(262 days)
Use the 3MM Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MM AttestTM Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 20 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 35 minutes |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
Use the 3MM Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Autoreader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal and gravity displacement steam sterilization cycles at 250°F (121°C).
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 cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure.
The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Packs have the same design as the predicate device but contain different monitoring products. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3MTM 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. The 1592 BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure. 3M™ Attest™ 1592 BI controls are provided with the Challenge Packs. 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.
The 3M™ Attest Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater are designed to incubate at 60°C and automatically read the 1592 BI for a fluorescent result within 24 minutes.
The provided text describes the acceptance criteria and study results for the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, and associated 3M™ Attest™ Auto-Readers 490 and 490H.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two main sets of non-clinical tests: one for the Biological Indicator (BI) and one for the Challenge Pack.
Biological Indicator (3M™ Attest™ Super Rapid Steam Biological Indicator 1592)
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Population (Total Viable Spore Count) | Greater than or equal to $10^6$ spores | Passed |
| D-Value | Greater than or equal to 1.5 minutes at 121°C | Passed |
| Z-Value | Greater than or equal to 10°C | Passed |
| Survival Time | Meets the longer of FDA and ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Kill Time | Meets ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Component Inhibition Studies | Components have no impact on the recovery of 10-100 organisms | Passed |
| Hold Time Assessment | D-value does not change when activated 7 days post sterilization | Passed |
| Reduced Incubation Time | 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 |
| Simulated Use | Verification of performance in claimed cycles | Passed |
Challenge Pack (3M™ Attest™ Super Rapid Steam Challenge Pack 51582)
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance of the Challenge Pack as compared to AAMI 16 Towel PCD | Challenge Pack is at least as resistant as the biological indicator AAMI 16 Towel Process Challenge Device (PCD) described in ANSI/AAMI ST79: 2017 | Passed |
| Resistance of the Challenge Pack as compared to the Biological Indicator alone | Challenge Pack provides a greater resistance than the Biological Indicator alone | Passed |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document refers to "non-clinical testing" conducted in accordance with various FDA guidance documents and international standards (e.g., ISO, ANSI/AAMI, USP). This typically implies prospective, laboratory-based testing designed to verify performance against pre-defined specifications. The document does not specify the exact sample sizes (number of BIs or Challenge Packs tested) for each individual test or the country of origin of the data. However, the nature of these tests (e.g., D-value, population) usually involves specific, rigorous protocols with statistically sufficient sample sizes to ensure reliable results according to the referenced standards.
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)
The ground truth for these types of biological indicator and challenge pack studies is established through controlled laboratory experiments and adherence to international standards and regulations. It is not based on expert consensus in the typical sense of medical image interpretation (e.g., radiologists). The "ground truth" here refers to the actual performance of the biological indicators under precisely controlled sterilization or simulated sterilization conditions, measured by established microbiological methods (e.g., viable spore counts after exposure to steam, fluorescence detection by the auto-reader coupled with conventional incubation).
Therefore, there are no "experts" in the clinical interpretation sense. The "experts" involved would be microbiologists, engineers, and quality assurance personnel responsible for designing, executing, and analyzing these standardized tests. Their qualifications would stem from their adherence to the specified regulatory and standard requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective and based on measurable biophysical and microbiological parameters, not subjective assessments requiring adjudication. The outputs are "Passed" or "Failed" based on whether the device meets the pre-defined quantitative acceptance criteria.
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
Not applicable. This device is a sterilization process indicator (a biological and chemical indicator system coupled with an auto-reader), not an imaging or diagnostic device involving human interpretation or AI assistance for clinical decision-making. The "reader" here is an automated "Auto-reader 490/490H" and its performance is evaluated against objective microbiological standards, not against human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the performance of the device system (biological indicator + auto-reader) is evaluated in a standalone manner. The auto-reader automatically detects fluorescence, which indicates sterilization failure. The study validates the device's ability to accurately provide a "Passed" or "Failed" result based on its internal mechanism. The comparison is made against traditional microbiological methods (e.g., 7-day conventional incubation) to confirm the accuracy of the rapid fluorescent readout, confirming >97% alignment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is established through reference laboratory methods and adherence to standardized performance requirements. For example:
- Microbiological Counts: Determining the initial viable spore population (population test).
- Resistance Parameters (D-value, Z-value, Survival Time, Kill Time): Measured by exposing the biological indicators to precisely controlled steam sterilization conditions and then assessing spore viability using standard microbiological culture techniques. This is the gold standard for BI performance.
- Reduced Incubation Time Alignment: Comparing the rapid fluorescent readout result (e.g., 24 minutes) with the result obtained from conventional 7-day incubation (which is considered the definitive ground truth for spore viability). This involves culturing the BIs after exposure and determining growth/no growth.
- Simulated Use: Performance testing within mock sterilization loads/cycles to ensure the device performs as expected in representative conditions.
8. The sample size for the training set
Not applicable. This device is a physical/biological indicator system, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" of the system is the manufacturing and calibration processes to ensure it meets the design specifications and regulatory standards.
9. How the ground truth for the training set was established
Not applicable, as there's no "training set" in the AI/ML context. The device's operational parameters and performance capabilities are based on its physical and biological design, as well as the manufacturing and testing processes that confirm its adherence to established standards for sterilization indicators.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
June 5, 2020
3M Company Hilary Hovde Regulatory Affairs Specialist Bldg. 275-5W-06 St.Paul, Minnesota 55144
Re: K192550
Trade/Device Name: 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack, 3M™ Attest™ Auto- Readers 490 and 490H Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 6, 2020 Received: May 7, 2020
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.
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
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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 Christopher K. Dugard, M.S. Acting 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) K192550
Device Name
3MTM Attest™ Super Rapid Steam Biological Indicator 1592 and 3MTM Attest™ Auto-reader 490 and 490H
Indications for Use (Describe)
Use the 3MM Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MM AttestTM Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 20 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 35 minutes |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB number."
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Indications for Use
510(k) Number (if known) K192550
Device Name
3MTM AttestTM Super Rapid Steam Challenge Pack 51582 and 3M™ Attest™ Auto-reader 490 and 490H
Indications for Use (Describe)
Use the 3MM Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software versio n 4.0.0 or greater to qualify or monitor dynamic-air-removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources , gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.go v
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "
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Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The number and letter are in a bold, sans-serif font. The logo is simple and recognizable.
510(k) Summary for K192550 3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, and 3M™ Attest™ Auto-readers 490 and 490H
3M Company 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Hilary B. Hovde Regulatory Affairs Specialist Phone Number: (651) 736-0364 FAX Number: (651) 737-5320
Submission Date: August 27, 2019
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Device Name and Classification- Biological Indicator:
| Trade Name: | 3M™ Attest™ Super Rapid Steam Biological Indicator 15923M™ Attest™ Auto-reader 4903M™ Attest™ Auto-reader 490H |
|---|---|
| Common/Usual Name: | Biological Indicator (BI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process[21 CFR § 880.2800(a), FRC] |
Predicate Device- Biological Indicator:
3MTM Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H, K173437
Indications for Use- 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 or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 20 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 35 minutes |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
Description of Device- Biological Indicator
The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal and gravity displacement steam sterilization cycles at 250°F (121°C).
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 cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of
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fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure.
| Feature | Submission Device:(K192550):3MTM AttestTMSuper Rapid SteamBiological Indicator 1592 and3MTM AttestTM Auto-reader490 and 490H | Predicate Device(K173437):3MTM AttestTMSuper Rapid ReadoutBiological Indicator 1492Vand3MTM 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 or the3MTM AttestTM Auto-reader490H having software version4.0.0 or greater to qualify ormonitor the followingsterilization cycles:Dynamic-air-removal(pre-vacuum andSFPP), 250°F (121°C),15 minutes Dynamic-air-removal(pre-vacuum andSFPP), 250°F (121°C),20 minutes Dynamic-air-removal(pre-vacuum andSFPP), 250°F (121°C),30 minutes Dynamic-air-removal(pre-vacuum andSFPP), 250°F (121°C),35 minutes Gravity Displacement,250°F (121°C),30 minutes | Use the 3MTM AttestTMSuper Rapid ReadoutBiological Indicator 1492Vin conjunction with both the3MTM AttestTM Auto-reader490 or the AttestTM Auto-reader 490H havingsoftware version 4.0.0 orgreater to qualify or monitordynamic-air-removal steamsterilization cycles of:3 minutes at 270°F(132°C) 4 minutes at 270°F(132°C) 3 minutes at 275°F(135°C) | The 3MTM AttestTMSuper Rapid SteamBiological Indicator1592 is intended toqualify or monitor bothdynamic-air-removal(pre-vacuum and SFPP)and gravitydisplacement cycles atvarious exposure timesat 250°F (121°C).Whereas the 3MTMAttestTM Super RapidReadout BiologicalIndicator 1492Visintended to qualify ormonitor dynamic-air-removal steamsterilization cycles atvarious exposure timesat 270°F (132°C) and275°F (135°C).Both BIs are intendedto be used inconjunction with the3MTM AttestTM Auto-reader 490 and the3MTM AttestTM Auto-reader 490H. |
| 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 the | When the enzyme that isnaturally occurring in thespore is in its active state, itis detected by measuring the | Identical |
| Feature | Submission Device:(K192550):3MTM Attest™Super Rapid SteamBiological Indicator 1592 and3MTM Attest™ Auto-reader490 and 490H | Predicate Device(K173437):3MTM Attest™Super Rapid ReadoutBiological Indicator 1492Vand3MTM Attest™Auto-reader 490 and 490H | Comparison |
| fluorescence 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. | fluorescence 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. | ||
| Auto-reader | 3MTM Attest™ Auto-reader 490having software version 4.0.0 orgreater or 3MTM Attest™ Auto-reader 490H having softwareversion 4.0.0 or greater | 3MTM Attest™ Auto-reader490 or 3MTM Attest™ Auto-reader 490H havingsoftware version 4.0.0 orgreater | The 3MTM Attest™Super Rapid SteamBiological Indicator1592 BI has a 24minute readout and isintended to be usedwith a 490 or 490Hhaving software version4.0.0 or greater.Indications for a 24minute time to resultwere cleared underK173437. |
| Viable sporepopulation | $\ge$ 1 x 106 | $\ge$ 1 x 106 | Identical |
| Resistance | D121 $\ge$ 1.5 min | D121 is N/AD132 $\ge$ 10 sD135 $\ge$ 8 s | The 3MTM Attest™Super Rapid SteamBiological Indicator1592 BI is indicated forqualifying andmonitoring sterilizationcycles at 121°Cwhereas the predicatedevice is indicated forqualifying andmonitoring sterilizationcycles at 132°C and135°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 |
| Feature | Submission Device:(K192550):3MTM AttestTMSuper Rapid SteamBiological Indicator 1592 and3MTM AttestTM Auto-reader490 and 490H | Predicate Device(K173437):3MTM AttestTMSuper Rapid ReadoutBiological Indicator 1492Vand3MTM AttestTMAuto-reader 490 and 490H | Comparison |
| Carrier material | Plastic | Plastic | Identical |
| Incubationtemperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Readout time | 24 minute final fluorescentresult in both the 490 and 490HAuto-readers having softwareversion 4.0.0 or greater.Optional visual pH colorchange result in 7 days | 24 minute final fluorescentresult in both the 490 and490H Auto-readers havingsoftware version 4.0.0 orgreater.1 hour final fluorescentresult in 490 Auto-readershaving software versionsless than 4.0.0.Optional visual pH colorchange result in 48 hours. | The 3MTM AttestTMSuper Rapid SteamBiological Indicator1592 BI has a 24minute readout and isintended to be usedwith a 490 or 490Hhaving software version4.0.0 or greater.Indications for a 24minute time to resultwere cleared underK173437. |
| Chemical indicator | Turns from pink to light brownor darker upon steam exposure | Turns from pink to lightbrown or darker upon steamexposure | Identical |
| Shelf-life | 6 months | 21 months | Real-time testing isongoing. |
Technological Characteristics Comparison Table – Biological Indicator
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TRADITIONAL PREMARKET NOTIFICATION [K192550]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592
3MTM Attest™ Super Rapid Steam Challenge Pack 51582
3M™ Attest™ Auto-readers 490 and 490H
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TRADITIONAL PREMARKET NOTIFICATION [K192550]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592
3M™ Attest™ Super Rapid Steam Challenge Pack 51582
3MTM Attest™ Auto-readers 490 and 490H
Summary of Nonclinical Testing- Biological Indicator
Testing was conducted on the biological indicator following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- ISO 11138-1:2017 Sterilization of health care products Biological indicators, Part 1: ● General Requirements
- ISO 11138-3:2017 Sterilization of health care products Biological indicators, Part 3: ● Biological indicators for moist heat sterilization processes
- . United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization and Chapter <55> Biological Indicators - Resistance Performance Tests
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The performance testing below demonstrate that the subject device met the acceptance criteria of the specified standards:
| Test | Results |
|---|---|
| Population (Total Viable Spore Count)Greater than or equal to $10^6$ spores | Passed |
| D-ValueGreater than or equal to 1.5 minutes at 121°C | Passed |
| Z-ValueGreater than or equal to $10$ °C | Passed |
| Survival TimeMeets the longer of FDA and ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Kill TimeMeets ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Component Inhibition StudiesComponents have no impact on the recovery of 10-100 organisms | Passed |
| Hold Time AssessmentD-value does not change when activated 7 days post sterilization | Passed |
| Reduced Incubation TimeMeets 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 |
| Simulated UseVerification of performance in claimed cycles | Passed |
3MT™ Attest™ Auto-reader 490 having software version 4.0.0 or greater and 3MTM Attest™ Auto-reader 490H
The 3M™ Attest™ Auto-reader 490 and the 3M™ Attest™ Auto-reader 490H were cleared for use with the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V under K173437. This submission extends the use of the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to the 3MTM Attest™ Super Rapid Steam Biological Indicator 1592.
The 3M™ Attest Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater are designed to incubate at 60°C and automatically read the 1592 BI for a fluorescent result within 24 minutes. The fluorescent readout at 24 minutes meets the FDA's requirement of > 97% alignment with the result after conventional incubation time of 7 days.
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Device Name and Classification- Challenge Pack:
| Trade Name: | 3MTM AttestTM Super Rapid Steam Challenge Pack 51582 |
|---|---|
| Common/Usual Name: | Biological Indicator (BI) Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process[21 CFR § 880.2800(a), FRC] |
Predicate Device- Challenge Pack:
3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H, K173519
Indications for Use- Challenge Pack
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 or the 3MTM Attest™ Autoreader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
Description of Device- Challenge Pack
The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Packs have the same design as the predicate device but contain different monitoring products. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3MTM 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. The 1592 BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure. 3M™ Attest™ 1592 BI controls are provided with the Challenge Packs. 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.
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| Feature | Submission Device:(K192550):3MTM AttestTMSuper Rapid SteamChallenge Pack 51582 and3MTM AttestTM Auto-reader490 and 490H | Predicate Device(K173519):3MTM AttestTM Super Rapid 5Steam-Plus Challenge Pack41482Vand3MTM AttestTM Auto-reader490 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 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). | Use the 3MTM AttestTM SuperRapid 5 Steam-Plus ChallengePack 41482V in conjunctionwith the 3MTM AttestTM Auto-reader 490 or 3MTM AttestTMAuto-reader 490H havingsoftware version 4.0.0 orgreater to qualify or monitordynamic-air-removal steamsterilization cycles of 4 minutesat 270°F (132°C) and 3 minutesat 275°F (135°C). | The 3MTM AttestTMSuper Rapid SteamChallenge Pack 51582 isintended to qualify ormonitor both dynamic-air-removal (pre-vacuumand SFPP) and gravitydisplacementsterilization cycles of 30minutes at 250°F(121°C). Whereas the3MTM AttestTM SuperRapid 5 Steam-PlusChallenge Pack isintended to qualify ormonitor dynamic-air-removal steamsterilization cycles atvarious exposure timesat 270°F (132°C) and275°F (135°C). |
| General Design | Layers of medical indexcards, some of which are die-cut to contain indicators,overwrapped and securedwith a label. | Layers of medical index cards,some of which are die-cut tocontain indicators, overwrappedand secured with a label. | Identical |
| BiologicalIndicator | 3MTM AttestTM Super RapidSteam Biological Indicator1592 | 3MTM AttestTM Super RapidReadout Biological Indicator1492V | The 51582 ChallengePack contains the new1592 BI as proposed inthis submission. |
| BiologicalIndicatorIncubationtemperature | 60 ± 2°C | 60 ± 2°C | Identical |
| BiologicalIndicator Readouttime | 24 minute final fluorescentresult in both the 490 and490H Auto-readers havingsoftware versions 4.0.0 orgreater. | 24 minute final fluorescentresult in both the 490 and 490HAuto-readers having softwareversions 4.0.0 or greater.1 hour final fluorescent result in490 Auto-readers having | The 3MTM AttestTMSuper Rapid SteamBiological Indicator1592 BI has a 24 minutereadout and is intendedto be used with a 490 or |
| Feature | Submission Device:(K192550):3MTM AttestTMSuper Rapid SteamChallenge Pack 51582 and3MTM AttestTM Auto-reader490 and 490H | Predicate Device(K173519):3MTM AttestTM Super Rapid 5Steam-Plus Challenge Pack41482Vand3MTM AttestTM Auto-reader490 and 490H | Comparison |
| software versions less than4.0.0. | 490H having softwareversion 4.0.0 or greater.Indications for a 24minute time to resultwere cleared underK173519. | ||
| 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 SteriGageTM ChemicalIntegrator | Both integrators meetFDA requirements andare Type 5 IntegratingIndicators as classifiedper ISO 11140-1. |
| ExternalChemical ProcessIndicator | Turns from yellow to brownor darker upon steamexposure | Turns from yellow to brown ordarker upon steam exposure | Identical |
| Shelf-life | 6 months | 21 months | Real-time testing isongoing. |
Technological Characteristics Comparison Table – Challenge Pack
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TRADITIONAL PREMARKET NOTIFICATION [K192550] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592
3M™ Attest™ Super Rapid Steam Challenge Pack 51582
3MTM Attest™ Auto-readers 490 and 490H
Summary of Nonclinical Testing- Challenge Pack
Testing was conducted on the challenge packs following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- Premarket Notification [510(k)] Submission for Chemical Indicators: Guidance for ● Industry and FDA Staff, December 19, 2003
- ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities
- ISO 11138-1:2017 Sterilization of health care products – Biological indicators, Part 1: General Requirements
- . ISO 11138-3:2017 Sterilization of health care products – Biological indicators, Part 3: Biological indicators for moist heat sterilization processes
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- ISO 11140-1:2014 Sterilization of health care products Chemical indicators, Part 1: ● General Requirements
- United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization and ● Chapter <55> Biological Indicators - Resistance Performance Tests
The performance testing below demonstrate that the subject device met the acceptance criteria of the specified standards:
| Test | Acceptance Criteria | Results |
|---|---|---|
| Resistance of theChallenge Pack ascompared to AAMI 16Towel PCD | Challenge Pack is at least as resistant as thebiological indicator AAMI 16 Towel ProcessChallenge Device (PCD) described in ANSI/AAMIST79: 2017 | Passed |
| Resistance of theChallenge Pack ascompared to theBiological Indicatoralone | Challenge Pack provides a greater resistance thanthe Biological Indicator alone | Passed |
Conclusion
The conclusions drawn from the non-clinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices, the 3MM Attest™ Super Rapid Readout Biological Indicator 1492V, 3MTM Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H (cleared under K173437) and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H (cleared under K173519), 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).