HARVEST GRAFT DELIVERY SYRINGE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a white rectangular label with the text "K04326" written on it in black ink. The text is written in a simple, sans-serif font, and the numbers are clearly legible. The label appears to be slightly worn or aged, with some minor imperfections and smudges visible on the surface. Phge 1 of 1 ## 510(k) Summary for the Harvest Graft Delivery System ## MAR 1 1 2005 | Submitter's Name and Address: | Harvest Technologies Corp.<br>40 Grissom Road, Suite 100<br>Plymouth, MA | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone Number: | 508-732-7530 | | Telefax Number: | 503-732-0400 | | Contact Person: | Jack Bonasera, Director, Regulatory Affairs | | Date Summary Prepared: | January 24, 2005 | | Device Trade Name: | Harvest Graft Delivery System | | Common Name: | Bone Graft Syringe | | Classification Name: | Piston Syringe (Product Code FMF) | | Substantial Equivalence: | The Harvest Graft Delivery System is substantially<br>equivalent to other bone graft delivery systems; e.g.,<br>Symphony Graft Delivery System marketed by Depuy<br>Acromed (K003286), Wright Medical Technology Bone<br>Graft Syringe (K023088) and INFLITRATE Marrow<br>Infusion Chamber (component of K031817), and the<br>IsoTis OrthoBiologics Aspirex-Bone Marrow Aspirate<br>Kit (K041991). | | Device Description: | The Harvest Graft Delivery System consists of a Graft<br>Syringe/Infusion Chamber with pre-seated polymer plug<br>and removable plunger and syringe cap; a dual liquid<br>applicator; female/female luer connector and push rod. A<br>commercially available bone marrow aspirate needle is<br>supplied separately for use with the system. | | Intended Use: | The Harvest Graft Delivery System is intended for the<br>aspiration of bone marrow, autologous blood, plasma, or<br>other body fluids. The system is indicated for the delivery<br>of allograft, autograft, or synthetic bone graft materials to<br>an orthopedic surgical site. In addition, it is designed to<br>facilitate pre-mixing of bone graft materials with the<br>aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma,<br>bone marrow or other specific blood component(s) as<br>deemed necessary by the clinical use requirements. | | Technological Characteristics: | The proposed device has the same technological<br>characteristics and is similar in design and configuration<br>compared with the predicate devices. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized stripes or chevrons, which are meant to represent the agency's mission of providing essential human services and protecting the health of all Americans. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 1 2005 Mr. John D. Bonasera Director, Regulatory Affairs Harvest Technologies Corporation 40 Grissom Road, Suite 100 Plymouth, Massachusetts 02360 Re: K043261 K643201 Trade/Device Name: Harvest Graph Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: March 4, 2005 Received: March 7, 2005 Dear Mr. Bonasera: We have reviewed your Section 510(k) premarket notification of intent to market the the indication We have reviewed your Section 510(x) premained institution of the indications referenced above and have determined the device is substantially intervation referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regally manced prource Amendments, or to commerce prior to May 28, 1976, the enactment as ansiscan of the Federal Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food, Drug. devices that have been reclassified in accordance with the provel application (PMA) devices that have been reciassince in accordance what approval applications (PMA). and Cosmetic Act (Act) that do not require approval antaxistions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, subject to the generation, listing of You may, merelore, market the device, subject to the gasts for annual registration, listing of general controls provisions of the Act include requirements for any and general controls provisions of the Fee mercials request of the sagainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it ( If your device is classifica (see above) nie existing major regulations affecting your device can may be subject to such additional controls. Txisting major may be subject to such additional controller entrologies of the 21. In addition, FDA may be found in the Code of Peachar regarming your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issualies of a backation of the requirements of the Act that FDA has made a determination that your device complies with other requirements of th that FDA has made a determination that Jour accred by other Federal agencies. You must of any Federal statutes and regulations administry, but not limited to: registration and fisting (21 comply with an the Act 3 requirements, mercialing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 -- Mr. John D. Bonasera This letter will allow you to begin marketing your device as described in your Section 5 (0(k) i his letter will anow you to ocgin hanketing your antial equivalence of your device to a legally premarket nothleadon: The PDA miding of backed on thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 ), please e If you desire specific advice for your device of your device note the regulation entitled. Contact the Office of Complance at (210) = 76 % at 807.97). You may obtain " Misbranding by relefence to premarket notifiedering on the Act from the Division of Small other gelleral informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolisanter Fristing Architectives port/index.html. Sincerely yours, Signature Gor Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(k) Number if Known: (K043261) Harvest Graft Delivery System Device Name: The Harvest Graft Delivery System is intended for the aspiration of bone Indications for Use: marrow, autologous blood, plasma, or other body fluids. The system is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. Prescription Use (Part 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number_Loy 326 Page | of |