(29 days)
No
The document describes a mechanical implant (intramedullary nail) and its indications for use, with no mention of AI or ML technology.
Yes
The device is used for the fixation of fractures, nonunions, and malunions in long bones, which are conditions that impair normal body function, thus having a therapeutic effect.
No
The provided text describes interlocking intramedullary nails, which are used for fracture fixation and reconstruction. This is a therapeutic device, not a diagnostic one.
No
The 510(k) summary describes an "Intramedullary Nail," which is a physical implant used for bone fixation. The summary focuses on mechanical testing and predicate devices that are also physical implants, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device used for the fixation of bone fractures and other orthopedic conditions within the body (in vivo). IVDs are used to examine specimens taken from the body (in vitro) to provide information about a patient's health.
- Device Description: While the description is "Not Found," the intended use strongly suggests a physical implantable device.
- No mention of biological samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which is characteristic of IVDs.
- Anatomical Site: The anatomical sites are "long bones" and "femoral head," which are locations within the body where surgical procedures are performed.
- Performance Studies: The performance study focuses on mechanical testing and in vivo loading, which is relevant to the structural integrity of an implantable device, not the analytical performance of an IVD.
Therefore, the information provided indicates a surgical implant used for orthopedic procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following rumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Trochanteric Antegrade Nail is for single use only.
Product codes
HSB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
A review of the mechanical test data indicated that the TriGen Trochanteric Antegrade Nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
Key Metrics
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 2 3 2004
K040462
page 1 of 1
Date of Summary: February 20, 2004
Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen Trochanteric Antegrade Nail
Contact Person and Address Kim Kelly Project Manager, Regulatory/Clinical Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566
Name of Device: TriGen Trochanteric Antegrade Nail Common Name: Intramedullary Nail
Device Classification Name
21 CFR 888.3020 Intramedullary fixation rod - Class II
Indications for Use
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Trochanteric Antegrade Nail is for single use only.
Mechanical and Clinical Data
A review of the mechanical test data indicated that the TriGen Trochanteric Antegrade Nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The substantial equivalence of the TriGen Trochanteric Antegrade Nail is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices – Smith & Nephew's Titanium Nail System (K981529) and Intramedullary Nail System (K983942).
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized symbol that consists of three wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2004
Ms. Kim Kelly Project Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116
Re: K040462
Trade/Device Name: TriGen Trochanteric Antegrade Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 20, 2004 Received: March 8, 2004
Dear Ms. Kelly:
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
Page 2 - Ms. Kim Kelly
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark M. Milliman
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
3
TriGen Trochanteric Antegrade Nail Indications Statement
040462
page 1 of 1
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following turnor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Trochanteric Antegrade Nail is for single use only.
Mark N Milkeon
Restorative,
510(k) Number K040462
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_