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510(k) Data Aggregation
(121 days)
3MTM Attest™ Super Rapid Steam Biological Indicator 1592:
Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 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 3MTM Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle | Exposure | Exposure |
|---|---|---|
| Type | Temperature | Time |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15, 20, 30, or 35 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 3, 3.5, 4, 5.5, or 6 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 3 or 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3, 3.5, or 10 minutes |
3MTM AttestTM Super Rapid Steam Challenge Pack 51582:
Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 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 3MTM Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| CycleType | ExposureTemperature | ExposureTime |
|---|---|---|
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| 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 |
3MTM AttestTM 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.
3MTM AttestTM 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.
3MTM Attest™ Mini Auto-reader 490M:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM 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 Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed for rapid and reliable qualification testing and routine monitoring of 250°F (121°C) dynamic-air-removal and gravity displacement steam sterilization processes and of dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities. The 1592 BI is used in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3MTM Attest™ Mini Autoreader 490M.
The 1592 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1592 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 1592 BI in the 490 Auto-reader, 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.
The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify and monitor dynamic-air-removal (pre-vacuum and SFPP) and gravity displacement steam sterilization processes at 250°F (121°C) and dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities.
The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain the monitoring products. The stacked cards are wrapped with sterilization wrap and secured with a label. The Challenge Packs are identical in design to the predicate device. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3M™ Attest™ Steam Chemical Integrator (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Chemical Integrator offers an immediate ACCEPT or REJECT reading. 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. 3MTM Attest™ 1592 BI controls are provided with the Challenge Packs.
The 1592 BI is specifically designed for rapid and reliable monitoring of the steam sterilization processes when used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, a 3MTM 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 1592 BI in the 490, 490H, or the 490M Auto-reader indicates a steam sterilization process failure.
The provided document outlines the FDA's 510(k) clearance for several 3M™ Attest™ sterilization monitoring devices. The information primarily focuses on the substantial equivalence to predicate devices and presents a summary of non-clinical testing performed.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a table summarizing the performance tests, standards, purpose, acceptance criteria, and results for the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 (BI) and the 51582 Challenge Pack.
| Item Tested | Test | Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| 1592 BI | Population | ISO 11138-1, ISO 11138-3, USP 34-NF29, and FDA Guidance document¹ | To evaluate the total viable spore count | ≥ 10⁶ spores | Passed |
| 1592 BI | D-Value | ISO 11138-1, ISO 11138-3, and FDA Guidance document¹ | To evaluate the resistance characteristics of the BI. | D121 ≥ 1.5 min, D132 ≥ 10 s, D134 or 135 ≥ 8 s | Passed |
| 1592 BI | Z-Value | ISO 11138-1, ISO 11138-3, and FDA Guidance document¹ | To evaluate the resistance characteristics of the BI. | ≥ 10°C | Passed |
| 1592 BI | Survival Time | ISO 11138-1, ISO 11138-3, and FDA Guidance document¹ | (Implicitly related to resistance) | Meets the longer of FDA and ISO 11138-1 and ISO 11138-3 requirements | Passed |
| 1592 BI | Kill Time | ISO 11138-1, ISO 11138-3, and FDA Guidance document¹ | (Implicitly related to resistance) | Meets ISO 11138-1 and ISO 11138-3 requirements | Passed |
| 1592 BI | Component Inhibition Studies | ISO 11138-1 and FDA Guidance document¹ | 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 | Passed |
| 1592 BI | Hold Time Assessment | ISO 11138-1 and FDA Guidance document¹ | To evaluate the effect of the labeled holding time on the resistance characteristics and spore recovery. | D-value does not change when activated 7 days post sterilization | Passed |
| 1592 BI | Reduced Incubation Time | ISO 11138-1 and FDA Guidance document¹ | To validate the reduction in incubation time from 7 days to 24 minutes. | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout time: Fluorescent result in 24 minutes | Passed |
| 1592 BI | Reduced Incubation Time | ISO 11138-1 and ISO 11138-8 | To validate the reduction in incubation time from 7 days to 24 minutes. | Meets requirement for Reduced Incubation Time specified in ISO 11138-8 | Passed |
| 1592 BI | Simulated Use | FDA Guidance document¹ | Verification of performance in claimed cycles | BI performs as intended in claimed cycles | Passed |
| 490 Auto-reader and 490M Mini Auto-reader | Verification of equivalent performance - 1592 BI in 490 Auto-reader and 490M Mini Auto-reader | N/A | Cross-over study of 1592 BI in 490 Auto-reader and 490M Mini Auto-reader | 1592 BI performs the same in 490 Auto-reader as compared to 490M Mini Auto-reader | Passed |
| 51582 Challenge Pack | Resistance of the 51582 Challenge Pack as compared to AAMI 16 Towel PCD in claimed cycles | ANSI/AAMI ST79 and FDA Guidance document¹ | To evaluate the 51582 Challenge Pack as compared to the AAMI 16 Towel PCD in claimed cycles | 51582 Challenge Pack demonstrates equivalent resistance as compared to the AAMI 16 Towel PCD in claimed cycles | Passed |
| 51582 Challenge Pack | Resistance of the 51582 Challenge Pack as compared to the 1592 Biological Indicator and the 3M™ Attest™ Chemical Integrator alone in claimed cycles | FDA Guidance document¹ | To evaluate the 51582 Challenge Pack as compared to the 1592 Biological Indicator itself and the 3M™ Attest™ Chemical Integrator alone in claimed cycles | 51582 Challenge Pack provides a greater challenge than 1592 Biological Indicator and 3M™ Attest™ Chemical Integrator itself in claimed cycles | Passed |
2. Sample size used for the test set and the data provenance:
The document mentions various tests but does not specify the exact sample sizes (number of BIs or challenge packs) used for each test. It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. The reference to "FDA Guidance document¹" and ISO standards implies laboratory-based, controlled studies, which are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. For biological indicators, the "ground truth" is typically established by microbiological culture methods (e.g., observing growth/no growth of spores after sterilization exposure), which are objective and don't involve expert human interpretation in the same way as, for example, medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided in the context of biological indicators. The outcome of these tests (e.g., spore growth, fluorescent signal) is typically objectively measured rather than requiring human adjudication of results.
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 is not applicable to this type of device (biological indicators for sterilization monitoring). MRMC studies are relevant for AI-powered diagnostic tools where human readers are involved in interpreting results. The 3M™ Attest™ Auto-readers provide an automated, objective fluorescent readout, not an interpretation that human readers would assist with or improve upon. Therefore, an MRMC study was not done.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the device (the 3M™ Attest™ Auto-readers and Biological Indicators) operates in a standalone (algorithm only) manner for fluorescence detection. The "Reduced Incubation Time" test, for instance, validates the automated fluorescent result provided by the Auto-reader against conventional 7-day incubation. The Auto-readers detect the fluorescent by-product from enzymatic hydrolysis, indicating a sterilization process failure, without human interpretation of the result.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The ground truth for the biological indicator tests is established by microbiological methods. This involves:
- Spore Count: Direct enumeration of viable spores (e.g., plate counts).
- Spore Viability/Inactivation: Observing actual growth or no growth of the Geobacillus stearothermophilus spores after exposure to sterilization conditions, typically through traditional culture methods (7-day incubation is the conventional ground truth). The fluorescent signal from the Auto-reader is then compared to this microbiological outcome.
8. The sample size for the training set:
The document does not specify a separate "training set" sample size. The studies described are primarily performance validation studies for the biological indicators and auto-readers. For devices like these, which are not AI/ML algorithms designed to learn from data in the traditional sense, a distinct "training set" as understood in machine learning is not typically applicable or defined. The Auto-reader's algorithm is based on detecting a specific biochemical reaction and does not undergo continuous learning in the field.
9. How the ground truth for the training set was established:
As there is no explicitly defined "training set" for an AI/ML algorithm, this question is not applicable in the context of this device. The "ground truth" for the validation of the device's performance, as mentioned in point 7, is established through standard microbiological techniques.
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