BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING

{0}------------------------------------------------ K050086 Page 1 of 2 # FEB 1 7 2006 ## 510(K) Summary For Brennen Medical, Inc.'s Silver Glucan Wound Dressing Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Date Prepared: January 27, 2006 | 1. | Submitter | Brennen Medical, Inc.<br>1290 Hammond Road<br>St. Paul, MN 55110 | |----|-------------|---------------------------------------------------------------------| | | | Kenneth Herland<br>V.P. Regulatory Affairs and Q.A.<br>651-429-7413 | | 2. | Device Name | | Proprietary Name: Common Name: Classification Name: Regulatory Class: Silver Glucan Wound Dressing (TBD) Dressing Dressing Unclassified ### Intented Usc 3. Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be use for partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Silver Glucan dressings may be used over partial thickness wounds, debrided wounds, and as a temporary covering for full thickness and grafted wounds. ### Device Description 4. Silver Glucan dressing consists of a nylon mesh coated with silver and oat glucan. The glucan facilitates the placement of the mesh and the silver protects the wound site from bacterial and yeast contamination. The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48". ### గ్ Predicate Device Comparision {1}------------------------------------------------ K050086 Brennen Medical, Inc. believes the Silver Glucan to be substantially equivalent in design, materials, function, and intended use as Acticoat Silver Coated Wound Dressing, a wownd dressing that is in commercial distribution and is presently marketed by Westain Medical (now under the name of Smith-Nephew) and previously reviewed by ODE under 510(k) K955453; and Silverlon Contact Wound Dressing reviewed on K981299. Both were found substantially equivalent. Also, the following predicate device(s) contain silver or glucan and have been reviewed by ODE and found substantially equivalent The predicate devices are: 1. Acticoat Silver Coated Dressing (K983833, K992221, K000051, K001519 and K002466); 2. Brennen Medical, Inc. Glucan II Wound Dressing (K964241). The predicate devices are all sterile, single use coverings for wounds. Each of the silver predicate devices, as well as this new device, employ silver metal on a support material. The support matrix varies for each of the products. Acticoat silver coated dressing is a 3ply gauze wound dressing consisting of an absorbent rayon/polyester core and an upper and lower layer of silver-coated high density polyethylene mesh designed to be a banner against microbial infections of a wound. Silverlon and Silver Glucan are composed of a polymeric material (nylon). While the support matrixes vary for each product the role it provides is the same; to provide a physical barrier to the wound and provide a substrate for Ag. The differences between the new Silver Glucan device and its predicate devices are minor and raise no new questions of safety or effectiveness. All of the products have the same intended use and are sterile and for single use. #### Biocompatibility 6. The Silver Glucan Wound Dressing was subjected to the following performance tests: - Biocompatability studies (including skin irritation, sensitization, and cytotoxicity) - Animal Wound Healing Study . - Silver dissolution . - Tensile strength . - Barrier efficacy . - Zone of inhibition . - Stability testing ● In all instances, the Silver Glucan Wound Dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 7 2006 Mr. Kenneth B. Herland Vice President Regulatory Affairs and Quality Assurance Brennen Medical, Inc. 1290 Hammond Road Saint Paul, Minnesota 55110 Re: K050086 K050080 Trade/Device Name: Brennen Medical Silver Glucan Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 6, 2006 Received: January 9, 2006 Dear Mr. Herland: We have reviewed your Section 510(k) premarket notification of intent to narket the indication we nave reviewed your becasin 3 ro(s) presses is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regars neatment date of the Medical Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Face to Fre commence prior to May 20, 1978, the exactions of the Federal Food, Drug, devices mall have been recurse in accee approval of a premarket approval application (PMA). and Costlience Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merciole, mance the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 acover) includes affecting major regulations affecting your device it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Obas of ements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I DTC issualite or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally it catal statutes and regaratents ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic forth in the quality bystells (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) I mis letter will and will you to organizal equivalence of your device of your device to a legally {3}------------------------------------------------ Page 2 - Mr. Herland 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 r the regulation and 11, 2011 and 11, 276, 11:55 and resealeries entitled if you desire specific advice for your ac not the ray a suggest note the regulation entitled. contact the Office of Compliance at (240) 276-0115. Also, please note the may ab contact the Office of Compliance at (216) 216 - 11 - 11 - 17 Part 807.97). You may obtain "Misbranding by reletence to premance nouthead.com of the Act from the Division of Small other general miormation on your responsion.com at its toll-free number (800) 638-2041 or 1 Manufacturers, International and Consumer Fibelance or or corph/industry/support/index.html. Sincerely yours, Mark A. Mellkerson Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known) Device Name: Brennen Medical Silver Glucan Wound Dressing ## Indications for Use Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penerration. The dressing may be used for partial and full thickness wounds including decabitus ulcers, venous stasis ulcers, diabelix ulcers. first and second degree burns, donor sites, and surgical wounds. Silver Glassis dicers, may be used over partial thickness wounds, and as a temporary covering for full thickness and grafted wounds. Presemption Use X (Per 21 CFR 801.109) ()[ર Over the Counter Use (Optimal Format 1-2-96) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, | (ODH) | |----------------------|-------| |----------------------|-------| (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K050086