PROWICK

{0}------------------------------------------------ Ko8 3007 Page 1 of 2 ## APR - 8 2009 Arthrex. SPECIAL 510(k): ProWick | Manufacturer/Distributor/Sponsor | Arthrex, Inc. | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 1370 Creekside Boulevard | | | Naples, FL 34108-1945 USA | | 510(k) Contact | Sally Foust, RAC | | | Regulatory Affairs Project Manager | | | Arthrex, Inc. | | | 1370 Creekside Boulevard | | | Naples, FL 34108-1945 USA | | | Telephone: 239/643.5553, ext. 1251 | | | Fax: 239/598.5508 | | | Email: sfoust@arthrex.com | | Trade Name | ProWick | | Common Name | Wound Dressing | | Product Code -Classification<br>Name | FRO | | | Dressing, Wound, Drug | | Predicate Device | Arthrex ProWick, K072378 | | Device Description and Intended<br>Use | The ProWick device is a post-surgical antimicrobial<br>wound dressing containing a variety of elements such<br>as elastic straps, waterproof bandages, dressing, foam<br>islands infused with a silver based antimicrobial agent,<br>and a reusable cold pack, sold sterile. | | | The Arthrex ProWick™ Postoperative Wound Dressing<br>is indicated for the management of post-surgical<br>wounds and the silver component present in the<br>dressing may act as a barrier to colonization of E coli, S<br>aureus, A. niger, C. albicans, and P. aeruginosa within<br>the dressing. | | Substantial Equivalence<br>Summary | The ProWick device is substantially equivalent to the<br>predicate ProWick device in which the basic features<br>and intended uses are the same. Any differences<br>between the ProWick device and the predicate ProWick<br>device is considered minor and do not raise questions<br>concerning safety and effectiveness. Based on the<br>information submitted, Arthrex, Inc. has determined that<br>ProWick with two-year shelf-life labeling is<br>substantially equivalent to the currently marketed<br>predicate device. | # 4 510(k) Summary of Safety and Effectiveness {1}------------------------------------------------ K08 3007 page 2 of 2 ArthreX. SPECIAL 510(k): ProWick ### 5 Introductio This SPECIAL 510(k) premarket notification is submitted to obtain clearance for the ProWick device with two-year shelf life labeling. This device is being submitted as a modification to K072378, Arthrex ProWick. The ProWick device with two-year shelf life labeling requires the submission of a premarket notification due to this labeling change. {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written in a circle around the eagle. The seal is black and white. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 8 2009 Arthrex, Inc. % Ms. Sally Foust Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945 Re: K083007 : Trade/Device Name: ProWick Regulatory Class: Unclassified Product Code: FRO Dated: March 31, 2009 Received: April 3, 2009 Dear Ms. Foust: 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 {3}------------------------------------------------ Page 2 - Ms. Sally Foust 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Mule A Mulkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Arthrex SPECIAL 510(k): ProVVick Indications for Use 510(k) Number: K082007 Device Name: ProWick The Arthrex ProWick™ Postoperative Wound Dressing is indicated for the management of post-surgical wounds and the sliver component present in the management of poss barrier to colonization of E. coli, S. aureus, A. niger, C. albicans, and P. aeruginosa within the dressing. Prescription Use _X_AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Per 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) PAGE 1 of 1 Dail Krone for MKM (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** k083007