(38 days)
Not Found
No
The summary describes a mechanical implant (humeral nail and screws) and its mechanical performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is an intramedullary nail used to stabilize fractures, which is a therapeutic intervention.
No
The device is an intramedullary nail used for stabilizing fractures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device is made of titanium and includes physical components like nails and screws, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating fractures of the humerus, which is a surgical intervention on the human body.
- Device Description: The device is a physical implant (humeral nail and screws) made of titanium, designed to be surgically inserted.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device described is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The titanium Telegraph® humeral nail is indicated for fractures of the upper extremity and/or the diaphysis of the humerus.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The titanium Telegraph® humeral nails are made of titanium and are available in two models :
- a short humeral nail (150mm length)
- a long humeral nail (from 210 to 310mm).
- These two models are available in four diameters: 7, 8, 9 and 10mm. These titanium humeral nails are intended to be used with titanium cancellous screws, available in 15 lengths (from 24 to 50mm) and with a 4mm diameter. The titanium Telegraph® humeral nail and the screws are supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity and/or the diaphysis of the 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)
Performance testing was performed in accordance with the recommendations set up in the FDA guidance document "Reviewers Guidance Checklist for Intramedullary Rods". The following tests were performed to validate the mechanical characteristics of the Titanium Telegraph humeral nail (according to ASTM F 1264-00 standard):
- Flexion test on 6 titanium Telegraph humeral nail
- Torsion test on 6 titanium Telegraph humeral nail
All results demonstrate that the proposed device is in accordance with the mechanical resistances required by the ASTM F 1264-00 standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 888.3020 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.
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Image /page/0/Picture/0 description: The image is a logo with the letters FH in a circle. The circle is surrounded by a gear-like design. Below the circle are the words "FOURNITURES HOSPITALIERES" in a rectangular box. Above the circle are the letters "G R O U P E".
- rue Nobel Z.I. DE KERNÉVEZ 29000 QUIMPER
FRANCE
Tél : 02 98 55 68 95
Fax : 02 98 53 42 13
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K 042372
OCT 7 - 2004
510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS TITANIUM TELEGRAPH® HUMERAL NAIL
SPONSOR IDENTIFICATION: Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER - FRANCE Tel: (33) 2.98.55.68.95 Fax: (33) 2.98.53.42.13
ESTABLISHMENT REGISTRATION NUMBER: 3003898228
OFFICIAL CONTACT PERSON: Christine QUENDEZ Regulatory Affairs Manager E-mail: fhi.rd@wanadoo.fr
Image /page/0/Picture/24 description: The image is a logo with the letters AFAQ stacked on top of each other. The letters are in a bold, sans-serif font. The top half of the logo is black, and the bottom half is white. Below the letters, the text "ISO 9001" is printed. Below that, the text "AFAQ N°1990/034 a" is printed.
DEVICE TRADE NAME: COMMON NAME: Intramedullary rod REGULATORY CLASS: Class II
DEVICE PRODUCT CODE:
DATE PREPARED:
PANEL CODE:
TITANIUM TELEGRAPH® HUMERAL NAIL 87 HSB 21 CFR 888.3020
Image /page/0/Picture/12 description: The image shows a logo with the letters 'G MED' stacked on top of each other. The 'G' is larger and bolder than 'MED'. Below the logo, the text 'EN 46001' is displayed. The logo appears to be a certification mark or symbol related to medical devices or quality management systems.
DEVICE DESCRIPTION:
The titanium Telegraph® humeral nails are made of titanium and are available in two models :
AUGUST 23th, 2004
- a short humeral nail (150mm length)
- a long humeral nail (from 210 to 310mm).
Image /page/0/Picture/17 description: The image shows a logo with a square border. Inside the square, there is a stylized letter "S" formed by two curved shapes, one above the other. Below the "S", the word "SHITEM" is written in a bold, sans-serif font. The logo appears to be for a company or organization with the name "SHITEM".
- These two models are available in four diameters: 7, 8, 9 and 10mm. These titanium humeral nails are intended to be used with titanium cancellous screws, available in 15 lengths (from 24 to 50mm) and with a 4mm diameter. The titanium Telegraph® humeral nail and the screws are supplied sterile.
INDICATIONS FOR USE:
The titanium Telegraph® humeral nail is indicated for fractures of the upper extremity and/or the diaphysis of the humerus.
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PREDICATE DEVICES:
The titanium Telegraph® humeral nail is similar to the Telegraph® humeral nail previously cleared in K033510.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
The proposed titanium Telegraph nails have the same intended use and indications for use as the predicate device. Design and manufacturing process is the same.
The only difference is the modification of the material. The proposed devices are made of titanium alloy according to ISO 5832/3 and ASTM F-136 standards. Performance tests were performed. Our proposed devices and the predicate devices were found to have results in compliance with the selected standard.
| Titanium Telegraph® Humeral nail | Telegraph® Humeral nail | |
|---|---|---|
| Manufacturer | F.H.I | F.H.I |
| 510 K number | Pending | K033510 |
| Intended use | Intended for fractures of the upper extremity | |
| and/or the diaphysis of the humerus. | Intended for use for proximal and/or | |
| diaphyseal fractures of the humerus. | ||
| Material | Titanium alloy | Stainless steel |
| Cylindrical | Yes | Yes |
| Sizes | ||
| Diameter | ||
| Length | Ø 7, 8, 9 and 10 mm | |
| Short nail: 150 mm | ||
| Long nail: 210, 230, 250, 270, 290, 310 mm | Ø 7, 8 and 9 mm | |
| Short nail: 150 mm | ||
| Long nail: 210, 230, 250, 270, 290, 310 mm | ||
| Interlocking | ||
| screws | Proximal: 3 self-stable screws | |
| Distal: 2 screws in the frontal plane | Proximal: 3 self-stable screws | |
| Distal: 2 screws in the frontal plane | ||
| Performance | ||
| tests | Flexion tests on 6 Titanium nail Ø7 and | |
| 310mm length, | ||
| Torsion tests on 6 Titanium nail Ø7 and | ||
| 310mm length. | ||
| (according to ASTM F 1264-00) | Flexion tests on 6 Titanium nail Ø7 and | |
| 310mm length, | ||
| Torsion tests on 6 Titanium nail Ø7 and | ||
| 310mm length. | ||
| (according to ASTM F 1264-00) | ||
| Sterile | Yes (Gamma) | Yes (Gamma) |
The following comparative table is provided to further demonstrate equivalence:
PERFORMANCES:
। -
Performance testing was performed in accordance with the recommendations set up in the FDA guidance document "Reviewers Guidance Checklist for Intramedullary Rods". The following tests were performed to validate the mechanical characteristics of the Titanium Telegraph humeral nail (according to ASTM F 1264-00 standard):
- Flexion test on 6 titanium Telegraph humeral nail
- Torsion test on 6 titanium Telegraph humeral nail
All results demonstrate that the proposed device is in accordance with the mechanical resistances required by the ASTM F 1264-00 standard.
CONCLUSION:
All these elements show the safety and effectiveness of our product. Our titanium Telegraph humeral nails are substantially equivalents to the Telegraph humeral nail cleared in K033510 in terms of intended use, design, safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2004
Christine Quendez Regulatory Affairs Manager Fournitures Hospitalieres Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 Quimper-France
Re: K042332
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: August 23, 2004 Received: August 30, 2004
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.
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Page 2 - Christine Quendez
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 (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 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,
Mark N. Mikkelsen
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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Indications for Use
510(k) Number (if known):
Device Name:
Titanium TELEGRAPH® Humeral Nail
Indications for Use:
The TELEGRAPH® Humeral Nail is indicated for fractures of the upper extremity and/or the diaphysis of the humerus.
Mark A. Millman
Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number.
Prescription Use Х (Part 21 CFR 801 Subpart D) AND/OR
Over the counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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