(165 days)
Use the 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ 490 Auto-reader to monitor the cycles below.
| Sterilization Type | Temperature | Time |
|---|---|---|
| Gravity Displacement | 270°F (132°C) | 3 minutes |
| Immediate Use Steam | ||
| Sterilization Cycle | ||
| (Flash) | 270°F (132°C) | 10 minutes |
| 275°F (135°C) | 3 minutes | |
| 275°F (135°C) | 10 minutes |
The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.
The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator (hereafter referred to as the 1491 Bl) is a self-contained biological indicator designed to be used with the 3M™ Attest™ 490 Auto-reader (hereafter referred to as the 490 Auto-reader) to routinely challenge 270°F (132°C) and 275°F (135°C) gravity-displacement steam sterilization cycles having exposure times > 3 minutes in length.
The 1491 BI is composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a blue cap. On each 1491 BI is a chemical process indicator that changes color from rose to brown when exposed to steam.
The 1491 Bl is a further improvement over the current 3M Attest Rapid Readout technology. Both the Attest Rapid Readout BIs and the Attest Super Rapid Readout Bls utlize the a-glucosidase enzyme system, which is generated naturally within growing G. stearothermophilus spores. The a -glucosidase enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate. The resultant fluorescent by-product is detected in the 490 Auto-reader. The detection of fluorescence upon incubation of the 1491 BI in the 490 Auto-reader indicates steam sterilization failure.
The 490 Auto-reader is designed to incubate at 56°C and automatically read the 1491 BI for a fluorescent result within 30 minutes. The 490 Auto-reader is also designed to allow further incubation of the 1491 BI for an optional visual pH color change of the growth media at 24 hours. Both the fluorescent readout at 30 minutes and the optional visual color readout at 24 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.
The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator and 3M™ Attest™ 490 Auto-reader are designed to monitor steam sterilization cycles. The study provided assesses the performance of both components against established standards and FDA guidance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Characterization of spores | > 90% Genetic similarity to Geobacillus stearothermophilus to ATCC™ 7953 | Pass |
| D-Value | ≥ 10 seconds at 132°C; ≥ 8 seconds at 135°C | Pass |
| Population (Total Viable Spore Count) | ≥ 10^6 spores | Pass |
| Survival/Kill Times | Survival Time = 1 min at 132°C or calculated survival time (whichever is greater); Survival Time = 40 seconds at 135°C or calculated survival time (whichever is greater); Kill time is calculated kill time at 132°C and at 135°C (per ANSI/AAMI/ISO 11138-1:2006, Annex E) | Pass |
| Reduced Incubation Time | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout times: Fluorescent result in 30 minutes; Optional visual color change result in 24 hours | Pass |
| Hold Time Assessment | D-value does not change when activated 7 days post-sterilization | Pass |
| Recovery Media Study | Ability to recover 10-100 organisms | Pass |
| Component Inhibition Studies | No impact of components on recovery of 10-100 organisms | Pass |
| Chemical Process Indicator | Chemical Process Indicator on the BI changes from rose to brown upon exposure to steam | Pass |
| Auto-reader Maintenance of Incubation Temperature | Must maintain 56 +/- 2°C over a period of 24 hrs | Pass |
| Auto-reader Safety Standards | Compliance to IEC 61010-1 (2001), IEC 61010-2-010 (2003), and IEC 60825-1 (1993) with amendments | Verified by Underwriters Laboratory |
| Auto-reader Electromagnetic Compatibility | Compliance to USA Title 47, Code of Federal Regulations (2009) for Radiated Emissions (FCC Part 15, Subpart B, Class A) and Conducted Emissions (FCC Part 15, Subpart B, Class A), and IEC 61326 | Verified by a certified Testing Laboratory |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: "Multiple lots" of 3M™ Attest™ 1491 Super Rapid Readout Biological Indicators were evaluated. Specific numbers are not provided for each test, but the product's performance refers to adherence to international and US standards for biological indicators.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, the testing was conducted in accordance with FDA guidance and international standards (ANSI/AAMI/ISO, USP), implying a controlled laboratory setting for these performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth for biological indicators is typically established through direct microbiological analysis (e.g., confirming spore viability and count, measuring D-values). Expert consensus in the human interpretation sense (like in image diagnostics) is not directly applicable here. The "experts" would be the scientists and microbiologists performing the tests and validating against the established standards.
4. Adjudication method for the test set:
- Adjudication methods (like 2+1 or 3+1 for human readers) are not applicable to this type of device testing. The device's performance is objectively measured against predefined scientific and engineering specifications (e.g., spore count, D-value, temperature control, fluorescent detection, chemical indicator color change).
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:
- No, an MRMC comparative effectiveness study was not done. This device is a biological indicator and an auto-reader, not an AI-assisted diagnostic tool that relies on human interpretation. The "reader" in this context is the auto-reader detecting a fluorescent signal.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was done. The entire set of tests described in the "Comparative Data" section evaluates the performance of the 3M™ Attest™ 1491 BI (biological component) and the 3M™ Attest™ 490 Auto-reader (the automated reading device/algorithm) either individually or as a system. For example, the auto-reader's ability to "automatically read the 1491 BI for a fluorescent result within 30 minutes" and maintain incubation temperature is a standalone performance measure. The "Reduced Incubation Time" test specifically compares the device's automated fluorescent result to the "conventional incubation time of 7 days," which serves as a gold standard for a biological indicator's performance.
7. The type of ground truth used:
- The ground truth employed for the various tests includes:
- Microbiological Standards: For spore characterization, D-value, population count, survival/kill times, recovery media, and component inhibition, the ground truth is established by recognized microbiological culturing and enumeration techniques, adhering to standards like ANSI/AAMI/ISO 11138-1 and -3, and United States Pharmacopeia (USP) chapters.
- Physical/Chemical Standards: For the chemical process indicator, the ground truth is the expected color change upon steam exposure. For the auto-reader's temperature maintenance, the ground truth is a precisely calibrated temperature range (56 +/- 2°C).
- Reference Standard (Conventional Incubation): For the "Reduced Incubation Time," the ground truth is the result obtained after the "conventional incubation time of 7 days," which is the established method for determining biological indicator failure/pass.
8. The sample size for the training set:
- The document does not mention a "training set" or "training data" in the context of machine learning. This device does not appear to be an AI/ML-based system that requires a distinct training phase. The system relies on enzyme detection and physical measurements, calibrated and validated against established standards.
9. How the ground truth for the training set was established:
- As a training set for an AI/ML algorithm is not discussed or implied for this device, this question is not applicable. The device's operational parameters and performance were likely developed and validated through iterative engineering and experimental testing based on scientific principles of microbial inactivation and enzyme activity, guided by the aforementioned industry 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).