(152 days)
Use the Attest 1296V Rapid Readout Steam and 41382V Rapid Readout Steam-Plus Process Challenge Devices to monitor 132°C (270°F) dynamic-air-removal (prevacuum) steam sterilization cycles with exposure time of 4 minutes.
The 3M™ Attest™ 1296V Rapid Readout Steam and 41382V Rapid Readout Steam-Plus Process Challenge Devices (PCDs) are specifically designed to be used in healthcare facilities to routinely challenge 270°F (132°C) dynamic-air-removal (prevacuum) steam sterilization cycles with exposure time of 4 minutes. The changes from the predicate device include an optimization of the PCD for prevacuum steam cycles and a replacement of the biological indicator (BI) from one based on a visual color change growth readout to one based on a fluorescence readout.
The PCD 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. A sheet of moisture absorbent material (absorbent pad) is placed over the wrapped PCD pack, and then the PCD pack is placed in a vented film pouch as the fully-assembled PCD sold to the customer. This construction regulates air removal and steam penetration and presents a challenge to better monitor multiple pulse vacuum-assisted steam cycles.
Each Attest 1296V Rapid Readout Steam PCD is supplied with a 1292 Rapid Readout biological indicator, which contain bacterial endospores of Geobacillus stearothermophilus. The Attest 41382V Rapid Readout Steam-Plus PCD is supplied with a 1292 Rapid Readout biological indicator and one SteriGage chemical integrator.
Each PCD has a chemical process indicator on the outside of the PCD that changes from vellow to dark brown/black when exposed to steam. In addition, there is a chemical process indicator on the Attest BI that changes color from rose to brown when exposed to steam. The Attest Rapid Readout biological indicator is specifically designed for a rapid fluorescent readout when used in conjunction with the 3MTM Attest™ Auto-reader. A fluorescence change indicates a steam sterilization process failure. Attest Rapid Readout biological indicator controls are provided with the PCD.
The provided text describes the acceptance criteria and the study for the 3M™ Attest™ 1296V Rapid Readout Steam and 41382V Rapid Readout Steam-Plus Process Challenge Devices (PCDs).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance Performance: • 1296V Rapid Readout Steam PCD vs. AAMI Towel Pack in a 4 minute, 132°C (270°F) cycle | • 1296V PCD has resistance greater than or equal to the AAMI Towel Pack | |
| • All PCDs are killed in a 4 minute, 132°C (270°F) cycle | Pass | |
| Resistance Performance: • 41382V Rapid Readout Steam-Plus PCD vs. AAMI Towel Pack in a 4 minute, 132°C (270°F) cycle | • 41382V PCD has resistance greater than or equal to the AAMI Towel Pack | |
| • All PCDs are killed in a 4 minute, 132°C (270°F) cycle | Pass | |
| Resistance Performance: • 1296V Rapid Readout Steam PCD vs. predicate 41380 Steam-Plus Test Pack in a 4 minute, 132°C (270°F) cycle | • 1296V PCD has resistance greater than or equal to the predicate 41380 Steam-Plus Test Pack | |
| • All PCDs are killed in a 4 minutes, 132°C (270°F) cycle | Pass | |
| Resistance Performance: • 41382V Rapid Readout Steam-Plus PCD vs. predicate 41380 Steam-Plus Test Pack in a 4 minute, 132°C (270°F) cycle | • 41382V PCD has resistance greater than or equal to the predicate 41380 Steam-Plus Test Pack | |
| • All PCDs are killed in a 4 minutes, 132°C (270°F) cycle | Pass | |
| Biological indicator contained within the PCD | Complies with ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSI/AAMI/ISO 11138-3:2006/(R)2010 | Complies (Implied by "Pass" for overall resistance) |
| Chemical integrator within the PCD (for 41382V Steam-Plus PCD) | Complies with the performance requirements of the FDA for chemical integrators as well as the international voluntary standard ANSI/AAMI/ISO 11140-1:2005 Complies with the performance requirements of the FDA for chemical integrators as well as the international voluntary standard ANSI/AAMI/ISO 11140-1:2005. | Complies (Implied by "Pass" for overall resistance) |
2. Sample size used for the test set and the data provenance
The document states "Multiple lots" were evaluated, but it does not specify the exact sample size (number of PCDs from each lot) used for the testing.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. The testing was conducted by 3M Health Care, which is based in St. Paul, MN, USA. The document suggests the study was conducted specifically for this submission, indicating it was likely prospective for the purpose of demonstrating substantial equivalence.
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. The device being tested is a biological indicator and process challenge device for sterilization. The ground truth in this context is determined by the survival or inactivation of bacterial spores (Geobacillus stearothermophilus) and the performance of chemical indicators under specific sterilization conditions, rather than expert interpretation of an image or clinical data.
4. Adjudication method for the test set
Not applicable, as the evaluation is based on objective biological and chemical indicator responses rather than subjective 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 or imaging device that involves human readers interpreting cases. It is a sterilization monitoring device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the PCDs and their contained biological/chemical indicators) under controlled sterilization conditions. The study determines if the PCDs adequately challenge the sterilization process and if the indicators accurately reflect the outcome. The operation of the biological indicator in the Attest system involves a rapid fluorescent readout by an "Attest Auto-reader," which implies an automated, standalone analysis of the biological indicator's performance. The results of the tests (Pass) demonstrate this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is the inactivation or survival of bacterial endospores (Geobacillus stearothermophilus) within the biological indicator, confirmed by a fluorescence readout. For the chemical integrators, the ground truth is the color change indicating exposure to sterilizing conditions, and its compliance with specified performance requirements. These are objective, scientifically measurable outcomes directly related to the function of a sterilization indicator. The performance against the AAMI Towel Pack also establishes a standard reference for ground truth regarding challenge to the sterilization cycle.
8. The sample size for the training set
Not applicable. This device is not a machine learning or AI algorithm that requires a training set. It is a physical device whose performance is intrinsically determined by its design and components.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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).