(154 days)
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.
The 3M Attest™ 1492V Super Rapid Readout Biological Indicator (SRBI) is a selfcontained biological indicator designed to be used with the 3M Attest™ 490 Auto-reader to qualify or routinely challenge dynamic-air-removal (prevacuum) steam sterilization cycles at 270°F (132°C) and at 275°F (135°C).
The Attest™ 1492V SRBI is composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1492V SRBI cap is a chemical process indicator that changes color from pink to light brown when exposed to steam.
The 1,492V SRBI is a further improvement over the current 3M Attest™ Rapid Readout technology. Both the Attest™ Rapid Readout BIs and the Attest™ Super Rapid Readout BIs utilize the a-glucosidase enzyme system, which is generated naturally within growing G. stearothermophilus organisms. 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 3M Attest™ 490 Autoreader. The detection of fluorescence upon incubation of the 1492V SRBI in the 490 Autoreader indicates a steam sterilization failure.
The 1492V SRBI is similar in design to the 3M Attest™ 1491 Super Rapid Readout Biological Indicator for Steam cleared as K 103277 for gravity displacement steam sterilization cvcles. Minor modifications were made to 1491 that resulted in the 1492V SRBI for dynamic-air-removal (prevacuum) steam sterilization cycles.
The Attest™ 490 Auto-reader has been cleared for use with the Attest™ 1491 Super Rapid Readout Biological Indicator for Steam under K103277. The current submission extends the use of the 490 Auto-reader to the 1492V SRBI.
The Attest™ 490 Auto-reader is designed to incubate at 56°C and automatically read the Attest™ 1492V SRBI for a fluorescent result within 1 hour. The 490 Auto-reader is also designed to allow further incubation of the 1492V SRBI for an optional visual pH color change of the growth media at 48 hours. Both the fluorescent readout at 1 hour and the optional visual readout at 48 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.
1. Acceptance Criteria and Device Performance
| Biological Indicator Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Characterization of spores | > 90% Genetic similarity to Geobacillus stearothermophilus ATCC™ 7953 | Pass |
| D-Value | Greater than or equal to 10 seconds at 132°C | |
| Greater than or equal to 8 seconds at 135°C | Pass | |
| Population (Total Viable Spore Count) | Greater than or equal to $10^6$ spores | Pass |
| Survival/Kill Times | Survival Time = Calculated survival time* or 1 minute at 132°C and 40 seconds at 135°C, whichever is longer; | |
| Kill time = Calculated kill time* at 132°C and at 135°C | ||
| *ANSI/AAMI/ISO 11138-1:2006/(R) 2010, 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 1 hour | ||
| Optional visual pH color change at 48 hours | Pass | |
| Hold Time Assessment | D-value does not change when activated 7 days post-sterilization | Pass |
| Component Inhibition Studies | Components have no impact on the recovery of 10-100 organisms | Pass |
| Chemical Process Indicator | Chemical Process Indicator on the BI changes from pink to light brown upon exposure to steam | Pass |
| Auto-reader Maintenance of Incubation Temperature | Maintain 56+/- 2°C over a period of 7 days | Pass |
2. Sample Size and Data Provenance
The document states that "Multiple lots of 3M Attest™ 1492V SRBIs were evaluated for performance" for the nonclinical testing. However, specific sample sizes for each test in the acceptance criteria, or the country of origin of the data, or whether it was retrospective or prospective, are not explicitly provided in the given text.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for the biological indicator's performance is established through adherence to recognized standards for sterilization biological indicators (e.g., D-value, population count, survival/kill times).
4. Adjudication Method
No adjudication method is mentioned, as the studies are focused on direct biological and physical performance testing against established standards, not human interpretation or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned. This type of study is typically relevant for interpretative devices where human variability in reading is a factor, which is not the case for a biological indicator and auto-reader system designed for automated readout.
6. Standalone Performance Study
Yes, standalone performance studies were conducted. The entire nonclinical testing section, including the table of acceptance criteria and results, represents the standalone performance of the 3M Attest™ 1492V Super Rapid Readout Biological Indicator (SRBI) when used with the 3M Attest™ 490 Auto-reader. These tests evaluate the device's intrinsic characteristics and functionality against predefined standards and guidance documents.
7. Type of Ground Truth Used
The ground truth used for the tests is based on:
- Scientific and Biological Standards: For tests like "Characterization of spores," "D-Value," "Population (Total Viable Spore Count)," and "Survival/Kill Times," the ground truth is derived from established microbiological principles, FDA guidance, and international standards (e.g., ANSI/AAMI/ISO 11138 series, USP chapters). These standards define the expected biological behavior and performance characteristics of a biological indicator.
- Engineering and Physical Standards: For tests like "Auto-reader Maintenance of Incubation Temperature," the ground truth is based on engineering specifications and calibration standards.
- Regulatory Requirements: For "Reduced Incubation Time," the ground truth is adherence to FDA's requirement for >97% alignment with conventional 7-day incubation.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or AI. Biological indicators and auto-readers are typically validated through performance testing against established physical and biological standards, not by training an algorithm on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an algorithm in this document describing a physical biological indicator and an auto-reader.
§ 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).