(199 days)
The 3M™ Attest™ 1294 Rapid Readout Biological Indicator for EO is used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3MTM Attest™ 290G Auto-reader.
The 3M™ Attest™ 1298 Rapid Readout Biological Indicator for EO Test Pack is a routine challenge pack used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M™ Attest™ 290G Auto-reader.
The 3M™ Attest TM 290G Auto-reader is designed to incubate and automatically read the 3M™ Attest ™ 1294 Rapid Readout Biological Indicators (RRBI) for EO at 37℃ for a final negative fluorescence reading at 4 hours.
The 3M™ Attest™ 1294 Rapid Readout Biological Indicator (RRBI) for EO (green cap) is a self contained device consisting of a standardized, viable population of Bacillus atrophaeus, (formerly Bacillus subtilis), spores specifically designed for the rapid, reliable monitoring of ethylene oxide (EO) sterilization processes when used in conjunction with the 3M™ Attest™ 290G Auto-reader.
The Attest 1294 RRBI for EO detects sterilization process failure through the activity of a naturally occurring enzyme, beta-glucosidase, produced by the organism during the germination and outgrowth process. The auto-reader detects the activity of this enzyme by reading a fluorescent product produced by the enzymatic breakdown of a substrate in the media. Presence of this enzyme indicates a sterilization process failure. The final negative biological indicator result, indicating an acceptable sterilization process, is made after 4 hours of incubation.
The Attest 1294 RRBI for EO may also be incubated for 7 days to obtain a visual pH color change. (The 7-dav incubation is not intended for routine use and may be used to validate of the fluorescent results.) The biochemical activity of viable Bacillus atrophaeus produces acid by-products that cause the media to change from green to yellow. This visual pH color change also indicates a sterilization process failure however, due to the high sensitivity of the 4-hour fluorescent results, there is no advantage to incubate the Attest 1294 RRBI beyond 4 hours.
The 3M™ Attest™ 1298 Rapid Readout Biological Indicator (RRBI) for EO Test Pack is specifically designed to routinely challenge the ethylene oxide (EO) sterilization process when used in conjunction with the 3M™ Attest™ Model 290G Auto-reader.
This Test Pack is designed to present a challenge to the EO sterilization process comparable to the routine EO biological indicator pack recommended by ANSI/AAMI ST41 (1999).
This document (K031012), a 510(k) Notification for a biological indicator system, details the device's performance through various tests but does not present a formal "acceptance criteria" table with corresponding "reported device performance." Instead, it discusses the testing undertaken to demonstrate substantial equivalence to predicate devices and adherence to relevant consensus standards.
Based on the provided text, the relevant information for an "acceptance criteria" table and the study details can be extracted and inferred as follows:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria are not presented in a table format, we infer them from the description of testing performed against recognized standards and the concept of "substantial equivalence." The reported performance is summarized qualitatively based on the text.
| Acceptance Criteria (Inferred from Standards & Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| 3M™ Attest™ 1294 Rapid Readout Biological Indicator for EO (RRBI for EO) | |
| Resistance Characteristics: Adherence to standards like ANSI/AAMI ST21 for EO biological indicators. | Demonstrated performance for Resistance Characteristics. Implies suitable D-value and survival/kill characteristics for EO sterilization. |
| Spore Population and Species Confirmation: Contains a standardized, viable population of Bacillus atrophaeus (formerly Bacillus subtilis) spores (ATCC 9372). | Demonstrated performance for Spore Population and species confirmation. Uses Bacillus atrophaeus (ATCC 9372). |
| Media Recovery: Capability of the culture media to support spore growth. | Demonstrated performance for Media Recovery. |
| 4-hour Fluorescent Readout Reliability: Consistent and accurate fluorescent signal reflecting enzyme activity for sterilization process failure detection within 4 hours. | Demonstrated performance for 4-hour Fluorescent Readout Reliability. "High sensitivity" of 4-hour fluorescent results is noted. Final negative reading at 4 hours. |
| Substantial Equivalence: Performance comparable to predicates (Steris® Verify™ and 3M™ Attest™ 1292 Rapid Readout Biological Indicator for Steam). | Testing demonstrated that the Attest 1294 RRBI for EO is substantially equivalent to the named predicates, sharing identical spore species and fluorescent byproduct characteristics. |
| 3M™ Attest™ 1298 Rapid Readout Biological Indicator for EO Test Pack | |
| Performance Comparison to Routine Test Pack: Challenge level comparable to the routine EO biological indicator pack recommended by ANSI/AAMI ST41 (1999). | Multiple lots tested for performance comparison to a routine test pack recommended by ANSI/AAMI ST41. Functions in the same manner as the ANSI/AAMI routine test pack for EO. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document mentions "Multiple lots" of both the Attest 1294 RRBI for EO and the Attest 1298 RRBI for EO Test Packs were tested. Specific numerical sample sizes (e.g., number of BIs, number of test packs, number of sterilization cycles) are not provided in this summary.
- Data Provenance: The document does not explicitly state the country of origin of the data. It appears to be generated internally by 3M Company, with testing protocols developed based on U.S. FDA draft guidance and ANSI/AAMI standards. The study is prospective in nature, as it involves testing new lots of the device for performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable here. The device is a biological indicator for monitoring sterilization processes itself, not a diagnostic tool where human experts establish ground truth. The "ground truth" for evaluating the biological indicator would be the effectiveness of the sterilization cycle, which is determined by physical and biological principles, not expert human interpretation of the indicator's output. The performance of the indicator is assessed against its ability to detect deviations from these principles.
4. Adjudication Method for the Test Set
This is not applicable. The outcome of the biological indicator (fluorescence or pH change) is an objective measurement. There is no ambiguous result that requires adjudication by human readers/experts.
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. This document describes a biological indicator for sterilization, not an image analysis or diagnostic device that involves human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is partially applicable in the sense that the 3M™ Attest™ 290G Auto-reader performs an automated reading (algorithm only) of the biological indicator's fluorescence. The entire system is designed for automatic detection of sterilization failure by the auto-reader. The document focuses on the performance of the biological indicator when read by this auto-reader, highlighting its "4-hour Fluorescent Readout Reliability." While not an "AI algorithm" in the modern sense, the auto-reader's function is automated and standalone regarding the interpretation of the biological indicator.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for evaluating the biological indicator's effectiveness is based on:
- Biological/Physiological Principles: The ability of Bacillus atrophaeus spores to survive defined sterilization conditions and subsequently germinate and produce the beta-glucosidase enzyme, leading to fluorescence.
- Comparison to Established Standards: The performance is benchmarked against consensus standards like ANSI/AAMI ST21, ST41, ST44, ST59, and USP, which define acceptable resistance characteristics for biological indicators and the challenge levels for test packs.
- Substantial Equivalence to Predicate Devices: The performance is also validated by demonstrating equivalence to previously cleared biological indicators that have a history of safe and effective use.
Essentially, the "ground truth" is the known outcome of correctly and incorrectly sterilized cycles, as defined by established microbiology and sterilization science.
8. The Sample Size for the Training Set
This is not applicable. This device is a biological indicator system, not a machine learning model that requires a "training set." Its function is based on biological response and fluorescent detection, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 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).