3M Attest Super Rapid 5 Steam-Plus Challenge Pack

K193154 · 3M Company · FRC · Feb 7, 2020 · General Hospital

Device Facts

• Record ID: K193154
• Device Name: 3M Attest Super Rapid 5 Steam-Plus Challenge Pack
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Feb 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M Attest Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M Attest Autoreader 490 or 3M Attest Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).

Device Story

Challenge pack contains 1492V biological indicator (BI) and steam chemical integrator within medical index card layers; overwrapped and labeled. Used in healthcare facilities to monitor steam sterilization efficacy. BI provides rapid fluorescent readout via 3M Attest Autoreader (490/490H); fluorescence indicates sterilization failure. Chemical integrator provides immediate accept/reject result for emergency implant load release. External process indicator changes color (yellow to brown/darker) upon steam exposure. Healthcare providers use results to verify sterilization cycle success; failure results prevent use of processed items, ensuring patient safety by preventing use of non-sterile instruments.

Clinical Evidence

Bench testing only. Performance testing demonstrated the challenge pack is at least as resistant as the AAMI 16-towel PCD and provides greater resistance than the biological indicator alone. Compliance with ISO 11138-1:2017, ISO 11138-3:2017, ISO 11140-1:2014, and USP <1035>/<55> standards confirmed.

Technological Characteristics

Challenge pack consists of medical index card layers, die-cut to hold indicators, overwrapped. Includes 1492V biological indicator (60±2°C incubation) and steam chemical integrator. External process indicator (yellow to brown). Connectivity via 3M Attest Autoreader 490/490H (v4.0.0+). Standards: ISO 11138-1/3, ISO 11140-1, ANSI/AAMI ST79.

Indications for Use

Indicated for qualifying or monitoring dynamic-air-removal steam sterilization cycles (4 min at 270°F/132°C or 3 min at 275°F/135°C) in healthcare facilities using 3M Attest Autoreader 490/490H (v4.0.0+).

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• 3M Attest Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M Attest Auto-reader 490, and 3M Attest Auto-reader 490H (K173519)

Reference Devices

• 3M Comply SteriGage Chemical Integrator for Steam (K101249)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 7, 2020

3M Company Mary Fretland Senior Regulatory Affairs Associate Bldg. 275-5W-06 St. Paul, Minnesota 55144

Re: K193154

Trade/Device Name: 3M Attest Super Rapid 5 Steam-Plus Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 1, 2019 Received: November 14, 2019

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 (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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Sreekanth Gutala, Ph.D. 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) K193154

#### Device Name

3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V

Indications for Use (Describe)

Use the 3MM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Autoreader 490 or 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamicair-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

|× 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 [e-mail]

"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."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The logo is simple and recognizable.

# 510(k) Summary for 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V K193154

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: [phone] FAX Number: [phone]

Date of Summary: February 04, 2020

{4}------------------------------------------------

#### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V

## Device Name and Classification:

| Trade Name: | 3MTM AttestTM Super Rapid 5 Steam-Plus Challenge Pack<br>41482V |
|------------------------|----------------------------------------------------------------------------|
| Common/Usual Name: | Biological Indicator (BI) Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>[21 CFR § 880.2800(a), FRC] |

## Predicate Device:

3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H, K173519

## Indications for Use

Use 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3MTM Attest™ Auto-reader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).

## Description of Device:

The 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V is specifically designed to qualify or routinely challenge dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).

The 41482V Challenge Packs consist 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 Pack has the same design as the predicate device except for a change to the chemical integrator contained within the Challenge Pack. Each 41482V Challenge Pack contains a 1492V BI and a 3M™ Attest™ Steam Chemical Integrator. The 1492V BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 or the 3MTM Attest™ Auto-reader 490H (software version 4.0.0 or greater). A fluorescence change indicates a steam sterilization process failure. 3MTM Attest™ 1492V BI controls are provided with the Challenge Packs. The 3M™ Attest™ Chemical Integrator offers an immediate Accept/Reject result that allows for implant load early release in emergency situations as defined in AAMI ST79. 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.

{5}------------------------------------------------

## TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V

# Technological Characterization

Provided below is a comparison of the technological similarities and differences between the subject device and the predicate device.

| Technical Characteristics Comparison Table | | |
|--------------------------------------------|--|--|
|--------------------------------------------|--|--|

| Feature | Subject Device: K193154<br>3MTM AttestTM Super Rapid 5<br>Steam-Plus Challenge Pack<br>41482V | Predicate Device<br>(K173519):<br>3MTM AttestTM Super Rapid 5<br>Steam-Plus Challenge Pack<br>41482V<br>and<br>3MTM AttestTM Auto-reader 490<br>and 490H | Comparison |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for<br>use | Use the 3MTM AttestTM Super<br>Rapid 5 Steam-Plus Challenge<br>Pack 41482V in conjunction with<br>the 3MTM AttestTM Auto-reader<br>490 or 3MTM AttestTM Auto-<br>reader 490H having software<br>version 4.0.0 or greater to qualify<br>or monitor dynamic-air-removal<br>steam sterilization cycles of 4<br>minutes at 270°F (132°C) and 3<br>minutes at 275°F (135°C). | Use the 3MTM AttestTM Super<br>Rapid 5 Steam-Plus Challenge<br>Pack 41482V in conjunction with<br>the 3MTM AttestTM Auto-reader<br>490 or 3MTM AttestTM Auto-<br>reader 490H having software<br>version 4.0.0 or greater to qualify<br>or monitor dynamic-air-removal<br>steam sterilization cycles of 4<br>minutes at 270°F (132°C) and 3<br>minutes at 275°F (135°C). | Identical |
| 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<br>Indicator | 3MTM AttestTM Super Rapid<br>Readout Biological Indicator<br>1492V | 3MTM AttestTM Super Rapid<br>Readout Biological Indicator<br>1492V | Identical |
| Biological<br>Indicator<br>Incubation<br>temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Biological<br>Indicator Readout<br>time | 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<br>software versions less than 4.0.0. | 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<br>software versions less than 4.0.0. | Identical |
| Resistance<br>Comparison to<br>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<br>Integrator | 3MTM AttestTM Steam Chemical<br>Integrator | 3MTM ComplyTM SteriGageTM<br>Chemical Integrator for Steam | Both integrators<br>meet FDA<br>requirements for a<br>chemical integrator |
| Feature | Subject Device: K193154<br>3MTM Attest™ Super Rapid 5<br>Steam-Plus Challenge Pack<br>41482V | Predicate Device<br>(K173519):<br>3MTM Attest™ Super Rapid 5<br>Steam-Plus Challenge Pack<br>41482V<br>and<br>3MTM Attest™ Auto-reader 490<br>and 490H | Comparison |
| External<br>Chemical Process<br>Indicator | Turns from yellow to brown or<br>darker upon steam exposure | Turns from yellow to brown or<br>darker upon steam exposure | Identical |
| Shelf-life | 21 months | 21 months | Identical |

{6}------------------------------------------------

#### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V

The design, fundamental technology and performance specifications for 3MTM Attest™ Steam Chemical Integrators are similar to the previously cleared device which is sold under the tradename 3M™ ComplyTM SteriGage™ Chemical Integrator for Steam (K101249). 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, rebranding of the device, and a modification to the materials used to construct the device. There have been no other changes to the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V nor to the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V contained within the Challenge Pack. Other than the change to the integrator, the Challenge Pack has the same materials and fundamental scientific technology.

# Summary of Non-clinical Testing

Testing was conducted on the Challenge 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 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
- 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

{7}------------------------------------------------

#### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V

Performance testing to demonstrate substantial equivalence to the predicate device has been completed and is summarized below:

| Test | Purpose | Acceptance Criteria | Results | | |
|------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------|
| Comparison<br>to<br>AAMI 16<br>Towel 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 indicator<br>AAMI 16 Towel Process Challenge<br>Device (PCD) described in<br>ANSI/AAMI ST79: 2017 | Passed | | |
| | | Comparison<br>to Biological<br>Indicator | Determine the resistance of<br>the Challenge Pack as<br>compared to the Biological<br>Indicator alone | Challenge Pack provides a greater<br>resistance than the Biological<br>Indicator alone | Passed |

# Conclusion

The conclusion drawn from the non-clinical tests performed demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices 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.