ARTHREX ASPIRATE KIT

{0}------------------------------------------------ K062365 \$\rho^{i/2}\$ ## SEP 2 9 2006 ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Aspirate Kit NAME OF SPONSOR: Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 510(K) CONTACT: Sally Foust, RAC Regulatory Affairs Project Manager TRADE NAME: Arthrex Aspirate Kit FAX: (239) 598-5539 Telephone: (239) 643-5553 ext. 1251 COMMON NAME: Piston Svringe # DEVICE PRODUCT CODE/CLASSIFICATION: FMF: Class II 21 CFR 880.5860 #### PREDICATE DEVICES K041991: Aspirex™ Bone Marrow Aspirate Kit, IsoTis OrthoBiologics K022246: Symphony Graft Delivery System, DePuy Acromed K012738: Symphony Graft Delivery System, DePuy Acromed # DEVICE DESCRIPTION AND INTENDED USE The Arthrex Aspirate Kit contains piston syringes, aspirating needle, Luer-lock and Slip Tip adaptors, cannula, and prep tray (bowl). The piston syringes consist of aspirating/delivery syringe and/or a mixing/delivery syringe. The piston syringes are designed with male Luer-lock connectors (nozzle) for fitting a female connector of a needle or an adaptor for connection to the other syringe or cannula used for mixing. The aspirating syringe is a 60 mL syringe, while the mixing syringe is 9 mL. Luer-lock and Slip Tip adaptors may be provided. The Arthrex Aspirate Kit is intended for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without pre-filling with a bone void filler (allograft, autograft or synthetic bone graft material). The kit is designed to facilitate the pre-mixing of autologous blood, bone marrow, I.V. fluids, platelet-rich plasma, or plasma with bone void filler and the delivery to {1}------------------------------------------------ an orthopedic surgical site, as deemed necessary by the clinical use requirements. # SUBSTANTIALLY EQUIVALENCE Arthrex has determined that the Arthrex Aspirate Kit is substantially equivalent to the predicate devices where basic features and intended uses are the same. Any design differences between the Arthrex Aspirate Kit when compared to predicate devices are considered minor and do not raise any questions concerning safety and effectiveness. Any differences have been found to have no apparent effect on the performance, function, or intended use of the device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 9 2006 Arthrex, Inc % Sally Foust, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945 Re: K062365 Trade Device Name: Arthrex Aspirate Kit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 11, 2006, Received: August, 14, 2006 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 101 about in the 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 ic may of basic to basis of Federal Regulations, Title 21, and 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 or uny I edolar 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 Of H 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. {3}------------------------------------------------ Page 2 - Sally Foust, RAC 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) 276-0120. 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 Manufasturers, 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 N. Wilkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Indications for Use 510(k) Number (if known): _ 3062365 Device Name Arthrex Aspirate Kit #### Indications for Use: The Arthrex Aspirate Kit is intended for the aspiration of bone marrow. autologous blood, plasma or other blood components with or without pre-filling with a bone void filler (allograft, autograft or synthetic bone graft material). The kit is designed to facilitate the pre-mixing of autologous blood, bone marrow. I.V. fluids, platelet-rich plasma, or plasma with bone void filler and the delivery to an orthopedic surgical site, as deemed necessary by the clinical use requirements. Prescription Use × (Per 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 IF NEEDED) Concurrence of CDRA, Office of Device Evaluation (ODE) Page 1 of 1 (Division Sign-Off) Division of General, Restorative, and Neurological Devices K062365 510(k) Number.