(295 days)
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.
§ 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).