3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M

K243501 · 3M Company · FRC · Jan 28, 2025 · General Hospital

Device Facts

• Record ID: K243501
• Device Name: 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Jan 28, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE: Use the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE in conjunction with the 3M™ Attest™ Auto-reader 490, the 3MM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycle: Cycle Type: Dynamic-air-removal, Exposure Temperature: 270°F (132°C), Exposure Time: 10 minutes. 3MTM AttestTM Auto-reader 490: The 3MTMAttest™ Auto-reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493, at 60°C for a final fluorescent result at 24 minutes. 3MTM AttestTM Auto-reader 490H: The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes. 3MTM AttestTM Mini Auto-reader 490M: The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1493, at 60°C for a final fluorescent result at 24 minutes.

Device Story

Device is a single-use biological indicator process challenge device (PCD) for steam sterilization monitoring. Input: 1492V biological indicator (BI) and steam chemical integrator (CI) contained within a clear plastic shell with a tortuous channel. Operation: PCD is placed in sterilization cycle; steam penetrates tortuous channel to reach indicators. Post-exposure, BI is incubated in 3M Attest Auto-reader (490, 490H, or 490M). Reader detects fluorescence from enzymatic hydrolysis of a non-fluorescent substrate; presence of fluorescence indicates sterilization failure. CI provides independent verification of exposure parameters (time, temperature, steam saturation) via color-migrating strip. Used in healthcare facilities by sterile processing staff. Output: Fluorescent result (BI) and visual color change (CI). Benefits: Provides rapid, reliable confirmation of sterilization process adequacy, ensuring patient safety by preventing use of non-sterile instruments.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via side-by-side testing with AAMI 16-towel PCD and standalone indicators per FDA guidance and ANSI/AAMI ST79:2017. Peel force testing performed per ASTM F88/F88M-15 and ASTM F2824-10. All acceptance criteria met.

Technological Characteristics

Single-use clear plastic shell with tortuous channel and foil lid. Contains 1492V BI (Geobacillus stearothermophilus spores, ≥10^6) and Type 5 chemical integrator. BI incubation at 60±2°C. Readout via fluorescence (24 min) or optional 48-hour pH color change. Connectivity: Standalone auto-reader. Standards: ASTM F88/F88M-15, ASTM F2824-10, ISO 11138-1:2017.

Indications for Use

Indicated for healthcare facilities to qualify or monitor 10-minute 270°F (132°C) dynamic-air-removal steam sterilization cycles using 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE in conjunction with specified 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

• VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly (K182931)

Submission Summary (Full Text)

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January 28, 2025

3M Company Michelle Larsen Principal RA Specialist 3M Center 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144

Re: K243501

Trade/Device Name: 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3MTM Attest™ Mini Auto-reader 490M Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 11, 2024 Received: November 12, 2024

Dear Michelle Larsen:

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

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

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Stephen A Anisko -S

Digitally signed by Ste Date: 2025.01.28 14:11:26

for: Christopher K. Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K243501

#### Device Name

3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE: 3M™ Attest™ Auto-reader 490: 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M.

#### Indications for Use (Describe)

3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE: Use the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE in conjunction with the 3M™ Attest™ Auto-reader 490, the 3MM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycle:

| Cycle Type | Exposure Temperature | Exposure Time |
|---------------------|----------------------|---------------|
| Dynamic-air-removal | 270°F (132°C) | 10 minutes |

3MTM AttestTM Auto-reader 490:

The 3MTMAttest™ Auto-reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493, at 60°C for a final fluorescent result at 24 minutes.

3MTM AttestTM Auto-reader 490H:

The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes.

3MTM AttestTM Mini Auto-reader 490M:

The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1493, at 60°C for a final fluorescent result at 24 minutes.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary for 3MTM Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M K243501

#### Sponsor Information:

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

Contact: Michelle M. Larsen Principal RA Specialist Phone Number: [phone] Fax Number: [phone] Email: [e-mail]

#### Date of Summary: 14 January 2025

#### 1. Device Name and Classification:

Common or Usual Name: Biological Indicator (BI) Challenge Pack

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#### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3MTM Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M

| Proprietary Name: | 3MTM AttestTM Super Rapid Steam Extended Cycle Clear<br>Challenge Pack 1492PCDE,<br>3MTM AttestTM Auto-reader 490,<br>3MTM AttestTM Auto-reader 490H,<br>3MTM AttestTM Mini Auto-reader 490M |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Indicator, Biological Sterilization Process |
| Device Classification: | Class II, 21 CFR 880.2800(a) |
| Product Code: | FRC |

# 2. Predicate Device:

VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly, K182931

## 3. Description of Device:

The 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE is designed to qualify and monitor extended dynamic-air-removal steam sterilization processes at 270°F (132°C) in healthcare facilities.

The 1492PCDE Challenge Pack consists of a clear plastic shell, with a tortuous channel allowing for air removal and sterilant penetration. The channel connects to a cavity containing the monitoring products and all are covered by a foil lid. The 1492PCDE is a single-use device.

Each 1492PCDE Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1492V (brown cap) and a 3M™ Attest™ Steam Chemical Integrator (CI). The CI verifies that the stated values for the three critical parameters of exposure time, temperature, and steam saturation have been achieved. Upon exposure to steam a dark color visible through a window migrates along the indicator strip and offers an ACCEPT or REJECT reading. The 1492V Biological Indicator (BI) is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1492V BI in the 490, 490H or 490M Auto-reader indicates a steam sterilization process failure. A chemical process indicator is present on the brown cap of the 1492V BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink

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to light brown or darker upon exposure to steam. The process indicator is used by the customer to verify that the challenge pack was exposed to steam.

# 4. Indications for Use

3MTM Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE: Use the 3MTM Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE in conjunction with the 3MTM Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3MTM Attest™ Mini Autoreader 490M to qualify or monitor the following steam sterilization cycle:

| Cycle Type | Exposure Temperature | Exposure Time |
|---------------------|----------------------|---------------|
| Dynamic-air-removal | 270°F (132°C) | 10 minutes |

# 3MTM AttestTM Auto-reader 490:

The 3MTMAttest™ Auto-reader 490 is designed to incubate and automatically read 3M Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493, at 60°C for a final luorescent result at 24 minutes.

# 3MTM AttestTM Auto-reader 490H:

The 3MTM Attest™ Auto-reader 490H is designed to incubate and automatically read 3MTM Attest™ Rapid Readout Biological Indicators 1295. 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes.

# 3MTM Attest™ Mini Auto-reader 490M:

The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1493, at 60°C for a final luorescent result at 24 minutes.

he submission device, the 3MTM Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, has the same intended use as the predicate device, the VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity™ Xtend 10 Assembly. Both he submission device and the predicate device are Single Use biological indicator process allenge devices that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process.

oth the submission and the predicate challenge packs are indicated to monitor 10-minute 270°F (132°C) dynamic-air-removal steam sterilization cycles. The submission challenge back is intended to be used in conjunction with the 3M™ Attest™ Auto-readers 490 and 0H, and 3M™ Attest™ Mini Auto-reader 490M. The 1492V Biological Indicator that is tained in the submission challenge pack was cleared for use with the Auto-readers per

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K241710. The differences in Indications for Use do not alter the fundamental Intended Use of these products as biological indicator process challenge devices and do not raise new questions of safety and effectiveness.

# 5. Comparison of Technological Characteristics with the Predicate Device

The submission challenge pack consists of a clear plastic shell and a tortuous channel connected to a cavity in the shell containing the monitoring products, all heat sealed with a foil lid. The predicate challenge pack consists of a reusable aluminum tube with a removable aluminum plug to allow loading of a single use assembly, containing the indicators, and a tortuous path challenge for air removal and steam penetration at the other sealed end. Both the submission and predicate challenge pack are designed to increase the resistance beyond that measured with a standalone biological indicator and both represent a challenge to the sterilization process equivalent to the AAMI reference PCD. Both the submission challenge pack and the predicate challenge pack contain a Biological Indicator (BI) that has been verified to qualify or monitor dynamic-air-removal steam sterilization cycles and both utilize a fluorescent result to indicate a steam sterilization process failure. Both the submission challenge pack and the predicate challenge pack contain a Chemical Indicator (CT) that are able to independently monitor and react to all critical parameters of the intended steam sterilization cycles. The process indicator present on the cap of the BI is visible through the clear plastic shell of the submission challenge pack whereas the chemical indicator is visible through the clear plastic sleeve assembly of the predicate challenge pack. Both the submission and predicate challenge pack contain a visible indicator that changes color upon steam exposure that is used by the customer to distinguish processed and unprocessed challenge packs. Both the submission challenge pack and the predicate challenge pack utilize a Biological Indicator which is intended to be used in conjunction with an incubator/reader to indicate a steam sterilization process failure.

The differences in technological characteristics between the submission and predicate challenge pack are illustrated in the Device Technological Characteristics Comparison Table (Table 1).

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| Feature | Submission Device:<br>(K243501)<br>3MTM AttestTM<br>Super Rapid Steam<br>Extended Cycle Clear<br>Challenge Pack<br>1492PCDE and<br>3MTM AttestTM Auto-<br>reader 490 and 490H and<br>3MTM AttestTM Mini<br>Auto-reader 490M | Predicate Device:<br>(K182931)<br>VERIFY All-In-One<br>STEAM Reusable Test<br>Pack employing the<br>Celerity™ Xtend 10<br>Assembly | Comparison |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Single Use biological<br>indicator process challenge<br>device | Single Use biological<br>indicator process challenge<br>device | Identical |
| Indications for use | Use the 3MTM AttestTM<br>Super Rapid Steam<br>Extended Cycle Clear<br>Challenge Pack<br>1492PCDE in conjunction<br>with the 3MTM AttestTM<br>Auto-reader 490, the<br>3MTM AttestTM Auto-<br>reader 490H having<br>software version 4.0.0 or<br>greater, or the 3MTM<br>AttestTM Mini Auto-reader<br>490M to qualify or<br>monitor the following<br>steam sterilization cycle:<br>• Dynamic-air-<br>removal, 270°F<br>(132°C), 10<br>minutes | The VERIFY All-In-One<br>STEAM Reusable Test<br>Pack employing the<br>Celerity Xtend 10<br>Assembly with a Celerity<br>20 STEAM Biological<br>Indicator and a Celerity 10<br>STEAM Chemical<br>Indicator can be used for<br>routine monitoring of 10-<br>minute 270°F/132°C<br>dynamic air removal steam<br>sterilization cycles. The<br>sleeve assembly is intended<br>to be used only with the<br>VERIFY All-In-One<br>STEAM Reusable Test<br>Pack. | The Indications for Use are<br>similar in that the subject<br>device and predicate device<br>are used to monitor 10-<br>minute 270°F/132°C<br>dynamic-air-removal steam<br>sterilization cycles.<br>The subject challenge pack<br>is intended to be used in<br>conjunction with the 3MTM<br>AttestTM Auto-readers 490<br>and 490H and the 3MTM<br>AttestTM Mini Auto-reader<br>490M. The 1492V BI<br>contained in the subject<br>challenge pack was cleared<br>for use with the Auto-<br>readers per K241710. |
| General<br>Design/Construction | Clear plastic tray with a<br>tortuous channel to the<br>cavity containing the<br>indicators, acting as a<br>challenge to limit air<br>removal and steam<br>penetration, sealed with a<br>foil lid. | The VERIFY All-in-One<br>STEAM Reusable Test<br>Pack consists of a reusable<br>aluminum tube with a<br>removable aluminum plug<br>to allow loading of the<br>Celerity Xtend 10<br>Assembly, containing the<br>indicators, and a tortuous<br>path challenge for air<br>removal and steam<br>penetration at the other<br>sealed end. | Both the subject challenge<br>pack and the predicate<br>challenge pack consist of a<br>BI and CI and are designed<br>and constructed with a<br>tortuous path to challenge<br>air removal and steam<br>penetration.<br>The subject challenge pack<br>is a single-use test pack. |
| Biological Indicator | 3MTM AttestTM Super<br>Rapid Readout Biological<br>Indicator 1492V with ≥ 1 | Celerity 20 STEAM<br>Biological Indicator with<br>1.0 – 4.0 x 106 <i>Geobacillus<br/>stearothermophilus</i> spores | Both the subject device and<br>the predicate device utilize<br>Self-Contained Biological<br>Indicators with ≥106 |
| Feature | Submission Device:<br>(K243501)<br>3MTM AttestTM<br>Super Rapid Steam<br>Extended Cycle Clear<br>Challenge Pack<br>1492PCDE and<br>3MTM AttestTM Auto-<br>reader 490 and 490H and<br>3MTM AttestTM Mini<br>Auto-reader 490M | Predicate Device:<br>(K182931)<br>VERIFY All-In-One<br>STEAM Reusable Test<br>Pack employing the<br>CelerityTM Xtend 10<br>Assembly | Comparison |
| | x 106 <i>Geobacillus</i><br><i>stearothermophilus</i> spores | | <i>Geobacillus</i><br><i>stearothermophilus</i> spores |
| Biological Indicator -<br>Resistance<br>Characteristics<br>• D value | D-value ≥ 10 seconds at<br>132°C<br>D-value ≥ 8 seconds at<br>134°C<br>D-value ≥ 8 seconds at<br>135°C | D121≥ 1.5 min<br>D132 ≥ 10s<br>D135 ≥ 8s | Similar, both BIs are<br>characterized with<br>Resistance Characteristics<br>(D-value and Survival/Kill)<br>that meet FDA and ISO<br>requirements. |
| Biological Indicator -<br>Resistance<br>Characteristics<br>• Survival/Kill | Survival Time =<br>Calculated survival time*<br>or 1 minute at 132°C and<br>40 seconds at 134°C and<br>135°C, whichever is<br>longer<br>Kill Time = Calculated kill<br>time* at 132°C, 134°C and<br>at 135°C | Survival Time – Meets the<br>longer of FDA and ISO<br>11138-3 requirements<br>Kill Time – Meets the<br>shorter of FDA and ISO<br>11138-3 requirements | |
| Biological Indicator<br>Incubation<br>temperature | 60 ± 2°C | 55-60°C | Similar, both the subject<br>device and the predicate<br>device contain a BI that has |
| Biological Indicator -<br>Readout time | 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 or in a 490M Auto-<br>reader.<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<br>for 490, 490H or 490M<br>Auto-readers. | 20 minute final fluorescent<br>result in CelerityTM Steam<br>Incubator. | been verified to qualify or<br>monitor dynamic-air-<br>removal steam sterilization<br>cycles.<br>The subject device has<br>different readout times than<br>the predicate device. |
| Feature | Submission Device:<br>(K243501)<br>3MTM Attest™<br>Super Rapid Steam<br>Extended Cycle Clear<br>Challenge Pack<br>1492PCDE and<br>3MTM Attest™ Auto-reader 490 and 490H and<br>3MTM Attest™ Mini Auto-reader 490M | Predicate Device:<br>(K182931)<br>VERIFY All-In-One<br>STEAM Reusable Test<br>Pack employing the<br>Celerity™ Xtend 10<br>Assembly | Comparison |
| Biological Indicator - Mechanism of Action | When the enzyme that is naturally occurring in the spore is in its active state, it is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non- fluorescent substrate. The resultant fluorescent by- product is detected by the Auto-reader. The presence of fluorescence upon incubation in the Auto-reader indicates a sterilization process failure. There is an optional visual pH color change which indicates a steam sterilization process failure. | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety | Similar, both the subject device and the predicate device utilize a fluorescent result. The subject device also utilizes an optional visual pH color change. |
| Chemical Indicator | 3MTM Attest™ Steam Chemical Integrator | Celerity 10 STEAM Chemical Indicator | The chemical indicators in the subject challenge pack |
| Chemical Indicator - Color Change | Dark color migrates along strip visible through a green window (ACCEPT) or red window (REJECT) | The Celerity 10 STEAM Chemical Indicator indicates a pass by a color change of yellow to blue/purple or a fail indicated by no color change or an incomplete color change. | and predicate challenge pack are able to independently monitor and react to all critical parameters of the intended sterilization cycle.<br>The CI in the subject device is a Type 5 moving front integrator whereas the CI in the predicate device is a Type 6 emulating indicator. |
| 3M™ Attest™ Mini Auto-reader 490M | | | |
| | Submission Device:<br>(K243501) | Predicate Device:<br>(K182931) | |
| Feature | 3M™ Attest™<br>Super Rapid Steam<br>Extended Cycle Clear<br>Challenge Pack<br>1492PCDE and<br>3M™ Attest™ Auto-<br>reader 490 and 490H and<br>3M™ Attest™ Mini<br>Auto-reader 490M | VERIFY All-In-One<br>STEAM Reusable Test<br>Pack employing the<br>Celerity™ Xtend 10<br>Assembly | Comparison |
| Mechanism to<br>distinguish processed and<br>unprocessed challenge<br>pack | Process indicator present<br>on 1492V BI cap is<br>visible through PCD and<br>turns color from pink to<br>light brown or darker<br>upon steam exposure. | The Celerity 10 STEAM<br>Chemical Indicator can be<br>evaluated for a pass or fail<br>prior to opening the assembly.<br>A change in color from<br>yellow to blue/purple<br>indicates a pass. | Both the subject and<br>predicate device contain an<br>indicator that changes color<br>upon exposure to steam that<br>is used by the customer to<br>verify the challenge pack<br>was exposed to steam. |
| Accessories | 3M™ Attest™ Auto-<br>reader 490 or the<br>3M™Attest™ Auto-<br>reader 490H or the 3M™<br>Attest™ Mini Auto-reader | Celerity STEAM<br>Incubator/reader | Similar, both the subject<br>device and the predicate<br>device utilize a BI which is<br>intended to be used in<br>conjunction with an<br>incubator/reader |

#### Table 1: Device Technological Characteristics Comparison Table

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# TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3M™ Attest™ Auto-readers 490 and 490H

3MTM Attest™ Mini Auto-reader 490M

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## TRADITIONAL PREMARKET NOTIFICATION [510(k)]

#### 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M

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## TRADITIONAL PREMARKET NOTIFICATION [510(k)]

#### 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M

* per ISO 11138-1:2017, Annex E

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#### 6. Nonclinical Comparison to the Predicate Device

The differences between the submission and predicate device have been evaluated through performance tests for the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE.

Three lots of 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, containing three lots of 1492V BIs and three lots of 1243R Cls, were tested side by side with standalone indicators 1492V BIs and 1243R CIs. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007.

Three lots of 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, containing three lots of 1492V BIs and three lots of 1243R Cls, were tested side by side with the AAMI 16 Towel PCD containing 1492V BIs and 1243R Cls. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510/k)] Submissions, October 4, 2007, and ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

Three lots of 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE were tested for peel force of the heat seal foil lid from the plastic shell. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids.

| Test<br>Performed | Device<br>Description | Applicable<br>Standards | Purpose | Acceptance<br>Criteria | Results |
|---------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Resistance of<br>1492PCDE<br>Challenge<br>Pack<br>compared to<br>AAMI 16<br>Towel PCD<br>in claimed<br>cycles | 1492PCDE<br>Challenge Pack | FDA Guidance¹<br>and ANSI/AAMI<br>ST79:2017,<br>Comprehensive<br>guide to steam<br>sterilization and<br>sterility assurance<br>in health care<br>facilities | Demonstrate<br>the<br>performance<br>of the<br>1492PCDE<br>Challenge<br>Pack is<br>equivalent to<br>the<br>performance<br>of the AAMI<br>16 Towel PCD<br>in the claimed<br>cycles | Indicators<br>contained in the<br>1492PCDE<br>Challenge Pack<br>must<br>demonstrate<br>equivalent<br>resistance as<br>compared to the<br>indicators<br>contained in the<br>AAMI 16 Towel<br>PCD in the<br>claimed cycles | Acceptance<br>criteria met |
| Resistance of<br>1492PCDE<br>Challenge | 1492PCDE<br>Challenge Pack | FDA Guidance¹ | Demonstrate<br>the 1492PCDE<br>Challenge | Indicators<br>contained in the<br>1492PCDE | Acceptance<br>criteria met |

Performance of the 1492PCDE challenge pack was verified through the following tests:

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## TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M

| Test<br>Performed | Device<br>Description | Applicable<br>Standards | Purpose | Acceptance<br>Criteria | Results |
|-------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Pack<br>compared to<br>standalone<br>indicators in<br>claimed<br>cycles | | | Pack provides<br>a greater<br>challenge than<br>the standalone<br>indicators in<br>the claimed<br>cycles | Challenge Pack<br>must<br>demonstrate<br>greater resistance<br>compared to the<br>standalone<br>indicators in the<br>claimed cycles | |
| 1492PCDE<br>Peel Force | 1492PCDE<br>Challenge Pack | ASTM F88 /<br>F88M-15:<br>Standard Test<br>Method for Seal<br>Strength of<br>Flexible Barrier<br>and ASTM F2824<br>– 10: Standard Test<br>Method for<br>Mechanical Seal<br>Strength Testing<br>for Round Cups<br>and Bowl<br>Containers with<br>Flexible Peelable<br>Lids | Demonstrate<br>acceptable<br>peel force of<br>Clear<br>Challenge<br>Pack<br>1492PCDE<br>heat seal foil<br>lid from plastic<br>shell | ≥30.2 lbf | Acceptance<br>criteria met |

1 FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007

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# 7. Clinical Comparison to the Predicate Device

Clinical testing was not required or completed for the submission device.

#### 8. Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the submission device, the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, the 3M™ Attest™ Auto-reader 490, the 3MTM Attest™ Autoreader 490H, and the 3MTM Attest™ Mini Auto-reader 490M, is as safe, as effective and performs as well as or better than the legally marketed predicate device, the VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly (cleared per K182931) Class II (21 CFR 880.2800), product code FRC.