MicroMatrix® UBM Particulate is intended for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Device Description

The subject device is composed of a resorbable porcine-derived extracellular matrix (ECM) scaffolds, specifically known as urinary bladder matrix (UBM). MicroMatrix devices are supplied as a dry, absorbent, white to off-white particulate with two particle size distributions, specifically <500um and <1000um. The particulate is packaged in an amber glass vial with butyl stopper and crimp sealed, which is then packaged in a peel-open outer pouch. The device is terminally sterilized using electron beam irradiation and is intended for one-time use. MicroMatrix can be applied to a wound either in the dry state or pre-hydrated with sterile saline and can be used in conjunction with other extracellular matrix derived sheets indicated for wound management.

AI/ML Overview

The provided text is related to an FDA 510(k) premarket notification for a medical device called MicroMatrix® UBM Particulate. This notification is for a device (a medical product), not an AI algorithm.

Therefore, many of the requested categories related to acceptance criteria and studies for AI algorithms (such as sample size for test/training sets, data provenance, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on nonclinical testing (bench tests) and that no animal or clinical studies were required.

Here's a breakdown of what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document lists "Performance Bench Test Results" and states that for each test, the device "Meets Acceptance Criteria." It does not provide the specific numerical acceptance criteria themselves, only the conclusion that they were met.

Test	Performance
Hydrated Onset Temperature	Meets Acceptance Criteria
Particle Size Analysis	Meets Acceptance Criteria
Package Integrity - Visual Inspection	Meets Acceptance Criteria
Package Integrity - Bubble Leak	Meets Acceptance Criteria
Package Integrity - Seal Strength	Meets Acceptance Criteria

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for the bench tests. The document only states "All testing was performed on production equivalent devices."
Data Provenance: Not applicable/not specified. These are laboratory bench tests on physical devices, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for AI algorithms is not relevant for physical device bench testing. The "ground truth" here is the established test methodology and the specifications the device is designed to meet, verified by laboratory personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses in AI studies.

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 device is not an AI algorithm. No MRMC study was conducted.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of AI. For the bench tests, the "ground truth" relates to the predetermined specifications and standards that the device must meet, verified through objective measurements and observations in a laboratory setting. For example, particle size analysis would have a specified acceptable range, and the "ground truth" is whether the measured particle size falls within that range. Similarly, package integrity tests have defined parameters for success.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. This is not an AI algorithm.

Summary

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July 11, 2024

ACell, Inc Simone Abramczyk Senior Specialist, Regulatory Affairs 6640 Eli Whitney Dr. Suite 200 Columbia, Maryland 21046

Re: K241706

Trade/Device Name: MicroMatrix® UBM Particulate Regulatory Class: Unclassified Product Code: KGN Dated: June 9, 2024 Received: June 13, 2024

Dear Simone Abramczyk:

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.

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

Sincerely,

Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241706

Device Name

MicroMatrix® UBM Particulate

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter Information
Name and Address	ACell, Inc.6640 Eli Whitney Drive Ste. 200Columbia, MD 21046
Telephone number	(301) 789-5682
Primary Contact	Simone Abramczyk
Date Summary Prepared	July 9, 2024
Name of Device
Trade or Proprietary Name	MicroMatrix® UBM Particulate
Device Class	Unclassified
Product Code	KGN
Predicate Information
Predicate Device	MicroMatrix® UBM Particulate: K172399
Device Description

Indications for Use

MicroMatrix® UBM Particulate is intended for the management of wounds including: partial and fullthickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. The device is intended for one-time use.

Technological Characteristics Compared to Predicate

The subject device has the same intended use, design, materials, sterility, and fundamental operation as the predicate devices. The change to extend shelf life to three (3) years, increase in carton size, and addition of MR safe information to the labeling does not impact the technological characteristics of the devices.

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Summary of Nonclinical and Clinical Testing Performed

The following performance testing has been conducted in support of the substantial equivalence determination. The testing utilized well-established methods, including those from FDA consensus standards. All testing was performed on production equivalent devices.

Performance Bench Test Results

Test	Conclusion
Hydrated Onset Temperature	Meets Acceptance Criteria
Particle Size Analysis	Meets Acceptance Criteria
Package Integrity - Visual Inspection	Meets Acceptance Criteria
Package Integrity - Bubble Leak	Meets Acceptance Criteria
Package Integrity - Seal Strength	Meets Acceptance Criteria

Animal Studies

No animal studies were required as appropriate verification of the subject devices was achieved based on the comparison to the predicate devices and from the results of the bench testing and engineering analysis.

Clinical Studies

No clinical studies were required as appropriate verification of the subject devices was achieved based on the comparison to the predicate devices and from the results of the bench testing and engineering analysis.

Conclusion

Based on testing and comparison to the predicate device, MicroMatrix® UBM Particulate does not raise different questions of safety and effectiveness and the results support a determination of substantial equivalence through this 510(k) Premarket Notification.

Regulation Number and Section

N/A