HEALEX BIOSPONGE WOUND DRESSING

{0}------------------------------------------------ K112191 Sentrex BioSponge Wound Dressing 510k Premarket Application 1/3 JUN - 5 200 # Section 5: 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: Applicant: Bionova Medical, Inc. 8275 Tournament Drive Suite 160 Memphis, TN 38125 Ph: (901) 748-2581 Fax: (901) 748-2583 Official Correspondent: M Squared Associates, Inc Deborah Lavoie Grayeski 901 King Street. Suite 200 Alexandria, VA 22314 Phone: 703-562-9800 ext. 250 Fax: 703-562-9797 Email: dgrayeski@msquaredassociates.com Date of Submission: July 27, 2011 Proprietary Name: Sentrex BioSponge Wound Dressing Common Name: Dressing, Wound, Drug Requlatory Class: Unclassified Product Codes: FRO Predicate Device(s): - . K071552, Puracol Plus AG Collagen Microscaffold BioSponge - . K080010, NOCC Hydrophilic BioSponge - . K092552, Scion Cardiovascular Clo-SurPLUS P.A.D. #### Device Description: The Sentrex BioSponge Wound Dressing is a sterile, porous, soft chitosan sponge dressing that provides a moist healing environment to support wound healing. The Sentrex Wound Dressing is provided dry, in 10 cm x 10 cm and 5 cm x 5 cm squares. The dressing is made of chitosan, a naturally occurring, biocompatible polysaccharide derived from shellfish. The shells are processed and chemically treated. Once in bandage form, they are sterilized by gamma irradiation and packed in a heat-sealed foil laminate pouch. The Sentrex Wound Dressing may be moistened with saline in accordance with physician recommendation. Bionova Medical, Inc. June 4, 2012 3 {1}------------------------------------------------ K112191 510k Premarket Application 2/3 #### Sentrex BioSponge Wound Dressing #### Intended Use: The Sentrex BioSponge Wound Dressing is indicated in the dressing and management of: - . Full thickness and partial thickness wounds - . Pressure ulcers - . Venous ulcers - . Ulcers caused by mixed vascular etiologies - . Diabetic ulcers - . First and second degree burns - . Donor sites and other bleeding surface wounds - Abrasions . - . Trauma wounds healing by secondary intention - . Dehisced wounds - . Surgical wounds - Dehisced surgical wounds ### Summary of Technological Characteristics The Sentrex BioSponge Wound Dressing is a sterile, porous, soft sponge dressing manufactured by a proprietary process from chitosan, a non-toxic, biodegradable, biocompatible, natural-based biopolymer. Chitosan has extensive safety data associated with its use in biomedical applications. Like collagen, chitosan induces a minimal foreign body reaction and retains more moisture than standard gauze, providing a moist environment to support wound healing. #### Summary of Nonclinical Testing Numerous studies including, biocompatibility testing, local tissue response testing, and bacterial inhibition (AATCC Test Method 100, Microbial Strike-Through Test, and Kirby-Bauer Antimicrobial Susceptibility Test performed with the naïve Sentrex BioSponge and the Sentrex BioSponge with antibiotics) testing demonstrate the performance of the Sentrex BioSponge Wound Dressing. {2}------------------------------------------------ KH2191 3/5 510k Premarket Application ## Determination of Substantial Equivalence The claim of substantial equivalence of the Sentrex Wound Dressing to the predicate devices is based on the comparison of the intended use, product technical/material characteristics, and performance characteristics. Bionova Medical, Inc. considers the Sentrex BioSponge Wound Dressing to be as safe and as effective, with substantially equivalent performance to the predicate devices. Bionova Medical, Inc. June 4, 2012 {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines representing its wings and body. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUN - 5 2012 Bionova Medical Inc. % M Squared Associates, Inc Ms. Deborah Lavoie Grayeski 901 King Street Suite 200 Alexandria, Virginia 22314 Re: K112191 Trade/Device Name: Sentrex Biosponge Wound Dressing Regulation Class: Unclassified Product Code: FRO Dated: May 29, 2012 Received: May 30, 2012 Dear Ms. Deborah Grayeski: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical {4}------------------------------------------------ ## Page 2 - Ms. Grayeski device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Eunice Keith Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K113191 510k Premarket Application # Section 4: Indications for Use Statement K112191 510(k) Number: Device Name: Sentrex BioSponge Wound Dressing Indications for Use: The Sentrex BioSponge Wound Dressing is indicated in the dressing and management of: - Full thickness and partial thickness wounds - Pressure ulcers - Venous ulcers - Ulcers caused by mixed vascular etiologies - Diabetic ulcers - First and second degree burns - Donor sites and other bleeding surface wounds - Abrasions - Trauma wounds healing by secondary intention - Dehisced wounds - Surgical wounds - Dehisced surgical wounds Prescription Use_ X (Part 21 CFR 801 Subpart D) ## AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Krone for MM (Division Sign-Off) Page 1 of 1 Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K112191 Bionova Medical, Inc. June 4, 2012