Graft Delivery Device with Integrated Stylet

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 7, 2015 Micromedics Incorporated Ms. Amy L. Peterson Senior Regulatory Affairs Specialist 1270 Eagan Industrial Road, Suite 120 Saint Paul, Minnesota 55121 Re: K151543 Trade/Device Name: Graft Delivery Device with Integrated Stylet Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: June 4, 2015 Received: June 8, 2015 Dear Ms. Peterson: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151543 #### Device Name Graft Delivery Device with Integrated Stylet ### Indications for Use (Describe) The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # Date of Summary Preparation: July 3, 2015 510(k) Applicant/Submitter Micromedics, Inc. d/b/a Nordson Medical 1270 Eagan Industrial Road St. Paul, MN 55121-1385 Tel: 651-452-1977; Fax: 651-452-1787 Establishment Registration #2183425 Contact Person Amy L. Peterson, M.A. Sr. Regulatory Affairs Specialist Micromedics, Inc. d/b/a Nordson Medical 1270 Eagan Industrial Road St. Paul, MN 55121-1385 Tel: 651-405-2182; Fax: 651-452-1787 | General Information | | | | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----------------------| | Trade Name | Graft Delivery Device with<br>Integrated Stylet | Common Name | Graft Delivery Device | | Classification<br>Information | Syringe, Piston<br>per 21 CFR 880.5860 (Class II) | Product Code | FMF | | | | Panel | General Hospital | | Predicate<br>Devices | Micromedics Inc's Graft Delivery System, K100754, cleared June 9, 2010<br>Biomet Biologics' CDO™ and Graft Preparation System, K072330, cleared<br>December 6, 2007 | | | ## Device Description The Graft Delivery Device with Integrated Stylet is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements. The Graft Delivery Device with Integrated Stylet consists of a syringe body, plunger with integrated stylet, tapered end cap, funnel, cap plug, and cannula. Hydration components (hydration tube or hydration adapter) are present in some configurations. Components are made of one or more of the following materials: acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, self-lubricating silicone, and 304 Stainless Steel. The device is packaged in a thermoformed tray with a Tyvek Iid. Each tray is then packaged in a labeled individual poly/Tyvek pouch. Five (5) pouched trays are then put into a shelf box and then a cardboard shipper box. Like the graft delivery device from K100754, the Graft Delivery Device with Integrated Stylet is sterilized using ethylene oxide. {4}------------------------------------------------ ## Intended Use / Indications The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements. ## Substantial Equivalence Comparison The Graft Delivery Device with Integrated Stylet is substantially equivalent to the predicate devices in the following characteristics: - Operational mode - Basic Scientific Technology . - . Intended Use - General physical characteristics . ## Summary of Non-Clinical Performance Data The Graft Delivery Device with Integrated Stylet was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 -Biological evaluation of medical devices, Part 1 – Evaluation and tests (2009) show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use and over the labeled shelf life. Testing was conducted for the following: - Plunger Force ● - Stylet Force ● - Closed System Leak ● - Vented System - Secondary Thumb Tab Force - Cannula Atraumatic Tip ● - Dimensional Testing ● - Cap Plug/Tapered End Cap/Syringe Finger Flange Strength - . Plunger Thumb Pad Strength - Cannula/Tapered End Cap Strength ● - . Hydration Adapter/Tapered End Cap Strength - Hydration Tube/Tapered End Cap Strength ● - Stylet Torque ● - . Stylet Buckling - Hydration Tube Strength ● - Sterilization ● - Shelf life ● - Packaging . - Summary of Clinical Performance Data None provided as a basis for substantial equivalence. ## Substantial Equivalence Conclusion As evidenced by the successful completion of non-clinical performance testing, the Graft Delivery Device with Integrated Stylet does not raise new questions of safety or effectiveness when compared to the predicate devices and is, therefore, substantially equivalent.