MATRISTEM WOUND MATRIX

K112409 · Acell, Inc. · KGN · Aug 29, 2011 · SU

Device Facts

• Record ID: K112409
• Device Name: MATRISTEM WOUND MATRIX
• Applicant: Acell, Inc.
• Product Code: KGN · SU
• Decision Date: Aug 29, 2011
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

MatriStem® Wound Matrix 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 Story

MatriStem® Wound Matrix is a sterile, porcine-derived, lyophilized extracellular matrix sheet. It functions as a wound dressing to maintain and support a healing environment for various wound types. The device is applied topically to the wound site by a healthcare professional. It is intended for one-time use. By providing a scaffold, it supports the natural healing process of the patient's tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and material characteristics compared to the predicate device.

Technological Characteristics

Sterile, porcine-derived, lyophilized extracellular matrix sheet. Device is a wound dressing. No performance standards established under Section 514.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites, grafts, post-Mohs/laser, podiatric, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds in patients requiring wound care.

Predicate Devices

• MatriStem® Wound Sheet (K092926)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for ACell, a regenerative medicine company. The logo features a cluster of seven teardrop-shaped cells on the left, followed by the text "ACell" in bold, sans-serif font. Below the text is the tagline "Healing Through Regenerative Medicine" in a smaller, italicized font. The logo is simple, clean, and professional, and it effectively communicates the company's focus on regenerative medicine.

AUG 2 9 2011

Toll Free: 800-826-2926 Phone: [phone] Fax: [phone] Website: www.acell.com

## 510(k) Summary

| Submitted by: | ACell, Inc.<br>6640 Eli Whitney Drive, Suite 200<br>Columbia, MD 21046 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Deborah Baker-Janis, M.S.E.E.<br>Senior Regulatory Affairs Specialist<br>Email: [e-mail]<br>Telephone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | August 19, 2011 |
| Trade Name:<br>Common Name:<br>Class/Product Code/Panel: | MatriStem® Wound Matrix<br>Animal-derived, extracellular matrix wound care product<br>Unclassified / KGN / General & Plastic Surgery |
| Predicate Device: | MatriStem® Wound Sheet (K092926) |
| Performance Standards: | No performance standards have been established under Section<br>514 of the Food, Drug, and Cosmetic Act applicable to this<br>device. |
| Device Description: | MatriStem® Wound Matrix is a sterile, porcine-derived,<br>naturally-occurring lyophilized extracellular matrix sheet that<br>maintains and supports a healing environment for wound<br>management. |
| Intended Use: | MatriStem® Wound Matrix is intended for the management of<br>wounds including: partial and full-thickness wounds, pressure<br>ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers,<br>tunnel/undermined wounds, surgical wounds (donor sites/grafts,<br>post-Mohs surgery, post-laser surgery, podiatric, wound<br>dehiscence), trauma wounds (abrasions, lacerations, second-<br>degree burns, and skin tears), and draining wounds. The device<br>is intended for one-time use. |
| Substantial Equivalence: | MatriStem® Wound Matrix is substantially equivalent to the<br>predicate device with respect to the indications for use, raw<br>material, dimensions and configuration, manufacturing<br>processes, packaging, sterilization, and shelf life. |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.

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

ACell, Inc. % Deborah Baker-Janis, M.S.E.E. Senior Regulatory Affairs Specialist 6640 Eli Whitney Drive, Suite 200 Columbia, Maryland 21046

AUG 2 9 2011

Re: K112409

Trade/Device Name: MatriStem® Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: August 19, 2011 Received: August 22, 2011

Dear Ms. Baker-Janis:

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, Or ug 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 (11) he 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

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Page 2 - Deborah Baker-Janis, M.S.E.E.

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as as a 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 100-1060.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its tolli me
1900) 638 0041 - 1901 700 700 1100 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/defaQlt.htm.

ge/MedicalDevices/ResourcesforFlowIndustry/delegator.htm

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K112409

Device Name:

MatriStem® Wound Matrix

## Indications for Use:

MatriStem® Wound Matrix 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.

Prescription Use__ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kune for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112409

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