(30 days)
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:
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Full Cycle Performance | Verify performance in each of the full cycles in the V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles). | 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 V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles). | 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 V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles). | Color change from blue toward pink. | Pass |
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.
§ 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).