(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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April 6, 2022
3M Company Hilary Hovde Regulatory Affairs Specialist 3M Center 2510 Conway Ave, Building 275-5W-06 Saint Paul, Minnesota 55144
Re: K213809
Trade/Device Name: 3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: March 17, 2022 Received: March 18, 2022
Dear Hilary Hovde:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Clarence Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213809
Device Name
3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3M™ Attest™ Auto-reader 490H, 3M™ Attest™ Mini Auto-reader 490M
Indications for Use (Describe)
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 3M™ 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.
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The indications for use for Attest™ Biological Indicators are provided in the product's Instructions for Use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, 3MTM Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M
3M Company 3M Health Care 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, MN 55144 USA
Contact: Hilary B. Hovde Regulatory Affairs Specialist Phone Number: (651) 736-0364 FAX Number: (651) 737-5320 hbhovde@mmm.com
Submission Date: April 5, 2022
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Device Name and Classification:
| Trade Name: | 3M™ Attest™ Super Rapid Steam Biological Indicator 15923M™ Attest™ Super Rapid Steam Challenge Pack 515823M™ Attest™ Auto-reader 4903M™ Attest™ Auto-reader 490H3M™ Attest™ Mini-Auto-reader 490M |
|---|---|
| Common/Usual Name: | Biological Indicator (BI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process[21 CFR § 880.2800(a), FRC] |
Predicate Device:
3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H, K192550
Reference Device: 3M™ Attest™ Mini Auto-reader 490M. K200092
Indications for Use - 1592 Biological Indicator
Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MTM 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 Autoreader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | ExposureTemperature | ExposureTime |
|---|---|---|
| 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 |
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Indications for Use – 51582 Challenge Pack
Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3MTM Attest™ Autoreader 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 | 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 |
Indications for Use - 490 Auto-reader
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.
Indications for Use - 490H Auto-reader
The 3MTM 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.
Indications for Use – 490M Mini Auto-reader
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 60ºC for a final fluorescent result at 24 minutes.
The indications for use for Attest™ Biological Indicators are provided in the product's Instructions for Use.
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Description of Device
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.
Comparison of Technological Characteristics with the Predicate and Reference Devices
The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 are part of a biological indicator system with the 3M™
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Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, or 3MTM Attest™ Mini Autoreader 490M. This 510(k) is to expand the indications for use of the 1592 BI and the 51582 Challenge Pack to qualify and monitor additional steam sterilization cycles and to extend the use of the 490M Mini Auto-reader to include the 1592 BI and the 1592 BI contained within the 51582 Challenge Pack. Safety and efficacy were demonstrated through performance testing.
| Feature | Submission Device:3MTM AttestTMSuper Rapid SteamBiological Indicator 1592,3MTM AttestTMAuto-reader 490 and 490H,and 3MTM AttestTMMini Auto-reader 490M | Predicate Device(K192550):3MTM AttestTMSuper Rapid SteamBiological Indicator 1592and3MTM AttestTMAuto-reader 490 and 490H | Comparison | |
|---|---|---|---|---|
| Indications for use | Use the 3MTM AttestTM SuperRapid Steam BiologicalIndicator 1592 in conjunctionwith the 3MTM AttestTM Auto-reader 490 having softwareversion 4.0.0 or greater, the3MTM AttestTM Auto-reader490H having software version4.0.0 or greater, or the 3MTMAttestTM Mini Auto-reader490M to qualify or monitor thefollowing steam sterilizationcycles:• 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 | Use the 3MTM AttestTMSuper Rapid SteamBiological Indicator 1592 inconjunction with the 3MTMAttestTM Auto-reader 490having software version4.0.0 or greater or the 3MTMAttestTM Auto-reader 490Hhaving software version4.0.0 or greater to qualify ormonitor the followingsterilization cycles:• 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 | Both the predicate andthe submission BIs areindicated for use ingravity displacementand dynamic air-removal (pre-vacuumand SFPP) sterilizationcycles at 250°F(121°C). The intent ofthis submission is toexpand the indicationsfor use to includedynamic air-removal(pre-vacuum and SFPP)sterilization cycles at270°F (132°C), 273°F(134°C), and 275°F(135°C).Both the submissionand predicate BIs areintended to be used inconjunction with the3MTM AttestTM Auto-reader 490 or the 3MTMAttestTM Auto-reader490H. The intent ofthis submission is toexpand the indicationsfor use to include theuse of the referencedevice, the 3MTM | |
| Feature | Submission Device:3MTM AttestTMSuper Rapid SteamBiological Indicator 1592,3MTM AttestTMAuto-reader 490 and 490H,and 3MTM AttestTMMini Auto-reader 490M | Predicate Device:(K192550):3MTM AttestTMSuper Rapid SteamBiological Indicator 1592and3MTM AttestTMAuto-reader 490 and 490H | Comparison | |
| (pre-vacuum and SFPP),275°F (135°C),3, 3.5, or 10 minutes | Attest™ Mini Auto-reader 490M (clearedper K200092). | |||
| Indicator Organism | Geobacillus stearothermophilustraceable to ATCCTM 7953 | Geobacillusstearothermophilustraceable to ATCCTM 7953 | Identical | |
| Mechanism ofAction | When the enzyme that isnaturally occurring in the sporeis in its active state, it isdetected by measuring thefluorescence produced by theenzymatic hydrolysis of a non-fluorescent substrate. Theresultant fluorescent by-productis detected by the Auto-reader.The presence of fluorescenceupon incubation in the Auto-reader indicates a sterilizationprocess failure. | When the enzyme that isnaturally occurring in thespore is in its active state, itis detected by measuring thefluorescence produced bythe enzymatic hydrolysis ofa non-fluorescent substrate.The resultant fluorescentby-product is detected bythe Auto-reader. Thepresence of fluorescenceupon incubation in theAuto-reader indicates asterilization process failure. | Identical | |
| Auto-reader | 3MTM AttestTM Auto-reader 490having software version 4.0.0 orgreater, 3MTM Attest™ Auto-reader, or 490H having softwareversion 4.0.0 or greater, or3MTM AttestTM Mini Auto-reader 490M | 3MTM Attest™ Auto-reader490 having software version4.0.0 or greater or 3MTMAttest™ Auto-reader 490Hhaving software version4.0.0 or greater | Both the submissionand predicate BIs areintended to be used inconjunction with the3MTM Attest™ Auto-reader 490 or the 3MTMAttest™ Auto-reader490H. The intent ofthis submission is toexpand the indicationsfor use to include theuse of the referencedevice, the 3MTMAttest™ Mini Auto-reader 490M (clearedper K200092).The 3MTM Attest™Super Rapid SteamBiological Indicator | |
| Feature | Submission Device:3MTM AttestTMSuper Rapid SteamBiological Indicator 1592,3MTM AttestTMAuto-reader 490 and 490H,and 3MTM AttestTMMini Auto-reader 490M | Predicate Device(K192550):3MTM AttestTMSuper Rapid SteamBiological Indicator 1592and3MTM AttestTMAuto-reader 490 and 490H | Comparison | |
| 1592 BI has a 24minute readout and canbe used in conjunctionwith a 490 or 490HAuto-reader havingsoftware version 4.0.0or greater or a 490MAuto-reader. | ||||
| Viable sporepopulation | ≥ 1 x 106 | ≥ 1 x 106 | Identical | |
| Resistance | D121 ≥ 1.5 minD132 ≥ 10 sD134 or 135 ≥ 8 s | D121 ≥ 1.5 min | The submission BI isindicated for qualifyingand monitoringsterilization cycles at121°C, 132°C, 134°C,and 135°C whereas thepredicate BI isindicated for qualifyingand monitoringsterilization cycles at121°C. | |
| Survival Time | Meets the longer of FDA andISO 11138-1 and ISO 11138-3requirements | Meets the longer of FDAand ISO 11138-1 and ISO11138-3 requirements | Identical | |
| Kill Time | Meets the ISO 11138-1 and ISO11138-3 requirements | Meets the ISO 11138-1 andISO 11138-3 requirements | Identical | |
| Carrier material | Plastic | Plastic | Identical | |
| Incubationtemperature | 60 ± 2°C | 60 ± 2°C | Identical | |
| Readout time | 24 minute final fluorescentresult in:• The 490 Auto-readerhaving software version4.0.0 or greateror• The 490H Auto-readerhaving software version4.0.0 or greateror• The 490M Mini Auto-reader | 24 minute final fluorescentresult in:• The 490 Auto-readerhaving software version4.0.0 or greateror• The 490H Auto-readerhaving software version4.0.0 or greater | Both the submissionand predicate BIs areintended to be used inconjunction with the3MTM AttestTM Auto-reader 490 or the 3MTMAttestTM Auto-reader490H. The intent ofthis submission is toexpand the indicationsfor use to include theuse of the reference | |
| Feature | Submission Device:3MTM AttestTMSuper Rapid SteamBiological Indicator 1592,3MTM AttestTMAuto-reader 490 and 490H,and 3MTM AttestTMMini Auto-reader 490M | Predicate Device(K192550):3MTM AttestTMSuper Rapid SteamBiological Indicator 1592and3MTM AttestTMAuto-reader 490 and 490H | Comparison | |
| Optional visual pH colorchange result in 7 days. | Optional visual pH colorchange result in 7 days | device, the 3MTMAttestTM Mini Auto-reader 490M (clearedper K200092).The 3MTM AttestTMSuper Rapid SteamBiological Indicator1592 BI has a 24minute readout and canbe used in conjunctionwith a 490 or 490HAuto-reader havingsoftware version 4.0.0or greater or a 490MAuto-reader. | ||
| Chemical indicator | Turns from pink to light brownor darker upon steam exposure | Turns from pink to lightbrown or darker upon steamexposure | Identical | |
| Shelf-life | 12 months | 6 months | Shelf life will beextended as real timedata is available. | |
| Submission Device: | Reference Device(K200092): | |||
| Feature | 3MTM AttestTMAuto-reader 490,3MTM AttestTMAuto-reader 490H,3MTM AttestTMMini Auto-reader 490M, | 3MTM AttestTMMini Auto-reader 490M | Comparison | |
| Indications for use | 490490H490M | The 3MTMAttestTM Autoreader 490 is designed toincubate andautomatically read 3MTMAttestTM Rapid ReadoutBiological Indicators1295 and 3MTM AttestTMSuper Rapid ReadoutBiological Indicators,catalog numbers 1491,1492V, and 1592 at60°C for a finalfluorescent result at 24minutes.The 3MTM AttestTMAuto-reader 490H isdesigned to incubate andautomatically read 3MTMAttestTM Rapid ReadoutBiological Indicators1295, 3MTM AttestTMSuper Rapid ReadoutBiological Indicators,catalog numbers 1491and 1492V, and 3MTMAttest Super RapidSteam BiologicalIndicators 1592 at 60°Cfor a final fluorescentresult at 24 minutes.The 3MTM AttestTM MiniAuto-reader 490M isdesigned to incubate andautomatically read 3MTMAttestTM Rapid ReadoutBiological Indicators1295 and 3MTM AttestTMSuper Rapid ReadoutBiological Indicators,catalog numbers 1491,1492V and 1592, at60°C for a final | The 3MTM AttestTM MiniAuto-reader 490M isdesigned to incubate andautomatically read 3MTMAttestTM Rapid ReadoutBiological Indicators 1295and 3MTM AttestTM SuperRapid Readout BiologicalIndicators, catalog numbers1491 and 1492V, at 60°Cfor a final fluorescent resultat 24 minutes.The indications for use forAttestTM BiologicalIndicators are provided inthe product's Instructionsfor Use. | Both the submissionand predicate BIs areintended to be used inconjunction with the3MTM AttestTM Auto-reader 490 or the 3MTMAttestTM Auto-reader490H. The intent ofthis submission is toexpand the indicationsfor use to include theuse of the referencedevice, the 3MTMAttestTM Mini Auto-reader 490M. |
| Feature | Submission Device: | Reference Device (K200092): | Comparison | |
| 3MTM AttestTM Auto-reader 490,3MTM AttestTM Auto-reader 490H,3MTM AttestTM Mini Auto-reader 490M | fluorescent result at 24 minutes.The indications for use for AttestTM Biological Indicators are provided in the product's Instructions for Use. | 3MTM AttestTM Mini Auto-reader 490M | ||
| Incubationtemperature | 490 | 60 ± 2°C | 60 ± 2°C | Identical |
| 490H | 60 ± 2°C | |||
| 490M | 60 ± 2°C | |||
| Readout time | 490 | 24 minutes | ||
| 490H | 24 minutes | 24 minutes | Identical | |
| 490M | 24 minutes | |||
| Feature | Submission Device:3MTM AttestTMSuper Rapid SteamChallenge Pack 51582,3MTM AttestTMAuto-reader 490 and 490H,and 3MTM AttestTMMini Auto-reader 490M | Predicate Device(K192550):3MTM Attest TMSuper Rapid SteamChallenge Pack 51582 and3MTM AttestTMAuto-reader 490 and 490H | Comparison | |
| Indications foruse | Use the 3MTM AttestTM SuperRapid Steam Challenge Pack51582 in conjunction with the3MTM AttestTM Auto-reader490 having software version4.0.0 or greater, the 3MTMAttestTM Auto-reader 490Hhaving software version 4.0.0or greater, or the 3MTMAttestTM Mini Auto-reader490M to qualify or monitor:• 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 | Use the 3MTM AttestTM SuperRapid Steam Challenge Pack51582 in conjunction with the3MTM AttestTM Auto-reader490 having software version4.0.0 or greater or the 3MTMAttestTM Auto-reader 490Hhaving software version 4.0.0or greater to qualify ormonitor dynamic-air removal(pre-vacuum and SFPP) orgravity displacement steamsterilization cycles of 30minutes at 250°F (121°C). | Both the predicate andthe submissionChallenge Packs areindicated for use inGravity Displacementand Dynamic air-removal (pre-vacuumand SFPP) steamsterilization cycles at250°F (121°C). Theintent of this submissionis to expand theindications for use toinclude Dynamic air-removal (pre-vacuumand SFPP) sterilizationcycles at 270°F (132°C),273°F (134°C), and275°F (135°C).Both the submission andpredicate ChallengePacks contain a 1592 BIthat is intended to beused in conjunction withthe 3MTM AttestTM Auto-reader 490 or the 3MTMAttestTM Auto-reader490H. The intent of thissubmission is to expandthe indications for use toinclude the use of thereference device, the3MTM AttestTM MiniAuto-reader 490M(cleared per K200092). | |
| General Design | Layers of medical index cards,some of which are die-cut tocontain indicators | Layers of medical index cards,some of which are die-cut tocontain indicators | Identical | |
| Feature | Submission Device:3MTM AttestTMSuper Rapid SteamChallenge Pack 51582,3MTM AttestTMAuto-reader 490 and 490H,and 3MTM AttestTMMini Auto-reader 490M | Predicate Device(K192550):3MTM AttestTMSuper Rapid SteamChallenge Pack 51582 and3MTM AttestTMAuto-reader 490 and 490H | Comparison | |
| overwrapped and secured witha label. | overwrapped and secured witha label. | |||
| BiologicalIndicator | 3MTM AttestTM Super RapidSteam Biological Indicator1592 | 3MTM AttestTM Super RapidSteam Biological Indicator1592 | Identical | |
| BiologicalIndicatorIncubationtemperature | 60 ± 2°C | 60 ± 2°C | Identical | |
| BiologicalIndicator Readouttime | 24 minute final fluorescentresult in the 490 or 490HAuto-readers having softwareversions 4.0.0 or greater or the490M Mini Auto-reader. | 24 minute final fluorescentresult in both the 490 and490H Auto-readers havingsoftware versions 4.0.0 orgreater. | Both the submission andthe predicate BIs have a24 minute readout andare indicated to be usedwith a 490 or 490HAuto-reader havingsoftware version 4.0.0 orgreater. The intent ofthis submission is toexpand the indicationsfor use to include the useof the reference device,the 3MTM AttestTM MiniAuto-reader 490Mwhich also has a 24minute readout (clearedper K200092). | |
| ResistanceComparison tothe AAMI ST7916 Towel PCD | Equivalent in resistance to theAAMI ST7916 Towel PCD | Equivalent in resistance to theAAMI ST7916 Towel PCD | Identical | |
| ChemicalIntegrator | 3MTM AttestTM ChemicalIntegrator | 3MTM AttestTM ChemicalIntegrator | Identical | |
| ExternalChemical ProcessIndicator | Turns from yellow to brown ordarker upon steam exposure | Turns from yellow to brown ordarker upon steam exposure | Identical | |
| Shelf-life | 12 months | 6 months | Shelf life will beextended as real timedata is available. |
Technical Characteristics Comparison Table – Biological Indicator
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TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582
3M™ Attest™ Auto-readers 490 and 490H
3M™ Attest™ Mini Auto-reader 490M
{10}------------------------------------------------
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H
3M™ Attest™ Mini Auto-reader 490M
{11}------------------------------------------------
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid Steam Biological Indicator 1592 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 3MTM Attest™ Auto-readers 490 and 490H
3MTM Attest™ Mini Auto-reader 490M
Technical Characteristics Comparison Table - Auto-readers
Both the submission and predicate BIs are intended to be used in conjunction with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (both having software version 4.0.0 or greater). The intent of this submission is to expand the indications for use to include the use of the reference device, the 3M™ Attest™ Mini Auto-reader 490M (cleared per K200092). The table below is a comparison of the three Auto-reader models that can be used in conjunction with the 3MTM Attest™ Super Rapid Steam Biological Indicator 1592.
{12}------------------------------------------------
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M
{13}------------------------------------------------
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H
3M™ Attest™ Mini Auto-reader 490M
{14}------------------------------------------------
Technical Characteristics Comparison Table – Challenge Pack
{15}------------------------------------------------
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M
{16}------------------------------------------------
Summary of Non-Clinical Testing
The differences between the subject and predicate devices have been evaluated through performance tests to provide evidence of substantial equivalence for the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582.
The device performance was verified through the following tests:
| ItemTested | Test | Standard | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|---|
| 1592 BI | Population | ISO 11138-1,ISO 11138-3,USP 34-NF29,andFDA Guidancedocument¹ | To evaluate thetotal viable sporecount | ≥ 106 spores | Passed |
| 1592 BI | D-Value | ISO 11138-1,ISO 11138-3,andFDA Guidancedocument¹ | D121 ≥ 1.5 minD132 ≥ 10 sD134 or 135 ≥ 8 s | Passed | |
| 1592 BI | Z-Value | ISO 11138-1,ISO 11138-3,andFDA Guidancedocument¹ | To evaluate theresistancecharacteristics ofthe BI. | ≥ 10°C | Passed |
| 1592 BI | Survival Time | ISO 11138-1,ISO 11138-3,andFDA Guidancedocument¹ | Meets the longer ofFDA and ISO11138-1 and ISO11138-3requirements | Passed | |
| 1592 BI | Kill Time | ISO 11138-1,ISO 11138-3,andFDA Guidancedocument¹ | Meets ISO 11138-1and ISO 11138-3requirements | Passed | |
| 1592 BI | Component InhibitionStudies | ISO 11138-1 andFDA Guidancedocument¹ | To evaluate theeffects of carrierand packagingmaterials on theresistancecharacteristics ofthe BI. | Components haveno impact on therecovery of 10-100organisms | Passed |
| 1592 BI | Hold TimeAssessment | ISO 11138-1 andFDA Guidancedocument¹ | To evaluate theeffect of thelabeled holdingtime on theresistancecharacteristics | D-value does notchange whenactivated 7 dayspost sterilization | Passed |
| ItemTested | Test | Standard | Purpose | AcceptanceCriteria | Results |
| and spore | |||||
| recovery. | |||||
| 1592 BI | Reduced IncubationTime | ISO 11138-1 andFDA Guidancedocument1 | To validate thereduction inincubation timefrom 7 days to 24minutes. | Meets FDA'srequirements forReducedIncubation Timewith > 97%alignment with theconventionalincubation time of7 days for thefollowing readouttime:Fluorescent result | Passed |
| 1592 BI | Reduced IncubationTime | ISO 11138-1 andISO 11138-8 | To validate thereduction inincubation timefrom 7 days to 24minutes. | in 24 minutesMeets requirementfor ReducedIncubation Timespecified in ISO11138-8 | Passed |
| 1592 BI | Simulated Use | FDA Guidancedocument1 | Verification ofperformance inclaimed cycles | BI performs asintended in claimedcycles | Passed |
{17}------------------------------------------------
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
1 Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007
| Item Tested | Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 490Auto-readerand 490MMiniAuto-reader | Verification ofequivalentperformance-1592 BI in 490Auto-reader and490M Mini Auto-reader | Cross-over study of1592 BI in 490 Auto-reader and 490M MiniAuto-reader | 1592 BI performs thesame in 490 Auto-reader as compared to490M Mini Auto-reader | Passed |
{18}------------------------------------------------
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
| ItemTested | Test | Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| 51582ChallengePack | Resistance ofthe 51582Challenge Packas compared toAAMI 16Towel PCD inclaimed cycles | ANSI/AAMI ST79andFDA Guidancedocument1 | To evaluate the51582 ChallengePack as comparedto the AAMI 16Towel PCD inclaimed cycles | 51582 ChallengePack demonstratesequivalent resistanceas compared to theAAMI 16 TowelPCD in claimedcycles | Passed |
| 51582ChallengePack | Resistance ofthe 51582Challenge Packas compared tothe 1592BiologicalIndicator andthe 3MTMAttestTMChemicalIntegrator alonein claimedcycles | FDA Guidancedocument1 | To evaluate the51582 ChallengePack as comparedto the 1592BiologicalIndicator itselfand the 3MTMAttestTM ChemicalIntegrator alone inclaimed cycles | 51582 ChallengePack provides agreater challengethan 1592 BiologicalIndicator and 3MTMAttestTM ChemicalIntegrator itself inclaimed cycles | Passed |
1 Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007
Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the subject devices, the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, the 3MTM Attest™ Auto-reader 490, the 3MTM Attest™ Auto-reader 490H, and the 3MTM Attest™ Mini Auto-reader 490M, are substantially equivalent to, and are as safe and as effective as the legally marketed predicate device, the 3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Autoreader 490H (cleared under K192550) and the reference device, the 3MTM Attest™ Mini Autoreader 490M (cleared under K200092), Class II (21 CFR 880.2800), product code FRC.
§ 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).