(15 days)
Not Found
Not Found
No
The description focuses on a mechanical modification (radius of curvature) of an intramedullary rod for fracture fixation and makes no mention of AI or ML.
Yes
The device is described as an intramedullary rod used for the fixation of femoral fractures, which fits the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as an "intramedullary rod intended to be used in the fixation of femoral fractures." Its purpose is to treat or fix fractures, not to diagnose them.
No
The device description clearly states it is an intramedullary rod, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text clearly describes the device as an "intramedullary rod intended to be used in the fixation of femoral fractures." This is a surgical implant used directly within the body to stabilize broken bones.
- Intended Use: The intended use is to fix femoral fractures, which is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The intended use of the modified Long Length Gamma® Nail is identical to that of the predicate Long Length Gamma® Nail: the product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.
Product codes (comma separated list FDA assigned to the subject device)
87 HSB
Device Description
This Special 510(k) submission is intended to address a design modification to the predicate Long Length Gamma® Nail. The existing Long Length Gamma® Nail is an intramedially rod intended to be used in the fixation of femoral fractures 'occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The design modification involves changing the radius of curvature in the A-P plane. The modified device will allow the surgeon greater intraoperative flexibility in treating a variety of femoral The modified Long Length Gamma® Nails are substantially equivalent to the fractures. existing design of Long Length Gamma® Nails, which were cleared for marketing via the The materials used in the manufacture of the modified device are identical to 510(k) process. those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck, intercondylar notch
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/2 description: The image contains a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'K993670'. The characters are written in a simple, clear style, with consistent stroke thickness. The image is in black and white, with the characters standing out against the background.
Nov | 6 1999
Special 510(k) Summary - Device Modification Summary of Safety and Effectiveness for the Modified Long Length Gamma® Nail
| Proprietary Name: | Long Length Gamma® Nail |
|---|---|
| Common Name : | Intramedullary Rod |
| Classification Name and Reference : | 21 CFR 888.3020 Intramedullary Fixation Rod |
| Proposed Regulatory Class : | Class II |
| Device Product Code : | 87 HSB |
| For Information contact: | Nancy Rieder |
| Regulatory Affairs | |
| Howmedica Osteonics Corp. | |
| 359 Veterans Boulevard | |
| Rutherford, N.J. 07070 | |
| (201) 507-7956 | |
| Fax: (201) 507-6870 |
This Special 510(k) submission is intended to address a design modification to the predicate Long Length Gamma® Nail. The existing Long Length Gamma® Nail is an intramedually rod intended to be used in the fixation of femoral fractures 'occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The design modification involves changing the radius of curvature in the A-P plane. The modified device will allow the surgeon greater intraoperative flexibility in treating a variety of femoral The modified Long Length Gamma® Nails are substantially equivalent to the fractures. existing design of Long Length Gamma® Nails, which were cleared for marketing via the The materials used in the manufacture of the modified device are identical to 510(k) process. those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product.
' Historically, Howmedica Osteonics has intended this product to be used in fracture management as a result of trauma, non-unions, mal-unions, pathological fractures, and impending pathological fractures.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Ms. Margaret Crowe Howmedica Osteonics 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
K993670 Re: Long Length Gamma® Nail Trade Name: Regulatory Class: II Product Code: HSB October 29, 1999 Dated: Received: November 1, 1999
Dear Ms. Crowe:
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 registration, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulatory 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.
2
Page 2 - Ms. Margaret Crowe
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 requlation (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 requlation 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,
James F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993670
Long length Gamma® Nail Device Name:
Indications For Use:
The intended use of the modified Long Length Gamma® Nail is identical to that of the predicate Long Length Gamma® Nail: the product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.
(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
Over-The-Counter Use
(Optional Format 1-2-96)