(85 days)
Use the 3MM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Autoreader 490 or 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamicair-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 5 Steam-Plus Challenge Pack 41482V is specifically designed to qualify or routinely challenge dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 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 Pack has the same design as the predicate device except for a change to the chemical integrator contained within the Challenge Pack. Each 41482V Challenge Pack contains a 1492V BI and a 3M™ Attest™ Steam Chemical Integrator. The 1492V BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 or the 3MTM Attest™ Auto-reader 490H (software version 4.0.0 or greater). A fluorescence change indicates a steam sterilization process failure. 3MTM Attest™ 1492V BI controls are provided with the Challenge Packs. The 3M™ Attest™ Chemical Integrator offers an immediate Accept/Reject result that allows for implant load early release in emergency situations as defined in AAMI ST79. 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 provided document describes the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, a Class II medical device (sterilization process indicator). The document focuses on demonstrating the substantial equivalence of this device to a predicate device (K173519).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Comparison to AAMI 16 Towel PCD | Determine the resistance of the Challenge Pack as compared to an AAMI 16 Towel Process Challenge Device (PCD) | Challenge Pack is at least as resistant as the biological indicator AAMI 16 Towel PCD described in ANSI/AAMI ST79: 2017 | Passed |
| Comparison to Biological Indicator (alone) | Determine the 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:
The document does not explicitly state the sample sizes used for the resistance tests. It only states that "Performance testing to demonstrate substantial equivalence to the predicate device has been completed."
Regarding data provenance:
- Country of Origin: Not specified, but given the company (3M) and the FDA submission, it's likely the testing was conducted in the US or a country with comparable regulatory standards.
- Retrospective or Prospective: The testing described appears to be prospective as it involves performance testing (resistance studies) of the new device against established standards and a predicate device. This is a typical approach for premarket notification (510(k)) submissions.
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 in this context. The device is a "sterilization process indicator" (a physical/chemical indicator of sterilization effectiveness), not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for this device's performance is objectively measured resistance to sterilization processes, not subjective human assessment.
4. Adjudication method for the test set:
Not applicable. As the device is a physical/chemical indicator, its performance is measured objectively, not through human interpretation requiring adjudication.
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 not an AI-assisted diagnostic tool. No human reader study was conducted or required for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not a software algorithm; it is a physical biological indicator.
7. The type of ground truth used:
The ground truth for this device's performance is established by objective physical and biological measurements related to sterilization effectiveness and resistance. This includes:
- Standardized Sterilization Cycles: Exposure to defined steam sterilization parameters (e.g., 4 minutes at 270°F, 3 minutes at 275°F).
- Biological Indicator Response: The viability of the Geobacillus stearothermophilus spores within the biological indicator, determined by fluorescent readout in the specific auto-readers. A positive fluorescent result indicates sterilization failure (growth of spores), and a negative result indicates sterilization success (no growth).
- Predicate Device Performance: Comparison to the known performance of the legally marketed predicate device (K173519) and adherence to industry standards like ANSI/AAMI ST79.
- Chemical Integrator Response: The visual change of the chemical integrator inside the pack, which provides an immediate "Accept/Reject" result.
8. The sample size for the training set:
Not applicable. This is a hardware/biological device, not a machine learning model. Therefore, there is no "training set" in the context of AI. The device's design and manufacturing are based on scientific principles and established standards, not iterative training data.
9. How the ground truth for the training set was established:
Not applicable. (See 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).