(63 days)
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ Auto-reader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to monitor the cycles below.
| Sterilization Type | Temperature | Time |
|---|---|---|
| 270°F (132°C) | 3 minutes | |
| Gravity Displacement | 270°F (132°C) | 10 minutes |
| Steam Sterilization Cycle | 275°F (135°C) | 3 minutes |
| 275°F (135°C) | 10 minutes |
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 is a self-contained biological indicator (BI) specifically designed to be used with the 3MTM Attest™ Auto-reader 490 or the 3MTM Attest™ Auto-reader 490H (software version 4.0.0 or greater) to routinely monitor gravity displacement steam sterilization cycles at 132°C and 135°C.
The 1491 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1491 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 a processed 1491 BI in the 490 Auto-reader or the 490H Auto-reader (software version 4.0.0 or greater) indicates a sterilization failure.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 and 3M™ Attest™ Auto-reader 490/490H.
1. Table of Acceptance Criteria and Reported Device Performance
This product is a biological indicator system, not a device that relies on traditional performance metrics like sensitivity/specificity for disease detection. Instead, its performance is evaluated against established standards for sterilization monitoring.
| Acceptance Criteria / Test (based on ISO, USP, FDA guidance) | Reported Device Performance (Results) |
|---|---|
| Positive Control | Passed |
| Survival Time (Calculated or 1 min @ 132°C, 40 sec @ 135°C) | Passed |
| Kill Time (Calculated @ 132°C and 135°C) | Passed |
| Reduced Incubation Time (Fluorescent result in 24 min, >97% alignment with 7-day conventional incubation) | Passed |
| D-Value (≥ 10 seconds at 132°C; ≥ 8 seconds at 135°C) | Passed |
| Population (Total Viable Spore Count) (≥ 10^6 spores) | Passed |
| Component Inhibition Studies (No impact on recovery of 10-100 organisms) | Passed |
| Holding Time Assessment (D-value does not change when activated 7 days post sterilization) | Passed |
| Auto-reader Maintenance of Incubation Temperature (Maintain 60 ± 2°C over 24 hours) | Passed |
| IEC 61010-1 (Safety requirements for electrical equipment) | Compliant |
| IEC 61010-2-010 (Safety requirements for laboratory equipment) | Compliant |
| FCC Part 15, Subpart B, Class A (Radiated and Conducted Emissions) | Compliant |
| IEC 61326-1 (EMC Requirements) | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each test within the "Summary of Nonclinical Testing" section. Instead, for each test, it simply reports "Passed" for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ Auto-reader 490 with a final fluorescent readout of 24 minutes and an incubation temperature of 60°C.
The data provenance is from nonclinical testing conducted by 3M Company, following FDA guidance and international standards (ISO, USP, ANSI/AAMI). There is no information provided about the country of origin of the data beyond "3M Company" which is based in St. Paul, Minnesota, USA. The study design is not specifically labeled "retrospective" or "prospective," but given it's for a 510(k) submission, it's a prospective collection of new test data to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (biological indicator for sterilization) does not involve human expert interpretation for establishing ground truth in the same way a diagnostic imaging AI might. The ground truth for biological indicators is established through controlled laboratory methods and adherence to validated scientific standards (e.g., specific spore counts, resistance characteristics, and survival/kill times under defined sterilization parameters). The "ground truth" is a measurable biological response, not an expert assessment.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the assessment is based on measurable biological and physical parameters according to standardized test methods, not expert adjudication of subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a biological indicator system for monitoring sterilization, not a diagnostic imaging or interpretive device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described is primarily standalone performance of the biological indicator and auto-reader system. The "Nonclinical Comparison to the Predicate Device" and "Summary of Nonclinical Testing" sections detail the performance of the device itself against established criteria and standards. The system automatically reads and interprets the fluorescent signal from the biological indicator. While a human initiates the process and reads the final result (e.g., "Passed"), the core performance metrics are derived from the automated system's capabilities.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Biological Activity and Resistance Characteristics: Specifically, the known and measurable resistance of Geobacillus stearothermophilus spores (traceable to ATCC™ 7953) to defined steam sterilization cycles. This includes metrics like D-value, survival time, and kill time.
- Physical and Chemical Standards: Performance metrics related to incubation temperature, spore population counts, and the absence of inhibitory components.
- Regulatory and Industry Standards: Compliance with ISO 11138-1:2017, ISO 11138-3:2017, ANSI/AAMI/ISO 18472:2006, United States Pharmacopeia Chapters and , and FDA Guidance for Biological Indicators.
- Electrical and Electromagnetic Compatibility Standards: Compliance with IEC 61010-1, IEC 61010-2-010, FCC Part 15, and IEC 61326-1.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI algorithm development. This device is a biological indicator system, not an AI or machine learning model that requires a training phase. The software changes mentioned for the Auto-reader (reducing readout time, changing incubation temp) are likely based on engineering design and validation rather than a data-driven training process.
9. How the Ground Truth for the Training Set was Established
As there is no described "training set" for an AI/ML algorithm development, this question is not applicable. The device's functionality is based on biological and electro-mechanical principles validated against established scientific and regulatory standards.
§ 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).