(22 days)
Not Found
No
The summary describes a mechanical implant for fracture stabilization and explicitly states that AI/ML is not mentioned.
Yes
The device is described as being intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur, which is a therapeutic function.
No
Explanation: The device is described as a surgical implant (nail system) used for stabilizing fractures, not for diagnosing conditions or diseases.
No
The device description explicitly states it is a "Trochanteric Dyax Nail System" fabricated from titanium alloy, describing physical components like nails and screws, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize various types of intertrochanteric fractures of the proximal femur." This describes a surgical implant used within the body to treat a physical condition.
- Device Description: The device is described as a "nail system" fabricated from titanium alloy, designed to be implanted in the bone. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical implant used to fix a bone fracture.
N/A
Intended Use / Indications for Use
The device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.
Product codes
HSB
Device Description
This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Trochanteric Gamma® Nail System. The subject device, named the Trochanteric Dyax Nail System, is a line extension of the Trochanteric Gamma® Nail System. The predicate Trochanteric Gamma® Nail System is fabricated from stainless steel. The subject Trochanteric Dyax Nail System is fabricated from titanium alloy. The design change for the nail involves changing the proximal diameter and changing the distal screw hole diameter and configuration. The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible with the Trochanteric Dyax Nail.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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
510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness:
NOV 1 4 2001 Line Extension to the Trochanteric Gamma® Nail System
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: | October 22, 2001 |
| Device Identification | |
| Proprietary Name: | Trochanteric Dyax Nail System (formerly the
Trochanteric Gamma® Nail System) |
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod, 21 CFR §888.3020 |
This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Trochanteric Gamma® Nail System. The subject device, named the Trochanteric Dyax Nail System, is a line extension of the Trochanteric Gamma® Nail System. The predicate Trochanteric Gamma® Nail System is fabricated from stainless steel. The subject Trochanteric Dyax Nail System is fabricated from titanium alloy. The design change for the nail involves changing the proximal diameter and changing the distal screw hole diameter and configuration. The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible with the Trochanteric Dyax Nail.
The predicate Trochanteric Gamma® Nails an intramedullary rod intended to be used for stabilizing various types of intertrochanteric fractures of the proximal femur. There is no change in intended use for the modified device when compared to the previously cleared product. The subject Trochanteric Dyax Nails are substantially equivalent to the existing design of Trochanteric Gammas Nails which were determined substantially equivalent via the 510(k) process.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is enclosed within a circular border, and the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2001
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K013524
Trade/Device Name: Trochanteric Dyax Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 22, 2001 Received: October 23, 2001
Dear Ms. Ariemma:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set 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.
2
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
fo Mark N. Milkman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NOV 1 4 2001
Page 1 of 1
510(k) Number (if known): Kol 3524
Device Name: Trochanteric Dyax Nails (line extension to the Trochanteric Gamma® Nail)
Indications For Use:
The 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 A
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Mark N Millkerson
(Division Sign-Off) Division of General, Festorative and Neurological Devices K013524
510(k) Number _