(106 days)
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD): Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow systems: STERRAD 100S® Sterilization System, STERRAD NX® Sterilization System (Standard and Advanced cycles), STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cvcles), STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles), STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles). V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), V-PRO® 60 Low Temperature Sterilization System (Lumen, and Flexible cycles), V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles). V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
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 Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD is designed as a standard method of rapid and reliable routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes. The 1295PCD Challenge Pack consists of a clear plastic shell, with two individual channels allowing for air removal and sterilant penetration. Those two individual channels connect to a cavity containing the monitoring products and all are covered by a foil lid. The 1295PCD is a single-use device. Each 1295PCD Challenge Pack contains a 3M™ Attest™ Rapid Readout Biological Indicator (BI) 1295 (pink cap) and a 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (CI) 1348. The 1348 CI verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved and offers an ACCEPT or REJECT reading. The 1295 BI is specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Autoreader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H. The presence of fluorescence within the specified incubation time for the 1295 BI in the 490, 490M, or the 490H Auto-reader indicates a sterilization process failure. A printed chemical process indicator is present on the cap of the 1295 BI and is visible through the clear plastic shell of the challenge pack. The process indicator turns color upon exposure to vaporized hydrogen peroxide and is used by the customer to verify that the challenge pack was exposed to vaporized hydrogen peroxide.
Here's an analysis of the acceptance criteria and supporting studies for the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD) and associated Auto-readers, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Item Tested | Test | Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| 1295PCD Challenge Packs and Standalone chemical and biological indicators | PCD Resistance Characterization | FDA Guidance¹ and ANSI/AAMI/ISO 11138-1:2017 | Demonstrate indicators within the 3M™ Attest™ Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD have greater resistance compared to standalone indicators in a fractional exposure cycle. | Indicators perform as intended | Passed |
| 1295PCD Challenge Packs | PCD Functionality | FDA Guidance¹ and ANSI/AAMI/ISO 11138-1:2017 | Demonstrate performance of the 3M™ Attest™ Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD in a pass cycle. | Indicators perform as intended | Passed |
| 1295PCD Challenge Packs | PCD Functionality | FDA Guidance¹ and ANSI/AAMI/ISO 11138-1:2017 | Demonstrate performance of the 3M™ Attest™ Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD in a fail cycle. | Indicators perform as intended | Passed |
| 1295PCD Challenge Pack | PCD Peel Force | ASTM F88 / F88M-15 and ASTM F2824 – 10 | Demonstrate acceptable peel force of Clear Challenge Pack 1295PCD heat seal foil lid from plastic shell | ≥8.5lbF and ≤20lbF (lbF = pounds force) | Passed |
| 1295PCD Challenge Pack | Cycle Performance | FDA Guidance¹ | Demonstrate performance of the 3M™ Attest™ Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD in the claimed sterilizers and cycles in the Indications for Use. | Indicators perform as intended | Passed |
Study Details from the Provided Document:
2. Sample Size Used for the Test Set and Data Provenance
- PCD Resistance Characterization: Three lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (containing three lots of 1295 BIs and three lots of 1348 CIs) were tested side-by-side with standalone 1295 BIs and 1348 CIs. The document does not specify the exact number of units or replicates within each lot.
- PCD Functionality (Pass Cycle): Not explicitly stated, but implies the same sample size as Resistance Characterization.
- PCD Functionality (Fail Cycle): Not explicitly stated, but implies the same sample size as Resistance Characterization.
- PCD Peel Force: Three lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD were tested. The exact number of units or replicates is not specified.
- Cycle Performance: Four lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD were subjected to simulated use testing. The exact number of units or replicates is not specified.
- Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective as it involves active testing of newly manufactured lots of the device and comparing them against standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document describes non-clinical performance testing of mechanical and biological indicators. There is no mention of human experts being used to establish ground truth for the performance of the sterilization indicators. The ground truth for biological indicator performance (survival/kill) would be determined by microbiological culturing and fluorescence detection as described in the mechanism of action. Chemical indicator performance is determined by visual color change and quantitative measurement of critical parameters.
4. Adjudication Method for the Test Set
Not applicable, as this was non-clinical laboratory testing, not a study involving human interpretation or subjective judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least not mentioned as part of this submission).
- The device is a sterilization process indicator and auto-reader system; its performance is evaluated objectively based on biological and chemical reactions, not human diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, the concepts of "algorithm only" or "standalone" performance in the context of AI are not directly applicable to this device.
- The 3M™ Attest™ Auto-readers (490, 490H, 490M) are designed to automatically read the biological indicators for a final fluorescent result at 24 minutes. This is an automated detection system. However, it's not described as an "AI algorithm" in the common sense for diagnostic imaging or similar applications. Its performance is intrinsically "standalone" in its reading function, without human interpretation of the fluorescent signal, but the overall system involves human handling of the challenge pack and interpretation of the auto-reader display.
7. Type of Ground Truth Used
The ground truth used for the non-clinical tests would be:
- Microbiological Growth/No Growth: For biological indicators (BIs), the definitive ground truth for sterilization effectiveness is the absence of microbial growth after exposure to a sterilization process, and growth after inadequate exposure or no exposure. This is typically determined by standard microbiological culture methods. The document mentions the 1295 BI utilizes an enzyme system and fluorescence measurement, with an optional pH indicator, indicating these are the readouts used, which are correlated to the viability of Geobacillus stearothermophilus spores.
- Known Sterilization Parameters: For chemical indicators (CIs) and for challenging the system, the ground truth is established by precisely controlling sterilization parameters (time, temperature, concentration of vaporized hydrogen peroxide) in a laboratory setting to create "pass" and "fail" conditions.
- Mechanical Measurement: For peel force, the ground truth is based on physical measurement using calibrated equipment.
8. Sample Size for the Training Set
The document does not describe the development or training of an AI algorithm in the traditional sense, so there is no mention of a training set sample size. The Auto-readers are described as devices that incubate and automatically read biological indicators, implying a fixed automated process rather than a machine learning model that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an AI training set, this question is not applicable based on the provided document. The functionality of the auto-readers is based on detecting fluorescence and relating it to biological indicator activity, which is a deterministic process rather than a learned one from a training set.
§ 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).