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Use the 3M TM Attest TM Rapid Readout Biological Indicator 1295 in conjunction with the 3M TM Attest TM 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 and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cvcles) V-PRO® &2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) SteroScope® Sterilization System

Use the 3M IM Attest TM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: 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® maXLow Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (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) SteroScope® Sterilization System

3M™ Attest™ Rapid Readout Biological Indicator 1295: 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 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3MTM 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.

3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E: The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate. There has been no change to the product construction compared to the predicate submission, K212022. The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber. Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and concentration of vaporized hydrogen peroxide.

The provided text describes premarket notification for two devices: 3M™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E. The key new information in this submission is the addition of the "SteroScope® Sterilization System" to the indications for use for both devices. The acceptance criteria and the study performance for this new indication are detailed.

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

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Device: 3M™ Attest™ Rapid Readout Biological Indicator 1295 (for SteroScope® Sterilization System)

Device: 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (for SteroScope® Sterilization System)

Study Details

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

The document does not explicitly state the specific numerical sample sizes for the test sets (e.g., number of BIs or CIs tested in each condition). Instead, it uses qualitative statements like "All biological indicators" and quantitative statements related to percentages of the population of indicators.

• Data Provenance: The testing was "performed in a health care facility" (for the Chemical Indicator) and implicitly in a laboratory/testing environment for the Biological Indicator. The data is prospective, as it was generated specifically to demonstrate performance for the expanded indications. The country of origin is not specified, but given the FDA submission, it's likely U.S.-based or compliant with U.S. regulatory standards.

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

The document does not mention the use of experts or their qualifications for establishing ground truth. The ground truth for these types of devices (Biological and Chemical Indicators) is typically established through precisely controlled sterilization cycles using calibrated equipment and defined parameters (e.g., successful sterilization leading to no growth for BIs, or specific chemical changes for CIs). The "Visual assessment" mentioned for the CI implies human observation, but it doesn't specify if these were expert readers or how many.

4. Adjudication method for the test set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1). For the chemical indicator, it mentions "Visual assessment," but no details on multiple readers or adjudication are provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI devices, where human perception and interpretation are key variables. For sterilization indicators, the evaluation focuses on the device's intrinsic performance against defined physical/chemical/biological criteria rather than how human readers' diagnostic accuracy is improved with AI assistance.

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

This question is not directly applicable in the context of these specific devices. The Biological Indicator's readout is automated by an "Auto-reader," which itself performs the "algorithm" (fluorescence detection). The Chemical Indicator's performance is determined by a visual color change. There isn't an "AI algorithm" in the typical sense (e.g., for image analysis) being evaluated here. The "standalone" performance is essentially the performance of the indicators themselves, which is what the non-clinical tests evaluate.

7. The type of ground truth used

• For the 3M™ Attest™ Rapid Readout Biological Indicator 1295:
  • Biological Ground Truth: Absence or presence of fluorescent and/or microbial growth, indicating kill or survival of Geobacillus stearothermophilus spores after exposure to sterilization cycles. This is established by standard microbiological methods and incubation in the auto-reader.
• For the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E:
  • Physical/Chemical Ground Truth: The successful achievement of specified exposure time, temperature, and vaporized hydrogen peroxide concentration (ACCEPT result) or failure to achieve these conditions (REJECT result). This is confirmed by the color change progression of the indicator and validated against the known conditions of the sterilization cycles (i.e., "complete/full cycle" vs. "fractional/incomplete cycle"). The "Visual assessment" is against this physical/chemical ground truth.

8. The sample size for the training set

The document does not provide information on a "training set" or its sample size. These devices are physical/chemical/biological indicators, not AI/machine learning models that typically require training data. The testing described is verification and validation, not model training.

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

As there is no mention of a "training set" or AI/ML model for these devices, this question is not applicable to the provided information.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

The 3M Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of STERRAD® vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate 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 to pink upon exposure to vaporized hydrogen peroxide is located on the top of the 1295 BI utilizes the same fundamental technology that exists in current 3M Attest™ Rapid Readout and Super Rapid Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Autoreader indicates a sterilization failure.

This document describes a premarket notification (510(k)) for the 3M™ Attest™ Rapid Readout Biological Indicator 1295.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state "acceptance criteria" for the entire device as one might expect for a diagnostic or imaging AI. Instead, it presents a comparison to a predicate device, focusing on specific performance characteristics of the biological indicator (BI). The assumption is that the new device's performance matching the predicate device, especially for the additional sterilizer, meets the regulatory requirements.

Here's a table derived from the "Comparison to Predicate Device" section, identifying the characteristics (which serve as performance metrics for this type of device) and their reported values. The "acceptance criteria" here are implicitly that the device performs the same as the predicate device for these characteristics.

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

The document states: "No clinical data was included in this premarket application submission." This implies that testing was nonclinical. For biological indicators, this typically involves laboratory testing under controlled conditions rather than human patient data.

• Sample size for test set: Not explicitly stated in terms of number of biological indicators tested, but implied to be sufficient for nonclinical testing.
• Data provenance: Not explicitly stated, but the nature of the device (biological indicator) suggests lab-based, controlled experiments rather than clinical data from a specific country or retrospective/prospective collection related to human subjects.

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)

Not applicable. For a biological indicator, the "ground truth" is typically established by physical/chemical properties and microbiological testing (e.g., presence or absence of viable spores after sterilization, fluorescence detection) rather than expert human interpretation.

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

Not applicable, as no human expert interpretation or adjudication is mentioned for establishing the ground truth or evaluating performance.

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

Not applicable. This device is a biological indicator for sterilization processes, not an AI or imaging device that would involve human readers or MRMC studies.

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

This concept is not directly applicable to a biological indicator. The "device" in this context is the BI itself, which functions by a chemical and biological reaction detected by an auto-reader. The performance described is inherent to the BI and its interaction with the sterilization process and the auto-reader, without a "human-in-the-loop" in the diagnostic sense. The comparison provided is for the BI's performance alone against its predicate.

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

The "ground truth" for a biological indicator is based on:

• Microbiological viability testing: Determining the presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
• Physical/chemical properties: Verifying D-value, survival time, kill time, and chemical indicator color change.
• The effectiveness of the sterilization process itself, often validated against established standards.

8. The sample size for the training set

Not applicable. This device is a biological indicator, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. No training set is involved.

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