(262 days)
Use the 3MM Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MM AttestTM Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 20 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 35 minutes |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
Use the 3MM Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Autoreader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal and gravity displacement steam sterilization cycles at 250°F (121°C).
The 1592 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1592 cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure.
The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Packs have the same design as the predicate device but contain different monitoring products. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3MTM Attest™ Steam Chemical Integrator (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Chemical Integrator offers an immediate ACCEPT or REJECT reading. The 1592 BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure. 3M™ Attest™ 1592 BI controls are provided with the Challenge Packs. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.
The 3M™ Attest Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater are designed to incubate at 60°C and automatically read the 1592 BI for a fluorescent result within 24 minutes.
The provided text describes the acceptance criteria and study results for the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, and associated 3M™ Attest™ Auto-Readers 490 and 490H.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two main sets of non-clinical tests: one for the Biological Indicator (BI) and one for the Challenge Pack.
Biological Indicator (3M™ Attest™ Super Rapid Steam Biological Indicator 1592)
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Population (Total Viable Spore Count) | Greater than or equal to $10^6$ spores | Passed |
| D-Value | Greater than or equal to 1.5 minutes at 121°C | Passed |
| Z-Value | Greater than or equal to 10°C | Passed |
| Survival Time | Meets the longer of FDA and ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Kill Time | Meets ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Component Inhibition Studies | Components have no impact on the recovery of 10-100 organisms | Passed |
| Hold Time Assessment | D-value does not change when activated 7 days post sterilization | Passed |
| Reduced Incubation Time | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout time: Fluorescent result in 24 minutes | Passed |
| Simulated Use | Verification of performance in claimed cycles | Passed |
Challenge Pack (3M™ Attest™ Super Rapid Steam Challenge Pack 51582)
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance of the Challenge Pack as compared to AAMI 16 Towel PCD | Challenge Pack is at least as resistant as the biological indicator AAMI 16 Towel Process Challenge Device (PCD) described in ANSI/AAMI ST79: 2017 | Passed |
| Resistance of the Challenge Pack as compared to the Biological Indicator alone | Challenge Pack provides a greater resistance than the Biological Indicator alone | Passed |
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 refers to "non-clinical testing" conducted in accordance with various FDA guidance documents and international standards (e.g., ISO, ANSI/AAMI, USP). This typically implies prospective, laboratory-based testing designed to verify performance against pre-defined specifications. The document does not specify the exact sample sizes (number of BIs or Challenge Packs tested) for each individual test or the country of origin of the data. However, the nature of these tests (e.g., D-value, population) usually involves specific, rigorous protocols with statistically sufficient sample sizes to ensure reliable results according to the referenced standards.
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)
The ground truth for these types of biological indicator and challenge pack studies is established through controlled laboratory experiments and adherence to international standards and regulations. It is not based on expert consensus in the typical sense of medical image interpretation (e.g., radiologists). The "ground truth" here refers to the actual performance of the biological indicators under precisely controlled sterilization or simulated sterilization conditions, measured by established microbiological methods (e.g., viable spore counts after exposure to steam, fluorescence detection by the auto-reader coupled with conventional incubation).
Therefore, there are no "experts" in the clinical interpretation sense. The "experts" involved would be microbiologists, engineers, and quality assurance personnel responsible for designing, executing, and analyzing these standardized tests. Their qualifications would stem from their adherence to the specified regulatory and standard requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective and based on measurable biophysical and microbiological parameters, not subjective assessments requiring adjudication. The outputs are "Passed" or "Failed" based on whether the device meets the pre-defined quantitative acceptance criteria.
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 sterilization process indicator (a biological and chemical indicator system coupled with an auto-reader), not an imaging or diagnostic device involving human interpretation or AI assistance for clinical decision-making. The "reader" here is an automated "Auto-reader 490/490H" and its performance is evaluated against objective microbiological standards, not against human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the performance of the device system (biological indicator + auto-reader) is evaluated in a standalone manner. The auto-reader automatically detects fluorescence, which indicates sterilization failure. The study validates the device's ability to accurately provide a "Passed" or "Failed" result based on its internal mechanism. The comparison is made against traditional microbiological methods (e.g., 7-day conventional incubation) to confirm the accuracy of the rapid fluorescent readout, confirming >97% alignment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is established through reference laboratory methods and adherence to standardized performance requirements. For example:
- Microbiological Counts: Determining the initial viable spore population (population test).
- Resistance Parameters (D-value, Z-value, Survival Time, Kill Time): Measured by exposing the biological indicators to precisely controlled steam sterilization conditions and then assessing spore viability using standard microbiological culture techniques. This is the gold standard for BI performance.
- Reduced Incubation Time Alignment: Comparing the rapid fluorescent readout result (e.g., 24 minutes) with the result obtained from conventional 7-day incubation (which is considered the definitive ground truth for spore viability). This involves culturing the BIs after exposure and determining growth/no growth.
- Simulated Use: Performance testing within mock sterilization loads/cycles to ensure the device performs as expected in representative conditions.
8. The sample size for the training set
Not applicable. This device is a physical/biological indicator system, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" of the system is the manufacturing and calibration processes to ensure it meets the design specifications and regulatory standards.
9. How the ground truth for the training set was established
Not applicable, as there's no "training set" in the AI/ML context. The device's operational parameters and performance capabilities are based on its physical and biological design, as well as the manufacturing and testing processes that confirm its adherence to established standards for sterilization indicators.
§ 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).