(161 days)
Not Found
No
The description focuses on mechanical components and testing, with no mention of AI/ML terms or functionalities.
Yes
The device is a system of intramedullary nails, lag screws, and distal locking cortical bone screws used for the fixation of femur fractures, indicating a direct role in treating a medical condition.
No
Explanation: This device is described as a "Hip Fracture System" designed for the "fixation of fractures of the femur." This indicates it is an orthopedic implant used for treatment (fixation), not for diagnosing conditions.
No
The device description explicitly lists hardware components: intramedullary nails, lag screws, and distal locking cortical bone screws. The performance studies also describe mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the fixation of fractures of the femur. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an intramedullary nail system with screws, which are implants used in orthopedic surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided describes a surgical implant used to treat bone fractures, which falls under the category of orthopedic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures and combinations of these fractures, pathological fractures in both diaphyseal and trochanteric areas, and nonunion or malunion.
Product codes
HSB
Device Description
The VAN Hip Fracture System includes short and long intramedullary nails, lag screws and distal locking cortical bone screws. The nail contains an angle adjust feature that allows for the neck/shaft angle to be adjusted to accommodate anatomical variations in the femoral neck angle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, femoral neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical Testing: Static and dynamic mechanical testing was performed on the VAN Hip Fracture System in accordance with ASTM F384, Standard Specifications and Test Methods of Metallic Angled Orthopedic Fracture Fixation Devices. The results demonstrate that the VAN Hip Fracture System is substantially equivalent to a predicate device in side-by-side testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR 1 0 2014
5. 510(k) Summary
| Device Trade Name: | VAN Hip Fracture System |
|---|---|
| Manufacturer: | EPIX Orthopaedic, Corp. |
| 191 Pine Lane | |
| Los Altos, CA 94022 | |
| Contact: | Ms. Michelle McDonough |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | September 30, 2013 |
| Common Name: | Intramedullary Fixation Rod |
| Classification: | 21 CFR 888.3020, Intramedullary fixation rod. |
| Class: | II |
| Product Code: | HSB |
Indications For Use:
The VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures and combinations of these fractures, pathological fractures in both diaphyseal and trochanteric areas, and nonunion or malunion
Device Description:
The VAN Hip Fracture System includes short and long intramedullary nails, lag screws and distal locking cortical bone screws. The nail contains an angle adjust feature that allows for the neck/shaft angle to be adjusted to accommodate anatomical variations in the femoral neck angle.
Predicate Device:
The VAN Hip Fracture System is substantially equivalent to the Stryker Howmedica Osteonics Gamma 3 Nail System (K032244), Biomet Vari-Angle Hip Screw (VHS) System (K964880), and Disc-O-Tech Fixion Nail (K010988).
1
Preclinical Testing:
Static and dynamic mechanical testing was performed on the VAN Hip Fracture System in accordance with ASTM F384, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. The results demonstrate that the VAN Hip Fracture System is substantially equivalent to a predicate device in side-by-side testing.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2014
EPIX Orthopaedic, Corp. % Ms. Michelle McDonough Senior Associate, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors 1331 H Street, NW, 12th Floor Washington, DC 20005
Re: K133104
Trade/Device Name: VAN Hip Fracture System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 27, 2014 Received: January 28, 2014
Dear Ms. McDonough:
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 complics 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 sct
3
Page 2 - Ms. Michelle McDonough
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
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
4
Indications for Use 4.
510(k) Number (if known):
Device Name: VAN Hip Fracture System
The VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanterie fractures, pertrochanterie fractures, subtrochanterie fractures and combinations of these fractures, pathological fractures in both diaphyscal and trochanteric areas, and nonunion or malunion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
C
{
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices