PRECISE Trauma Nail System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 16, 2015 Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Project Manager 13900 Alton Parkway, Suite 123 Irvine, California 92618 Re: K142599 Trade/Device Name: PRECICE Trauma Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 22, 2014 Received: December 23, 2014 Dear Ms. Shelburne: 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}------------------------------------------------ Page 2 – Ms. Rebecca Shelburne 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 vours. # Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K142599 Device Name PRECICE Trauma Nail System Indications for Use (Describe) The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and nonunions of long bones. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | 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) {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Ellipse. The logo consists of three overlapping circles on the left and the word "ELLIPSE" in bold, sans-serif font on the right. The circles are in shades of blue and green, and the word "ELLIPSE" is in dark blue. 13900 Alton Parkway. Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com ## Ellipse PRECICE Trauma Nail System 510(k) Summary - K TBD September 2014 - 1. Ellipse Technologies, Incorporated Company: 13900 Alton Parkway, Suite 123 Irvine, CA 92618 - Rebecca Shelburne Contact: Regulatory Affairs Specialist Phone: (949) 837-3600 x227 Fax: (949) 837-3664 Date of Submission: September 12, 2014 - 2. Proprietary Trade Name: Ellipse PRECICE Trauma Nail System - Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020) 3. - 4. Product Code: HSB (Rod, Fixation, Intramedullary and Accessories) - 5. Product Description: The Ellipse PRECICE Trauma Nail System is composed of the PRECICE Trauma Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Trauma Nail is supplied sterile by gamma radiation while the locking screws and accessories are supplied non-sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques. - 6. Indications: The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones. - 7. Substantial equivalence: A detailed comparison to the predicate device demonstrates that the Ellipse PRECICE Trauma Nail System is substantially equivalent to the following 510(k) cleared device: Trade Name: PRECICE® Trauma Nail System Common Name: Intramedullary Fixation Rod K141447 510(k) Clearance Number: {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Ellipse. The logo consists of three overlapping ellipses on the left side of the word "ELLIPSE". The ellipses are in shades of blue and green. The word "ELLIPSE" is in a dark blue sans-serif font. 13900 Alton Parkway. Suite 123 Irvine. California 92618 U Office: 949-837-3600 949-837-3664 www.ellipse-tech.com Substantial equivalence is based on same intended use, identical technological characteristics and principles of operation. The Ellipse PRECICE Trauma Nail System and the predicate device have the same intended use. Specifically, the PRECICE Trauma Nail System and the predicate are both designed to treat long bones using compression fracture reduction techniques. The PRECICE Trauma Nail System subject of this premarket notification is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones, specifically. The Ellipse PRECICE Trauma Nail has the same technological characteristics and principles of operation as that of the predicate. The design of both devices are identical. Both devices are inserted into the intramedullary canal of the long bone and secured with locking screws. Both devices are adjusted non-invasively by the Ellipse External Remote Controller (ERC). There are no changes to the design of the PRECICE Trauma Nail being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE Trauma Nail System is applicable. These tests include mechanical testing according to the methods outlined in the standard ASTM F1264-03, validation of the gamma radiation sterilization cycle in accordance with the VDmax 35 methodology as given in ANSI/AAMI/ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6, and design verification and validation, shelf life testing for the packaging after accelerated aging, O-ring seal performance testing and biocompatibility in accordance with ISO 10993-1 for the intended use of the device. There are no changes to the design of the ERC being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE Trauma Nail System for the ERC are applicable. Conclusions can be drawn from these tests that the PRECICE Trauma Nail System is substantially equivalent to the predicate device.