(91 days)
3M™ Attest™ Super Rapid Readout Biological Indicator 1493:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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 cycles:
Cycle Type: Gravity Displacement, Exposure Temperature: 250°F (121°C), Exposure Time: 30 minutes
Cycle Type: Dynamic-air-removal (pre-vacuum and SFPP), Exposure Temperature: 250°F (121°C), Exposure Time: 15, 20, 30, or 35 minutes
3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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 cycles:
Cycle Type: Gravity Displacement, Exposure Temperature: 250°F (121°C), Exposure Time: 30 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 1493 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, and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 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 1493, at 60°C for a final fluorescent result at 24 minutes.
The 3MTM Attest™ Super Rapid Readout Biological Indicator (BI) 1493 is a self-contained biological indicator specifically designed for rapid and reliable qualification testing and routine monitoring of 121°C (250°F) dynamic-air-removal and gravity-displacement steam sterilization processes in healthcare facilities. The 1493 BI is used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The 1493 BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1493 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490 Autoreader, the 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.
The 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG is specifically designed to qualify and monitor gravity steam sterilization processes at 250°F (121°C) in healthcare facilities. The 1493PCDG Challenge Pack consists of a clear plastic shell with an opening to the cavity containing the monitoring products, all covered by a foil lid. The 1493PCDG is a single-use device. Each 1493PCDG Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493 and a 3M™ Attest™ Steam Chemical Integrator (CI) (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Steam Chemical Integrator offers an immediate ACCEPT or REJECT reading. A chemical process indicator is present on the cap of the 1493 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. 3M™ Attest™ 1493 BI controls are provided with the Challenge Pack.
The 1493 BI is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization process when used in conjunction with the 3MM Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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 1493 BI in the 490. 490H or 490M Auto-reader indicates a steam sterilization process failure.
Here's a breakdown of the acceptance criteria and the study information for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 and related devices, as extracted from the provided text:
1. Acceptance Criteria and Reported Device Performance
Biological Indicator (1493 BI)
| Test Performed | Device Description | Applicable Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| Population | 1493 BI | FDA Guidance¹, ISO 11138-1:2017² | To evaluate the total viable spore count | ≥ 10⁶ spores | Acceptance criteria met |
| Positive Control Test | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate performance of BI without steam exposure | All BIs must be fluorescent positive at 24 minutes and visual pH color change positive (yellow) at 168 hours | Acceptance criteria met |
| D-value for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate the resistance characteristics of the BI | D-value must be ≥ 1.5 minutes | Acceptance criteria met |
| Z-value for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | Not explicitly stated but implied to be part of characterizing resistance | Z-value must be ≥ 10°C | Acceptance criteria met |
| Survival for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate the resistance characteristics of the BI | Meets the requirements for Calculated survival time* or 5 minutes, whichever is longer (*ISO 11138-1:2017) | Acceptance criteria met |
| Kill for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | Not explicitly stated but implied to be part of characterizing resistance | Meets the requirements for Calculated kill time* (*ISO 11138-1:2017) | Acceptance criteria met |
| Component Inhibition Studies | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate the effects of carrier and packaging materials on the resistance characteristics of the BI | Components have no impact on the recovery of 10-100 organisms | Acceptance criteria met |
| Holding Time Assessment for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate the effect of the labeled holding time on the D-value | D-value must be within +/- 20% of the initial D-value calculated per ISO 11138-1:2017 | Acceptance criteria met |
| Reduced Incubation Time for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-8:2021⁴ | To validate the reduction in incubation time from 7 days (visual color change) to 24 minutes (fluorescent readout) | Meets FDA's requirements for Reduced Incubation Time with ≥ 97% alignment with the conventional incubation time | Acceptance criteria met |
| Attest 1493 Simulated Use | 1493 BI | FDA Guidance¹ | Verification of performance in claimed cycles | The following readout times: • Fluorescent result in 24 minutes | Acceptance criteria met |
| 490 and 490M Auto-reader Performance | 1493 BI | FDA Guidance¹, ISO 11138-1:2017² | Verify equivalent performance of the 1493BI with the 3M™ Attest 490 and 490M Auto-readers | BIs must be fluorescent positive in 24 minutes and visual pH color change (growth) positive at 168 hours | Acceptance criteria met |
Challenge Pack (1493PCDG)
| Test Performed | Device Description | Applicable Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| Resistance of 1493PCDG Challenge Pack compared to AAMI 16 Towel PCD in claimed cycle | 1493PCDG | FDA Guidance¹ and ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities | Demonstrate the performance of the 1493PCDG Challenge Pack is equivalent to the performance of the AAMI 16 Towel PCD in the claimed cycle | Indicators contained in the 1493PCDG Challenge Pack must demonstrate equivalent resistance as compared to the indicators contained in the AAMI 16 Towel PCD in the claimed cycle | Acceptance criteria met |
| Resistance of 1493PCDG Challenge Pack compared to standalone indicators in claimed cycle | 1493PCDG | FDA Guidance¹ | Demonstrate the 1493PCDG Challenge Pack provides a greater challenge than the standalone indicators in the claimed cycle | Indicators contained in the 1493PCDG Challenge Pack must demonstrate greater resistance compared to the standalone indicators in the claimed cycle | Acceptance criteria met |
| 1493PCDG Peel Force (unsterilized) | 1493PCDG | ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids | Demonstrate acceptable peel force of Clear Challenge Pack 1493PCDG heat seal foil lid from plastic shell | ≥2.75lbF and ≤10lbF | Acceptance criteria met |
| 1493PCDG Peel Force (pre and post-sterilization) | 1493PCDG | ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowel Containers with Flexible Peelable Lids | Demonstrate acceptable peel force of Clear Challenge Pack 1493PCDG heat seal foil lid from plastic shell, pre and post sterilization | ≥2.75lbF and ≤10lbF | Acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
- Biological Indicator (1493 BI):
- Population, Positive Control Test, D-value, Z-value, Survival, Kill, Component Inhibition Studies, Reduced Incubation Time, Simulated Use: 3 lots of 1493 BIs were tested.
- Holding Time Assessment: 2 lots of 1493 BIs were tested.
- 490 and 490M Auto-reader Performance: 1 lot of 1493 BIs was evaluated.
- Challenge Pack (1493PCDG):
- Resistance compared to AAMI 16 Towel PCD: 3 lots of 1493PCDG (containing 3 lots of 1493 BIs and 3 lots of 1243R CIs) were tested.
- Resistance compared to standalone indicators: 3 lots of 1493PCDG (containing 3 lots of 1493 BIs and 3 lots of 1243R CIs) were tested.
- Peel Force: 3 lots of 1493PCDG were tested for both unsterilized and pre/post sterilization conditions.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, tests were conducted according to recognized international (ISO) and US (FDA, AAMI, ASTM) standards, suggesting controlled laboratory environments.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The "device" in question (biological indicators and challenge packs for sterilization) directly measures biological viability and physical characteristics. The ground truth for these types of devices is established through direct laboratory measurements, microbiological assays (like spore counts and viability after exposure), and physical property testing, rather than expert interpretation of images or clinical data. Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. As described above, the studies involve direct measurement and laboratory testing against predefined criteria in recognized standards, not subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The devices described here (biological indicators and auto-readers) are designed for direct, objective measurement of sterilization efficacy, not for human interpretation that would be enhanced by AI assistance.
6. Standalone Performance Study
Yes, standalone performance studies were done. All the tests listed in the tables (Population, D-value, Survival, Kill, Reduced Incubation Time, Simulated Use, etc., for the BI, and Resistance, Peel Force for the Challenge Pack) represent the standalone performance of the devices as they are intended to function without human interpretation. For example, the auto-readers automatically provide a fluorescent result, which is the direct output of the system.
7. Type of Ground Truth Used
- Biological Indicator (1493 BI): The ground truth is primarily established through direct microbiological testing (e.g., enumeration of viable spores, determination of D-values, survival, and kill times through controlled exposure to steam under defined conditions) and physical/chemical measurements (e.g., fluorescent or pH color change as an indicator of spore viability/growth). This is based on established sterilization science principles and standards.
- Challenge Pack (1493PCDG): The ground truth for the challenge pack's resistance is established by comparing its performance to recognized reference standards (e.g., AAMI 16 Towel PCD) and to standalone indicators, all under controlled sterilization conditions. Physical integrity is assessed via mechanical property testing (peel force).
8. Sample Size for the Training Set
Not applicable. The devices described are not AI/machine learning devices that require a separate "training set" of data to learn patterns or make predictions. They are physical and chemical indicators that operate based on biological and material science principles.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for these devices.
§ 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).