(28 days)
Not Found
No
The summary describes a mechanical implant (intramedullary nail) and its intended use for fracture fixation. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The performance studies focus on mechanical testing.
Yes
The device is an intramedullary nail system used to treat fractures, non-unions, and malalignments of the humerus, which are therapeutic interventions.
No
The "Intended Use / Indications for Use" section specifies that the TriGen Straight Humeral Nail System is indicated for treating fractures and other bone conditions, rather than for diagnosing them. The device description identifies it as an "Intramedullary Nail," which is an implant used in surgical repair.
No
The device description explicitly states "Intramedullary Nail," which is a physical hardware implant. The intended use also describes a system for treating bone fractures, further indicating a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating fractures and other conditions of the humerus (a bone). This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as an "Intramedullary Nail," which is a surgical implant used to stabilize bones.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status or disease
- Using reagents or assays
IVDs are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical implant used to fix a broken bone.
N/A
Intended Use / Indications for Use
The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System 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
humerus
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)
A review of the mechanical test data indicated that the TriGen Straight Humeral Nail System is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
OCT - 1 2003
Ko327da
page 1 of 1
Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen Straight Humeral Nail System
Contact Person and Address
Date of Summary: September 2, 2003
Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-5153
Name of Device: TriGen Straight Humeral Nail System Common Name: Intramedullary Nail
Device Classification Name
21 CFR 888.3020 Intramedullary Fixation Rod - Class II
Indications for Use
The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only.
Mechanical and Clinical Data
A review of the mechanical test data indicated that the TriGen Straight Humeral Nail System 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 Straight Humeral Nail System 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), Smith & Nephew's Intramedullary Nail System (K983942), and Acumed's Polarus nails (K951740).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wing, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT = 1 2003
Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. 1450 East Brooks Road Memphis, Tennessee 38116
Re: K032722
Trade/Device Name: TriGen Straight Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Inrtramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 2, 2003 Received: September 4, 2003
Dear Ms. Akil:
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. Janet Johnson Akil
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 yours,
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
K03a7a2
TriGen Straight Humeral Nail System Indications Statement
The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only.
Marli N. Mellema
Restorative and Neuro 510(k) Number -
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use