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510(k) Data Aggregation
(119 days)
3M ATTEST(TM) AUTO-READER
The 3M Attest™ 390 Auto-reader is designed to incubate and automatically read the 3M Attest™ Rapid Readout Biological Indicators for Steam, 1291 and 1292, at 60°C for a final fluorescent result at 1 hour for 1291 and 3 hours for 1292.
The 3M Attest™ 390G Auto-reader is designed to incubate and automatically read the 3M Attest™ Rapid Readout Biological Indicator for Ethylene Oxide, 1294, at 37°C for a final fluorescent result at 4 hours.
The Attest™ 390 and 390G Auto-readers are used in conjunction with Attest™ Rapid Readout Biological Indicators by trained personnel in central sterilization departments to monitor sterilization processes. The 390 and 390G Auto-readers, like its predecessors the Attest™ 290, 290G and 490 Auto-readers, have two functions. First, the devices serve to incubate the biological indicator (BI) at the temperature appropriate to the organism. Second, the devices determine whether a potential sterilization failure may have occurred by measuring the intensity of fluorescence produced by an enzymatic reaction associated with spore growth inside the selfcontained biological indicator.
The 390 and 390G Auto-readers include a Crusher Well in which the Attest™ Rapid Readout biological indicators are activated. After activation, the user places the biological indicator into one of the 10 color-coded Incubation Wells. The 390 and 390G Auto-readers have an incubation block controlled to the appropriate temperature for their respective biological indicators. The Auto-readers contain a LCD panel that shows the time remaining for incubation. Fluorescence detection at each incubation well is accomplished by the use of a UV LED and a photo diode sensor. As soon as a positive result is detected, a '+' sign is shown as an indication of sterilization cycle failure, accompanied by an audible alarm. At the end of the specified incubation time, if a negative result is detected, a '-' sign is shown on the LCD panel as indication of an adequate sterilization cycle. When the test is complete, as indicated by the (+) or (-) symbol on the Auto-reader LCD panel under the incubating BI, the customer records the result and disposes of the biological indicator.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Auto-reader | Testing | Acceptance Criteria | Result |
|---|---|---|---|
| 390 | Qualification testing with Attest™ 1291 BI | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout time: • Fluorescent result in 1 hour. Survival/Kill: All BIs survive after exposure at the survival time and all BIs are killed after exposure at the kill time. | Pass |
| 390 | Qualification testing with Attest™ 1292 BI | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout time: • Fluorescent result in 3 hours. Survival/Kill: All BIs survive after exposure at the survival time and all BIs are killed after exposure at the kill time. | Pass |
| 390 | Auto-reader Maintenance of Incubation Temperature | Maintain 60+/- 2ºC over the specified incubation period. | Pass |
| 390G | Qualification testing with Attest™ 1294 BI | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout time: • Fluorescent result in 4 hours. Survival/Kill: All BIs survive after exposure at the survival time and all BIs are killed after exposure at the kill time. | Pass |
| 390G | Auto-reader Maintenance of Incubation Temperature | Maintain 37+/- 2ºC over the specified incubation period. | Pass |
| Both | Electrical Safety (IEC 61010-1, IEC 61010-2-010) | Compliance to specified international safety standards. | Pass |
| Both | Electromagnetic Compatibility (USA Title 47, FCC Part 15, IEC 61326) | Compliance to specified electromagnetic compatibility standards for radiated emissions, conducted emissions, and general EMC requirements. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the exact sample size (number of biological indicators or test runs) used for the qualification testing. It only mentions "Multiple lots of 3M Attest™ Rapid Readout biological indicators were evaluated for performance."
- Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification for submission to the FDA, suggesting the evaluation was conducted for US regulatory purposes. The data is presented as retrospective in the sense that the testing was completed prior to the submission for regulatory approval.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The concept of "experts" and "ground truth" in the typical AI/medical device context (e.g., radiologists interpreting images) does not directly apply here. The device being evaluated is an auto-reader for biological indicators (BIs) used to monitor sterilization processes.
- Ground Truth Establishment: The ground truth for the biological indicator performance testing is established by comparing the rapid readout results (fluorescent result at 1, 3, or 4 hours) to the "conventional incubation time of 7 days." This conventional incubation time is the established method for determining sterility failure or success, and the biological indicators themselves are a well-defined standard for monitoring sterilization.
- Experts: No external human experts are mentioned as establishing this ground truth. The "ground truth" for BI performance is inherent in the established standard for biological indicator readout over 7 days.
4. Adjudication Method for the Test Set:
Not applicable in the traditional sense. The "adjudication" (comparison) is automated: the device's rapid fluorescent result is compared to the established 7-day conventional incubation result for the biological indicators. The acceptance criteria specify a "> 97% alignment" for this comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human interpretation directly impacts the outcome (e.g., diagnostic imaging). This device is an auto-reader for biological indicators, where the primary function is automated detection of fluorescence and temperature maintenance. There's no human "reader" in the loop for the primary function being tested for performance against the acceptance criteria.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was performed. The entire evaluation described is of the automated device (the 3M Attest™ 390 and 390G Auto-readers) in conjunction with its respective biological indicators. The device functions automatically to incubate, read fluorescence, and provide a positive/negative result without human intervention in the interpretation of the BI's sterility status.
7. Type of Ground Truth Used:
The ground truth used is based on established standard biological indicator performance (conventional 7-day incubation results) and physical measurement standards (temperature maintenance, electrical safety, EMC). Specifically, for BI qualification, it is a comparison against the long-standing 7-day incubation period result, which serves as the "gold standard" for determining bacterial growth in the BI.
8. Sample Size for the Training Set:
The document does not provide any information regarding a "training set" or its sample size. This is expected because the device likely operates based on a fixed algorithm for fluorescence detection and temperature control, rather than a machine learning model that would require a dedicated training phase. The device's performance is validated against established biological indicator principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As no training set is mentioned or implied for a machine learning model, there is no ground truth established for a training set. The device follows pre-defined detection parameters and physical controls.
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(154 days)
3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER
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.
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