Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on chemical and biological indicators and an auto-reader that detects fluorescence. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
This device is a sterility assurance product used to monitor and qualify sterilization processes, not to treat or diagnose patients.

Diagnostic

No
The device is used to monitor and qualify sterilization processes, not to diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components including a plastic shell, channels, a cavity, a foil lid, a biological indicator, and a chemical indicator. While it interacts with software in an auto-reader, the device itself is a physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is for "routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes." This is a quality control function for sterilization equipment, not a test performed on a biological sample from a patient to diagnose a condition or provide information for diagnosis.
Device Description: The device contains a biological indicator and a chemical indicator. These are used to assess the effectiveness of a sterilization process by challenging it with resistant organisms (in the BI) and monitoring critical parameters (in the CI). This is a process control, not a diagnostic test.
Lack of Biological Sample Testing: The device does not involve testing any biological samples (blood, urine, tissue, etc.) from a patient.
Performance Studies: The performance studies described are focused on the device's ability to indicate successful or unsuccessful sterilization cycles, not on its ability to diagnose a medical condition in a patient.

In summary, the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD is a sterilization process indicator, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FRC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical testing was performed in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, issued October 04, 2007, and ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products-Biological Indicators- Part 1: General requirements (FDA Recognition Number 14-502).

Test Name: Full Cycle Performance
Purpose: Verify performance in the full normal cycle of a loaded SteroScope® Sterilization System.
Acceptance Criteria: Chemical Indicator will change color in the ACCEPT region of the indicator window to a b* value equal to or greater than -18 (PASS); Biological Indicator will result in 100% florescence NEGATIVE response.
Result: Pass

Test Name: Incomplete Cycle Performance
Purpose: Verify performance in an incomplete normal cycle of a loaded SteroScope® Sterilization System.
Acceptance Criteria: Chemical Indicator will change color in the ACCEPT region of the indicator window to a b* value less than -20 (FAIL); Biological Indicator will result in 100% florescence POSITIVE response.
Result: Pass

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K233814

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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

3

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: