(122 days)
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.
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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.
§ 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).