(352 days)
Double Engine Intramedullary Nail System is intended to be implanted into the medullary canal of tibia for alignment, stabilization, fixation of fractures caused by trauma or disease.
Double Engine Intramedullary Nail System is composed of intramedullary nails, interlocking screws, and end caps. Intramedullary nails are provided in variety of lengths and anatomical deigns to accommodate the medullary canal of long bones (tibia). Interlocking screws are used for axial compression and preventing rotation. End caps on intramedullary nails are intended to facilitate removal and to allow length adjustment of the nail.
The provided text does not contain information about acceptance criteria for a device's performance, a study proving device performance against such criteria, expert evaluations, or AI/software-related details.
The document is a 510(k) summary for the Double Engine Intramedullary Nail System, which is a physical orthopedic implant. It focuses on demonstrating substantial equivalence to a predicate device through bench tests of material properties and mechanical strength, rather than clinical performance or AI algorithm assessment.
Therefore, I cannot provide the requested information. The text describes a regulatory submission for a medical device based on physical and mechanical properties, not an AI or software device with specific performance metrics against clinical outcomes or expert ground truth.
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Premarket Notification 510(k)
MAY 2 1 2014 Section 3 510(k) Summary
This 510(k) summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: _ K131609
3.1 Date of Submission
May 31, 2013
3.2 Submission Correspondent
Mr. Da Zeng Xiamen Double Engine Medical Material Co., Ltd. No.218, Houxiang Road, Haicang District, Xiamen, 361022, China Tel: 86-0592-6087078 Fax: 86-0592-6587093 Email: zengda@Double-Engine.com; da52827@gmail.com
3.3 Proposed Device
Device Name: Double Engine Intramedullary Nail Systems
Classification: II
Product Code: HSB
Regulation Number: 21 CF 888.3020
Review Panel: Orthopedic
Material:
Double Engine Intramedullary Nail System is manufactured from titanium alloy that meets ASTM F1472.
Intended Use Statement:
Double Engine Intramedullary Nail System is intended to be implanted into the medullary canal of tibia for alignment, stabilization, fixation of fractures caused by trauma or disease.
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· 3.4 Devices Description
Double Engine Intramedullary Nail System is composed of intramedullary nails, interlocking screws, and end caps. Intramedullary nails are provided in variety of lengths and anatomical deigns to accommodate the medullary canal of long bones (tibia). Interlocking screws are used for axial compression and preventing rotation. End caps on intramedullary nails are intended to facilitate removal and to allow length adjustment of the nail.
3.5 Predicate Device Information
Synthes (USA) Tibial Nail System EX K040762
3.6 Non-Clinical Tests Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the ASTM F1264 (Standard Specification and Test Methods for Intramedullary Fixation Devices).
3.7 Substantially Equivalent Conclusion
As compared with predicate devices, equivalence for Double Engine Intramedullary Nail System is based on similarities of intended use, material, physical characteristics, geometric design, and mechanical strength. Therefore, Double Engine believes that there are sufficient evidences to conclude that the Double Engine Intramedullary Nail System is substantially equivalent to existing legally marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2014
Xiamen Double Engine Medical Material Company, Limited Mr. Da Zeng 218 Houxiang Road, Haicang District, Xiamen 3610022 Fujian China
Re: K131609
Trade/Device Name: Double Engine Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 18, 2014 Received: April 18, 2014
Dear Mr. Zeng:
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
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Page 2 - Mr. Da Zeng
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.
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Sincerely yours,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 2 Statement of Intended Use
510(k) Number: K131609
Device Name: Double Engine Intramedullary Nail System
Intend Use Statement:
Double Engine Intramedullary Nail System is intended to be implanted into the medullary canal of tibia for alignment, stabilization of fractures caused by trauma or disease.
×PRESCRIPTION USE
OVER-THE-COUNTER USE
(21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Casev
Division
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.