MicroMatrix® 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 (donor sites/grafts, post-Mohs 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 a resorbable, porcine-derived, extracellular matrix scaffold containing epithelial basement membrane, specifically known as Urinary Bladder Matrix ("UBM"). The devices are supplied as a dry, absorbent, white to off-white particulate with two particle distributions, specifically <500um and <1000µm. The particulate is packaged in an amber glass vial with butyl stopper and crimp sealed. The device vial is then packaged in a peel-open outer pouch that is terminally sterilized using electron beam irradiation. 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 sheet based extracellular matrix derived scaffolds indicated for wound management. MicroMatrix is composed of resorbable extracellular matrix particles comprised of UBM. Submitted in vitro and in vivo studies suggest that the product will be sloughed from the skin during the normal wound healing process or will be incorporated (remodeled) into the wound bed via enzymatic degradation, cellular infiltration, capillary growth, and/or integration by the surrounding host tissue. The device is intended for one time use.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called MicroMatrix®. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain the specific detailed information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert details for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sample sizes and ground truth methods.

This document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with detailed acceptance criteria and results. The "PERFORMANCE DATA" section states: "Packaging validation, LAL endotoxin, and shelf life studies were submitted in support of the modifications to MicroMatrix® described in this 510(k)." This indicates that performance data related to these specific aspects were provided, but the document does not elaborate on their acceptance criteria or detailed results in a format that would fulfill the request.

Therefore, I cannot provide the requested information from the given text.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 6, 2017 ACell, Inc. % Mr. John Smith Hogan Lovells 555 Thirteenth Street., NW Washington, District of Columbia 20004

Re: K172399

Trade/Device Name: MicroMatrix Regulatory Class: Unclassified Product Code: KGN Dated: August 8, 2017 Received: August 8, 2017

Dear Mr. Smith:

We have reviewed vour 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, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract hability 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely. Jennifer R. Stevenson -ਟਤ 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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510(k) Number (if known)

K172399

Device Name

MicroMatrix®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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K172399

510(k) SUMMARY

Date Prepared:	September 27, 2017
Manufacturer Name:
Submitted by:	ACell, Inc.6640 Eli Whitney DriveColumbia, MD 21046
Contact Person:	Salman ElmiVice President & Deputy General Counsel; Head ofRegulatory AffairsACell, Inc.Phone: (410) 953-8500Email: salelmi@acell.comFax: (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 Primary Predicate Device:Cook Biotech Inc. Cook® ECM Powder (K152033)Reference Devices:ACell Inc. MicroMatrix® (K153754)ACell Inc. Cytal™ Wound Matrix (K152721)

DEVICE DESCRIPTION

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extracellular matrix particles comprised of UBM. Submitted in vitro and in vivo studies suggest that the product will be sloughed from the skin during the normal wound healing process or will be incorporated (remodeled) into the wound bed via enzymatic degradation, cellular infiltration, capillary growth, and/or integration by the surrounding host tissue. The device is intended for one time use.

INDICATIONS FOR USE

MicroMatrix® 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, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

PERFORMANCE DATA

Packaging validation, LAL endotoxin, and shelf life studies were submitted in support of the modifications to MicroMatrix® described in this 510(k).

COMPARISON TO PREDICATE DEVICE

MicroMatrix® has the same intended use and indications for use as the predicate device. The technological characteristics of MicroMatrix® are unchanged from the previously cleared MicroMatrix® device (K153754) and substantially equivalent to the predicate in that both devices are comprised of porcine-derived, collagen extracellular matrix (ECM) scaffolds. Further, both the subject and predicate devices are particulate forms of FDA cleared extracellular matrix sheets, (Cytal® Wound Matrix and Oasis® Wound Matrix respectively) that are also intended for wound management. The subject and predicate devices are packaged and terminally sterilized. The minor differences between MicroMatrix® and the identified predicate do not raise different questions of safety or efficacy.

CONCLUSION

Based on testing and comparison to the predicate device. 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.

Regulation Number and Section

N/A