto-reader).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the in vitro performance tests is based on microbiological and physical measurements related to sterilization efficacy. This includes:
- The known viability and resistance characteristics of Geobacillus stearothermophilus spores.
- The controlled conditions of the sterilization cycles (full, half, fractional).
- The ability of the indicator to show growth when viable spores are present (lack of sterilization) and no growth when spores are killed (successful sterilization).
- Objective measurements of fluorescence and color change.
8. The Sample Size for the Training Set
This information is not applicable, as the device is not an AI/ML model that requires a "training set." It is a physical biological indicator.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
§ 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).