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 luorescent result at 24 minutes.

Device Description

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 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.

AI/ML Overview

The provided document does not describe a study involving an AI/software as a medical device (SaMD). Instead, it details a 510(k) premarket notification for a sterilization process indicator system (3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, 3M™ Attest™ Auto-reader 490, 3M™ Attest™ Auto-reader 490H, 3M™ Attest™ Mini Autoreader 490M).

Therefore, many of the requested elements pertaining to AI/SaMD studies (e.g., test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and are not present in the document.

However, I can extract the relevant acceptance criteria and study information for this medical device as described in the document.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: 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. This system is a sterilization process indicator, not an AI or imaging device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Resistance of 1492PCDE Challenge Pack compared to AAMI 16 Towel PCD in claimed cycles	Indicators contained in the 1492PCDE Challenge Pack must demonstrate equivalent resistance as compared to the indicators contained in the AAMI 16 Towel PCD in the claimed cycles.	Acceptance criteria met
Resistance of 1492PCDE Challenge Pack compared to standalone indicators in claimed cycles	Indicators contained in the 1492PCDE Challenge Pack must demonstrate greater resistance compared to the standalone indicators in the claimed cycles.	Acceptance criteria met
1492PCDE Peel Force (of the heat seal foil lid from the plastic shell)	≥30.2 lbf (This criterion is explicitly stated but the unit of measurement "lbf" is inferred from the context of "peel force" and likely means "pounds-force". However, the document does not explicitly define "lbf" in relation to the "30.2 lbf" value)	Acceptance criteria met

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Resistance testing: "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 CIs, were tested side by side..." This refers to three manufacturing lots of the complete challenge pack, each containing BIs and CIs.
- Peel Force: "Three lots of 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE were tested for peel force..."
Data Provenance: The document does not specify the country of origin of the data. The tests are described as "nonclinical" and are laboratory/bench tests, not patient data. It is inherently "prospective" in that these are tests conducted to evaluate the performance of newly manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not Applicable. This is a hardware/chemical/biological indicator device. The "ground truth" for its function relies on physical and biological principles of sterilization effectiveness (e.g., growth or no growth of spores after sterilization, chemical indicator color change) and engineered peel strength, not expert interpretation of complex data like medical images.

4. Adjudication Method for the Test Set:

Not Applicable. See point 3. Testing is objective based on measurable outcomes (e.g., spore growth, resistance time, peel force), not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is not an AI-assisted diagnostic or interpretive device. No human readers or AI assistance are involved in its primary function for evaluating sterilization.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical device and biological indicator system, not an algorithm. The "auto-readers" interpret fluorescence from the biological indicators, which is an automated process, but it's part of the device's inherent function, not an AI or standalone algorithm as generally understood in the context of SaMD.

7. The Type of Ground Truth Used:

The ground truth is based on:
- Biological Indicator (BI) performance: Growth or no growth of Geobacillus stearothermophilus spores after exposure to sterilization cycles, as read by the auto-readers. This is the definitive biological validation of sterilization.
- Chemical Indicator (CI) performance: Color change (ACCEPT/REJECT) indicating exposure to critical sterilization parameters.
- Physical Strength (Peel Force): Mechanical measurement of the force required to peel the lid.
- Comparison to AAMI 16 Towel PCD: A recognized standard challenge device for sterilization.

8. The Sample Size for the Training Set:

Not Applicable. This is not a machine learning or AI device that requires a "training set" in the context of software development.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. See point 8.

Summary

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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

3MTM AttestTM Auto-reader 490:

3MTM AttestTM Auto-reader 490H:

3MTM AttestTM Mini Auto-reader 490M:

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: (651) 394-8173 Fax Number: (651) 737-5320 Email: mmlarsen@solventum.com

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 ClearChallenge Pack 1492PCDE,3MTM AttestTM Auto-reader 490,3MTM AttestTM Auto-reader 490H,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:

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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:

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:(K243501)3MTM AttestTMSuper Rapid SteamExtended Cycle ClearChallenge Pack1492PCDE and3MTM AttestTM Auto-reader 490 and 490H and3MTM AttestTM MiniAuto-reader 490M	Predicate Device:(K182931)VERIFY All-In-OneSTEAM Reusable TestPack employing theCelerity™ Xtend 10Assembly	Comparison
Intended Use	Single Use biologicalindicator process challengedevice	Single Use biologicalindicator process challengedevice	Identical
Indications for use	Use the 3MTM AttestTMSuper Rapid SteamExtended Cycle ClearChallenge Pack1492PCDE in conjunctionwith the 3MTM AttestTMAuto-reader 490, the3MTM AttestTM Auto-reader 490H havingsoftware version 4.0.0 orgreater, or the 3MTMAttestTM Mini Auto-reader490M to qualify ormonitor the followingsteam sterilization cycle:• Dynamic-air-removal, 270°F(132°C), 10minutes	The VERIFY All-In-OneSTEAM Reusable TestPack employing theCelerity Xtend 10Assembly with a Celerity20 STEAM BiologicalIndicator and a Celerity 10STEAM ChemicalIndicator can be used forroutine monitoring of 10-minute 270°F/132°Cdynamic air removal steamsterilization cycles. Thesleeve assembly is intendedto be used only with theVERIFY All-In-OneSTEAM Reusable TestPack.	The Indications for Use aresimilar in that the subjectdevice and predicate deviceare used to monitor 10-minute 270°F/132°Cdynamic-air-removal steamsterilization cycles.The subject challenge packis intended to be used inconjunction with the 3MTMAttestTM Auto-readers 490and 490H and the 3MTMAttestTM Mini Auto-reader490M. The 1492V BIcontained in the subjectchallenge pack was clearedfor use with the Auto-readers per K241710.
GeneralDesign/Construction	Clear plastic tray with atortuous channel to thecavity containing theindicators, acting as achallenge to limit airremoval and steampenetration, sealed with afoil lid.	The VERIFY All-in-OneSTEAM Reusable TestPack consists of a reusablealuminum tube with aremovable aluminum plugto allow loading of theCelerity Xtend 10Assembly, containing theindicators, and a tortuouspath challenge for airremoval and steampenetration at the othersealed end.	Both the subject challengepack and the predicatechallenge pack consist of aBI and CI and are designedand constructed with atortuous path to challengeair removal and steampenetration.The subject challenge packis a single-use test pack.
Biological Indicator	3MTM AttestTM SuperRapid Readout BiologicalIndicator 1492V with ≥ 1	Celerity 20 STEAMBiological Indicator with1.0 – 4.0 x 106 Geobacillusstearothermophilus spores	Both the subject device andthe predicate device utilizeSelf-Contained BiologicalIndicators with ≥106
Feature	Submission Device:(K243501)3MTM AttestTMSuper Rapid SteamExtended Cycle ClearChallenge Pack1492PCDE and3MTM AttestTM Auto-reader 490 and 490H and3MTM AttestTM MiniAuto-reader 490M	Predicate Device:(K182931)VERIFY All-In-OneSTEAM Reusable TestPack employing theCelerityTM Xtend 10Assembly	Comparison
	x 106 Geobacillusstearothermophilus spores		Geobacillusstearothermophilus spores
Biological Indicator -ResistanceCharacteristics• D value	D-value ≥ 10 seconds at132°CD-value ≥ 8 seconds at134°CD-value ≥ 8 seconds at135°C	D121≥ 1.5 minD132 ≥ 10sD135 ≥ 8s	Similar, both BIs arecharacterized withResistance Characteristics(D-value and Survival/Kill)that meet FDA and ISOrequirements.
Biological Indicator -ResistanceCharacteristics• Survival/Kill	Survival Time =Calculated survival timeor 1 minute at 132°C and40 seconds at 134°C and135°C, whichever islongerKill Time = Calculated killtime at 132°C, 134°C andat 135°C	Survival Time – Meets thelonger of FDA and ISO11138-3 requirementsKill Time – Meets theshorter of FDA and ISO11138-3 requirements
Biological IndicatorIncubationtemperature	60 ± 2°C	55-60°C	Similar, both the subjectdevice and the predicatedevice contain a BI that has
Biological Indicator -Readout time	24 minute final fluorescentresult in both the 490 and490H Auto-readers havingsoftware version 4.0.0 orgreater or in a 490M Auto-reader.1 hour final fluorescentresult in 490 Auto-readershaving software versionsless than 4.0.0.Optional visual pH colorchange result in 48 hoursfor 490, 490H or 490MAuto-readers.	20 minute final fluorescentresult in CelerityTM SteamIncubator.	been verified to qualify ormonitor dynamic-air-removal steam sterilizationcycles.The subject device hasdifferent readout times thanthe predicate device.
Feature	Submission Device:(K243501)3MTM Attest™Super Rapid SteamExtended Cycle ClearChallenge Pack1492PCDE and3MTM Attest™ Auto-reader 490 and 490H and3MTM Attest™ Mini Auto-reader 490M	Predicate Device:(K182931)VERIFY All-In-OneSTEAM Reusable TestPack employing theCelerity™ Xtend 10Assembly	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.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:(K243501)	Predicate Device:(K182931)
Feature	3M™ Attest™Super Rapid SteamExtended Cycle ClearChallenge Pack1492PCDE and3M™ Attest™ Auto-reader 490 and 490H and3M™ Attest™ MiniAuto-reader 490M	VERIFY All-In-OneSTEAM Reusable TestPack employing theCelerity™ Xtend 10Assembly	Comparison
Mechanism todistinguish processed andunprocessed challengepack	Process indicator presenton 1492V BI cap isvisible through PCD andturns color from pink tolight brown or darkerupon steam exposure.	The Celerity 10 STEAMChemical Indicator can beevaluated for a pass or failprior to opening the assembly.A change in color fromyellow to blue/purpleindicates a pass.	Both the subject andpredicate device contain anindicator that changes colorupon exposure to steam thatis used by the customer toverify the challenge packwas exposed to steam.
Accessories	3M™ Attest™ Auto-reader 490 or the3M™Attest™ Auto-reader 490H or the 3M™Attest™ Mini Auto-reader	Celerity STEAMIncubator/reader	Similar, both the subjectdevice and the predicatedevice utilize a BI which isintended to be used inconjunction with anincubator/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.

TestPerformed	DeviceDescription	ApplicableStandards	Purpose	AcceptanceCriteria	Results
Resistance of1492PCDEChallengePackcompared toAAMI 16Towel PCDin claimedcycles	1492PCDEChallenge Pack	FDA Guidance¹and ANSI/AAMIST79:2017,Comprehensiveguide to steamsterilization andsterility assurancein health carefacilities	Demonstratetheperformanceof the1492PCDEChallengePack isequivalent totheperformanceof the AAMI16 Towel PCDin the claimedcycles	Indicatorscontained in the1492PCDEChallenge Packmustdemonstrateequivalentresistance ascompared to theindicatorscontained in theAAMI 16 TowelPCD in theclaimed cycles	Acceptancecriteria met
Resistance of1492PCDEChallenge	1492PCDEChallenge Pack	FDA Guidance¹	Demonstratethe 1492PCDEChallenge	Indicatorscontained in the1492PCDE	Acceptancecriteria 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

TestPerformed	DeviceDescription	ApplicableStandards	Purpose	AcceptanceCriteria	Results
Packcompared tostandaloneindicators inclaimedcycles			Pack providesa greaterchallenge thanthe standaloneindicators inthe claimedcycles	Challenge Packmustdemonstrategreater resistancecompared to thestandaloneindicators in theclaimed cycles
1492PCDEPeel Force	1492PCDEChallenge Pack	ASTM F88 /F88M-15:Standard TestMethod for SealStrength ofFlexible Barrierand ASTM F2824– 10: Standard TestMethod forMechanical SealStrength Testingfor Round Cupsand BowlContainers withFlexible PeelableLids	Demonstrateacceptablepeel force ofClearChallengePack1492PCDEheat seal foillid from plasticshell	≥30.2 lbf	Acceptancecriteria 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.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).