(27 days)
Not Found
Not Found
No
The summary provides no information about the device's technology, and there are no mentions of AI, ML, or related concepts. The intended use is for a mechanical implant (humeral nail).
Yes
The device is indicated for fractures, which is a condition requiring treatment, and internal fixation devices like Humeral Nails are used to treat and stabilize these fractures.
No
Explanation: The device, the Telegraph® Humeral Nail, is indicated for treating fractures of the humerus, which is a therapeutic rather than a diagnostic function.
No
The device is described as a "Humeral Nail," which is a physical implant used for fracture fixation. This is a hardware device, not software.
Based on the provided information, the Telegraph® Humeral Nail is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for treating fractures of the humerus. This is a surgical implant used in vivo (within the body) to stabilize bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. The description of the Telegraph® Humeral Nail does not mention any such use or interaction with biological specimens outside the body.
Therefore, the Telegraph® Humeral Nail is a medical device, but it falls under the category of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Telegraph® Humeral Nail is indicated for proximal and/or diaphyseal fractures of the humerus.
Product codes
HSB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Key Metrics
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Ms. Christine Quendez Fournitures Hospitalières Industric ZI de Kernevez - 6 Rue Nobel Ouimper France 29000
Re: K033510
Trade/Device Name: Telegraph® Humeral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 24, 2003 Received: November 13, 2003
Dear Ms. Quendez:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) (c regary atment date of the Medical Device Amendments, or to commerce prior to may 20, 1978, the eccordance with the provisions of the Federal Food, DNIg, devices mat have been recented in quire approval of a premarket approval application (PMA). and Cosmete Act (11ct) that to not secure, subject to the general controls provisions of the Act. The I ou may, mercere, manel and not include requirements for annual registration, listing of general control.s provisions of ractice, 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 If your device is elassified (600 wor vy als. Existing major regulations affecting your device can may be subject to basil deal 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 r least be advised that I Dr i modalite of vour device complies with other requirements of the Act that 1191 has intact a and regulations administered by other Federal agencies. You must or any I caeaf statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), advening (21 CFR Part 820); and if applicable, the electronic (2000); 1050 forth in the quarty of the ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Ms. Christine Quendez
This letter will allow you to begin marketing your device as described in your Scction 510(k) I mis loter with and in yourse of substantial equivalence of your device to a legally premaired 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 if you demo specific as no liance 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 other general miornational 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,
Sincerely yours,
Mark A. 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
2
510 K Number (if known):
Device Name:
K0335/0
TELEGRAPH® HUMERAL NAIL
Indications For Use:
The Telegraph® Humeral Nail is indicated for proximal and/or diaphyseal fractures of the humerus.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | \checkmark |
| Over-The-Counter Use |
(Optional Format 1-2-96)