ACELL UBM HYDRATED WOUND DRESSING

K022854 · Acell, Inc. · KGN · Dec 30, 2002 · SU

Device Facts

• Record ID: K022854
• Device Name: ACELL UBM HYDRATED WOUND DRESSING
• Applicant: Acell, Inc.
• Product Code: KGN · SU
• Decision Date: Dec 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The ACell UBM Hydrated Wound Dressing 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, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Device Story

ACell UBM Hydrated Wound Dressing is a sterile, single-use topical wound dressing composed of porcine collagen. It is applied to various wound types, including chronic ulcers, surgical wounds, and trauma wounds, to assist in wound management. The device is intended for use by healthcare professionals. It functions as a physical barrier and dressing to support the wound environment. No complex electronics or software are involved.

Clinical Evidence

Bench testing only. Biocompatibility and performance testing were conducted to assess the material; the device passed all requirements.

Technological Characteristics

Composed of porcine collagen. Supplied sterile in single sheet sizes ranging from 2 x 4 cm to 14 x 20 cm. Topical wound dressing form factor.

Indications for Use

Indicated for management of 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, second-degree burns, skin tears), and draining wounds.

Predicate Devices

• SIS Wound Dressing II (K993948)
• AcryDerm® Advanced Wound Dressing (K943781)

Submission Summary (Full Text)

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## DEC 3 0 2002

## 510(k) SUMMARY—ACell UBM Hydrated Wound Dressing

| Submitter Name: | ACell, Incorporated |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 10555 Guilford Road<br>Suite 113<br>Jessup, Maryland 20790 |
| Contact Person: | James R. DeFrancesco<br>Chief Executive Officer |
| Phone Number: | 410-715-1700 |
| Fax Number: | 301-317-0776 |
| Date Prepared: | August 15, 2002 |
| Device Trade Name: | ACell UBM Hydrated Wound Dressing |
| Device Common Name: | Topical Wound Dressing |
| Classification Name: | Bandage, Liquid (79KMF) |
| Predicate Devices: | K993948, Cook Biotech, Inc., SIS Wound Dressing II<br>K943781, AcryMed, Inc., AcryDerm® Advanced Wound Dressing |
| Device Description: | The ACell UBM Hydrated Wound Dressing is primarily composed of<br>porcine collagen and is supplied sterile in single sheet sizes ranging<br>from 2 x 4 cm to 14 x 20 cm |
| Intended Use: | The ACell UBM Hydrated Wound Dressing is intended for the<br>management of wounds including: partial and full-thickness wounds,<br>pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers,<br>tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-<br>Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma<br>wounds (abrasions, lacerations, second-degree burns, and skin tears),<br>and draining wounds. The device is intended for one-time use. |

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Sponsor: ACell, Inc. Traditional 510(k) Premarket Noti The ACell UBM Hydrated Wound Dressing was subjected to a number Discussion of tests of tests to assess the biocompatibility and the performance of the and test results. material. It passed the requirements of all tests and was shown to be safe and effective as a wound dressing. This device, with respect to material composition, device characteristics Conclusion: and intended use, is substantially equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

DEC 30 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ACell, Inc. c/o Patsy J. Trisler, J.D., RAC Senior Director, Medical Device Consulting PharmaNet, Inc. 815 Connecticut Avenue, NW, Suite 610 Washington, D.C. 20006

Re: K022854

Trade/Device Name: ACell UBM Hydrated Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: November 22, 2002 Received: November 25, 2002

Dear Ms. Trisler:

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 such 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): 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Patsy J. Trisler, J.D., RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally; for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

Hof Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Sponsor: ACell, Inc. .

K022854

Device Name:

ACell UBM Hydrated Wound Dressing

Indications for Use:

510(k) Number (if known):

The ACell UBM Hydrated Wound Dressing 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, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <b>X</b> |
|------------------------------------------|----------|
|------------------------------------------|----------|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)

Miriam C. Prevost

K022854

Section 4.0

00020

Section 4.0