(72 days)
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Not Found
No
The summary describes a mechanical implant for fracture stabilization and makes no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
This device is intended for stabilizing fractures, which is a structural support function rather than a therapeutic treatment for disease or illness.
No
Explanation: The device description states its purpose is to stabilize intertrochanteric fractures, making it a therapeutic device, not a diagnostic one. It doesn't mention any function related to identifying or analyzing medical conditions.
No
The device description clearly states it is a "family of femoral nails, lag screws set screws rno cap screws for intramedullary nailing of proximal femoral fractures," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilizing various types of intertrochanteric fractures of the proximal femur." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a system of "femoral nails, lag screws set screws rno cap screws for intramedullary nailing of proximal femoral fractures." These are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
This device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.
Product codes
HSB
Device Description
The Gamma® Locking Nail System consist of a family of femoral nails, lag screws set screws rno cap screws for intramedullary nailing of proximal femoral fractures. This line extension is a and ouplification of the currently marketed Gamma nails cleared under various 510(k) notifications. mounter, or the builter, rounder nails will retain the major design features of the previously cleared Gamma nails and will be made from Orthinox® stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
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
510(k) Summary
7 1813
Gamma® Locking Nail System Proprietary Name: Common Name: Femoral Nail Intramedullary Fixation Rod Classification Name & 21 CFR 888.3020 Reference: Proposed Regulatory Class: II 87HSB Device Product Code:
For information contact:
Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870
The Gamma® Locking Nail System consist of a family of femoral nails, lag screws set screws rno cap screws for intramedullary nailing of proximal femoral fractures. This line extension is a and ouplification of the currently marketed Gamma nails cleared under various 510(k) notifications. mounter, or the builter, rounder nails will retain the major design features of the previously cleared Gamma nails and will be made from Orthinox® stainless steel.
This device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.
The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to Howmedica's Standard and Long Gamma Locking Nails and Howmedica's Omega Compression Hip Screw System.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping, curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1997
Ms. Vivian Kelly Manger, Requlatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
K972813 Re: Trade Name: Gamma® Nail Line Extension Requlatory Class: II Product Code: нав Dated: July 28, 1997 Received: July 29, 1997
Dear Ms. Kelly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ್ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Vivian Kelly
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
Indications for Use
510(k) Number (if known): K97 2813
Device Name: Gamma® Nail Line Extension
Indications for Use:
This device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
יי י
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off) Division of General Restorative Device 510(k) Number