(130 days)
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.
| Acceptance Criteria (Implicit: Same as Predicate) | Reported Device Performance (3M™ Attest™ 1295 Biological Indicator) |
|---|---|
| Organism: Geobacillus stearothermophilus traceable to ATCC™ 7953 | Geobacillus stearothermophilus traceable to ATCC™ 7953 |
| Viable spore population: ≥1x10^6 | ≥1x10^6 |
| Resistance characteristics: | |
| • D-value: (Tested at 10 mg/L vaporized hydrogen peroxide) D10 mg/L ≥ 1 second | (Tested at 10 mg/L vaporized hydrogen peroxide) D10 mg/L ≥ 1 second |
| • Survival Time: > 5 seconds | Survival Time > 5 seconds |
| • Kill Time: = 7 minutes | Kill Time = 7 minutes |
| Carrier material: Polyethylene terephthalate | Polyethylene terephthalate |
| Incubation temperature: 60 +/- 2 °C | 60 +/- 2 °C |
| Readout time: 4 hour fluorescence result read on 3M 490H Auto-reader | 4 hour fluorescence result read on 3M 490H Auto-reader |
| Chemical indicator: H2O2 sensitive ink; appears blue until processed, then appears pink | H2O2 sensitive ink; appears blue until processed, then appears pink |
| Shelf-life: 18 months | 18 months |
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.
§ 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).