3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H

K192550 · 3M Company · FRC · Jun 5, 2020 · General Hospital

Device Facts

• Record ID: K192550
• Device Name: 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Jun 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3M Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles: Dynamic-air-removal (pre-vacuum and SFPP) 250°F (121°C) 15 minutes; Dynamic-air-removal (pre-vacuum and SFPP) 250°F (121°C) 20 minutes; Dynamic-air-removal (pre-vacuum and SFPP) 250°F (121°C) 30 minutes; Dynamic-air-removal (pre-vacuum and SFPP) 250°F (121°C) 35 minutes; Gravity Displacement 250°F (121°C) 30 minutes. Use the 3M Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).

Device Story

System comprises self-contained biological indicator (BI) 1592, challenge pack 51582, and auto-readers 490/490H. BI 1592 contains Geobacillus stearothermophilus spores and media ampoule in plastic sleeve. After steam sterilization, BI is incubated in auto-reader at 60°C. Auto-reader detects fluorescence resulting from enzymatic hydrolysis of non-fluorescent substrate by active enzyme in spores; fluorescence indicates sterilization failure. Challenge pack 51582 contains BI 1592 and chemical integrator within medical index card layers to simulate AAMI ST79 16-towel process challenge device. Used by healthcare personnel to verify sterilization efficacy. Output is binary (pass/fail) provided via auto-reader interface. Benefits include rapid 24-minute readout for sterilization monitoring.

Clinical Evidence

Bench testing only. Performance verified against ISO 11138-1:2017, ISO 11138-3:2017, and USP <1035>/<55>. Testing confirmed spore population ≥ 10^6, D-value ≥ 1.5 min at 121°C, and Z-value ≥ 10°C. Reduced incubation time (24 minutes) demonstrated >97% alignment with 7-day conventional incubation. Challenge pack resistance verified as equivalent to AAMI ST79 16-towel PCD.

Technological Characteristics

Plastic-housed self-contained biological indicator; Geobacillus stearothermophilus spores; enzymatic fluorescence detection; 60°C incubation; chemical process indicator (pink to brown); challenge pack uses medical index cards; software-controlled auto-reader (v4.0.0+); compliant with ISO 11138-1/3, ISO 11140-1, and ANSI/AAMI ST79.

Indications for Use

Indicated for healthcare facilities to qualify or monitor steam sterilization cycles (dynamic-air-removal and gravity displacement) at 250°F (121°C) using 3M Attest™ Super Rapid Steam Biological Indicator 1592 or 3M Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with compatible 3M Attest™ Auto-readers.

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 Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H (K173437)
• 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H (K173519)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

June 5, 2020

3M Company Hilary Hovde Regulatory Affairs Specialist Bldg. 275-5W-06 St.Paul, Minnesota 55144

## Re: K192550

Trade/Device Name: 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack, 3M™ Attest™ Auto- Readers 490 and 490H Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 6, 2020 Received: May 7, 2020

## Dear Hilary Hovde:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Christopher K. Dugard, M.S. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K192550

#### Device Name

3MTM Attest™ Super Rapid Steam Biological Indicator 1592 and 3MTM Attest™ Auto-reader 490 and 490H

#### Indications for Use (Describe)

Use the 3MM Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MM AttestTM Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:

| Cycle Type | Exposure Temperature | Exposure Time |
|-------------------------------------------|----------------------|---------------|
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 20 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 35 minutes |
| Gravity Displacement | 250°F (121°C) | 30 minutes |

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

J Prescription Use (Part 21 CFR 801 Subpart D)

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

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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:

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### Indications for Use

510(k) Number (if known) K192550

Device Name

3MTM AttestTM Super Rapid Steam Challenge Pack 51582 and 3M™ Attest™ Auto-reader 490 and 490H

#### Indications for Use (Describe)

Use the 3MM Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software versio n 4.0.0 or greater to qualify or monitor dynamic-air-removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources , gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] v

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "

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Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The number and letter are in a bold, sans-serif font. The logo is simple and recognizable.

# 510(k) Summary for K192550 3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, and 3M™ Attest™ Auto-readers 490 and 490H

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

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

Submission Date: August 27, 2019

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#### Device Name and Classification- Biological Indicator:

| Trade Name: | 3M™ Attest™ Super Rapid Steam Biological Indicator 1592<br>3M™ Attest™ Auto-reader 490<br>3M™ Attest™ Auto-reader 490H |
|------------------------|------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Biological Indicator (BI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>[21 CFR § 880.2800(a), FRC] |

### Predicate Device- Biological Indicator:

3MTM Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H, K173437

#### Indications for Use- Biological Indicator

Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:

| Cycle Type | Exposure Temperature | Exposure Time |
|-------------------------------------------|----------------------|---------------|
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 20 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 35 minutes |
| Gravity Displacement | 250°F (121°C) | 30 minutes |

### Description of Device- Biological Indicator

The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal and gravity displacement steam sterilization cycles at 250°F (121°C).

The 1592 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1592 cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of

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fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure.

| Feature | Submission Device:<br>(K192550):<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592 and<br>3MTM AttestTM Auto-reader<br>490 and 490H | Predicate Device<br>(K173437):<br>3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator 1492V<br>and<br>3MTM AttestTM<br>Auto-reader 490 and 490H | Comparison |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM AttestTM Super<br>Rapid Steam Biological<br>Indicator 1592 in conjunction<br>with the 3MTM AttestTM Auto-<br>reader 490 having software<br>version 4.0.0 or greater or the<br>3MTM AttestTM Auto-reader<br>490H having software version<br>4.0.0 or greater to qualify or<br>monitor the following<br>sterilization cycles:<br>Dynamic-air-removal<br>(pre-vacuum and<br>SFPP), 250°F (121°C),<br>15 minutes Dynamic-air-removal<br>(pre-vacuum and<br>SFPP), 250°F (121°C),<br>20 minutes Dynamic-air-removal<br>(pre-vacuum and<br>SFPP), 250°F (121°C),<br>30 minutes Dynamic-air-removal<br>(pre-vacuum and<br>SFPP), 250°F (121°C),<br>35 minutes Gravity Displacement,<br>250°F (121°C),<br>30 minutes | Use the 3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator 1492V<br>in conjunction with both the<br>3MTM AttestTM Auto-reader<br>490 or the AttestTM Auto-<br>reader 490H having<br>software version 4.0.0 or<br>greater to qualify or monitor<br>dynamic-air-removal steam<br>sterilization cycles of:<br>3 minutes at 270°F<br>(132°C) 4 minutes at 270°F<br>(132°C) 3 minutes at 275°F<br>(135°C) | The 3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator<br>1592 is intended to<br>qualify or monitor both<br>dynamic-air-removal<br>(pre-vacuum and SFPP)<br>and gravity<br>displacement cycles at<br>various exposure times<br>at 250°F (121°C).<br>Whereas the 3MTM<br>AttestTM Super Rapid<br>Readout Biological<br>Indicator 1492Vis<br>intended to qualify or<br>monitor dynamic-air-<br>removal steam<br>sterilization cycles at<br>various exposure times<br>at 270°F (132°C) and<br>275°F (135°C).<br>Both BIs are intended<br>to be used in<br>conjunction with the<br>3MTM AttestTM Auto-<br>reader 490 and the<br>3MTM AttestTM Auto-<br>reader 490H. |
| Indicator Organism | <i>Geobacillus stearothermophilus</i><br>traceable to ATCCTM 7953 | <i>Geobacillus<br/>stearothermophilus</i><br>traceable to ATCCTM 7953 | Identical |
| Mechanism of<br>Action | When the enzyme that is<br>naturally occurring in the spore<br>is in its active state, it is<br>detected by measuring the | When the enzyme that is<br>naturally occurring in the<br>spore is in its active state, it<br>is detected by measuring the | Identical |
| Feature | Submission Device:<br>(K192550):<br>3MTM Attest™<br>Super Rapid Steam<br>Biological Indicator 1592 and<br>3MTM Attest™ Auto-reader<br>490 and 490H | Predicate Device<br>(K173437):<br>3MTM Attest™<br>Super Rapid Readout<br>Biological Indicator 1492V<br>and<br>3MTM Attest™<br>Auto-reader 490 and 490H | Comparison |
| | fluorescence produced by the<br>enzymatic hydrolysis of a non-<br>fluorescent substrate. The<br>resultant fluorescent by-product<br>is detected by the Auto-reader.<br>The presence of fluorescence<br>upon incubation in the Auto-<br>reader indicates a sterilization<br>process failure. | fluorescence produced by<br>the enzymatic hydrolysis of<br>a non-fluorescent substrate.<br>The resultant fluorescent<br>by-product is detected by<br>the Auto-reader. The<br>presence of fluorescence<br>upon incubation in the<br>Auto-reader indicates a<br>sterilization process failure. | |
| Auto-reader | 3MTM Attest™ Auto-reader 490<br>having software version 4.0.0 or<br>greater or 3MTM Attest™ Auto-<br>reader 490H having software<br>version 4.0.0 or greater | 3MTM Attest™ Auto-reader<br>490 or 3MTM Attest™ Auto-<br>reader 490H having<br>software version 4.0.0 or<br>greater | The 3MTM Attest™<br>Super Rapid Steam<br>Biological Indicator<br>1592 BI has a 24<br>minute readout and is<br>intended to be used<br>with a 490 or 490H<br>having software version<br>4.0.0 or greater.<br>Indications for a 24<br>minute time to result<br>were cleared under<br>K173437. |
| Viable spore<br>population | $\ge$ 1 x 106 | $\ge$ 1 x 106 | Identical |
| Resistance | D121 $\ge$ 1.5 min | D121 is N/A<br>D132 $\ge$ 10 s<br>D135 $\ge$ 8 s | The 3MTM Attest™<br>Super Rapid Steam<br>Biological Indicator<br>1592 BI is indicated for<br>qualifying and<br>monitoring sterilization<br>cycles at 121°C<br>whereas the predicate<br>device is indicated for<br>qualifying and<br>monitoring sterilization<br>cycles at 132°C and<br>135°C. |
| Survival Time | Meets the longer of FDA and<br>ISO 11138-1 and ISO 11138-3<br>requirements | Meets the longer of FDA<br>and ISO 11138-1 and ISO<br>11138-3 requirements | Identical |
| Kill Time | Meets the ISO 11138-1 and ISO<br>11138-3 requirements | Meets the ISO 11138-1 and<br>ISO 11138-3 requirements | Identical |
| Feature | Submission Device:<br>(K192550):<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592 and<br>3MTM AttestTM Auto-reader<br>490 and 490H | Predicate Device<br>(K173437):<br>3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator 1492V<br>and<br>3MTM AttestTM<br>Auto-reader 490 and 490H | Comparison |
| Carrier material | Plastic | Plastic | Identical |
| Incubation<br>temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Readout time | 24 minute final fluorescent<br>result in both the 490 and 490H<br>Auto-readers having software<br>version 4.0.0 or greater.<br>Optional visual pH color<br>change result in 7 days | 24 minute final fluorescent<br>result in both the 490 and<br>490H Auto-readers having<br>software version 4.0.0 or<br>greater.<br>1 hour final fluorescent<br>result in 490 Auto-readers<br>having software versions<br>less than 4.0.0.<br>Optional visual pH color<br>change result in 48 hours. | The 3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator<br>1592 BI has a 24<br>minute readout and is<br>intended to be used<br>with a 490 or 490H<br>having software version<br>4.0.0 or greater.<br>Indications for a 24<br>minute time to result<br>were cleared under<br>K173437. |
| Chemical indicator | Turns from pink to light brown<br>or darker upon steam exposure | Turns from pink to light<br>brown or darker upon steam<br>exposure | Identical |
| Shelf-life | 6 months | 21 months | Real-time testing is<br>ongoing. |

### Technological Characteristics Comparison Table – Biological Indicator

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# TRADITIONAL PREMARKET NOTIFICATION [K192550]

# 3M™ Attest™ Super Rapid Steam Biological Indicator 1592

3MTM Attest™ Super Rapid Steam Challenge Pack 51582

3M™ Attest™ Auto-readers 490 and 490H

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# TRADITIONAL PREMARKET NOTIFICATION [K192550]

# 3M™ Attest™ Super Rapid Steam Biological Indicator 1592

3M™ Attest™ Super Rapid Steam Challenge Pack 51582

3MTM Attest™ Auto-readers 490 and 490H

# Summary of Nonclinical Testing- Biological Indicator

Testing was conducted on the biological indicator following the FDA guidance and the standards below:

- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- ISO 11138-1:2017 Sterilization of health care products Biological indicators, Part 1: ● General Requirements
- ISO 11138-3:2017 Sterilization of health care products Biological indicators, Part 3: ● Biological indicators for moist heat sterilization processes
- . United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization and Chapter <55> Biological Indicators - Resistance Performance Tests

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The performance testing below demonstrate that the subject device met the acceptance criteria of the specified standards:

| Test | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Population (Total Viable Spore Count)<br>Greater than or equal to $10^6$ spores | Passed |
| D-Value<br>Greater than or equal to 1.5 minutes at 121°C | Passed |
| Z-Value<br>Greater than or equal to $10$ °C | Passed |
| Survival Time<br>Meets the longer of FDA and ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Kill Time<br>Meets ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Component Inhibition Studies<br>Components have no impact on the recovery of 10-100 organisms | Passed |
| Hold Time Assessment<br>D-value does not change when activated 7 days post sterilization | Passed |
| Reduced Incubation Time<br>Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout time:<br>• Fluorescent result in 24 minutes | Passed |
| Simulated Use<br>Verification of performance in claimed cycles | Passed |

## 3MT™ Attest™ Auto-reader 490 having software version 4.0.0 or greater and 3MTM Attest™ Auto-reader 490H

The 3M™ Attest™ Auto-reader 490 and the 3M™ Attest™ Auto-reader 490H were cleared for use with the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V under K173437. This submission extends the use of the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to the 3MTM Attest™ Super Rapid Steam Biological Indicator 1592.

The 3M™ Attest Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater are designed to incubate at 60°C and automatically read the 1592 BI for a fluorescent result within 24 minutes. The fluorescent readout at 24 minutes meets the FDA's requirement of > 97% alignment with the result after conventional incubation time of 7 days.

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### Device Name and Classification- Challenge Pack:

| Trade Name: | 3MTM AttestTM Super Rapid Steam Challenge Pack 51582 |
|------------------------|----------------------------------------------------------------------------|
| Common/Usual Name: | Biological Indicator (BI) Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>[21 CFR § 880.2800(a), FRC] |

### Predicate Device- Challenge Pack:

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

### Indications for Use- Challenge Pack

Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Autoreader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).

### Description of Device- Challenge Pack

The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).

The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Packs have the same design as the predicate device but contain different monitoring products. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3MTM Attest™ Steam Chemical Integrator (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Chemical Integrator offers an immediate ACCEPT or REJECT reading. The 1592 BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure. 3M™ Attest™ 1592 BI controls are provided with the Challenge Packs. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.

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| Feature | Submission Device:<br>(K192550):<br>3MTM AttestTM<br>Super Rapid Steam<br>Challenge Pack 51582 and<br>3MTM AttestTM Auto-reader<br>490 and 490H | Predicate Device<br>(K173519):<br>3MTM AttestTM Super Rapid 5<br>Steam-Plus Challenge Pack<br>41482V<br>and<br>3MTM AttestTM Auto-reader<br>490 and 490H | Comparison |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | Use the 3MTM AttestTM Super<br>Rapid Steam Challenge Pack<br>51582 in conjunction with the<br>3MTM AttestTM Auto-reader<br>490 having software version<br>4.0.0 or greater or the 3MTM<br>AttestTM Auto-reader 490H<br>having software version 4.0.0<br>or greater to qualify or<br>monitor dynamic-air removal<br>(pre-vacuum and SFPP) or<br>gravity displacement steam<br>sterilization cycles of 30<br>minutes at 250°F (121°C). | Use the 3MTM AttestTM Super<br>Rapid 5 Steam-Plus Challenge<br>Pack 41482V in conjunction<br>with the 3MTM AttestTM Auto-<br>reader 490 or 3MTM AttestTM<br>Auto-reader 490H having<br>software version 4.0.0 or<br>greater to qualify or monitor<br>dynamic-air-removal steam<br>sterilization cycles of 4 minutes<br>at 270°F (132°C) and 3 minutes<br>at 275°F (135°C). | The 3MTM AttestTM<br>Super Rapid Steam<br>Challenge Pack 51582 is<br>intended to qualify or<br>monitor both dynamic-<br>air-removal (pre-vacuum<br>and SFPP) and gravity<br>displacement<br>sterilization cycles of 30<br>minutes at 250°F<br>(121°C). Whereas the<br>3MTM AttestTM Super<br>Rapid 5 Steam-Plus<br>Challenge Pack is<br>intended to qualify or<br>monitor dynamic-air-<br>removal steam<br>sterilization cycles at<br>various exposure times<br>at 270°F (132°C) and<br>275°F (135°C). |
| General Design | Layers of medical index<br>cards, some of which are die-<br>cut to contain indicators,<br>overwrapped and secured<br>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>Steam Biological Indicator<br>1592 | 3MTM AttestTM Super Rapid<br>Readout Biological Indicator<br>1492V | The 51582 Challenge<br>Pack contains the new<br>1592 BI as proposed in<br>this submission. |
| Biological<br>Indicator<br>Incubation<br>temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Biological<br>Indicator Readout<br>time | 24 minute final fluorescent<br>result in both the 490 and<br>490H Auto-readers having<br>software versions 4.0.0 or<br>greater. | 24 minute final fluorescent<br>result in both the 490 and 490H<br>Auto-readers having software<br>versions 4.0.0 or greater.<br>1 hour final fluorescent result in<br>490 Auto-readers having | The 3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator<br>1592 BI has a 24 minute<br>readout and is intended<br>to be used with a 490 or |
| Feature | Submission Device:<br>(K192550):<br>3MTM AttestTM<br>Super Rapid Steam<br>Challenge Pack 51582 and<br>3MTM AttestTM Auto-reader<br>490 and 490H | Predicate Device<br>(K173519):<br>3MTM AttestTM Super Rapid 5<br>Steam-Plus Challenge Pack<br>41482V<br>and<br>3MTM AttestTM Auto-reader<br>490 and 490H | Comparison |
| | | software versions less than<br>4.0.0. | 490H having software<br>version 4.0.0 or greater.<br>Indications for a 24<br>minute time to result<br>were cleared under<br>K173519. |
| 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 Chemical<br>Integrator | 3MTM SteriGageTM Chemical<br>Integrator | Both integrators meet<br>FDA requirements and<br>are Type 5 Integrating<br>Indicators as classified<br>per ISO 11140-1. |
| External<br>Chemical Process<br>Indicator | Turns from yellow to brown<br>or darker upon steam<br>exposure | Turns from yellow to brown or<br>darker upon steam exposure | Identical |
| Shelf-life | 6 months | 21 months | Real-time testing is<br>ongoing. |

# Technological Characteristics Comparison Table – Challenge Pack

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#### TRADITIONAL PREMARKET NOTIFICATION [K192550] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592

3M™ Attest™ Super Rapid Steam Challenge Pack 51582

3MTM Attest™ Auto-readers 490 and 490H

### Summary of Nonclinical Testing- Challenge Pack

Testing was conducted on the challenge packs following the FDA guidance and the standards below:

- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- Premarket Notification [510(k)] Submission for Chemical Indicators: Guidance for ● Industry and FDA Staff, December 19, 2003
- ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities
- ISO 11138-1:2017 Sterilization of health care products – Biological indicators, Part 1: General Requirements
- . ISO 11138-3:2017 Sterilization of health care products – Biological indicators, Part 3: Biological indicators for moist heat sterilization processes

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- ISO 11140-1:2014 Sterilization of health care products Chemical indicators, Part 1: ● General Requirements
- United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization and ● Chapter <55> Biological Indicators - Resistance Performance Tests

The performance testing below demonstrate that the subject device met the acceptance criteria of the specified standards:

| Test | Acceptance Criteria | Results |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Resistance of 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 |

## Conclusion

The conclusions drawn from the non-clinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices, the 3MM Attest™ Super Rapid Readout Biological Indicator 1492V, 3MTM Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H (cleared under K173437) and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H (cleared under K173519), Class II (21 CFR 880.2800), product code FRC.