(160 days)
Use the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 or 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V are specifically designed to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 1496V and 41482V Challenge Packs consist 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. Each 1496V Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V while the 41482V Challenge Pack contains a 1492V BI and a 3M™ SteriGage™ Steam Chemical Integrator (Type 5 Integrating Indicators as categorized by ISO 11140-1:2014). The 1492V BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater). A fluorescence change indicates a steam sterilization process failure. 3M™ Attest™ 1492V BI controls are provided with the Challenge Packs. Each Challenge Pack has a process indicator on the outside of the device that changes from vellow to brown or darker when exposed to steam.
This submission is addressing a software change to the 3M™ Attest™ Auto-reader 490 to reduce the final fluorescent readout for the 1492V BI from 1 hour to 24 minutes, and to change the incubation temperature from 56°C to 60°C making the 490 Auto-reader identical to the 490H Auto-reader (software version 4.0.0 or greater). The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V are the same design as the previously cleared devices of the same model numbers. The ComplyTM SteriGage™ Steam Chemical Integrators contained within the 41482V challenge pack are the same as those in the predicate device. The device has the same materials and fundamental scientific technology.
The provided text describes the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V, 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and the 3M™ Attest™ Auto-reader 490 and 490H, particularly focusing on a software change to the Auto-reader that reduces the readout time and changes the incubation temperature. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| 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 |
| Auto-reader Maintenance of Incubation Temperature | Auto-reader maintains incubation temperature of $60 \pm 2$ ℃ over a period of 7 days | Passed |
| Auto-reader electrical safety (IEC 61010-1, IEC 61010-2-010) | Compliance to safety requirements for electrical equipment for measurement, control, and laboratory use. | Verified by Underwriters Laboratory |
| Auto-reader electromagnetic compatibility (USA Title 47 CFR, IEC 61326-1:2012) | Compliance to requirements for radiated emissions, conducted emissions, and general EMC requirements for electrical equipment for measurement, control, and laboratory use. | Verified by certified Testing Laboratory |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of challenge packs or biological indicators) used for the resistance tests. It refers to general "testing" and "evaluations." The data provenance is not specified, but given it's a 3M product and an FDA submission, it's highly likely the testing was conducted in a controlled laboratory environment (likely in the US or collaborating with US-based labs) and is prospective in nature, designed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of device (biological indicator and auto-reader for sterilization) does not involve expert interpretation in the same way as medical imaging or diagnostic tests. The ground truth for biological indicators is objective: bacterial growth (or lack thereof) indicates sterilization failure (or success). The "ground truth" for the tests mentioned (resistance, temperature maintenance, safety, EMC) is based on established scientific and engineering standards. Therefore, no human "experts" are engaged in adjudicating the results in the traditional sense; rather, the tests are performed according to validated protocols and assessed against predefined criteria.
4. Adjudication method for the test set
Not applicable. The tests described are objective performance measurements against established standards, not subjective interpretations requiring adjudication by experts.
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 and an auto-reader for sterilization processes. It's not an AI-powered diagnostic tool requiring human interpretation or MRMC studies. The device provides a direct, objective result (fluorescent positive/negative) indicating sterilization effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is essentially a "standalone" system in terms of its core function: the Auto-reader reads the biological indicator and provides a result. There is no human interpretation of an algorithm output that then influences a decision. The fluorescent result is the output, signaling success or failure. The document focuses on the performance of the biological indicator and the auto-reader together, which is its intended standalone function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's primary function (sterilization monitoring) relies on the principle of microbial death.
- Resistance of Challenge Pack: Ground truth is established by comparing its resistance to a recognized standard - the AAMI 16 Towel Process Challenge Device (PCD) described in ANSI/AAMI ST79:2017. This standard itself is based on extensive research and consensus within the sterilization community regarding a robust challenge to sterilization processes.
- Biological Indicator Performance: The biological indicator (BI) itself contains Geobacillus stearothermophilus spores. The "ground truth" for its function is the viability of these spores after exposure to sterilization conditions. If spores survive, the sterilization process failed, indicated by fluorescence in the Auto-reader. If they are all killed, the process was successful, and no fluorescence is detected.
- Auto-reader Temperature Maintenance: The ground truth is the actual measured temperature by calibrated sensors, compared against the specified range ($60 \pm 2$ ℃).
- Electrical Safety and EMC: Ground truth is compliance with specified international and national standards (IEC 61010-1, IEC 61010-2-010, USA Title 47 CFR, IEC 61326-1:2012).
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm that requires a "training set." Its functionality is based on biological response (spore viability) and physical measurements (fluorescence, temperature), not pattern recognition learned from data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).