(24 days)
No
The 510(k) summary describes a mechanical orthopedic implant (humeral nail and screws) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a humeral nail, which is an implant used to stabilize fractures in the humerus, thereby restoring the anatomical integrity and function of the bone. This falls under the definition of a therapeutic device as it directly treats a medical condition.
No
The device description indicates it is a humeral nail and associated screws, intended for stabilizing fractures. It is a surgical implant, not a device used to diagnose a medical condition.
No
The device description clearly states it is a physical implant (humeral nail and screws) made of titanium, which are hardware components. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is indicated for treating bone fractures (proximal and/or diaphyseal fractures of the humerus). This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a physical implant (humeral nail and screws) made of titanium, designed to be inserted into the bone. This is a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to stabilize bone fractures.
N/A
Intended Use / Indications for Use
The titanium Telegraph humeral nail is indicated for proximal and/or diaphyseal fractures of the humerus
Product codes
HSB
Device Description
The Titanium Telegraph® Humeral Nail is designed to be inserted in the proximal extremity of the humerus. It is made of titanium (according to ASTM 136) and is available in two models: the short humeral nail (150mm) and the long humeral nail (from 210 to 310mm). All models are available in three diameters (7, 8, 9 and 10mm). These two Humeral Nail are intended to be used with cancellous screws and selfthreating cortical cotter screws, supplied by FH Industrie.
This special 510(k) is being submitted to propose clearance of the titanium selfthreating cortical cotter screws intended to be used with the Titanium Telegraph® Humeral Nail cleared in K042332. FH Industrie will manufacture and commercialize these screws. These screws are made of titanium (according to ISO 5832 and ASTM F-136) and are available in 4 lengths (24, 28, 30, 32mm) and with a 4mm diameter
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)
Risk to health have been addressed through the specified materials, Processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.
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
AUG 2 2 2005
510 (K) SUMMARY - Titanium TELEGRAPH® HUMERAL NAIL
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
SUBMITTER:
Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER, France
COMPANY CONTACT:
C.Ouendez Regulatory Affairs Manager Phone number: 33.2.98.55.68.95 Fax number: 33.2.98.53.42.13
July 27th 2005 DATE PREPARED:
DEVICE NAME:
Trade Name: Common name: Classification name: Titanium TELEGRAPH® HUMERAL NAIL Humeral Nail Intramedullary Rod
PREDICATE DEVICES:
Titanium TELEGRAPH® HUMERAL NAIL Fournitures Hospitalieres Industrie K042332
TELEGRAPH® HUMERAL NAIL. Fournitures Hospitalieres Industrie K033510
DEVICE DESCRIPTION :
The Titanium Telegraph® Humeral Nail is designed to be inserted in the proximal extremity of the humerus. It is made of titanium (according to ASTM 136) and is available in two models: the short humeral nail (150mm) and the long humeral nail (from 210 to 310mm). All models are available in three diameters (7, 8, 9 and 10mm). These two Humeral Nail are intended to be used with cancellous screws and selfthreating cortical cotter screws, supplied by FH Industrie.
This special 510(k) is being submitted to propose clearance of the titanium selfthreating cortical cotter screws intended to be used with the Titanium Telegraph® Humeral Nail cleared in K042332. FH Industrie will manufacture and commercialize these screws.
1
These screws are made of titanium (according to ISO 5832 and ASTM F-136) and are available in 4 lengths (24, 28, 30, 32mm) and with a 4mm diameter
INTENDED USE :
The titanium Telegraph® humeral nail is indicated for proximal and/or diaphyseal fractures of the humerus
TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICES :
The proposed Titanium Telegraph® Humeral nail is now provided with sterile cancellous screws and sterile self-threating cortical cotter screws. It has exactly the same intended use and same design as the predicate devices. No change was made on the design and material and of the humeral nail. Diameters and lengths remain unchanged.
The main difference between the new and the previous devices is that these self-threating cortical cotter screws will be manufactured in titanium and supplied with the device. The screws are all made of the same material (titanium), have the same design and are available in similar diameters and lengths.
PERFORMANCE DATA:
Risk to health have been addressed through the specified materials, Processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.
CONCLUSION:
All these elements show the safety and effectiveness of our product. The titanium Telegraph® Humeral Nail is substantially equivalent to the selected predicate devices in terms of intended use, safety, and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Ms. Christine Quendez Regulatory Affairs Manager Fournitures Hospitaliéres Industrie ZI de Kernevez, 6 Rue Nobel 29000 Quimper, France
Re: K052058
Trade/Device Name: TITANIUM TELEGRAPH HUMERAL NAIL Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 27, 2005 Received: August 3, 2005
Dear Ms. Quendez:
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.
3
Page 2 - Ms. Christine Quendez
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse FDA finding of substantial equivalence of your device to a legally premated 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 11 you assno specific and Compliance at (240) 276-0120. 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 golferal micronational 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,
Aubau Inelund
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KOC2058 510(k) Number (if known): TITANIUM TELEGRAPH HUMERAL NAIL Device Name:
The titanium Telegraph humerail nail is indicated for Indications for Use: proximal and/or diaphyseal fractures of the humerus
Prescription Use >> (Part 21 CFR 801 Subpart D) AND/OR
Over the counter Use (21 CFR 801 Subpart C)
510(k) Number_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Barbara Bruetus for MK
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K052058 |