(21 days)
Not Found
No
The document describes a mechanical implant (intramedullary nail) and its accessories, with no mention of software, image processing, AI, or ML. The performance studies focus on mechanical testing.
Yes
The device is indicated for the treatment of various types of bone fractures, nonunions, and malunions, which are medical conditions that require therapeutic intervention to promote healing and restore function.
No
The document describes a device used to treat bone fractures, not diagnose them.
No
The device description explicitly states "Intramedullary Nail and Accessories," indicating a physical hardware device used for fracture fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implantable nail for fixing bone fractures. This is a surgical device used directly on the patient's body.
- Device Description: The description "Intramedullary Nail and Accessories" further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions in vitro (outside the body).
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only.
Product codes (comma separated list FDA assigned to the subject device)
JDS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone (femoral shaft/neck, intertrochanteric, intracapsular)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
A review of the mechanical test data indicated that the TriGen InterTAN nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivoloading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K981529, K993289, K983942, K013524, K010780
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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FEB 2, 0 2004
Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen InterTAN
Contact Person and Address
Date of Summary: January 29, 2004
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 InterTAN Common Name: Intramedullary Nail and Accessories
Device Classification Name
21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories - Class II
Indications for Use
InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only.
Mechanical and Clinical Data
A review of the mechanical test data indicated that the TriGen InterTAN nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivoloading without failure.
Substantial Equivalence Information
The substantial equivalence of the TriGen InterTAN 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), Generic Trauma Internal Fixation System (K993289), Intramedullary Nail System (K983942),the Stryker Howmedica Trochanteric Dyax Nail System (K013524), and the DePuy Trochanteric Nail (K010780).
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Ms. Kim Kelly Project Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116
Re: K040212
Trade/Device Name: TriGen InterTAN Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bonc fixation appliances and accessories Regulatory Class: II
Product Code: JDS Dated: January 29, 2004 Received: January 30, 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 Marufacturers, 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,
/ Mark N. Millbern
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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Hoala
TriGen InterTAN Indications Statement
InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only.
L. Merle N. Milkesen
Division Division of General, Restorative, and Neurological Devices
040212 510(k) Number
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _ OR