(91 days)
3M™ Attest™ Super Rapid Readout Biological Indicator 1493:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
Cycle Type: Gravity Displacement, Exposure Temperature: 250°F (121°C), Exposure Time: 30 minutes
Cycle Type: Dynamic-air-removal (pre-vacuum and SFPP), Exposure Temperature: 250°F (121°C), Exposure Time: 15, 20, 30, or 35 minutes
3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
Cycle Type: Gravity Displacement, Exposure Temperature: 250°F (121°C), Exposure Time: 30 minutes
3M™ Attest™ Auto reader 490:
The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Auto-reader 490H:
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Mini Auto-reader 490M:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1493, at 60°C for a final fluorescent result at 24 minutes.
The 3MTM Attest™ Super Rapid Readout Biological Indicator (BI) 1493 is a self-contained biological indicator specifically designed for rapid and reliable qualification testing and routine monitoring of 121°C (250°F) dynamic-air-removal and gravity-displacement steam sterilization processes in healthcare facilities. The 1493 BI is used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The 1493 BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1493 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490 Autoreader, the 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.
The 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG is specifically designed to qualify and monitor gravity steam sterilization processes at 250°F (121°C) in healthcare facilities. The 1493PCDG Challenge Pack consists of a clear plastic shell with an opening to the cavity containing the monitoring products, all covered by a foil lid. The 1493PCDG is a single-use device. Each 1493PCDG Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493 and a 3M™ Attest™ Steam Chemical Integrator (CI) (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Steam Chemical Integrator offers an immediate ACCEPT or REJECT reading. A chemical process indicator is present on the cap of the 1493 BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink to light brown or darker upon exposure to steam. 3M™ Attest™ 1493 BI controls are provided with the Challenge Pack.
The 1493 BI is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization process when used in conjunction with the 3MM Attest™ Auto-reader 490 having software version 4.0.0 or greater, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490. 490H or 490M Auto-reader indicates a steam sterilization process failure.
Here's a breakdown of the acceptance criteria and the study information for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 and related devices, as extracted from the provided text:
1. Acceptance Criteria and Reported Device Performance
Biological Indicator (1493 BI)
| Test Performed | Device Description | Applicable Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| Population | 1493 BI | FDA Guidance¹, ISO 11138-1:2017² | To evaluate the total viable spore count | ≥ 10⁶ spores | Acceptance criteria met |
| Positive Control Test | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate performance of BI without steam exposure | All BIs must be fluorescent positive at 24 minutes and visual pH color change positive (yellow) at 168 hours | Acceptance criteria met |
| D-value for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate the resistance characteristics of the BI | D-value must be ≥ 1.5 minutes | Acceptance criteria met |
| Z-value for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | Not explicitly stated but implied to be part of characterizing resistance | Z-value must be ≥ 10°C | Acceptance criteria met |
| Survival for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate the resistance characteristics of the BI | Meets the requirements for Calculated survival time* or 5 minutes, whichever is longer (*ISO 11138-1:2017) | Acceptance criteria met |
| Kill for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | Not explicitly stated but implied to be part of characterizing resistance | Meets the requirements for Calculated kill time* (*ISO 11138-1:2017) | Acceptance criteria met |
| Component Inhibition Studies | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate the effects of carrier and packaging materials on the resistance characteristics of the BI | Components have no impact on the recovery of 10-100 organisms | Acceptance criteria met |
| Holding Time Assessment for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-3:2017³ | To evaluate the effect of the labeled holding time on the D-value | D-value must be within +/- 20% of the initial D-value calculated per ISO 11138-1:2017 | Acceptance criteria met |
| Reduced Incubation Time for 121°C (250°F) cycles | 1493 BI | FDA Guidance¹, ISO 11138-1:2017², and ISO 11138-8:2021⁴ | To validate the reduction in incubation time from 7 days (visual color change) to 24 minutes (fluorescent readout) | Meets FDA's requirements for Reduced Incubation Time with ≥ 97% alignment with the conventional incubation time | Acceptance criteria met |
| Attest 1493 Simulated Use | 1493 BI | FDA Guidance¹ | Verification of performance in claimed cycles | The following readout times: • Fluorescent result in 24 minutes | Acceptance criteria met |
| 490 and 490M Auto-reader Performance | 1493 BI | FDA Guidance¹, ISO 11138-1:2017² | Verify equivalent performance of the 1493BI with the 3M™ Attest 490 and 490M Auto-readers | BIs must be fluorescent positive in 24 minutes and visual pH color change (growth) positive at 168 hours | Acceptance criteria met |
Challenge Pack (1493PCDG)
| Test Performed | Device Description | Applicable Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| Resistance of 1493PCDG Challenge Pack compared to AAMI 16 Towel PCD in claimed cycle | 1493PCDG | FDA Guidance¹ and ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities | Demonstrate the performance of the 1493PCDG Challenge Pack is equivalent to the performance of the AAMI 16 Towel PCD in the claimed cycle | Indicators contained in the 1493PCDG Challenge Pack must demonstrate equivalent resistance as compared to the indicators contained in the AAMI 16 Towel PCD in the claimed cycle | Acceptance criteria met |
| Resistance of 1493PCDG Challenge Pack compared to standalone indicators in claimed cycle | 1493PCDG | FDA Guidance¹ | Demonstrate the 1493PCDG Challenge Pack provides a greater challenge than the standalone indicators in the claimed cycle | Indicators contained in the 1493PCDG Challenge Pack must demonstrate greater resistance compared to the standalone indicators in the claimed cycle | Acceptance criteria met |
| 1493PCDG Peel Force (unsterilized) | 1493PCDG | ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids | Demonstrate acceptable peel force of Clear Challenge Pack 1493PCDG heat seal foil lid from plastic shell | ≥2.75lbF and ≤10lbF | Acceptance criteria met |
| 1493PCDG Peel Force (pre and post-sterilization) | 1493PCDG | ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowel Containers with Flexible Peelable Lids | Demonstrate acceptable peel force of Clear Challenge Pack 1493PCDG heat seal foil lid from plastic shell, pre and post sterilization | ≥2.75lbF and ≤10lbF | Acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
- Biological Indicator (1493 BI):
- Population, Positive Control Test, D-value, Z-value, Survival, Kill, Component Inhibition Studies, Reduced Incubation Time, Simulated Use: 3 lots of 1493 BIs were tested.
- Holding Time Assessment: 2 lots of 1493 BIs were tested.
- 490 and 490M Auto-reader Performance: 1 lot of 1493 BIs was evaluated.
- Challenge Pack (1493PCDG):
- Resistance compared to AAMI 16 Towel PCD: 3 lots of 1493PCDG (containing 3 lots of 1493 BIs and 3 lots of 1243R CIs) were tested.
- Resistance compared to standalone indicators: 3 lots of 1493PCDG (containing 3 lots of 1493 BIs and 3 lots of 1243R CIs) were tested.
- Peel Force: 3 lots of 1493PCDG were tested for both unsterilized and pre/post sterilization conditions.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, tests were conducted according to recognized international (ISO) and US (FDA, AAMI, ASTM) standards, suggesting controlled laboratory environments.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The "device" in question (biological indicators and challenge packs for sterilization) directly measures biological viability and physical characteristics. The ground truth for these types of devices is established through direct laboratory measurements, microbiological assays (like spore counts and viability after exposure), and physical property testing, rather than expert interpretation of images or clinical data. Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. As described above, the studies involve direct measurement and laboratory testing against predefined criteria in recognized standards, not subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The devices described here (biological indicators and auto-readers) are designed for direct, objective measurement of sterilization efficacy, not for human interpretation that would be enhanced by AI assistance.
6. Standalone Performance Study
Yes, standalone performance studies were done. All the tests listed in the tables (Population, D-value, Survival, Kill, Reduced Incubation Time, Simulated Use, etc., for the BI, and Resistance, Peel Force for the Challenge Pack) represent the standalone performance of the devices as they are intended to function without human interpretation. For example, the auto-readers automatically provide a fluorescent result, which is the direct output of the system.
7. Type of Ground Truth Used
- Biological Indicator (1493 BI): The ground truth is primarily established through direct microbiological testing (e.g., enumeration of viable spores, determination of D-values, survival, and kill times through controlled exposure to steam under defined conditions) and physical/chemical measurements (e.g., fluorescent or pH color change as an indicator of spore viability/growth). This is based on established sterilization science principles and standards.
- Challenge Pack (1493PCDG): The ground truth for the challenge pack's resistance is established by comparing its performance to recognized reference standards (e.g., AAMI 16 Towel PCD) and to standalone indicators, all under controlled sterilization conditions. Physical integrity is assessed via mechanical property testing (peel force).
8. Sample Size for the Training Set
Not applicable. The devices described are not AI/machine learning devices that require a separate "training set" of data to learn patterns or make predictions. They are physical and chemical indicators that operate based on biological and material science principles.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for these devices.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 25, 2024
3M Company Michelle Larsen Principal RA Specialist 3M Center 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144
Re: K242538
Trade/Device Name: 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3MTM Attest™ Auto-reader 490; 3MTM Attest™ Auto-reader 490H; 3MTM Attest™ Mini Autoreader 490M Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: August 26, 2024
Dear Michelle Larsen:
Received: August 26, 2024
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Stephen A. Digitally signed by
Stephen A. Anisko -S
Anisko -S Date: 2024.11.25
11:20:05 -05'00'
for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control 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
Submission Number (if known)
Device Name
3M™ Attest™ Super Rapid Readout Biological Indicator 1493;
3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG;
3M™ Attest™ Auto-reader 490;
3M™ Attest™ Auto-reader 490H;
3M™ Attest™ Mini Auto-reader 490M
Indications for Use (Describe)
3M™ Attest™ Super Rapid Readout Biological Indicator 1493:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | 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 |
3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Exposure | Exposure | |
|---|---|---|
| Cycle Type | Temperature | Time |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
3M™ Attest™ Auto reader 490:
The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Auto-reader 490H:
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Mini Auto-reader 490M:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1493, at 60°C for a final fluorescent result at 24 minutes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary for 3MTM Attest™ Super Rapid Readout Biological Indicator 1493, 3MTM Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG. 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M K242538
Sponsor Information:
3M Company 3M Center 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, MN 55144-1000, USA
Contact: Michelle M. Larsen, Principal RA Specialist Phone Number: (651) 467-3991 Fax Number: (651) 737-5320 Email: mmlarsen@solventum.com
Date of Summary: 19 November 2024
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1. Device Name and Classification:
| Common or Usual Name: | Biological Indicator (BI) |
|---|---|
| Proprietary Name: | 3MTM AttestTM Super Rapid Readout Biological Indicator1493, |
| 3MTM AttestTM Super Rapid Steam Gravity Clear ChallengePack 1493PCDG, | |
| 3MTM AttestTM Auto-reader 490, | |
| 3MTM AttestTM Auto-reader 490H, | |
| 3MTM AttestTM Mini Auto-reader 490M | |
| Classification Name: | Indicator, Biological Sterilization Process |
| Device Classification: | Class II, 21 CFR 880.2800(a) |
| Product Code: | FRC |
2. Predicate Device:
3M™ Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3M™ Attest™ Auto-reader 490H, and 3MTM Attest™ Mini- Auto-reader 490M, K213809
3. Description of Device:
The 3MTM Attest™ Super Rapid Readout Biological Indicator (BI) 1493 is a self-contained biological indicator specifically designed for rapid and reliable qualification testing and routine monitoring of 121°C (250°F) dynamic-air-removal and gravity-displacement steam sterilization processes in healthcare facilities. The 1493 BI is used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M.
The 1493 BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1493 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490 Autoreader, the 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.
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The 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG is specifically designed to qualify and monitor gravity steam sterilization processes at 250°F (121°C) in healthcare facilities.
The 1493PCDG Challenge Pack consists of a clear plastic shell with an opening to the cavity containing the monitoring products, all covered by a foil lid. The 1493PCDG is a single-use device. Each 1493PCDG Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493 and a 3M™ Attest™ Steam Chemical Integrator (CI) (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Steam Chemical Integrator offers an immediate ACCEPT or REJECT reading. A chemical process indicator is present on the cap of the 1493 BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink to light brown or darker upon exposure to steam. 3M™ Attest™ 1493 BI controls are provided with the Challenge Pack.
The 1493 BI is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization process when used in conjunction with the 3MM Attest™ Auto-reader 490 having software version 4.0.0 or greater, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490. 490H or 490M Auto-reader indicates a steam sterilization process failure.
4. Indications for Use
3MTM Attest™ Super Rapid Readout Biological Indicator 1493:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure 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 |
3MTM Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or
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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 cvcles:
| Cycle Type | ExposureTemperature | Exposure Time |
|---|---|---|
| Gravity Displacement | 250°F (121°C) | 30 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 1493 at 60°C for a final fluorescent result at 24 minutes.
3MTM Attest™ Auto-reader 490H:
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, and 3MTM Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 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 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1493, at 60°C for a final fluorescent result at 24 minutes.
The submission device, the 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493, has the same intended use as the predicate device, the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592. Both the submission device and the predicate device are Single Use biological sterilization indicators that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process. Both the submission and predicate BIs are intended to be used in conjunction with a 3MTM Attest™ Auto-reader 490, a 3MTM Attest™ Auto-reader 490H, or a 3MTM Attest™ Mini Auto-reader 490M to qualify or monitor gravity displacement and dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) steam sterilization cycles at 250°F (121°C). The predicate BI covers additional dynamic-air-removal steam sterilization cycles (270°F/132°C, 273°F/134°C and 275°F/135°C) compared to the submission BI. The differences in Indications for Use do not alter the fundamental Intended Use of these products as sterilization process monitors and do not raise new questions of safety and effectiveness.
K242538
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The submission device, the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, has the same intended use as the predicate device, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582. Both the submission device and the predicate device are Single Use biological indicator process challenge devices that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process. Both the submission and predicate challenge packs are intended to be used in conjunction with a 3M™ Attest™ Auto-reader 490, a 3M™ Attest™ Auto-reader 490H, or a 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor gravity displacement steam sterilization cycles at 250°F (121°C). The predicate challenge pack also covers dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) steam sterilization cycles (250°F/121°C, 270°F/132°C, 273°F/134°C and 275°F/135°C') compared to the submission challenge pack. The differences in Indications for Use do not alter the fundamental Intended Use of these products as biological indicator process challenge devices and do not raise new questions of safety and effectiveness.
5. Comparison of Technological Characteristics with the Predicate Device
Biological Indicator
The submission device, 3M™ Attest™ Super Rapid Readout Biological Indicator 1493, is the same design, materials, and construction as the previously cleared predicate device, 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 (cleared per K213809). The only difference is the 1493 BI is claiming use with fewer cycles compared to the 1592 BI. Both the submission device and the predicate device utilize the same spores to accomplish their intended use as biological sterilization indicators. The submission and predicate device are intended to qualify or monitor gravity displacement and dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) steam sterilization cycles at 250°F (121°C) while the predicate device covers additional dynamic-air-removal steam sterilization cvcles at 270°F (132°C), 273°F (134°C) and 275°F (135°C). The Resistance Characteristics (D-Value, Survival/Kill Window) of the submission device and the predicate device both cover the monitoring of steam sterilization cycles at 250°F (121°C). The predicate device was cleared per K213809 for use with the 3M™ Attest™ Auto-reader 490, the 3MTM Attest™ Autoreader 490H, and the 3M™ Attest™ Mini-Auto-reader 490M. The accessories (Autoreaders) are the same for both the submission and predicate device and the readout time or the time to a result is the same for both the submission and predicate device.
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The differences in technological characteristics between the submission and predicate biological indicators are illustrated in the Device Technological Characteristics Comparison Table - Biological Indicator (Table 1).
| Feature | Submission Device:(K242538)3MTM AttestTM SuperRapid ReadoutBiological Indicator1493, 3MTM AttestTMSuper Rapid SteamGravity ClearChallenge Pack1493PCDGand3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Predicate Device:(K213809)3MTM AttestTM SuperRapid Steam BiologicalIndicator 1592, 3MTMAttestTM Super RapidSteam Challenge Pack51582and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Comparison |
|---|---|---|---|
| Intended Use | Single Use sterilizationprocess indicator | Single Use sterilizationprocess indicator | Identical |
| Indications for use | Use the 3MTM AttestTMSuper Rapid ReadoutBiological Indicator 1493in conjunction with the3MTM AttestTM Auto-reader 490 havingsoftware version 4.0.0 orgreater, the 3MTMAttestTM Auto-reader490H having softwareversion 4.0.0 or greater,or the 3MTM AttestTMMini Auto-reader 490Mto qualify or monitor thefollowing steamsterilization cycles:• GravityDisplacement, 250°F(121°C),30 minutesand Dynamic-air-removal | Use the 3MTM AttestTMSuper Rapid SteamBiological Indicator 1592in conjunction with the3MTM AttestTM Auto-reader 490 havingsoftware version 4.0.0 orgreater, the 3MTMAttestTM Auto-reader490H having softwareversion 4.0.0 or greater,or the 3MTM AttestTMMini Auto-reader 490Mto qualify or monitor thefollowing steamsterilization cycles:• GravityDisplacement, 250°F(121°C),30 minutesand Dynamic-air-removal | Both the predicateand submission BIsare indicated forqualifying andmonitoring gravitydisplacement anddynamic-air-removalsteam sterilizationcycles at 250°F(121°C). Thepredicate BI isindicated forqualifying andmonitoringadditional dynamic-air-removal steamsterilization cycles(270°F/132°C,273°F/134°C and275°F/135°C). |
| Table 1: Device Technological Characteristics Comparison Table - Biological Indicator | ||
|---|---|---|
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| Feature | Submission Device:(K242538)3MTM AttestTM SuperRapid ReadoutBiological Indicator1493, 3MTM AttestTMSuper Rapid SteamGravity ClearChallenge Pack1493PCDGand3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Predicate Device:(K213809)3MTM AttestTM SuperRapid Steam BiologicalIndicator 1592, 3MTMAttestTM Super RapidSteam Challenge Pack51582and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Comparison |
|---|---|---|---|
| (pre-vacuum andSFPP), 250°F(121°C),15, 20, 30, or 35minutes | (pre-vacuum andSFPP), 250°F(121°C),15, 20, 30, or 35minutes• Dynamic-air-removal(pre-vacuum andSFPP), 270°F(132°C),3, 3.5, 4, 5.5, or 6minutes• Dynamic-air-removal(pre-vacuum andSFPP), 273°F(134°C),3 or 4 minutes• Dynamic-air-removal(pre-vacuum andSFPP), 275°F(135°C), 3, 3.5, or 10minutes | Both the predicateand submission BIsare intended to beused in conjunctionwith the same auto-readers. | |
| GeneralDesign/Construction | Plastic vial containing aspore carrier and mediaampoule, enclosed with acolor-coded cap withchemical process | Plastic vial containing aspore carrier and mediaampoule, enclosed with acolor-coded cap withchemical process | Identical |
| Feature | Submission Device:(K242538)3MTM AttestTM SuperRapid ReadoutBiological Indicator1493, 3MTM AttestTMSuper Rapid SteamGravity ClearChallenge Pack1493PCDGand3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Predicate Device:(K213809)3MTM AttestTM SuperRapid Steam BiologicalIndicator 1592, 3MTMAttestTM Super RapidSteam Challenge Pack51582and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Comparison |
| indicator located on topof cap. | indicator located on topof cap. | ||
| Carrier Material | Plastic | Plastic | Identical |
| Media Ampoule | Crushable glass ampoulecontaining a growthmedia and a fluorescenceindicator which iscorrelated to an optionaluse pH indicator. | Crushable glass ampoulecontaining a growthmedia and a fluorescenceindicator which iscorrelated to an optionaluse pH indicator. | Identical |
| Chemical indicator | Turns from pink to lightbrown or darker uponsteam exposure | Turns from pink to lightbrown or darker uponsteam exposure | Identical |
| Indicator Organism | Geobacillusstearothermophilustraceable to ATCCTM7953 | Geobacillusstearothermophilustraceable to ATCCTM7953 | Identical |
| Viable sporepopulation | ≥ 1 x 106 | ≥ 1 x 106 | Identical |
| Mechanism of Action | When the enzyme that isnaturally occurring in thespore is in its active state,it is detected bymeasuring thefluorescence produced bythe enzymatic hydrolysisof a non-fluorescentsubstrate. The resultantfluorescent by-product isdetected by the Auto- | When the enzyme that isnaturally occurring in thespore is in its active state,it is detected bymeasuring thefluorescence produced bythe enzymatic hydrolysisof a non-fluorescentsubstrate. The resultantfluorescent by-product isdetected by the Auto- | Identical |
| Feature | Submission Device:(K242538)3MTM AttestTM SuperRapid ReadoutBiological Indicator1493, 3MTM AttestTMSuper Rapid SteamGravity ClearChallenge Pack1493PCDGand3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Predicate Device:(K213809)3MTM AttestTM SuperRapid Steam BiologicalIndicator 1592, 3MTMAttestTM Super RapidSteam Challenge Pack51582and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Comparison |
| fluorescence uponincubation in the Auto-reader indicates asterilization processfailure. | fluorescence uponincubation in the Auto-reader indicates asterilization processfailure. | ||
| • D-value | D-Value ≥ 1.5 min at121°C | D-Value ≥ 1.5 min at121°CD-value ≥ 10 seconds at132°CD-value ≥ 8 seconds at134°C, 135°C | Both the predicateand submission BIsare indicated forqualifying andmonitoring gravitydisplacement anddynamic-air-removalsteam sterilizationcycles at 250°F(121°C). Thepredicate BI isindicated forqualifying andmonitoringadditional dynamic-air-removal steamsterilization cycles(270°F/132°C,273°F/134°C and275°F/135°C). |
| Survival Time | Meets the longer of FDAand ISO 11138-1 and ISO11138-3 requirements | Meets the longer of FDAand ISO 11138-1 and ISO11138-3 requirements | Identical |
| Kill Time | Meets the ISO 11138-1 andISO 11138-3 requirements | Meets the ISO 11138-1 andISO 11138-3 requirements | Identical |
| Feature | Submission Device:(K242538)3MTM AttestTM SuperRapid ReadoutBiological Indicator1493, 3MTM AttestTMSuper Rapid SteamGravity ClearChallenge Pack1493PCDGand3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Predicate Device:(K213809)3MTM AttestTM SuperRapid Steam BiologicalIndicator 1592, 3MTMAttestTM Super RapidSteam Challenge Pack51582and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Comparison |
| Incubation temperature | 60 $\pm$ 2°C | 60 $\pm$ 2°C | Identical |
| Readout time | 24 minute finalfluorescent result in:The 490 Auto-readerhaving softwareversion 4.0.0 orgreater or The 490H Auto-reader havingsoftware version4.0.0 or greater or The 490M MiniAuto-readerOptional visual pH colorchange result in 7 days. | 24 minute finalfluorescent result in:The 490 Auto-readerhaving softwareversion 4.0.0 orgreater or The 490H Auto-reader havingsoftware version4.0.0 or greater or The 490M MiniAuto-readerOptional visual pH colorchange result in 7 days. | Identical |
| Shelf Life | 24 months | 24 months | Identical |
| Accessories(Auto-readers) | 3MTM AttestTM Auto-reader 490 havingsoftware version 4.0.0 orgreater, 3MTM AttestTMAuto-reader, or 490Hhaving software version4.0.0 or greater, or 3MTMAttestTM Mini Auto-reader 490M | 3MTM AttestTM Auto-reader 490 havingsoftware version 4.0.0 orgreater, 3MTM AttestTMAuto-reader, or 490Hhaving software version4.0.0 or greater, or 3MTMAttestTM Mini Auto-reader 490M | Identical |
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Challenge Pack
The submission device, the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, consists of a clear plastic shell with a cavity opening in the shell to the monitoring products, all heat sealed with a foil lid. The predicate device, the 3MIM Attest™ Super Rapid Steam Challenge Pack 51582, consists of layers of medical index cards, some of which are die-cut to contain indicators, overwrapped and secured with a label. Both the submission and predicate device are designed to increase the resistance beyond that measured with a standalone biological indicator and both represent a challenge to the sterilization process equivalent to the AAMI reference PCD. The predicate device utilizes the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 that was cleared per K213809. The submission device utilizes the 3M™ Attest Super Rapid Readout Biological Indicator 1493 which is the subject biological indicator of this submission. The submission BI (1493) is the same design, materials, and construction as the previously cleared predicate BI (1592). The only difference is the 1493 BI is claiming use with fewer cycles compared to the 1592 BI. Both the submission and predicate device utilize the same Chemical Integrator (CI), the 3M™ Attest™ Steam Chemical Integrator (cleared per K220942). The process indicator dot on the predicate device is present on the outer label of the overwrapped device whereas the process indicator on the submission device is present on the cap of the 1493 BI which is visible through the clear challenge pack. Both the submission and predicate device contain a visible process indicator that changes color upon steam exposure that is used by the customer to distinguish processed and unprocessed challenge packs. The accessories (Auto-readers) are the same for both the submission and predicate device and the readout time or the time to a result is the same for both the submission and predicate device.
The differences in technological characteristics between the submission and predicate challenge packs are illustrated in the Device Technological Characteristics Comparison Table - Challenge Pack (Table 2).
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| Feature | Submission Device:(242538)3M™ Attest™ SuperRapid ReadoutBiological Indicator1493, 3M™ Attest™Super Rapid SteamGravity ClearChallenge Pack1493PCDGand3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Predicate Device:(K213809)3M™ Attest™ SuperRapid Steam BiologicalIndicator 1592, 3M™Attest™ Super RapidSteam Challenge Pack51582and3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Comparison | |
|---|---|---|---|---|
| Intended Use | Single Use biologicalindicator processchallenge device | Single Use biologicalindicator processchallenge device | Identical | |
| Indications for use | Use the 3M™ Attest™Super Rapid SteamGravity Clear ChallengePack 1493PCDG inconjunction with the3M™ Attest™ Auto-reader 490 havingsoftware version 4.0.0 orgreater, the 3M™Attest™ Auto-reader490H having softwareversion 4.0.0 or greater,or the 3M™ Attest™Mini Auto-reader 490Mto qualify or monitor thefollowing steamsterilization cycles:• GravityDisplacement, 250°F(121°C),30 minutes | Use the 3M™ Attest™Super Rapid SteamChallenge Pack 51582 inconjunction with the3M™ Attest™ Auto-reader 490 havingsoftware version 4.0.0 orgreater, the 3M™Attest™ Auto-reader490H having softwareversion 4.0.0 or greater,or the 3M™ Attest™Mini Auto-reader 490Mto qualify or monitor thefollowing steamsterilization cycles:• GravityDisplacement, 250°F(121°C),30 minutes• Dynamic-air-removal(pre-vacuum andSFPP),250°F (121°C),30 minutes | Both the submissionand predicatechallenge packs areindicated forqualifying andmonitoring gravitydisplacement steamsterilization cycles at250°F (121°C). Thepredicate challengepack is alsoindicated forqualifying andmonitoring dynamic-air-removal steamsterilization cycles(250°F/121°C,270°F/132°C,273°F/134°C, and275°F/135°C).The submission BI(1493) that iscontained in thesubmission PCD is | |
| Feature | Submission Device:(242538)3M™ Attest™ SuperRapid ReadoutBiological Indicator1493, 3M™ Attest™Super Rapid SteamGravity ClearChallenge Pack1493PCDGand3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Predicate Device:(K213809)3M™ Attest™ SuperRapid Steam BiologicalIndicator 1592, 3M™Attest™ Super RapidSteam Challenge Pack51582and3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Comparison | |
| Dynamic-air removal(pre-vacuum andSFPP), 270°F(132°C),4 minutes Dynamic-air removal(pre-vacuum andSFPP), 273°F(134°C),4 minutes Dynamic-air removal(pre-vacuum andSFPP), 275°F(135°C), 3 minutes | the same design,materials, andconstruction as thepredicate BI (1592)that is contained inthe predicate PCD(51582). Both thepredicate andsubmission BIs areindicated forqualifying andmonitoring gravitydisplacement anddynamic-air-removalsteam sterilizationcycles at 250°F(121°C). Thepredicate BI isindicated forqualifying andmonitoringadditional dynamic-air-removal steamsterilization cycles(270°F/132°C,273°F/134°C and275°F/135°C).Both the submissionand predicate | |||
| Feature | Submission Device:(242538)3M™ Attest™ SuperRapid ReadoutBiological Indicator1493, 3M™ Attest™Super Rapid SteamGravity ClearChallenge Pack1493PCDGand3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Predicate Device:(K213809)3M™ Attest™ SuperRapid Steam BiologicalIndicator 1592, 3M™Attest™ Super RapidSteam Challenge Pack51582and3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Comparison | |
| challenge packsutilize the sameChemical Integrator(CI). The 1243R CIis indicated for usein 250°F (121°C)gravity and 250°F(121°C), 270°F(132°C), 273°F(134°C) and 275°F(135°C) dynamic-air-removal steamsterilization cycles(per K220942).Both the predicateand submissionchallenge packs areintended to be usedin conjunction withthe same auto-readers. | ||||
| GeneralDesign/Construction | Clear plastic tray with acavity opening in theshell to the indicators,acting as a challenge tolimit air removal andsteam penetration, sealedwith a foil lid. | Layers of medical indexcards, some of which aredie-cut to containindicators, overwrappedand secured with a label. | Both the submissionand predicatechallenge packs aredesigned to increaseresistance beyondthat measured with astandalone BI andboth represent a | |
| Feature | Submission Device:(242538)3M™ Attest™ SuperRapid ReadoutBiological Indicator1493, 3M™ Attest™Super Rapid SteamGravity ClearChallenge Pack1493PCDGand3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Predicate Device:(K213809)3M™ Attest™ SuperRapid Steam BiologicalIndicator 1592, 3M™Attest™ Super RapidSteam Challenge Pack51582and3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Comparison | |
| challenge to thesterilization processequivalent to theAAMI referencePCD. | ||||
| Biological Indicator | 3M™ Attest™ SuperRapid Readout BiologicalIndicator 1493 | 3M™ Attest™ SuperRapid Steam BiologicalIndicator 1592 | The predicate BI andthe submission BIare the same design,materials, andconstruction. | |
| Biological IndicatorIncubationtemperature | 60 ± 2°C | 60 ± 2°C | Identical | |
| Biological IndicatorReadout time | 24 minute finalfluorescent result in:• The 490 Auto-readerhaving softwareversion 4.0.0 orgreateror• The 490H Auto-reader havingsoftware version4.0.0 or greateror• The 490M MiniAuto-reader | 24 minute finalfluorescent result in:• The 490 Auto-readerhaving softwareversion 4.0.0 orgreateror• The 490H Auto-reader havingsoftware version4.0.0 or greateror• The 490M MiniAuto-reader | Identical | |
| Chemical Integrator | 3M™ Attest™ SteamChemical Integrator | 3M™ Attest™ SteamChemical Integrator | Identical | |
| Feature | Submission Device:(242538)3MTM Attest™ SuperRapid ReadoutBiological Indicator1493, 3MTM Attest™Super Rapid SteamGravity ClearChallenge Pack1493PCDGand3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Predicate Device:(K213809)3MTM Attest™ SuperRapid Steam BiologicalIndicator 1592, 3MTMAttest™ Super RapidSteam Challenge Pack51582and3M™ Attest™ Auto-reader 490 and 490Hand 3MTM Attest™Mini Auto-reader 490M | Comparison | |
| Chemical IntegratorEndpointSpecifications(Minimum StatedValues) | 250°F/121°C: 16.5minutes270°F/132°C: 2.0minutes273°F/134°C: 1.4minutes275°F/135°C: 1.2minutes | 250°F/121°C: 16.5minutes270°F/132°C: 2.0minutes273°F/134°C: 1.4minutes275°F/135°C: 1.2minutes | Identical | |
| Chemical IntegratorColor Change | Dark color migratesalong strip visiblethrough a green window(ACCEPT) or redwindow (REJECT) | Dark color migratesalong strip visiblethrough a green window(ACCEPT) or redwindow (REJECT) | Identical | |
| Mechanism todistinguish processedand unprocessedchallenge pack | Process indicator presenton 1493 BI cap is visiblethrough PCD and turnscolor from pink to lightbrown or darker uponsteam exposure. | External ChemicalProcess Indicator turnsfrom yellow to brown ordarker upon steamexposure. | Both the submissionand predicatechallenge packcontain a processindicator thatchanges color uponsteam exposure thatis used by thecustomer to verifythat the challengepack was exposed tosteam. | |
| ResistanceComparison to theAAMI ST79 16 TowelPCD | Equivalent in resistanceto the AAMI ST79 16Towel PCD | Equivalent in resistanceto the AAMI ST79 16Towel PCD | Identical | |
| Shelf Life | 24 months | 24 months | Identical | |
| Feature | Submission Device:(242538)3M™ Attest™ SuperRapid ReadoutBiological Indicator1493, 3M™ Attest™Super Rapid SteamGravity ClearChallenge Pack1493PCDGand3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Predicate Device:(K213809)3M™ Attest™ SuperRapid Steam BiologicalIndicator 1592, 3M™Attest™ Super RapidSteam Challenge Pack51582and3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Comparison | |
| Accessories(Auto-readers) | 3M™ Attest™ Auto-reader 490 havingsoftware version 4.0.0 orgreater, 3M™ Attest™Auto-reader, or 490Hhaving software version4.0.0 or greater, or 3M™Attest™ Mini Auto-reader 490M | 3M™ Attest™ Auto-reader 490 havingsoftware version 4.0.0 orgreater, 3M™ Attest™Auto-reader, or 490Hhaving software version4.0.0 or greater, or 3M™Attest™ Mini Auto-reader 490M | Identical |
Table 2: Device Technological Characteristics Comparison Table – Challenge Pack
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6. Nonclinical Comparison to the Predicate Device
Biological Indicator
The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Readout Biological Indicator 1493.
Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were tested for minimum spore Population. Testing was completed per the Guidance for Industry and FDA Staff. Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, and ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements.
Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were tested for Positive Control, D-Value, Z-value, Survival, Kill, and Component Inhibition Studies. Testing was completed per the 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,
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and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
Two lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 was tested for a Holding Time Assessment. Testing was completed per the 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, and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were tested for Reduced Incubation Time. Testing was completed per the 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, and ISO 11138-8:2021 Sterilization of health care products -Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator.
Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were evaluated for simulated use testing in the claimed cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007.
One lot of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were evaluated for performance in the 3MTM Attest™ Auto-reader 490 and 3MTM Attest™ Mini Auto-reader 490M. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, and ISO 11138-1:2017 Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements.
| TestPerformed | DeviceDescription | ApplicableStandards | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|---|
| Population | 1493 BI | FDA Guidance1,ISO 11138-1:20172 | To evaluate thetotal viablespore count | $\geq$ 106 spores | Acceptancecriteria met |
| PositiveControl Test | 1493 BI | FDA Guidance1,ISO 11138-1:20172and ISO 11138-3:20173 | To evaluateperformance ofBI withoutsteam exposure | All BIs must befluorescentpositive at 24minutes andvisual pH colorchange positive(yellow) at 168hours | Acceptancecriteria met |
| TestPerformed | DeviceDescription | ApplicableStandards | Purpose | AcceptanceCriteria | Results |
| D-value for121°C(250°F)cycles | 1493 BI | FDA Guidance¹,ISO 11138-1:2017²and ISO 11138-3:2017³ | To evaluate theresistancecharacteristicsof the BI | D-value mustbe ≥ 1.5minutes | Acceptancecriteria met |
| Z-value for121°C(250°F)cycles | 1493 BI | FDA Guidance¹,ISO 11138-1:2017²and ISO 11138-3:2017³ | Z-value must be≥ 10°C | Acceptancecriteria met | |
| Survival for121C°(250°F)cycles | 1493 BI | FDA Guidance¹,ISO 11138-1:2017²and ISO 11138-3:2017³ | To evaluate theresistancecharacteristicsof the BI | Meets therequirementsfor Calculatedsurvival time*or 5 minutes,whichever islonger* ISO 11138-1:2017 | Acceptancecriteria met |
| Kill for121C°(250°F)cycles | 1493 BI | FDA Guidance¹,ISO 11138-1:2017²and ISO 11138-3:2017³ | Meets therequirementsfor Calculatedkill time** ISO 11138-1:2017 | Acceptancecriteria met | |
| ComponentInhibitionStudies | 1493 BI | FDA Guidance¹,ISO 11138-1:2017²and ISO 11138-3:2017³ | To evaluate theeffects ofcarrier andpackagingmaterials on theresistancecharacteristicsof the BI | Componentshave no impacton the recoveryof 10-100organisms | Acceptancecriteria met |
| HoldingTimeAssessmentfor 121°C(250°F)cycles | 1493 BI | FDA Guidance¹,ISO 11138-1:2017²and ISO 11138-3:2017³ | To evaluate theeffect of thelabeled holdingtime on the D-value | D-value mustbe within +/-20% of theinitial D-valuecalculated perISO 11138-1:2017 | Acceptancecriteria met |
| ReducedIncubationTime for121°C(250°F)cycles | 1493 BI | FDA Guidance¹,ISO 11138-1:2017²and ISO 11138-8:2021⁴ | To validate thereduction inincubation timefrom 7 days(visual colorchange) to 24minutes(fluorescentreadout) | Meets FDA'srequirementsfor ReducedIncubationTime with ≥97% alignmentwith theconventionalincubation time | Acceptancecriteria met |
| TestPerformed | DeviceDescription | ApplicableStandards | Purpose | AcceptanceCriteria | Results |
| Attest 1493SimulatedUse | 1493 BI | FDA Guidance1 | Verification ofperformance inclaimed cycles | the followingreadout times:• Fluorescentresult in 24minutes | Acceptancecriteria met |
| 490 and490M Auto-readerPerformance | 1493 BI | FDA Guidance1,ISO 11138-1:20172 | Verifyequivalentperformance ofthe 1493BIwith the 3MTMAttest 490 and490M Auto-readers | BIs must befluorescentpositive in 24minutes andvisual pH colorchange(growth)positive at 168hours | Acceptancecriteria met |
Performance of the 1493 Biological Indicator (BI) was verified through the following tests:
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1 FDA Guidance for Industry and FDA Staff, Biological Indicator (Bl) Premarket Notification [510(k)] Submissions, October 4. 2007
2 ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General Requirements
3 ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
4 ISO 11138-8:2021 Sterilization of health care products – Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
Challenge Pack
The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG.
Three lots of 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, containing three lots of 1493 BIs and three lots of 1243R Cls, were tested side by side with the AAMI 16 Towel PCD containing 1493 Bls and 1243R CIs. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007, and ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
Three lots of 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, containing three lots of 1493 BIs and three lots of 1243R CIs, were tested side by side with standalone indicators 1493 Bls and 1243R Cls. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007.
Three lots of 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG were tested for peel force of the heat seal foil lid from the plastic shell. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for
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Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids.
Three lots of 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG were tested for peel force of the heat seal foil lid from the plastic shell, pre and post sterilization. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids.
| Test | Device | Applicable | Purpose | Acceptance | Results |
|---|---|---|---|---|---|
| Performed | Description | Standards | Criteria | ||
| Resistanceof1493PCDGChallengePackcompared toAAMI 16Towel PCDin claimedcycle | 1493PCDGChallenge Pack | FDA Guidance1 andANSI/AAMIST79:2017,Comprehensiveguide to steamsterilization andsterility assurance inhealth care facilities | Demonstratethe performanceof the1493PCDGChallenge Packis equivalent tothe performanceof the AAMI 16Towel PCD inthe claimedcycle | Indicatorscontained in the1493PCDGChallenge Packmustdemonstrateequivalentresistance ascompared to theindicatorscontained in theAAMI 16Towel PCD inthe claimedcycle | Acceptancecriteria met |
| Resistanceof1493PCDGChallengePackcompared tostandaloneindicators inclaimedcycle | 1493PCDGChallenge Pack | FDA Guidance1 | Demonstratethe 1493PCDGChallenge Packprovides agreaterchallenge thanthe standaloneindicators in theclaimed cycle | Indicatorscontained in the1493PCDGChallenge Packmustdemonstrategreaterresistancecompared to thestandaloneindicators in theclaimed cycle | Acceptancecriteria met |
| 1493PCDGPeel Force | 1493PCDGChallenge Pack | ASTM F88 / F88M-15: Standard TestMethod for SealStrength of FlexibleBarrier and ASTMF2824 - 10:Standard TestMethod for | Demonstrateacceptable peelforce of ClearChallenge Pack1493PCDGheat seal foil lidfrom plasticshell | ≥2.75lbF and≤10lbF | Acceptancecriteria met |
Performance of the 1493PCDG challenge pack was verified through the following tests:
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| TestPerformed | DeviceDescription | ApplicableStandards | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|---|
| Mechanical SealStrength Testing forRound Cups andBowl Containerswith FlexiblePeelable Lids | |||||
| 1493PCDGPeel Force | 1493PCDGChallenge Pack | ASTM F88 / F88M-15: Standard TestMethod for SealStrength of FlexibleBarrier and ASTMF2824 - 10:Standard TestMethod forMechanical SealStrength Testing forRound Cups andBowl Containerswith FlexiblePeelable Lids | Demonstrateacceptable peelforce of ClearChallenge Pack1493PCDGheat seal foil lidfrom plasticshell, pre andpoststerilization | ≥2.75lbF and≤10lbF | Acceptancecriteria met |
1 FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification (510(k)] Submissions, October 4, 2007
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7. Clinical Comparison to the Predicate Device
Clinical testing was not required or completed for the submission biological indicator or submission challenge pack.
8. Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the submission device, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493, the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, the 3MTM Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H, and the 3MTM Attest™ Mini Auto-reader 490M, is as safe, as effective and performs as well or better than the legally marketed predicate device, the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, the 3MTM Attest™ Autoreader 490, the 3M™ Attest™ Auto-reader 490H, and the 3MTM Attest™ Mini Auto-reader 490M (cleared per K213809) 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).