3M Attest Steam Chemical Integrator Test Pack

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July 2, 2020 3M Center Mary Fretland Senior Regulatory Affairs Associate 2510 Conway Avenue, Building 275-5W-06 St. Paul, MN 55144 Re: K200766 Trade/Device Name: 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: June 03, 2020 Received: June 04, 2020 Dear Mary Fretland: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 (OS) 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). 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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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K200766 Device Name 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 Indications for Use (Describe) - Use the 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 to monitor: - · 121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes - · 132°C (270°F) dynamic-air-removal steam sterilization cycle at 4 minutes - · 135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes | 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. 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The logo is simple and recognizable. # 510(k) Summary for # 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 # K200766 3M Company, 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000 > Contact: Mary Fretland Senior Regulatory Affairs Associate Phone Number: (651) 737-2296 FAX Number: (651) 737-5320 Date of Summary: July 02, 2020 {4}------------------------------------------------ #### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 ### Device Names and Classification: | Trade Name: | 3MTM AttestTM Steam Chemical Integrator Test<br>Pack 41360 | |------------------------|----------------------------------------------------------------------------| | Common/Usual Name: | Chemical Indicator (CI) Challenge Pack | | Device Classification: | Class II | | Classification Name: | Indicator, Biological Sterilization Process<br>[21 CFR § 880.2800(b), FRC] | #### Predicate Device: 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, K193154 #### Indications for Use: #### 3MTM Attest™ Steam Chemical Integrator Test Pack 41360: Use the 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 to monitor: - 121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes . - 132°C (270°F) dynamic-air-removal steam sterilization cvcle at 4 minutes . - 135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes ● #### Description of Device: 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 is specifically designed to routinely challenge the steam sterilization process in healthcare facilities. This convenient disposable process challenge device presents a challenge to the sterilization process equivalent to the 16towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI). Each test pack contains a process indicator on the outside that changes from yellow to brown or darker when steam processed. Each pack contains a 3M™ Attest™ Steam Chemical Integrator and a record keeping sheet. The 3MTM Attest™ Steam Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. When exposed to steam sterilization conditions, the chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked REJECT or ACCEPT. The extent of migration depends on steam, time, and temperature. ### Nonclinical Comparison to the Predicate Device This submission is addressing a change to the 3M™ Attest™ Steam Chemical Integrator contained within the 3MTM Attest™ Steam Chemical Integrator Test Pack 41360. The design, fundamental technology and performance specifications for 3M™ Attest™ Steam Chemical Integrators are similar to the previously cleared device which is sold under the tradename 3MTM ComplyTM SteriGage™ Steam Chemical Integrator Test Pack (K894399). {5}------------------------------------------------ ### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 There have been no changes to the integrator's performance specifications or fundamental scientific technology. The changes to the integrator included an expansion of the indications for use, re-branding of the device, and a modification to the materials used to construct the device. Test Packs have the same intended use as the previously marketed devices and make use of the same fundamental scientific technology. | | Subject Device<br>(K200766): | Predicate Device<br>(K193154): | | |-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------| | Feature | 3M™ Attest™ Steam<br>Chemical Integrator Test Pack<br>41360 | 3M™ Attest™ Super Rapid 5<br>Steam-Plus Challenge Pack<br>41482V | Comparison | | Indications for use | Use the 3M™ Attest™ Steam<br>Chemical Integrator Test Pack<br>41360 to monitor:<br>• 121°C (250°F) gravity<br>displacement steam sterilization<br>cycle at 30 minutes<br>• 132°C (270°F) dynamic-air-<br>removal steam sterilization cycle<br>at 4 minutes<br>• 135°C (275°F) dynamic-air-<br>removal steam sterilization cycle<br>at 3 minutes | Use the 3M™ Attest™ Super<br>Rapid 5 Steam-Plus Challenge<br>Pack 41482V in conjunction with<br>the 3M™ Attest™ Auto-reader<br>490 or 3M™ Attest™ Auto-reader<br>490H having software version<br>4.0.0 or greater to qualify or<br>monitor:<br>dynamic-air-removal steam<br>sterilization cycles of 4 minutes at<br>270°F (132°C) and 3 minutes at<br>275°F (135°C). | Two shared<br>cycles with<br>predicate<br>device, one<br>unique cycle. | | General Design | Layers of medical index cards,<br>some of which are die-cut to<br>contain indicators, overwrapped<br>and secured with a label. | Layers of medical index cards,<br>some of which are die-cut to<br>contain indicators, overwrapped<br>and secured with a label. | Identical | | Biological Indicator | NA | 3M™ Attest™ Super Rapid<br>Readout Biological Indicator<br>1492V<br>(cleared via K173437) | Subject device<br>does not<br>contain a BI. | | Biological Indicator<br>Incubation temperature | NA | 60 ± 2°C | Subject device<br>does not<br>contain a BI. | | Biological Indicator<br>Readout time | NA | 24-minute final fluorescent result<br>in both the 490 and 490H Auto-<br>readers having software versions<br>4.0.0 or greater.<br>1-hour final fluorescent result in<br>490 Auto-readers having software<br>versions less than 4.0.0. | Subject device<br>does not<br>contain a BI. | | Resistance Comparison<br>to the AAMI ST79<br>16 Towel PCD | Equivalent in resistance to the<br>AAMI ST79<br>16 Towel PCD | Equivalent in resistance to the<br>AAMI ST79<br>16 Towel PCD | Identical | | Chemical Integrator | 3M™ Attest™ Steam Chemical<br>Integrator (cleared via K191236) | 3M™ Attest™ Steam Chemical<br>Integrator (cleared via K191236) | Identical | | Shelf life | Two (2) years | 21 months | Similar | ### Technical Characteristics Comparison Table {6}------------------------------------------------ # TRADITIONAL PREMARKET NOTIFICATION [510(k)] #### 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 ### Summary of Non-clinical Testing Testing was conducted on the Test Pack 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 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General Requirements Performance testing to demonstrate substantial equivalence to the predicate device has been completed and is summarized below: | Test | Purpose | Acceptance Criteria | Results | |---------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Comparison to<br>AAMI 16 Towel<br>PCD | Determine the resistance of<br>the Challenge Pack as<br>compared to an AAMI 16<br>Towel PCD | Challenge Pack is at least as<br>resistant as the biological<br>indicator AAMI 16 Towel<br>Process Challenge Device<br>(PCD) described in<br>ANSI/AAMI ST79: 2017 | Passed | | Comparison to<br>Biological Indicator | Determine the resistance of<br>the Challenge Pack as<br>compared to the Biological<br>Indicator alone | Challenge Pack provides a<br>greater resistance than the<br>Biological Indicator alone | Passed | ## Conclusion The conclusion drawn from the non-clinical tests performed demonstrates that the subject device is as safe, as effective and perform as well as or better than the legally marketed predicate device, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V (cleared under K193154), Class II (21 CFR 880.2800), product code FRC.