(98 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 the following systems: AMSCO® V-PRO™ 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles). AMSCO® V-PRO™ max Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO™ 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) and in STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo 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 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 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 the 490H Auto-reader indicates a sterilization failure.
The document describes a 510(k) premarket notification for the 3M™ Attest™ Rapid Readout Biological Indicator 1295. This submission aims to expand the indications for use of an existing device to include additional sterilizers.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria (Internal Standard) | Reported Device Performance |
|---|---|---|
| Full Cycle Performance Verification – STERRAD® NX with ALLClearTM Technology, STERRAD® 100NX with ALLClearTM Technology, AMSCO® V-PROTM 1, AMSCO® V-PROTM 1 Plus and AMSCO® V-PRO 60 | Implied "Pass" (effective sterilization monitoring) | Pass |
| Half Cycle Performance Verification – STERRAD® NX with ALLClearTM Technology, STERRAD® 100NX with ALLClearTM Technology, AMSCO® V-PROTM 1, AMSCO® V-PROTM 1 Plus and AMSCO® V-PRO 60 | Implied "Pass" (detection of sterilization failure) | Pass |
| Chemical Indicator (CI) Color Change | Implied "Pass" (correct color transition) | Pass |
| Verification of population characteristics | Implied "Pass" (spore count and resistance) | Pass |
Note: The document states that testing was "in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, and ANSV/AAMI/ISO 11138-1:2006/(R) 2010 Sterilization of health care products- Biological indicators- Part 1: General requirements." These standards outline specific performance requirements for biological indicators, which would serve as the detailed acceptance criteria, although they are not explicitly listed in this summary. For example, ISO 11138-1 specifies D-value requirements (resistance) and population count. The table in the document implicitly refers to meeting these established standards by indicating "Pass."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample size used for each "Performance Test." It refers to "testing of the 3M™ Attest™ Rapid Readout Biological Indicator 1295" in conjunction with various sterilizers. The specific number of BIs tested in each cycle, or in total, is not provided in this summary.
- Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification to the US FDA, so the testing was likely conducted in the US or under US regulatory guidelines. The data is nonclinical, focusing on device performance under controlled laboratory conditions, not on patient outcomes or clinical usage. It is prospective in the sense that the tests were specifically conducted to demonstrate the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not applicable to this type of device and study. The "ground truth" for a biological indicator is established by controlled laboratory sterilization conditions (e.g., exposure to known sterilant concentrations for specific times) and subsequent microbiological culturing to determine spore viability, not by expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set:
- Not applicable in the context of biological indicator performance testing. The "ground truth" (sterilization success/failure, population count, D-value) is determined by objective laboratory methods (e.g., culture growth, spectrophotometry).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This submission describes a biological indicator, which is a device for monitoring sterilization processes, not for human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was effectively done. The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a device that interacts with the 3M™ Attest™ Auto-reader 490H to produce a "fluorescent readout of 24 minutes." The performance tests (Full Cycle, Half Cycle, CI Color Change, Population Characteristics) evaluated the integrity and function of the BI system (BI + Auto-reader) without human intervention in the interpretation of the biological outcome beyond observing the auto-reader's output or visual color change. The phrase "detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure" describes the automated, standalone output of the device combination.
7. The Type of Ground Truth Used:
- The ground truth for this device is based on microbiological viability (survival or kill of Geobacillus stearothermophilus spores) under controlled sterilization conditions. This involves:
- Known exposure to sterilant: Exposing the biological indicators to specific cycles in various sterilizers (e.g., Full Cycle and Half Cycle conditions).
- Microbiological culture: Incubating the BIs after exposure to determine if the spores are alive (growth indicated by fluorescence) or killed (no growth).
- Population counts: Determining the initial number of viable spores on the carrier.
- Resistance characteristics (D-value, Survival/Kill Window): Quantifying the resistance of the spores to the sterilant under controlled conditions.
8. The Sample Size for the Training Set:
- The document does not report a training set sample size. This is because the device described is a biological indicator, not an AI/ML algorithm that requires a training set. The device operates based on established microbiological principles and chemical reactions.
9. How the Ground Truth for the Training Set was Established:
- As there is no training set for an AI/ML algorithm, this question is not applicable. The underlying principles of how biologic indicators should perform (e.g., spore resistance, growth media reaction, fluorescence detection) are based on well-established microbiology and analytical chemistry, not on machine learning from a training set.
§ 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).