(21 days)
Not Found
Not Found
No
The summary describes a mechanical device (an intramedullary rod) with a design modification to its curvature. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes.
The device is used for the fixation of femoral fractures, which is a therapeutic intervention.
No
Explanation: The device is an intramedullary rod used for fixation of femoral fractures. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an intramedullary rod, which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of femoral fractures." This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an "intramedullary rod," which is a surgical implant used to stabilize bones.
- Anatomical Site: The device is used directly on the "femoral fractures," which is an in-vivo application.
- IVD Definition: In vitro diagnostics are tests performed on samples (like blood, urine, or tissue) taken from the human body to detect diseases, conditions, or infections. This device does not fit that description.
The device is a surgical implant used for orthopedic fixation.
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
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 intramedullary 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 fractures. The modified Long Length Gamma® Nails are substantially equivalent to the existing design of Long Length Gamma® Nail which was determined substantially equivalent via the 510(k) process. The materials used to manufacture the modified device are identical to 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 fractures, femoral neck, femoral shaft
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)
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
Special 510(k) Summary of Safety and Effectiveness:
Device Modifications to the Long Length Gamma Nail
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|---------------------------------------------------------------------|
| Contact Person: | Karen Ariemma
Regulatory Affairs Specialist |
| Date of Summary Preparation: | July 10, 2001 |
| Device Identification | |
Long Length Gamma® Nail Proprietary Name: Intramedullary Nail Common Name: Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020
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 intramedullary 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 fractures. The modified Long Length Gamma® Nails are substantially equivalent to the existing design of Long Length Gamma® Nail which was determined substantially equivalent via the 510(k) process. The materials used to manufacture the modified device are identical to those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product.
1 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2001 AUG
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
K012158 Re :
Long Length Gamma® Nails Trade/Device Name: 888.3020 Regulation Number: Requlatory Class: II Product Code: HSB Dated: July 10, 2001 Received: July 11, 2001
Dear Ms. Ariemma:
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 be basyood of bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
2
Page 2 - Ms. Ariemma
this response to your premarket notification submission does this response to your premained on the have under sections 531 not arrect any obligation for devices under the Electronic through 542 of the Act 101 xovisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as a This lecter will arrow your warket notification. The FDA described in your 510 (K) promazios of your device to a legally marketed predicate device results in a classification for your marketed predicate device robated in the market.
If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulation (21 cm fare son and son and the Office of
vitro diagnostic devices), please contact the for guegti Compliance at (301) 594-4692. Additionally, for questions on Compliance at (301) 354 ining of your device, please contact the Dromocion and adversibling on July 2019 - Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance Obcalled from the Browbion (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
втилелиноко
Celia M. Witten, Ph.D., M.D. Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): K___________________________________________________________________________________________________________________________________________________
Device Name: Long Length Gamma® Nails
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 X
OR
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Asmuklellertpmcuu
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K012158