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510(k) Data Aggregation
(104 days)
3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric
Chemical Indicator 1348/1348E
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)
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Full Cycle Performance | Verify performance in each of the full cycles in the SteroScope® Sterilization System. | All biological indicators display a negative fluorescent and negative growth response. | Pass |
| Fractional Cycle Performance | Verify performance in fractional cycles for each of the cycles within the SteroScope® Sterilization System. | All biological indicators display a negative fluorescent and negative growth response. | Pass |
| Chemical Indicator (CI) Color Change | Demonstrate the color change of the CI when exposed to the SteroScope® Sterilization System. | Color change from blue toward pink. | Pass (implicitly, as part of the BI unit) |
Device: 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (for SteroScope® Sterilization System)
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Complete (Full) Cycle Performance | Verify performance in the complete (full) cycle of a loaded SteroScope® Sterilization System. | Visual assessment of the chemical indicator yields an ACCEPT result with ≥ 95% accuracy. | |
| At least 80% of the population of indicators tested has a measured color change value corresponding to an ACCEPT result. | Pass, 100% accuracy | ||
| Pass, >99.9% population | |||
| Fractional Cycle Performance | Verify performance in an incomplete cycle of a loaded SteroScope® Sterilization System. | Visual assessment of the chemical indicator yields a REJECT result with ≥ 95% accuracy. | |
| At least 80% of the population of indicators tested has a measured color change value corresponding to a REJECT result. | Pass, 100% accuracy | ||
| Pass, >99.9% population |
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.
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(295 days)
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following 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® 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 3MTM 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.
The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount 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 to 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 amount of vaporized hydrogen peroxide.
Here's a summary of the acceptance criteria and study information for the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Health Care Facility Simulated Use Testing on STERIZONE® VP4 Sterilizer (Cycle 1) | Assess color change of indicator after exposure to representative complete and incomplete cycles for the STERIZONE® VP4 Sterilizer (Cycle 1) | The 3M™ Tri-Metric CI turns from blue toward pink in the ACCEPT region of the indicator window to indicate a "PASS" (reaches endpoint) when exposed to a complete cycle in the STERIZONE® VP4 Sterilizer (Cycle 1). The 3M™ Tri-Metric CI turns from blue toward pink only within the REJECT region of the indicator window to indicate a "FAIL" (does not reach endpoint) when exposed to an incomplete cycle in the STERIZONE® VP4 Sterilizer (Cycle 1). | All Tri-Metric CIs tested met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (i.e., number of indicators) used for the sterile and incomplete cycles during the "Health Care Facility Simulated Use Testing." It broadly states "All Tri-Metric CIs tested met acceptance criteria," implying multiple indicators were used.
The data provenance is prospective, as the testing was conducted to evaluate the device's performance in a healthcare facility setting, specifically for the STERIZONE® VP4 Sterilizer (Cycle 1). The country of origin for the data is not specified, but the submission is from a US-based company to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for reading the chemical indicators. However, for a chemical indicator, the "ground truth" performance is typically based on the objective visual change of the indicator after exposure to defined sterilization conditions (complete vs. incomplete cycles). The acceptance criteria detail very specific visual outcomes ("blue toward pink in the ACCEPT region" for pass, and "blue toward pink only within the REJECT region" for fail), implying a relatively objective assessment rather than subjective expert interpretation, though standard operating procedures would likely be in place for reading.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. Given the objective nature of chemical indicator color change and defined "ACCEPT" and "REJECT" zones, it's likely that a single trained observer could determine the outcome, or multiple observers could independently read and have their results compared, without a formal adjudication process being explicitly detailed in this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a chemical indicator, which is a standalone device that provides a visual reading, not an AI or diagnostic tool that assists human readers in interpreting complex data. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply here.
6. Standalone Performance Study
Yes, a standalone study was done. The "Health Care Facility Simulated Use Testing on STERIZONE® VP4 Sterilizer (Cycle 1)" was a standalone performance study. The chemical indicators were subjected to complete and incomplete sterilization cycles, and their performance (color change) was evaluated independently of any human intervention beyond the initial setup and final visual assessment. The results directly demonstrate the algorithm-only performance (e.g., the indicator's intrinsic ability to react to the sterilization process).
7. Type of Ground Truth Used
The ground truth used was based on the objective conditions of the sterilization cycles. This means:
- Complete Cycle: The indicator was exposed to the full, verified sterilization parameters (time, temperature, vaporized hydrogen peroxide concentration) of a successful STERIZONE® VP4 Cycle 1.
- Incomplete Cycle: The indicator was exposed to conditions known to be insufficient for sterilization (e.g., shorter time, lower temperature, insufficient sterilant).
The color change of the indicator was then compared against these known conditions.
8. Sample Size for the Training Set
This product is a chemical indicator, not a machine learning or AI-driven device. Therefore, there is no training set in the context of AI or machine learning algorithms. The device's performance is based on its chemical reaction properties, which are inherent to its design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this type of device. The chemical indicator's design and manufacturing are developed based on established scientific principles of chemical reactions to sterilants, rather than being "trained" on data.
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(122 days)
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NXº System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX ® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).
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.
The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount 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 amount of vaporized hydrogen peroxide.
Here's a breakdown of the acceptance criteria and study information for the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Health Care Facility Simulated Use Testing: | |
| Color change of the indicator was assessed after exposure to representative complete and incomplete cycles for various STERRAD® and STERIS® V-PRO® sterilizers. | Pass |
| Worst Case Sterilant Exposure Testing: | |
| Ensured color change in overexposure conditions was similar to color change observed for in-pack monitoring of the same cycle. | Pass |
| Endpoint Color Stability: | |
| After VH2O2 processing, chemical indicator samples were placed in a shelf life study to confirm the chemical indicator samples conserved their color change reading over time. | Pass |
| Shelf Life Testing: | |
| 6 months of shelf life testing assessing endpoint and non-endpoint conditions. | Pass |
Note on "Acceptance Criteria": The document lists "Stated Values" for the chemical indicator, which represent the minimum conditions at which the indicator is designed to reach its endpoint (change color to "ACCEPT"). These are:
- VH2O2: 5.1 mg/L
- Exposure Time: 1 minute
- Temperature: 50°C
The general acceptance criteria for the nonclinical testing seem to be 'Pass' for each test, indicating that the device performed as expected under the tested conditions.
Study Details
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the test set (e.g., how many individual indicators were tested for each sterilizer type or condition). It mentions "chemical indicator samples" for endpoint color stability and shelf life testing.
- Data Provenance: The document implies the testing was conducted by the manufacturer, 3M Company, as part of their premarket notification. The location of the testing is not explicitly stated (e.g., country of origin), but it's likely internal to 3M's development and validation processes. The study is prospective as it's part of the premarket submission for a new device.
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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 human experts to establish ground truth for reading the chemical indicator's color change. Chemical indicators are typically designed for objective visual interpretation, where the "ground truth" is defined by the physical/chemical properties of the indicator and its response to specific sterilization parameters, as determined by laboratory measurements of those parameters.
- Therefore, this question is not directly applicable in the context of this device and study.
-
Adjudication method for the test set:
- None specified. As mentioned above, the assessment of a chemical indicator's color change against defined "ACCEPT" or "REJECT" zones is generally a direct visual interpretation, not requiring expert adjudication in the same way, for example, a medical imaging diagnosis might. The endpoint specifications are based on the physical chemistry of the indicator.
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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. This is a chemical indicator, not an AI-powered diagnostic device or a system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical chemical indicator, not an algorithm. Its performance is inherent in its physical and chemical interaction with the sterilant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device is based on the defined physical/chemical parameters of the sterilization process (VH2O2 concentration, exposure time, and temperature) and the indicator's designed response to these parameters. The "Stated Values" (SV) in Table 1 define the minimum conditions for a successful ("ACCEPT") outcome. The "Health Care Facility Simulated Use Testing" and "Worst Case Sterilant Exposure Testing" would have used calibrated sterilization equipment to establish these ground truth conditions.
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The sample size for the training set:
- Not applicable. This device is a passive chemical indicator, not a machine learning model, so there is no "training set." Its design and performance are based on chemical engineering and empirical testing rather than iterative learning from data.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
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