3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader

K173519 · 3M Company · FRC · Apr 23, 2018 · General Hospital

Device Facts

• Record ID: K173519
• Device Name: 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Apr 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 or 3MTM 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

System comprises biological indicator (BI) challenge packs and auto-reader; used to monitor steam sterilization efficacy. Challenge packs contain BI 1492V (and chemical integrator in 41482V); placed in sterilizer to challenge cycle. Post-sterilization, BI is incubated in 3M Attest Auto-reader 490/490H. Auto-reader detects fluorescence indicating presence of active enzymes; fluorescence change signifies sterilization failure. Software version 4.0.0+ enables 24-minute rapid readout at 60°C incubation. Healthcare providers use output to verify sterilization cycle success before releasing instruments for patient use. Benefits include rapid sterility assurance, reducing wait times for surgical instrument availability.

Clinical Evidence

No clinical data included. Bench testing only. Performance validated via resistance testing against AAMI 16 Towel PCDs, temperature stability testing (60±2°C), and electrical safety/EMC compliance (IEC 61010-1, IEC 61010-2-010, IEC 61326-1, FCC Part 15).

Technological Characteristics

Challenge packs consist of medical index cards, die-cut holders, and overwrapped labels. Biological indicator uses fluorescent enzyme detection. Auto-reader provides automated incubation and optical sensing. Connectivity: Standalone. Software: Version 4.0.0+. Sterilization: Steam. Compliance: ISO 11138-1/3, ISO 18472, ANSI/AAMI ST79.

Indications for Use

Indicated for use in healthcare facilities to qualify or monitor dynamic-air-removal steam sterilization cycles (4 min at 270°F/132°C or 3 min at 275°F/135°C) using 3M Attest Super Rapid Readout Biological Indicators.

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 Readout Steam Challenge Pack 1496V, 3M Attest Super Rapid 5 Steam-Plus Challenge Pack 41482V, and 3M Attest Auto-reader 490 (K121593)

Reference Devices

• 3M Attest Auto-reader 490H (K171003)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 23, 2018

3M Company Hilary Hovde Regulatory Affairs Associate 3M Center, Building 275-5W-06 St Paul, Minnesota 55144

Re: K173519

Trade/Device Name: 3M Attest Super Rapid Readout Steam Challenge Pack 1496V, 3M Attest Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: March 19, 2018 Received: March 22, 2018

Dear Hilary Hovde:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

# Sincerely, Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### Device Name

3MTM Attest™ Super Rapid Readout Steam Challenge Pack 1496V, 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H

#### Indications for Use (Describe)

Use the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 or 3MTM 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).

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the 3M logo. The logo consists of the number "3" and the letter "M" in a bold, sans-serif font. The color of the text is red, and the background is white. The logo is simple and recognizable.

# 510(k) Summary for 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V 3M™ Attest™ Auto-reader 490 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater)

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

> Contact: Hilary B. Hovde Regulatory Affairs Associate Phone Number: [phone] FAX Number: [phone]

Submission Date: April 19, 2018

K173519

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### Device Name and Classification:

| Common or Usual Name: | Biological Indicator |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | 3MTM AttestTM Super Rapid Readout Steam Challenge Pack 1496V<br>3MTM AttestTM Super Rapid 5 Steam-Plus Challenge Pack 41482V<br>3MTM AttestTM Auto-reader 490<br>3MTM AttestTM Auto-reader 490H |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR § 880.2800(a)) |
| Device Classification: | Class II |
| Product Code: | FRC |

### Predicate Device:

- 3MTM Attest™ Super Rapid Readout Steam Challenge Pack 1496V, 3MTM . Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and 3MTM Attest™ Auto-reader 490, K121593
#### Reference Device:

- 3MTM Attest™ Auto-reader 490H, K171003 .
## Description of Device:

The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V are specifically designed 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).

The 1496V and 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 Packs have the same design as the predicate device. Each 1496V Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V while the 41482V Challenge Pack contains a 1492V BI and a 3M™ SteriGage™ Steam Chemical Integrator (Type 5 Integrating Indicators as categorized by ISO 11140-1:2014). The 1492V BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater). A fluorescence change indicates a steam sterilization process failure. 3M™ Attest™ 1492V BI controls are provided with the Challenge Packs. Each Challenge Pack has a process indicator on the outside of the device that changes from vellow to brown or darker when exposed to steam.

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This submission is addressing a software change to the 3M™ Attest™ Auto-reader 490 to reduce the final fluorescent readout for the 1492V BI from 1 hour to 24 minutes, and to change the incubation temperature from 56°C to 60°C making the 490 Auto-reader identical to the 490H Auto-reader (software version 4.0.0 or greater). The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V are the same design as the previously cleared devices of the same model numbers. The ComplyTM SteriGage™ Steam Chemical Integrators contained within the 41482V challenge pack are the same as those in the predicate device. The device has the same materials and fundamental scientific technology.

## Summary of Nonclinical Testing

As the change is to the 3M™ Attest™ Auto-reader software, testing was conducted on the biological indicators and the challenge packs following the FDA guidance and the standards below:

- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- 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
- ANSI/AAMI/ISO 18472:2006 Sterilization of Health Care Products – Biological and Chemical Indicators: Test Equipment
- United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization and . Chapter <55> Biological Indicators - Resistance Performance Tests

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#### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid Readout Steam Challenge Pack 1496V 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V 3MTM Attest™ Auto-reader 490 and 490H

The functionality of the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 and the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater) with a final fluorescent readout of 24 minutes and an incubation temperature of 60°C was demonstrated in the following tests:

| Test | Acceptance Criteria | Results |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Resistance of the<br>Challenge Pack as<br>compared to AAMI 16<br>Towel PCD | Challenge Pack is at least as resistant as the<br>biological indicator AAMI 16 Towel Process<br>Challenge Device (PCD) described in ANSI/AAMI<br>ST79: 2017 | Passed |
| Resistance of the<br>Challenge Pack as<br>compared to the<br>Biological Indicator<br>alone | Challenge Pack provides a greater resistance than<br>the Biological Indicator alone | Passed |
| Auto-reader Maintenance<br>of Incubation<br>Temperature | Auto-reader maintains incubation temperature of<br>$60 \pm 2$ ℃ over a period of 7 days | Passed |

The results of these evaluations showed that the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V present a challenge to the sterilization process equivalent to the biological indicator AAMI 16 Towel PCD described in ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

The Attest™ Auto-readers were tested for safety by Underwriters Laboratory to verify compliance to:

- IEC 61010-1 (2010) 3rd Edition; Safety requirements for electrical equipment for . measurement, control, and laboratory use – Part 1: General requirements, and
- . IEC 61010-2-010 (2014) 3rd Edition; Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-010: Particular requirements for laboratory equipment for the heating of materials

In addition the 3M™ Attest™ Auto-readers 490 and 490H have been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:

- USA Title 47, Code of Federal Regulations for:
- Radiated Emissions (FCC Part 15, Subpart B, Class A) O
- o Conducted Emissions (FCC Part 15, Subpart B, Class A), and
- . IEC 61326-1:2012 Electrical Equipment for Measurement, Control, and Laboratory Use – EMC Requirements

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No clinical data was included in this premarket application submission.

### Indications for Use

Use the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and 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).

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## TRADITIONAL PREMARKET NOTIFICATION [510(k)]

#### 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V 3M™ Attest™ Auto-reader 490 and 490H

# Comparison to Predicate Device

| | Submission Device:<br>3MTM Attest™ | Predicate Device (K121593):<br>3MTM Attest™ |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Super Rapid Readout<br>Steam Challenge Pack 1496V and<br>3MTM AttestTM Super Rapid 5 | Super Rapid Readout<br>Steam Challenge Pack 1496V and<br>3MTM Attest™ Super Rapid 5 |
| | Steam-Plus Challenge Pack 41482V | Steam-Plus Challenge Pack 41482V |
| Indications for use | Use the 3MTM Attest™ Super Rapid Readout<br>Steam Challenge Pack 1496V and the 3MTM<br>Attest™ Super Rapid 5 Steam-Plus Challenge<br>Pack 41482V in conjunction with the 3MTM<br>AttestTM Auto-reader 490 or 3MTM AttestTM<br>Auto-reader 490H having software version 4.0.0<br>or greater to qualify or monitor dynamic-air- | Use the 3M™ Attest™ Super Rapid<br>Readout Steam Challenge Pack 1496V<br>and the 3MTM Attest™ Super Rapid 5<br>Steam-Plus Challenge Pack 41482V in<br>conjunction with the 3MTM AttestTM<br>Auto-reader 490 to qualify or monitor<br>dynamic-air-removal (pre-vacuum)<br>steam sterilization cycles 270°F<br>(132°C) at 4 minutes and 275°F<br>(135°C) at 3 minutes. |
| | removal steam sterilization cycles of 4 minutes<br>at 270°F (132°C) and 3 minutes at 275°F<br>(135°C). | The 3MTM Attest™ Super Rapid<br>Readout Biological Indicator 1492V<br>contained in the challenge pack<br>provides a final fluorescent result in 1<br>hour. An optional visual pH color<br>change result is observed in 48 hours. |
| General Design | Layers of medical index cards, some of which<br>are die-cut to contain indicators, overwrapped<br>and secured with a label. | Identical |
| Biological Indicator | 3MTM Attest™ Super Rapid Readout Biological<br>Indicator 1492V | Identical |
| Biological Indicator<br>Incubation<br>temperature | 60 ± 2°C | 56 ± 2°C |
| Biological Indicator<br>Readout time | 24 minute final fluorescent result in both the 490<br>and 490H Auto-readers having software versions<br>4.0.0 or greater.<br>1 hour final fluorescent result in 490 Auto-<br>readers having software versions less than 4.0.0. | 1 hour final fluorescent result in 490<br>Auto-readers. |
| Resistance<br>Comparison to the<br>AAMI ST79<br>16 Towel PCD | Equivalent in resistance to the AAMI ST79<br>16 Towel PCD | Identical |
| Chemical Integrator | The 3M™ Attest™ Super Rapid Readout Steam<br>Challenge Pack 1496V does not contain a<br>chemical integrator.<br>The 3MTM Attest™ Super Rapid 5 Steam-Plus<br>Challenge Pack 41482V contains a 3M™<br>SteriGage™ Chemical Integrator | Identical |
| External Chemical<br>Process Indicator | Turns from yellow to brown or darker upon<br>steam exposure | Identical |
| Shelf-life | 21 months | Identical |

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## Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the 3MTM Attest™ Super Rapid Readout Steam Challenge Pack 1496V, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, the 3MTM Attest™ Auto-reader 490, and the 3MTM Attest™ Autoreader 490H are as safe, as effective, and perform as well as or better than the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and the 3M™ Attest™ Auto-reader 490 (K121593).