FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:

Cycle Type	Exposure Temperature	Exposure Time
Dynamic-air-removal (pre-vacuum and SFPP)	270°F (132°C)	3, 3.5, 4, 5.5, or 6 minute
Dynamic-air-removal (pre-vacuum and SFPP)	273°F (134°C)	3 or 4 minutes
Dynamic-air-removal (pre-vacuum and SFPP)	275°F (135°C)	3, 3.5 or 10 minutes

3M™ Attest™ Auto-reader 490:

The 3M™ Attest™ Auto-reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.

3M™ Attest™ Auto-reader 490H:

The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60℃ for a final fluorescent result at 24 minutes.

3M™ Attest™ Mini Auto-reader 490M:

The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.

Device Description

The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H (having software version 4.0.0 or greater), or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal steam sterilization cycles at 132°C, 134°C and 135°C.

The 1492V BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1492V 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 the 1492V BI in the 490 Autoreader, the 490H Auto-reader (software version 4.0.0 or greater), or the 490M Mini Autoreader indicates a sterilization failure.

AI/ML Overview

The provided text describes the acceptance criteria and study results for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V and associated auto-readers (490, 490H, 490M). This is for a 510(k) submission (K241710) to expand the indications for use to include additional exposure temperatures and times for dynamic-air-removal steam sterilization cycles.

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

Test Performed	Device Description	Applicable Standards	Purpose	Acceptance Criteria	Reported Device Performance
Positive Control Test	1492V BI	FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-3:2017	To evaluate performance of BI without steam exposure	All BIs must be fluorescent positive at 24 minutes and visual pH color change positive (yellow) at 48 hours	Acceptance criteria met
D-value for 134°C (273°F) cycles	1492V BI	FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-3:2017	Not explicitly stated for D-value alone; part of evaluating resistance characteristics	D-value must be ≥ 8 seconds	Acceptance criteria met
Survival for 134°C (273°F) cycles	1492V BI	FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-3:2017	To evaluate the resistance characteristics of the BI	Meets the requirements for Calculated survival time* or 40 seconds, whichever is longer.

ISO 11138-1:2017 | Acceptance criteria met |
| Kill for 134°C (273°F) cycles | 1492V BI | FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-3:2017 | Not explicitly stated for Kill alone; part of evaluating resistance characteristics | Meets the requirements for Calculated kill time*
ISO 11138-1:2017 | Acceptance criteria met |
| Reduced Incubation Time for 134°C (273°F) cycles | 1492V BI | FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-8:2021 | To validate the reduction in incubation time from 7 days (visual color change) to 24 minutes (fluorescent readout) and 48 hours (visual pH color change) | 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 24 minutes
• Visual pH color change result in 48 hours | Acceptance criteria met |
| Holding Time Assessment for 134°C (273°F) cycles | 1492V BI | FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-3:2017 | To evaluate the effect of the labeled holding time on the D-value | D-value must be within +/- 20% of the initial D-value calculated per ISO 11138-1:2017 | Acceptance criteria met |
| Attest 1492V Simulated Use | 1492V BI | FDA Guidance¹ | Verification of performance in claimed cycles | BI performs as intended in claimed cycles | Acceptance criteria met |

Note: The source document refers to "FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007" as "FDA Guidance¹".

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- Positive Control, D-Value, Survival, and Kill for 134°C cycles: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested. The specific number of BIs per lot for testing isn't explicitly stated but would be determined by the referenced ISO standards (ISO 11138-1:2017 and ISO 11138-3:2017).
- Reduced Incubation Time for 134°C cycles: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested. (Specific number of BIs per lot determined by ISO 11138-8:2021).
- Holding Time Assessment for 134°C cycles: One lot of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V was tested. (Specific number of BIs per lot determined by ISO 11138-1:2017 and ISO 11138-3:2017).
- Simulated Use Testing: Four lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were evaluated. (Specific number of BIs per lot determined by FDA Guidance¹).
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission by a U.S. company (3M Company, St. Paul, MN), it can be inferred the testing was likely conducted in a controlled laboratory environment aligned with U.S. regulatory requirements and standards, implying a prospective testing approach for these performance studies.

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 type of device (biological indicator for sterilization) does not involve human expert interpretation of images or other subjective data for ground truth establishment. The ground truth is objective, based on the growth or non-growth of microorganisms (fluorescence and visual pH change), and measured by an auto-reader and laboratory methods (plating for D-value, survival, and kill). Therefore, experts in the sense of radiologists providing interpretations are not applicable here. The "experts" would be the laboratory personnel performing the sterility testing and enumeration, governed by the specified ISO standards and FDA guidance. Their qualifications are inherent in following these validated procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where human consensus is needed (e.g., image interpretation). This is a biological and physical performance study with objective endpoints (fluorescence, pH change, microbial growth counts). Therefore, no human adjudication method was employed or necessary. The "adjudication" is inherent in the quantitative and qualitative results generated by the auto-readers and laboratory microbiological techniques according to the established standards.

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 for sterilization monitoring, not an AI-assisted diagnostic tool that requires human reader interpretation. The performance is assessed based on the BI's ability to accurately indicate sterilization success or failure.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in a sense. The core of the device's function is the biological indicator itself and the auto-reader's algorithmic interpretation of the fluorescence. The performance evaluation metrics (D-value, survival, kill, reduced incubation time, holding time assessment) are "standalone" in that they assess the intrinsic performance of the BI and auto-reader system without a human repeatedly making the final decision based on their output. The auto-reader's "algorithm" automatically reads the fluorescent result. The final visual pH change is a secondary, optional, human-observable check, but the primary rapid readout is automated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this biological indicator is established by microbiological methods and physical-chemical principles as defined by the referenced ISO standards (ISO 11138-1, ISO 11138-3, ISO 11138-8) and FDA guidance specific to biological indicators.
- For D-value, survival, and kill times, the ground truth is determined by the actual microbial load reduction after exposure to various sterilization conditions. This involves traditional microbiology techniques like plate counting to determine the number of viable spores remaining after exposure.
- For the auto-reader's performance (fluorescence and pH change), the ground truth is the presence or absence of viable (germinated and metabolically active) spores, confirmed by the microbiological culture. A positive result (fluorescence/pH change) indicates spore survival, meaning sterilization failure; a negative result indicates spore death, meaning sterilization success.

8. The sample size for the training set

The document describes a 510(k) submission for an expanded indication for use of an existing device. It discusses non-clinical performance testing (verification and validation) for the updated indications. It does not mention a "training set" in the context of an AI/ML model, as this is a traditional medical device (biological indicator and auto-reader) whose function is based on biological and chemical reactions, not adaptive algorithms trained on large datasets. Therefore, the concept of a "training set" in this context is not applicable.

9. How the ground truth for the training set was established

As explained above, the concept of a "training set" is not applicable to this submission, as it's not an AI/ML device being developed and trained. The document focuses on demonstrating the device's performance against established standards and its equivalence to a predicate device.

Summary

Regulation Number and Section

§ 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).