ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING

{0}------------------------------------------------ SEP 1 2 2001 ## Special 510(k) Summary | Contact Person: | Dr. Bruce L. Gibbins, Chairman & CTO | |----------------------------|---------------------------------------------------| | Date of preparation: | July 3, 2001 | | Device Name (proprietary): | AcryDerm Silver Antimicrobial Perforated Dressing | | Common Name: | Moist antimicrobial wound dressing | | Classification Name: | Hydrophilic Wound Dressing | | Classification: | Unclassified | Legally marketed device(s) for substantial equivalence comparison: AcryDerm Silver Antimicrobial Strands (AcryMed, Inc., OR) Description of Device: AcryDerm Silver Antimicrobial Perforated Dressing is a line extension Description of Device. TeryDerm Silver Antimicrobial Strands. The new product is or the previously cleared product, rese matrix material, has the same composition and is made made from the same meetined one facturing process as the predicate. The new product is an tront substantiany an equiralent manances and problems for the wound dressing that contains aosorocit, perforuced inforemine porjudy of microbial contaminants in contact with the antineroblar silver that minons the group erforated Dressing will be supplied sterile packaged in single use heat sealed medical grade poly-laminate pouches. The single use primaries will be m single use nour source into dispenser boxes for distribution. Biocompatibility has been packed, with a product misers, mits and it (Biological Evaluation of Medical Devices). Intended Use of the Device: AcryDerm Silver Antimicrobial Perforated Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds. Technological Characteristics: AcryDerm Silver Antimicrobial Perforated Dressing is a I ecfinetion of that controls wound moisture levels through dual function of donation perforated sheet arossing that conferred by its content of stabilized antimicrobial silver. The product carries the general classification name, "Hydrophilic wound dressing". The The produce carries the general entimicrobial Perforated Dressing is identical to the predicate device, AcryDerm Silver Antimicrobial Strands. AcryDerm Silver Antimicrobial Perforated Dressing contains silver that may control microbial contamination of the dressing. Manufacturing: AcryDerm Silver Antimicrobial Perforated Dressing will be manufactured according to the product specifications and under good manufacturing practices that ensure the device is safe and effective for its intended use. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the base of the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 9 2007 Bruce Gibbons, Ph.D. Chairman and Chief Technical Officer AcryMed, Inc. 12232 SW Garden Place Portland, Oregon 97223 Re: K012116 Trade/Device Name: AcryDerm Silver Antimicrobial Perforated Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 7, 2001 Received: August 13, 2001 Dear Dr. Gibbons: This letter corrects our substantially equivalent letter of September 12, 2001. We have reviewed your Section 510(k) premarket notification of intent to market the device w t nave reviewed your Section of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered price to May 20, 1978, in econdance with the provisions of the Federal Food, Drug, devices that have boom require approval of a premarket approval application (PMA). and Cosmetic Act (110.) that be novice, subject to the general controls provisions of the Act. The I ou may, mereloro, mans of the Act include requirements for annual registration, listing of general controls provisions a ractice, 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 If your device is crassified (see aboro) the exist on the regulations affecting your device can may be subject to such additional controls. Existing major regulations FDA m may be subject to such additional controliar in the 21, Parts 800 to 898. In addition, FDA may be found in the Couv acements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 issualles or our device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or ally redelal statutes and regulations daminding, but not limited to: registration and listing (21 comply will an the Act 3 requirements, mortaling, cannotacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Bruce Gibbons, Ph.D. 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. 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 A. Mulhern Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health {3}------------------------------------------------ Page 16 NUMBER (IF KNOWN): 510(k) AcryDerm Silver Antimicrobial Perforated DEVICE NAME: Dressing INDICATIONS FOR USE: AcryDerm Silver Antimicrobial Perforated Dressing is an effective barrier to bacterial AcryDelini Silver Antimicrobial Perfer function of the dressing may help reduce infection in penetialion. The althineroolar barrer Tunetion of the dressing this stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. first and second degree burns, abrasions and lacerations, donor sites and surgical rist and second degroe barns, derasted and grafted partial thickness wounds. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription use Use<br>(Per 21 CFR 801.109) | | |-----------------------------------------------------------|-------------------------------------------| | OR | Over-The-Counter-Use<br>(Optional Format) | | (Division Sign-Off) | | | Division of General, Restorative and Neurological Devices | | | 510(k) Number | K012116 |