InFill Graft Delivery System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 17, 2014 Pinnacle Spine Group, LLC Ms. Rebecca K Pine Official Correspondent 1601 Elm Street, Suite 300 Dallas. Texas 75201 Re: K143488 Trade/Device Name: InFill™ Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Regulatory Class: Class II Product Code: FMF Dated: December 4, 2014 Received: December 8, 2014 Dear Ms. Pine: 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 {1}------------------------------------------------ device-related adverse events) (21 CFR 803); 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. 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/Resourcesfor You/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, Binita S. Ashar -S 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}------------------------------------------------ # 5. Indications for Use Statement | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Food and Drug Administration | | | Indications for Use | | | | Form Approved: OMB No. 0910-0120 | | | Expiration Date: January 31, 2017 | | | See PRA Statement below. | | 510(k) Number (if known) | K143488 | | Device Name | InFill™ Graft Delivery System | | Indications for Use (Describe) | The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. | | Type of Use (Select one or both, as applicable) | | | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." FORM FDA 3881 (1/14) {3}------------------------------------------------ #### 6. 510(k) Summary This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | APPLICANT: | Pinnacle Spine Group, LLC | |---------------------------|--------------------------------------------------------------------------------------------------------------| | DATE PREPARED: | December 4, 2014 | | CONTACT PERSON: | Rebecca K Pine<br>1601 Elm Street, Suite 300<br>Dallas, TX 75201<br>Phone: 760.809.5178<br>Fax: 760.290.3216 | | TRADE NAME: | InFill™ Graft Delivery System | | COMMON NAME: | Piston Syringe | | CLASSIFICATION<br>NAME: | Piston Syringe | | DEVICE<br>CLASSIFICATION: | Class 2, per 21 CFR 880.5860 | | PRODUCT CODE | FMF | | PREDICATE DEVICES: | InFill™ graft Delivery System (K121476) | ## Substantially Equivalent To: The modified InFill™ Graft Delivery System is substantially equivalent in intended use, principal of operation and technological characteristics to the InFill™ Graft Delivery System cleared under premarket notification K121476 ## Description of the Device Subject to Premarket Notification: The modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannulated applicator tip and accessories for mixing bone graft materials and filling of the system. The modified InFill™ Graft Delivery System is provided sterile, for single use only. ## Indication for Use: The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. ## Technical Characteristics: The modified InFill™ Graft Delivery System has the same technological characteristics and is similar in overall design, materials and configuration compared to the current InFill™ Graft Delivery System as shown in the table below. {4}------------------------------------------------ | | Modified InFill™ Graft Delivery System | InFill™ Graft Delivery System (K121476) | |-------------------------|----------------------------------------|-----------------------------------------------| | Materials | SAME | Medical grade polymers | | Method of filling | SAME | Front-loaded via barrel | | How supplied | SAME | Sterile, single use only | | Syringe | | | | Syringe type | SAME | Piston | | Plunger Actuation | SAME | Screw | | Principle of operation | SAME | Facilitates delivery of bone graft material. | | Material use | SAME | Bone graft materials | | Bone graft pre-loaded | SAME | No | | Tip type | SAME | Luer lock | | Syringe Volume | SAME | 12cc | | Barrel markings | SAME | Milliliter, graduated | | Barrel transparency | SAME | Clear | | Cannula | | | | Cannula length | 300mm<br>275mm<br>150mm | 275mm (10.8 in) | | Cannula tip | SAME | Smooth, atraumatic | | Marking | SAME | No | | Cannula OD | 3.5mm<br>4.8mm<br>8.0mm | 4.8mm | | Hub | SAME | Threaded screw | | Accessories | | | | Mixing accessories | SAME | Mixing plunger, closed syringe cap (optional) | | Filling accessories | SAME | Funnel, stand (optional) | | Graft removal accessory | SAME | Stylet (optional) | ## Performance Data: All necessary testing has been performed for the InFill™ Graft Delivery System to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device design was qualified through the following tests: - . Simulated Use Testing {5}------------------------------------------------ - Volume Verification - . Maximum Force Verification - Force to Dispense Verification ● - Separation Force Testing . - Liquid Leak Testing ● The modified InFill™ Graft Delivery System met all specified criteria and did not raise new safety or performance questions. #### Basis for Determination of Substantial Equivalence: The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified InFill™ Graft Delivery System is found to have a safety and effectiveness profile that is similar to the predicate device and is determined by Pinnacle Spine Group LLC, to be substantially equivalent to the InFill™ Graft Delivery System (K121476).