(84 days)
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.
The ACell™ Powder Wound Dressing is composed of porcine collagen from urinary bladder matrix. It is an absorbent, white to off-white, particulate that is lyophilized and to be used as a topical application. The product is sterile, for single use and is non-pyrogenic.
The provided text is a 510(k) summary for the ACell™ Powder Wound Dressing, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical studies or standalone algorithm performance.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text because the 510(k) submission for this type of device (a topical wound dressing) typically relies on material composition, device characteristics, and intended use comparison to predicates, along with biocompatibility and sterility data, rather than clinical performance metrics in the way, for example, a diagnostic AI device would.
The document states: "This device, with respect to material composition, device characteristics, and intended use, is substantially equivalent to the predicate devices." This is the core argument of a 510(k) for this kind of device, not a performance study.
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Applicant: ACell, Inc.
510(k) SUMMARY----------------------------------------------------------------------------------------------------------------------------------------------------------------
| Submitter Name: | ACell, Incorporated | JUN 2 3 2006 |
|---|---|---|
| Submitter Address: | 10555 Guilford RoadSuite 113Jessup, Maryland 20794 | |
| Contact Person: | James R. DeFrancescoChief 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 DressingK030921, Collagen Matrix, Inc., Collagen Topical Wound Dressing | |
| Statement of IntendedUse: | The ACell™ Powder Wound Dressing is intended for themanagement of topical wounds including: partial and full-thicknesswounds, pressure ulcers, venous ulcers, diabetic ulcers, chronicvascular 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 drainingwounds. The device is intended for one-time use. | |
| Device Description: | The ACell™ Powder Wound Dressing is composed of porcinecollagen from urinary bladder matrix. It is an absorbent, white tooff-white, particulate that is lyophilized and to be used as a topicalapplication. The product is sterile, for single use and is non-pyrogenic. | |
| Comparison to thePredicate Devices: | This device, with respect to material composition, devicecharacteristics, and intended use, is substantially equivalent to thepredicate devices. |
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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
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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
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Applicant: ACell, Inc.
510(k) Number (if known):
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
N/A