(35 days)
ACell® MatriStem® Wound Sheet is intended for the management of wounds including: partial and full-thickness 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, seconddegree burns, skin tears) and draining wounds. The device is intended for one-time use.
ACell® MatriStem® Wound Sheets are sterile, porcine-derived, lyophilized single or multi-layer extracellular matrix sheets available in various sizes with or without fenestrations or meshed.
This 510(k) submission (K092926) for the ACell® MatriStem® Wound Sheet does not contain acceptance criteria or study data demonstrating device performance against specific criteria.
Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (ACell® UBM Lyophilized Wound Dressing, K021637). The core argument is that the new device is "identical to the predicate device with respect to fundamental scientific technology, materials, processing and intended use." It explicitly states that "The addition of multiple layers and fenestrations/meshes do not raise new issues of safety and effectiveness."
Therefore, the requested information about acceptance criteria and study details is not available within this document. The FDA cleared this device based on its similarity to an already approved device, rather than requiring new performance studies against specific acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for "ACell", a company focused on regenerative medicine. The logo features a cluster of rounded shapes to the left, followed by the company name in bold, sans-serif font. Below the name, the tagline "Healing through Regenerative Medicine" is written in a cursive font.
ACell, Inc. 8671 Robert Fulton Drive, Ste. B Columbia, MD 21046 Toll Free: 800-826-2926 Phone: 410-715-1700 Fax: 410-715-4511 Website: www.acell.com
OCT 2 8 2009
510(k) Summary
Submitted by:
ACell, Inc. 8671 Robert Fulton Drive, Suite B Columbia, MD 21046
Contact Person:
Rodney W. Bosley, Sr. Vice President Phone: (410) 715-1700 Fax: (410) 715-4511
September 21, 2009 Date Prepared:
ACell® MatriStem® Wound Sheet Device Trade Name: Wound Dressing Common/Usual Name: Proposed Classification: Dressing, Wound, Collagen Unclassified, 79 KGN - General & Plastic Surgery
Device Description:
ACell® MatriStem® Wound Sheets are sterile, porcine-derived, lyophilized single or multi-layer extracellular matrix sheets available in various sizes with or without fenestrations or meshed.
Indications For Use:
ACcli® MatriStem® Wound Sheet is intended for the management of wounds including: partial and full-thickness 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, seconddegree burns, skin tears) and draining wounds. The device is intended for one-time use.
Predicate Device:
| 510(k) # | Device | Manufacturer |
|---|---|---|
| K021637 | ACell® UBM Lyophilized Wound Dressing | ACell, Inc. |
Substantial Equivalence:
ACell® MatriStem® Wound Sheets are identical to the predicate device with respect to fundamental scientific technology, materials, processing and intended use. The addition of multiple lavers and fenestrations/meshes do not raise new issues of safety and effectiveness. MatriStem® Wound Sheets are substantially equivalent to the legally marketed predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
ACell, Inc. % Mr. Rodney W. Bosley Sr. Vice President 8671 Robert Fulton Drive, Suite B Columiba, Maryland 21046
OCT 2 8 2009
Re: K092926
Trade/Device Name: ACell® MatriStem® Wound Sheet Regulatory Class: Unclassified Product Code: KGN Dated: September 21, 2009 Received: September 23, 2009
Dear Mr. Bosley:
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.
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 (reporting of medical device-related 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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Page 2 - Mr. Rodney W. Bosley
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/ucm115809.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/cdrh/mdr/ 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For
Mark N. Mello
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Qffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
KC92926 510(k) Number (if known):
Device Name:
ACell® MatriStem® Wound Sheet
Indications for Use:
ACell® MatriStem® Wound Sheet is intended for the management of wounds including: partial and full-thickness 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, seconddegree 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 Kucneka Mxr
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092926
N/A