MicroMatrix® is intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined 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

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

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the device MicroMatrix®. It outlines the device's indications for use and states its substantial equivalence to a predicate device.

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

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

The document does not explicitly state acceptance criteria in a table format with specific performance metrics such as sensitivity, specificity, accuracy, or other quantifiable measures typically associated with device performance in diagnostic or screening contexts. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

The "performance data" section primarily discusses biocompatibility testing and the support for labeling changes.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (as per ISO-10993-1) with 10X safety factor	Conducted for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, acute and subchronic toxicity, implantation, genotoxicity, and LAL endotoxin.
Hydration uptake for pre-hydration labeling	Supported by hydration uptake testing.
Support for use with other sheet-based ECM scaffolds	Supported by a retrospective review of published literature describing the clinical use of urinary bladder matrix devices in wound management.
No alteration to intended therapeutic effect or technological characteristics due to minor changes	Performance testing demonstrates comparable performance to predicates.
Does not raise different questions of safety or efficacy	No different questions of safety or efficacy raised by minor differences.

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

The document does not detail specific sample sizes for a "test set" in the context of clinical performance data for the MicroMatrix® itself. The "performance data" section mentions biocompatibility testing and a retrospective review of published literature.

Test set sample size: Not specified as a distinct clinical test set for performance metrics. Biocompatibility testing involved various in-vitro and in-vivo tests, but the specific number of samples or subjects is not provided.
Data provenance:
- Biocompatibility testing: Conducted according to ISO-10993-1. The location of these tests or the source of any in-vivo subjects is not specified.
- Literature review: Retrospective, for "published literature describing the clinical use of urinary bladder matrix devices in wound management." No country of origin is specified for this literature.

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)

This information is not provided. The document focuses on demonstrating substantial equivalence through biocompatibility testing and a literature review, not on a study involving expert-adjudicated ground truth for a clinical test set.

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

Not applicable. There is no mention of a clinical test set requiring adjudication in the context of expert consensus or interpretation.

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 document pertains to a medical device (wound dressing) and its regulatory clearance based on substantial equivalence, not an AI/CADe or CADx system that would typically involve human readers and MRMC studies.

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

Not applicable. This device is a physical wound dressing, not an algorithm.

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

For the "performance data" mentioned:

Biocompatibility: Ground truth is established by standardized testing protocols (ISO-10993-1) against defined endpoints (e.g., absence of cytotoxicity, sensitization, etc.).
Hydration uptake: Ground truth is established by physical measurements of hydration.
Clinical use with other scaffolds: Ground truth is derived from the "published literature describing the clinical use of urinary bladder matrix devices in wound management," which would encompass various types of clinical evidence including outcomes data, expert observations, etc., as documented in scientific publications.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or an algorithm that requires a training set.

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

Not applicable. There is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2016

ACell, Inc % Mr. John Smith Hogan Lovells 555 13th St., NW Washington, DC 20004

Re: K153754 Trade/Device Name: Micromatrix Regulatory Class: Unclassified Product Code: KGN Dated: February 19, 2016 Received: February 19, 2016

Dear Mr. Smith:

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 (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. 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153754

Device Name MicroMatrix®

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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510(k) SUMMARY

Date Prepared: March 10, 2016

Manufacturer Name: Submitted by:

ACell, Inc. 6640 Eli Whitney Drive Columbia, MD 21046

Contact Person:

Salman Elmi Vice President, Deputy General Counsel ACell, Inc. Phone: (410) 953-8500 Email: salelmi@acell.com Fax: (240) 465-8187

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	MicroMatrix®
Common/Usual Name:	Animal-derived, extracellular matrix wound care product
Regulation Name:	Collagen Wound Dressing
Device Class:	Unclassified
Product Code:	KGN
Reviewing Panel:	General & Plastic Surgery

PREDICATE DEVICE

Predicate Device: ACell Powder Wound Dressing (K060888)

DEVICE DESCRIPTION

Image /page/3/Picture/14 description: The image shows the logo for ACell. The logo consists of a cluster of seven teal circles arranged in a hexagonal pattern, followed by the text "ACell" in a bold, teal font. The text is slightly italicized, giving the logo a modern and dynamic appearance.

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INDICATIONS FOR USE

MicroMatrix® is intended for the management of topical wounds including: partial and fullthickness 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, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

PERFORMANCE DATA

Biocompatibility testing with a 10X safety factor in accordance with ISO-10993-1 (cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, acute and subchronic toxicity, implantation, genotoxicity, and LAL endotoxin) was conducted to support labeling changes to describe pre-hydration of MicroMatrix®, labeling changes to describe use of MicroMatrix® with other sheet based extracellular matrix derived scaffolds indicated for wound management, and the addition of a smaller particle size specification (<500 um). Labeling changes to describe pre-hydration of MicroMatrix® were also supported by hydration uptake testing. Labeling changes to describe use of MicroMatrix® with other sheet based extracellular matrix derived scaffolds indicated for wound management were also supported by a retrospective review of published literature describing the clinical use of urinary bladder matrix devices in wound management.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

MicroMatrix® has the same intended use as the predicate device, which is for management of wounds. The technological characteristics of the MicroMatrix® are substantially equivalent to the cleared predicate, as both are comprised of the same animal tissue-derived. collagen extracellular matrix (ECM) scaffolds that are packaged and terminally sterilized. The only minor differences between MicroMatrix® and the ACell Powder Wound Dressing predicate are the addition of a smaller particle size specification (<500 µm), and minor changes to the labeling to describe pre-hydration of MicroMatrix® and use of MicroMatrix® with other sheet based extracellular matrix derived scaffolds indicated for wound management. None of the changes alter the intended therapeutic effect of the device or its technological characteristics. The minor differences between the MicroMatrix® and the identified predicate do not raise different questions of safety or efficacy, and performance testing demonstrates that the device has comparable performance to the predicates.

CONCLUSION

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

Image /page/4/Picture/10 description: The image shows the logo for ACell. The logo consists of a cluster of teal-colored circles on the left, resembling a group of cells. To the right of the circles is the text "ACell" in a gray, sans-serif font, with the "ell" portion slightly smaller and raised.

Regulation Number and Section

N/A