ConMed Mixing and Delivery Kit

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is a stylized graphic of what appears to be a human figure or symbol, composed of three curved lines. and Drug Administratio New Hampshire Avential ment Control Control Control - 1 Spring, MD 20993-00 April 23, 201 ONMED Corporation Is. Dionne Sanders MS, I egulatory Articles in Sanders MS, I egulatory Articles in Arabican Para 1311 Concept Boulevard argo, Florida 33773 42535 ଧ de/Device Name: Conmed Mixing and Delivery gulation Number: 21 CFR 880.5860 gulation Name: Piston Syring tory Class: Class rch 13, 20 March 24, Code: FM March 13, 2 Sanders ﺍﻟﻘﻠ ﺍﻟﻤﺮﻛﺰ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ vice is classified (see above) into either class II (Special Controls) or class III (P subject to additional controls: Existing major regulations affective your develops, FD se be advised that FDA's sisunos of a substantial aquivalences actemination does novers. IDA made mindian mindia doui dovice minution desement. In Federa segulations and mo {1}------------------------------------------------ h in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electron duct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. ou letir specific advice or our labeling regulation (21 CFR Pat 801). 101 196-1 ision and Consumer Education at its foll-field mark (2). 101 196-11stor at Lesources (2000 mar <http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm>. 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 R Part 803), please go to p://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Surveillance and Biometrics/Division of Postmarket Surveillance. may obtain other general information on your responsibilities under the Act from t sion of Industry and Consumer Education at its toll-free number (800) 633-2041 on 7100 or a http://www.fda.gov/ICECI/ResourcesForYou/Industry/ ComplianceEnforcement/ucm059741.htm ncerely yours Jennifer R. Stevenson-S Ashar, M.D., M.B.A., F. vision of Surgical Device Evaluati Tice of Device Evaluati Inter for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K142535 Device Name CONMED Mixing and Delivery Kit #### Indications for Use (Describe) The CONMED Mixing and Delivery Kit is intended for delivery of allograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft or synthetic bone graft materials with IV fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of the word "CONMED" stacked vertically, with the letters in black. To the right of the letters is the word "CORPORATION" stacked vertically in a smaller font, with a blue line separating it from the word "CONMED". Below the text is a blue square with a white swoosh inside. # 0(k) SUMMA #### SUBMITTE I CONMED Corporation 1311 Concept Blvd. Largo, Florida 33773 none: 727-399-53 ax: 727-399-5264 Dionne Sanders MS, April 13, 2015 ontact Person: ate Prepared: #### DEVICE II iston Syringe Iston Syringe (21 CFR Part 880.586 NMED Mixing and Deliver Class II FMF Name of Device: Common Name : Name: Classification Name: Regullatory Collections: Regullatory Collass: Product Codes: ## REDICATE DEVIC III. | Device Name: | Arthrex Mixing and Delivery System | | Proposed Device | Predicate Device | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------------------------------------------| | Company Name: | Arthrex, Inc. | | CONMED Mixing and Delivery Kit | Arthrex Mixing and Delivery System<br>(K121124) | | 510(k) #: | K121124 | Manufacturer | CONMED Corporation | Arthrex, Inc. | | Intended Use | For delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition it is designed to facilitate pre-mixing of allograft, autograft or synthetic bone graft materials with IV fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) and deemed necessary by the clinical use requirements. | Same | | | | Components | 1 each - piston syringe (3ml) w/movable plunger and cap, funnel, long luer cannula, curved luer cannula, luer cap, obturator | 1 each – piston syringe w/movable plunger and cap (3ml or 14ml), straight delivery needle, curved delivery needle, luer cap, obturator, funnel*, articulating paddle elevator*<br>*some components sold separately | | | | Technological<br>Characteristics | For mixing and delivery of allograft autograft and synthetic bone graft materials to all orthopedic sites. | Same | | | | Materials | 18-month shelf life<br>3ml syringe fill capacity<br>Commonly used materials in the medical device industry | 5-year shelf life<br>3ml or 14ml syringe fill capacity<br>Same | | | ## EVICE DESCRIPTIC IV. The CONMED Mixing and Delivery Kit consists of a piston syringe, curved luer camula, straight luer lock, obturator, and finnel. The kit is supplied a single use, disposable ## DICATIONS FOR US i A INDCATIONS FOX Coaterials of Children Colleged on States Prospect of Stream The Collection Profituals on Priliopedia australians. Addition Microsofiale promisial, priberting {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for ComEd Corporation. The word "COMED" is written vertically in large, bold, black letters. To the right of the word is a thin, blue line, and then the word "CORPORATION" is written vertically in smaller letters. # COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI. The CONMED Mixing and Delivery Kit is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical s and the collect of safety or effectiveness. The similarities and differences between the predicate and proposed mixing kits are: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The text "CONMED" is stacked vertically in a bold, sans-serif font. Below the text is the word "CORPORATION" in a smaller, thinner font. Below the text is a blue square with a white, curved shape inside. ## ERFORMANCE DAT VII. Testing has been completed to demonstrate that the CONMED Mixing and Delive Kit performs as intended and is substantially equivalent to the predicate device. Completed testing includes the followin - Reliability - . - Transportation Biocompatibilit Sterilization ● - . - Shelf-life - Simulated Use Testing . ### ONCLUSION VIII. The CONNED Mixing and Delivery Kit has the interial weans trimamment sother technal beries messes and series werivers werk met met of the technology assessment of the comment