Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow systems:

STERRAD 100S® Sterilization System,

STERRAD NX® Sterilization System (Standard and Advanced cycles),

STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles),

STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles), STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles),

V-PRO® 1 Low Temperature Sterilization System (Lumen cycle),

V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles),

V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cvcles),

V-PRO® 60 Low Temperature Sterilization System (Lumen, and Flexible cycles),

V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles),

V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) SteroScope® Sterilization System

Device Description

The 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD is designed as a standard method of rapid and reliable routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes.

The 1295PCD Challenge Pack consists of a clear plastic shell, with two individual channels allowing for air removal and sterilant penetration. Those two individual channels connect to a cavity containing the monitoring products and all are covered by a foil lid. The 1295PCD is a single-use device.

Each 1295PCD Challenge Pack contains a 3M™ Attest™ Rapid Readout Biological Indicator (BI) 1295 (pink cap) and a 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (CI) 1348. The 1348 CI verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved and offers an ACCEPT or REJECT reading. The 1295 BI is specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3MTM Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H. The presence of fluorescence within the specified incubation time for the 1295 BI in the 490, 490M, or the 490H Auto-reader indicates a sterilization process failure. A printed chemical process indicator is present on the cap of the 1295 BI and is visible through the clear plastic shell of the challenge pack. The process indicator turns color upon exposure to vaporized hydrogen peroxide and is used by the customer to verify that the challenge pack was exposed to vaporized hydrogen peroxide.

AI/ML Overview

The document describes the non-clinical testing performed to determine the performance of the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD. This device is a sterilization biological indicator used for routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes. The study's focus was to demonstrate performance in a newly claimed sterilizer, the SteroScope® Sterilization System, as the submission device is otherwise identical to a previously cleared predicate device (K233814).

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Test Name	Purpose	Acceptance Criteria	Reported Device Performance
Full Cycle Performance	Verify performance in the full normal cycle of a loaded SteroScope® Sterilization System.	Chemical Indicator will change color in the ACCEPT region of the indicator window to a b* value equal to or greater than -18 (PASS)	Pass
		Biological Indicator will result in 100% fluorescence NEGATIVE response	Pass
Incomplete Cycle Performance	Verify performance in an incomplete normal cycle of a loaded SteroScope® Sterilization System.	Chemical Indicator will change color in the ACCEPT region of the indicator window to a b* value less than -20 (FAIL)	Pass
		Biological Indicator will result in 100% fluorescence POSITIVE response	Pass

Study Details

Sample sizes used for the test set and the data provenance: The document does not explicitly state the specific number of units (sample size) used for each test (Full Cycle Performance and Incomplete Cycle Performance). It only indicates that "nonclinical testing was performed." The data provenance is nonclinical testing conducted by the manufacturer (3M Company), specifically for the purpose of this 510(k) submission, and appears to be prospective testing for the additional indication. The country of origin of the data is not specified, but the submission is to the U.S. FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. For this type of device (sterilization biological indicator), "ground truth" is typically established by the physical and chemical parameters of the sterilization process itself, rather than human expert interpretation of images or data. The "ground truth" is whether the sterilization cycle was successful or failed based on controlled conditions.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The "readout" of the biological indicator (fluorescence positive/negative) and chemical indicator (color change/b* value) are direct measurements/observations, not subject to human adjudication in the typical sense of medical imaging interpretation.
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 device is a physical indicator for sterilization, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance is inherently "standalone" in function, as it is a physical indicator reacting to a sterilization process. The interpretation of the results from the biological indicator is done by an auto-reader (3M™ Attest™ Auto-reader 490, 490M, or 490H), which provides a definitive "positive" or "negative" fluorescent response. The chemical indicator also provides a direct visual result. There is no "algorithm only" performance that would be separate from the physical functioning of the device and its dedicated reader.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance is based on the controlled efficacy of the sterilization process. "Full cycle" conditions represent a successful sterilization based on established standards, intending for the BI to show no growth/negative fluorescence and the CI to show an "ACCEPT" result. "Incomplete cycle" conditions represent a failed sterilization, intending for the BI to show growth/positive fluorescence and the CI to show a "FAIL" result. This is a form of empirical validation against defined physical and biological outcomes under controlled laboratory conditions, rather than expert consensus or pathology on patient data.
The sample size for the training set: Not applicable and not mentioned. This is a physical device, a biological and chemical indicator, not an AI/machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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

June 27, 2024

3M Company Samantha Miller Regulatory Affairs Associate 3M Center 2510 Conway Avenue, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K241542

Trade/Device Name: 3MTM Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 30, 2024 Received: May 31, 2024

Dear Samantha Miller:

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.

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"

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(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 (QS) 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 OS 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.

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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Christopher K. Dugard -S

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

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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

Submission Number (if known)

K241542

Device Name

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)

Indications for Use (Describe)

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD): Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow systems: