(90 days)
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MM Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, at 60°C for a final fluorescent result at 24 minutes.
The following Indications for Use are proposed for the 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. The only change to the previously cleared indications for the Mini Auto-reader 490M as being able to be used in conjunction with each of the BIs:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to monitor gravity displacement steam sterilization cycles of 3 minutes at 270°F (132°C), 10 minutes at 270°F (132°C), 3 minutes at 275°F (135°C) and 10 minutes at 275°F (135°C). An optional visual pH color change result is observed in 24 hours.
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3MTM Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°C). An optional visual pH color change result is observed in 48 hours.
Use 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ 490/490H Autoreader or 3M™ Attest™ Mini Auto-reader 490M as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO™ 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® VPRO™ 60 Low Temperature Sterilization System (Lumen and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles). An optional visual pH color change result is observed in 7 days.
The 3M™ Attest™ Mini Auto-reader 490M is a compact, 4-well incubator for processing the steam biological indicators 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. These biological indicators (BIs) are used to monitor sterilization processing equipment. After a sterilization cycle is complete, the Bls are removed from the sterilizer, cooled as needed, activated, and placed into any available well in the Mini Auto-reader 490M. Incubation starts automatically, UV fluorescence, measured during each interval, is analyzed by measuring fluorescent by-product of enzyme that occurs naturally during biological growth of the spore. The maximum time-to-result is 24 minutes at 600C. An LED array on the front panel will display the time remaining for each BI, the result (positive or negative), and any error codes that occur. The device includes USB connectivity for in-field firmware updates, downloading data, and communicating to third party instrument tracking systems.
The 3MM Attest™ Mimi Auto-reader 490M is indicated to work as a system with the 1491, 1492V, and is not compatible with other BIs.
Here's a breakdown of the acceptance criteria and study information for the 3M™ Attest™ Mini Auto-reader 490M, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
The core acceptance criteria for the 3M™ Attest™ Mini Auto-reader 490M are based on its ability to accurately incubate and read specific 3M™ Attest™ Biological Indicators (BIs) to provide fluorescent results within a specified timeframe. The device's performance is compared against a predicate device (3M™ Attest™ 490/490H Auto-reader) and established safety and electromagnetic compatibility standards.
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (Implied / Predicate Performance) | Reported Device Performance (3M™ Attest™ Mini Auto-reader 490M) |
|---|---|---|
| Intended Use | Designed to incubate and automatically read 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V (for predicate) at 60°C for a final fluorescent result at 24 minutes. (Similar for 1491 and 1295 for other reference devices). | Designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V at 60°C for a final fluorescent result at 24 minutes. |
| Incubation Temperature | 60 ± 2º C | 60 ± 2º C |
| Readout Time | 24 minute final fluorescent result | 24 minute final fluorescent result |
| Fluorescence Detection | UV LED, optical filters, with sensing by photo diode | UV LED, photo diode with embedded optical filters |
| BI Compatibility | Each predicate/reference device was compatible with specific BIs (e.g., 1492V for K173437, 1491 for K173584, 1295 for K173435). | Compatible with 1491, 1492V, 1295. |
| Visual Indicator (Adequate Sterilization) | (-) on LCD display (for predicate) | (-) on dot matrix LED display (similar with different display technology) |
| Visual Indicator (Possible Sterilization Failure) | (+) on LCD display (for predicate) | (+) on dot matrix LED display (similar with different display technology) |
| Product Safety | Compliance to IEC 61010-1 (3rd Ed.) and IEC 61010-2-010 (3rd Ed.), IEC 62471 (2008) | Complies to IEC 61010-1 (2010) 3rd Edition; IEC 61010-2-010 (2014) 3rd Edition; IEC 62471 (2008). |
| EMC Compliance | Compliance to Title 47 CFR 15, Subclass B, for Class A type devices and IEC 61326-1 (2013) | Complies to Class A digital device pursuant to Part 15 of the FCC rules, and IEC 61326-1 (2013). |
| Comparative BI Performance | Predicate devices demonstrated adequate performance in positive control conditions, lethal sterilizer conditions (kill cycle), sub-lethal sterilizer conditions (survive cycle), and reduced incubation time. (Implied by substantial equivalence to predicate) | Demonstrated comparable performance to predicate: "Comparative BI performance was comprised of testing the 1491, 1492V, and 1295 BIs in both auto-readers under positive control conditions, lethal sterilizer conditions (kill cycle), sub-lethal sterilizer conditions (survive cycle), and reduced incubation time." |
| Analytical Sensitivity | Adequate analytical sensitivity using standard curves of reference dye solutions (Implied by substantial equivalence to predicate) | Tested using standard curves of reference dye solutions. |
| Signal-to-Noise Ratio | Adequate signal-to-noise measurements of fluorescent standards during incubation (Implied by substantial equivalence to predicate) | Tested using signal-to-noise measurements of fluorescent standards during incubation. |
| Fluorescence Background | Acceptable fluorescence background measurements (Implied by substantial equivalence to predicate) | Analysis of the fluorescence background measurements of both readers was performed. |
Study Details for Device Performance
The provided document doesn't detail a single, comprehensive "study" with specific sample sizes for test and training sets in a typical AI/software context. Instead, it describes nonclinical comparison testing to demonstrate substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved "testing the 1491, 1492V, and 1295 BIs in both auto-readers." This implies multiple BIs of each type were tested. The specific number of BIs and repetitions is not provided.
- Data Provenance: Not specified. The manufacturer (3M Company) is based in St. Paul, Minnesota, USA, suggesting the testing likely occurred in the USA or a controlled laboratory environment.
- Retrospective or Prospective: The nonclinical comparison testing described appears to be prospective testing, specifically designed to evaluate the new device against the predicate under controlled laboratory conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device and study. The "ground truth" for a biological indicator reader is based on the known biological response of the biological indicator to sterilization conditions. Experts would be involved in designing the test protocols for sterilization cycles and interpreting the results, but not in establishing a subjective "ground truth" like in image interpretation tasks. Sterilization efficacy is objectively measured.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used when subjective interpretations (like medical image diagnosis) require a consensus among multiple human readers. For this device, the "reading" is an automated fluorescent measurement.
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 is not an AI-assisted diagnostic device that involves human readers. It is an automated reader for biological indicators.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the described nonclinical comparison is a standalone (algorithm only) performance evaluation. The device (the auto-reader) automatically interprets the fluorescent signal from the biological indicators without human intervention in the reading process itself to determine a pass/fail result. Human users only activate the BI and place it into the reader, then read the final result displayed by the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the biological indicator testing is established by:
- Known Biological Response: The expected growth or no-growth of the Geobacillus stearothermophilus spores within the biological indicators under specific sterilization conditions.
- Controlled Sterilization Cycles: The tests involved "positive control conditions," "lethal sterilizer conditions (kill cycle)," and "sub-lethal sterilizer conditions (survive cycle)." These cycles are precisely controlled to known sterilization outcomes (i.e., complete kill or partial inactivation/survival leading to growth). The "ground truth" is therefore derived from the physical and biological conditions applied, not from human interpretation.
8. The sample size for the training set
Not applicable. This device is an auto-reader that performs fluorescent detection and signal processing based on a biological mechanism, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a system would involve engineering and calibration against known fluorescent standards and biological responses.
9. How the ground truth for the training set was established
Not applicable, as there isn't a "training set" in the conventional machine learning sense. The device's "knowledge" is built into its hardware and firmware, based on established scientific principles of bioluminescence/fluorescence and the known growth characteristics of the biological indicator organisms. This involves:
- Biochemical principles: Understanding the enzyme activity and fluorescent byproduct generation.
- Sterilization science: Knowledge of how sterilization processes affect microorganisms.
- Calibration: Using known standards (e.g., reference dye solutions) to calibrate the fluorescent detection system.
§ 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).