PCCS GRAFT DELIVERY SYSTEM

{0}------------------------------------------------ 1 2002 JUL . ''; # 510(k) Notification #### A. ADMINISTRATIVE INFORMATION Applicant or Sponsor: Biomet, Inc. P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46582 (FDA registration no. 1825034) Contact Person: Lonnie Witham Phone: (219) 267-6639 FAX: (219) 372-1683 Marketer/Distributor: Osseous Technologies, Inc., a Division of Biomet Orthopedics, Inc. P.O. Box 587 56 East Bell Drive Warsaw, IN 46582 ## Manufacturing Site(s): Contract Manufacturer: MicroMed, Inc. 124 Heritage Avenue Portsmouth, NH 03801 (FDA registration no. 1220894) Specification holder: Implant Innovations, Inc., a Biomet Company 4555 Riverside Drive Palm Beach Gardens, FL 33410 (FDA registration no. 1038806) #### в. DEVICE IDENTIFICATION Proprietary Name: Graft Delivery System Common or Usual Name: Piston Syringe Classification Name: Piston Syringe Device Classification: 21 CFR 880.5860 Piston Syringe - Class II Device Product Code: FMF Performance Standards/Guidance Documents: No performance standards have been developed for this type of device. 000004 {1}------------------------------------------------ Previous FDA Status: Per 21 CFR 880,5860 the device is Class II and may be cleared for marketing with a pre-market notification under section 510(k), ### C. DEVICE DESCRIPTIVE INFORMATION Intended Use: This device is intended for use in the delivery of allograft and autograft bone materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood components as deemed necessary by the clinical use requirements. Device Description: The Graft Delivery System will be configured using the following components. See Exhibit 1 for drawings and supplier catalog Information. - . Two commercially available disposable medical piston syringes - Applicator tips . This Graft Delivery System will be sold in coniunction with CelSep® Centrifuge System (K994148), CelSep® Centrifuge System (K994148) that consists of a compact bench top centrifuge designed for multi-purpose use in medical, industrial, and scientific laboratories, that includes a single-use processing disposable. Materials: Materials for the Graft Delivery System meet the requirements set forth in the current U.S. Pharmacopeia for Class IV and Class VI as well as the FDA modified ISO 10993-1 tests for biocompatibility for human body fluid of 30 days or less. Components are manufactured from medical grade resins. Labeling: Sample labels and labeling are included in Exhibit 2. Sterility Information: The Graft Delivery System consists of a 60cc Becton Dickinson disposable sterile syringe and a 10cc Becton Dickinson disposable sterile syringe. The devices are procured packaged and sterile, and will retain the original individual sterile package and labeling as provided from the Becton Dickinson. These same sterile disposable syringes were previously cleared for use in the processing disposable kit for the CelSep® Centrifyge System (K994148). Becton Dickinson has several premarket notifications cleared for marketing of piston syringes including K930321. K95064, and K980580. The two individual sterile packages will then be organized into a convenience pack by placing them in a rigid blister tray with a sealed Tyvek® lid. The outer lid of the kit will bear an Osseous Technologies label. Packaging Description: A description of the packaging is in Exhibit 2. 00005 {2}------------------------------------------------ Substantial Equivalence: The Graft Delivery System is substantially equivalent to the DePuy/AcroMed Symphony Graft Delivery System (K003286), a J &J Company, the Harvest Technologies SmartJet Bone Grafting Liquid Applicator (K011032), and the MicroMedics FibriJet Aerosol Applicator (K012868). See Exhibit 3 for predicate devices. | Summary Comparison<br>Osseous Tech., Symphony, and MicroMedics Delivery Systems | | | | |---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------| | Characteristic | Osseous | DePuy AcroMed | Micromedics | | | Technologies | Symphony<br>(K003286) | FibriJet | | | (This submission) | Harvest Tech.<br>SmartJet<br>(K011032) | (K012868) | | Intended Use | Delivery of allograft,<br>autograft to<br>orthopedic surgical<br>site and facilitate<br>pre-mixing of bone<br>graft with I.V. fluids,<br>bleed, plasma,<br>platelet rich plasma,<br>bone marrow or<br>other specific blood<br>components as<br>deemed necessary<br>by the clinical use<br>requirements. | Same as<br>Osseous Tech. | For simultaneous<br>delivery of two<br>non-homogenous<br>liquids to the<br>same area. | | Components | Commercially<br>marketed piston<br>syringes and<br>applicator tips in<br>straight and spray<br>configurations | Same as<br>Osseous Tech. | Same as<br>Osseous Tech. | | Labeling<br>Includes<br>Commercially<br>Available<br>Centrifuge | CelSep® Centrifuge<br>System<br>K994148 | SmartPrep<br>Centrifuge<br>System<br>K991430 | None Known | | Sterility | Sold Sterile - Single<br>use - Disposable | Same as<br>Osseous Tech. | Same as<br>Osseous Tech. | | Principle of<br>Operation | Fluids dispensed<br>from the applicator<br>tip by depressing<br>the syringe<br>plunger(s) | Same as<br>Osseous Tech. | Same as<br>Osseous Tech. | {3}------------------------------------------------ ### D. SUMMARY OF SAFETY AND EFFECTIVENESS A summary of information pertaining to the safety and effectiveness of this type of device is contained in Exhibit 4 for Summary of Safety and Effectiveness. 00007 ﻴ {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" encircling the image. The text is arranged in a circular fashion around the eagle symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 1 2002 JUL Biomet. Inc Lonnie Witham P. O. Box 587 Warsaw, Indiana 46581 - 0578 Re: K021071 Trade Name: Graft Delivery System Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 25, 2002 Received: April 2, 2002 Dear Mr. Witham: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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. {5}------------------------------------------------ Page 2 - Mr. Lonnie Witham 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Page 1 of 1 510(k) Number: |( 02/07/ Device Name: Graft Delivery System - Indications For Use: This device is intended for use in the delivery of allograft and autograft bone materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood components as deemed necessary by the clinical use requirements. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) OR Concurrence of CDRH, Office of Device Evaluation (ODE) × Prescription Use (Per 21 CFR 801.109) Over-The Counter Use (Optional Format 1-2-96) (Option (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number k021071 000003