(107 days)
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD):
Use the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD in conjunction with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cvcles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |
3M™ Attest™ Auto-reader (490):
The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Auto-reader (490H):
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Mini Auto-reader (490M):
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
The 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD is designed to qualify and monitor dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities.
The 1492PCD Challenge Pack consists of a clear plastic shell, and a tortuous channel allowing for air removal and sterilant penetration. The channel connects to a cavity containing the monitoring products and all are covered by a foil lid. The 1492PCD is a single-use device.
Each 1492PCD Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1492V (brown cap) and a 3M™ Attest™ Steam Chemical Integrator (CI). The CI verifies that the stated values for the three critical parameters of exposure time, temperature, and steam saturation have been achieved. Upon exposure to steam a dark color visible through a window migrates along the indicator strip and offers an ACCEPT or REJECT reading. The 1492V Biological Indicator (BI) is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1492V BI in the 490, 490H or 490M Auto-reader indicates a steam sterilization process failure. A chemical process indicator is present on the brown cap of the 1492V BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink to light brown or darker upon exposure to steam. The process indicator is used by the customer to verify that the challenge pack was exposed to steam.
The provided text describes the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD) and associated Auto-readers (490, 490H, 490M). This is a biological indicator system used to monitor steam sterilization processes, not an AI-based medical image analysis device. Therefore, many of the requested criteria (e.g., sample size for test set/training set, number of experts for ground truth, MRMC study, human-in-the-loop performance) are not applicable to this type of device and the information provided in the 510(k) summary.
However, I can extract the acceptance criteria and performance study details that are relevant to this biological indicator system, as described in the "Nonclinical Comparison to the Predicate Device" section.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance of 1492PCD Challenge Pack compared to AAMI 16 Towel PCD in claimed cycles | Indicators contained in the 1492PCD Challenge Pack must demonstrate equivalent resistance as compared to the indicators contained in the AAMI 16 Towel PCD in the claimed cycles. | Acceptance criteria met |
| Resistance of 1492PCD Challenge Pack compared to standalone indicators in claimed cycles | Indicators contained in the 1492PCD Challenge Pack must demonstrate greater resistance compared to the standalone indicators in the claimed cycles. | Acceptance criteria met |
| 1492PCD Peel Force (unsterilized) | ≥4.25 lbF and ≤16 lbF | Acceptance criteria met |
| 1492PCD Peel Force (pre and post sterilization) | ≥4.25 lbF and ≤16 lbF | Acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
For the resistance testing:
- Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested.
- These contained three lots of 1492V BIs and three lots of 1243R CIs.
- They were tested side by side with standalone indicators (1492V BIs and 1243R CIs) and with the AAMI 16 Towel PCD also containing 1492V BIs and 1243R CIs.
The exact number of individual devices or runs per lot is not specified, but for biological indicator testing, a standard number of replicates (e.g., 10-20) per test condition is typically used. - Data Provenance: The study appears to be a prospective laboratory-based performance study, conducted by the manufacturer (3M Company) in the U.S. (based on company location and FDA submission).
For the peel force testing:
- Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested.
The exact number of units per lot is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable. For biological indicator systems, "ground truth" is established by the known biological response of the indicator (e.g., spore kill/growth) under defined sterilization conditions, rather than human expert interpretation of images. The performance is objectively measured in a laboratory setting.
4. Adjudication Method for the Test Set
- This information is not applicable, as there is no human interpretation or subjective assessment to adjudicate. The fluorescence readings from the Auto-reader are objective, and chemical indicator endpoints are also designed for clear visual determination.
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
- This information is not applicable, as the device is a biological indicator system, not an AI-based medical image analysis device involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not directly applicable in the AI sense. However, the performance of the "algorithm" (the biological indicator system and auto-reader) is inherently standalone in its function of detecting biological indicator results (fluorescence). The results of the Auto-readers are objective and do not require human interpretation.
7. The Type of Ground Truth Used
- The ground truth for biological indicators is the presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions. This is determined by the biological response of the indicator (showing growth/fluorescence for live spores, no growth/no fluorescence for killed spores) under controlled laboratory conditions, correlated with known sterilization efficacy.
8. The Sample Size for the Training Set
- This is not applicable, as this is not an AI/ML device that requires a training set. The device's performance is based on its physical/chemical/biological design and validated through non-clinical laboratory testing.
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).