ACELL POWDER WOUND DRESSING

K060888 · Acell, Inc. · KGN · Jun 23, 2006 · SU

Device Facts

• Record ID: K060888
• Device Name: ACELL POWDER WOUND DRESSING
• Applicant: Acell, Inc.
• Product Code: KGN · SU
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The ACell™ Powder Wound Dressing is intended for the management of topical 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 Powder Wound Dressing is a sterile, non-pyrogenic, lyophilized porcine collagen derived from urinary bladder matrix; supplied as an absorbent, white to off-white particulate. Intended for topical application to manage various wound types; applied by clinicians to the wound bed. Acts as a wound dressing to support management of partial and full-thickness wounds, ulcers, and surgical/trauma sites. Single-use device.

Clinical Evidence

No clinical data provided; substantial equivalence based on material composition and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Material: Porcine collagen from urinary bladder matrix. Form: Lyophilized, absorbent particulate. Sterilization: Sterile. Single-use. Non-pyrogenic.

Indications for Use

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

Predicate Devices

• ACell UBM Lyophilized Wound Dressing (K021637)
• Collagen Topical Wound Dressing (K030921)

Submission Summary (Full Text)

{0}------------------------------------------------

Applicant: ACell, Inc.

## 510(k) SUMMARY----------------------------------------------------------------------------------------------------------------------------------------------------------------

| Submitter Name: | ACell, Incorporated | JUN 2 3 2006 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter Address: | 10555 Guilford Road<br>Suite 113<br>Jessup, Maryland 20794 | |
| Contact Person: | James R. DeFrancesco<br>Chief Executive Officer | |
| Phone Number: | 410-715-1700 | |
| Fax Number: | 410-715-4511 | |
| Date Prepared: | March 31, 2006 | |
| Device Trade Name: | ACell™ Powder Wound Dressing | |
| Device Common Name: | Topical Wound Dressing | |
| Classification Number: | Unclassified, Pre-amendment | |
| Classification Name: | Dressing, Wound, Collagen | |
| Product Code: | KGN | |
| Predicate Devices: | K021637, ACell, Inc., ACell UBM Lyophilized Wound Dressing<br>K030921, Collagen Matrix, Inc., Collagen Topical Wound Dressing | |
| Statement of Intended<br>Use: | The ACell™ Powder Wound Dressing is intended for the<br>management of topical wounds including: partial and full-thickness<br>wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic<br>vascular ulcers, tunneled/undermined wounds, surgical wounds<br>(donor sites/grafts, post-Moh's surgery, post-laser surgery,<br>podiatric, wound dehiscence), trauma wounds (abrasions,<br>lacerations, second-degree burns, and skin tears), and draining<br>wounds. The device is intended for one-time use. | |
| Device Description: | The ACell™ Powder Wound Dressing is composed of porcine<br>collagen from urinary bladder matrix. It is an absorbent, white to<br>off-white, particulate that is lyophilized and to be used as a topical<br>application. The product is sterile, for single use and is non-<br>pyrogenic. | |
| Comparison to the<br>Predicate Devices: | This device, with respect to material composition, device<br>characteristics, and intended use, is substantially equivalent to the<br>predicate devices. | |

. - - - - - - - -

.

Page 1 of 1
Rev 060206

:

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). 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 AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

ACell, Incorporated c/o Patsy J. Trisler, J. D., RAC Regulatory Consultant 5600 Wisconsin Avenue, Suite 509 Chevy Chase, Maryland 20815

Re: K060888

Trade/Device Name: ACell Powder Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: June 2, 2006 Received: June 2, 2006

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

{2}------------------------------------------------

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

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark Melkerson

Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Applicant: ACell, Inc.

510(k) Number (if known):

K060888

Device Name:

ACell™ Powder Wound Dressing

Indications for Use:

The ACe!!™ Powder Wound Dressing is intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites), post-Moh's surgery, post-laser surgery, podiatric, wounds, Surgiou Wounds (don't sites/grafies, p lacerations second-degree burns, and skin tearly, 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 (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Lehman

(Posted November 13, 2003)

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number k060855

Section 4.0

Rev 060206