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Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems:
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)

The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H or the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure.

The FDA 510(k) summary for the 3M™ Attest™ Rapid Readout Biological Indicator 1295 (K211705) describes the acceptance criteria and the study that proves the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The above table specifically refers to the nonclinical testing performed to demonstrate performance in the newly claimed sterilizer and cycles (STERIZONE® VP4 Sterilizer, Cycle 1), which is the primary reason for this new 510(k) submission as the device itself is identical to a previously cleared predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific numerical sample size for the test set used in the full, fractional, and chemical indicator performance tests. It states that "nonclinical testing was performed."

• Sample Size: Not explicitly quantified in the provided text.
• Data Provenance: The testing was nonclinical, performed in a laboratory setting to evaluate the device's performance with the newly included STERIZONE® VP4 Sterilizer (Cycle 1). The country of origin is not specified but implicitly linked to the sponsor, 3M Health Care, based in St. Paul, MN, USA. The study is prospective in nature as it is a validation of the device's performance under specific conditions to support regulatory clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information is generally not applicable to biological indicator performance studies. The ground truth for such studies is established through objective, predefined physical and biological measurements rather than expert human interpretation.

Therefore:

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1 used in clinical imaging studies) is not applicable here because the "readout" of a biological indicator (fluorescent and visual response) is a direct, objective measurement rather than a subjective interpretation requiring consensus among multiple readers.

Therefore:

• Adjudication Method: Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices involving human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on human performance. Biological indicators like the 3M™ Attest™ are designed for objective, automated readout and do not involve human diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the studies described are essentially "standalone" in nature, focusing on the biological indicator's performance based on its inherent characteristics and interaction with the auto-reader and sterilizer. The device functions independently in terms of its biological response to sterilization conditions, and the auto-reader provides an objective "readout" (fluorescent or visual response) without human intervention in the interpretation of the core sterilization effectiveness.

7. The Type of Ground Truth Used

The ground truth for biological indicator performance studies is based on:

• Biological Activity: The viability of Geobacillus stearothermophilus spores.
• Physical Parameters: The exposure of the BI to specific sterilant concentrations (vaporized hydrogen peroxide at 10 mg/L) and time.
• Negative Fluorescent/Visual Response: The absence of growth (negative fluorescent and negative visual response) for sterilized indicators and presence of growth for unsterile/fractionally treated indicators.
• Material Science: The color change of the chemical indicator based on chemical reaction with hydrogen peroxide.

Essentially, it relies on objective biological and chemical principles, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning algorithm. For biological indicators, performance is established through empirical testing against predefined standards (e.g., FDA Guidance, ANSI/AAMI/ISO 11138-1:2017) rather than training models. The document refers to "nonclinical testing" to demonstrate performance.

Therefore:

• Sample Size for Training Set: Not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI/ML algorithm:

• How Ground Truth for Training Set Was Established: Not applicable. Instead, the performance of the biological indicator (including its stated D-value and Survival/Kill Window) is established through rigorous testing methods defined by recognized standards for biological indicators.

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Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems:

STERRAD 100S® Sterilization System

STERRAD NX® Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)

STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)

V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)

V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)

V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)

V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)

V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)

V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)

The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490H or the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure.

The provided text describes the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and its performance in a non-clinical study to demonstrate its effectiveness in additional sterilization cycles.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the exact sample size (number of biological indicators) used for each test. However, it indicates tests were conducted in "each of the full cycles" and "fractional cycles" within the V-PRO® s2 system, implying multiple indicators were used per cycle type.
• Data Provenance: The study was a non-clinical testing performed by the device sponsor (3M Health Care) to support a premarket notification (510(k)). The data provenance is from internal testing conducted by the manufacturer. The country of origin of the data is not specified, but the sponsor is located in St. Paul, Minnesota, USA. The study is a prospective test designed to evaluate the device's performance under specified conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is a biological indicator for sterilization. The ground truth (i.e., whether sterilization was successful or not) is determined by the biological indicator's response (negative fluorescent and negative growth response for sterility) and the chemical indicator's color change, not by expert interpretation of complex data.

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

This information is not applicable. The outcome of the biological indicator (fluorescence and growth response) and the chemical indicator (color change) are objective readings, not subject to subjective adjudication by multiple readers.

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:

This information is not applicable. The device is a biological indicator, not an AI software intended for interpretation by human readers. It functions as a standalone indicator to confirm sterilization.

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

Yes, the study described is a standalone performance evaluation of the biological indicator. Its function is to independently indicate sterilization success or failure based on its biological and chemical responses, which are then read by a compatible auto-reader. The auto-reader (3M™ Attest™ Auto-reader 490H, 490 with software version 4.0.0+, or 490M) performs the "reading" of the biological indicator without human interpretation of raw data.

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

The ground truth is derived from the biological response of Geobacillus stearothermophilus spores on the indicator and the chemical reaction of the indicator.

• For the full and fractional cycle performance, the ground truth for successful sterilization is a "negative fluorescent and negative growth response" from the biological indicator, meaning the sterilization process successfully killed the spores.
• For the chemical indicator, the ground truth for successful exposure to the sterilant is a "color change from blue toward pink."

This is based on the principle that if the spores are killed and the chemical indicator changes color, the sterilization cycle has been effective.

8. The sample size for the training set:

This information is not applicable as this is a biological indicator, not an AI/machine learning device that requires a training set. The device's function is mechanistic based on biological and chemical reactions, not learned from data.

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

This information is not applicable for the same reason as point 8.

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