(85 days)
K 951740, K 010901
Not Found
No
The device description and performance studies focus on mechanical properties and standard testing, with no mention of AI or ML.
No
The device is an orthopedic implant for fixing bone fractures, which is a structural support function, not a therapeutic activity.
No
The description states that the device is an intramedullary nail for fixing fractures, which indicates a therapeutic rather than a diagnostic purpose. There is no mention of it being used to diagnose conditions or process diagnostic images.
No
The device description explicitly details a physical implant (humeral nail and screws) made of stainless steel with specific dimensions and features for bone fixation. This is a hardware medical device, not software-only.
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 by providing internal fixation. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (a humeral nail and screws) made of stainless steel, designed to be inserted into the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to stabilize bone fractures.
N/A
Intended Use / Indications for Use
Telegraph Humeral nail with locking screws is intended to be used for proximal and/or diaphyseal fractures of the humerus.
Telegraph® Humeral nail is indicated for proximal and/or diaphyseal fractures of the humerus.
Product codes
HSB
Device Description
The Telegraph® Humeral nail is designated to be inserted in the proximal extremity of the humerus. It is constructed from stainless steel (ISO 5832/1), length 150 mm for the short humeral nail or 210 to 310 mm length for the long humeral nail, all models are available in three diameters : 7, 8 and 9 mm. It has three proximal and two distal holes for 4.0 mm diameter, fully-threaded screws suitable for cancellous fixation of small bone fragments. The two distal holes can if necessary be used for locking. But its advantages result mainly from the possibilities afforded by the tree proximal screwholes.
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)
Performance characteristics of Telegraph® Humeral nail have been tested and approved through mechanical test according to standard ASTM.F-1264: Standard Specification and Test Methods for Intramedullary Rods. Moreover, verification, validation and design control activities demonstrate the safety and effectiveness of the Telegraph® Humeral Nail.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 951740, K 010901
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
Sponsor: Innervisions
DEC 2 4 2002
023241
page 1 of 2
510 (K) SUMMARY - TELEGRAPH® Humeral Nail
| Submitter name: | Fournitures Hospitalières Industrie |
|---|---|
| Submitter adress: | 6 Rue Nobel, Z.I. de Kernevez |
| QUIMPER, France 29000 | |
| Contact person: | C.QUENDEZ |
| Phone Number: | 33.2.98.55.68.95 |
| Fax Number: | 33.2.98.53.42.13 |
| Date prepared: | September 20, 2002 |
| Device Trade Name: | Telegraph® Humeral Nail |
| Device common name: | Humeral Nail |
| Classification name: | Intramedullary fixation rod |
| Predicate Devices: | Polarus |
| Acumed Inc. | |
| K 951740 | |
| Fixion™™ Intramedullary Nailing System | |
| Disc-O-Tech Medical Technologies, Inc. | |
| K 010901 | |
| Device description: | The Telegraph® Humeral nail is designated to be inserted in the |
| proximal extremity of the humerus. It is constructed from stainless steel | |
| (ISO 5832/1), length 150 mm for the short humeral nail or 210 to 310 | |
| mm length for the long humeral nail, all models are available in three | |
| diameters : 7, 8 and 9 mm. It has three proximal and two distal holes for | |
| 4.0 mm diameter, fully-threaded screws suitable for cancellous fixation | |
| of small bone fragments. | |
| The two distal holes can if necessary be used for locking. But its | |
| advantages result mainly from the possibilities afforded by the tree | |
| proximal screwholes. | |
| Intended use: | Telegraph® Humeral nail with locking screws is intended to be used for |
| proximal and/or diaphyseal fractures of the humerus. | |
| Device Technological | |
| Characteristics and | |
| Comparison to Predicate | |
| Devices: | The Telegraph® Humeral Nail has the same intended use, is made of |
| the same material, is available in similar diameters and lengths, and | |
| has a similar design as the predicate devices. |
1
Performance characteristics of Telegraph® Humeral nail have been Performance Data: tested and approved through mechanical test according to standard ASTM.F-1264: Standard Specification and Test Methods for Intramedullary Rods. Moreover, verification, validation and design control activities demonstrate the safety and effectiveness of the Telegraph® Humeral Nail.
The Telegraph Humeral Nail is substantially equivalent to predicate Conclusion: device in terms of intended use, safety, and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text appears to be part of a document or sign.
DEC 24 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fournitures Hospitalieres Industrie c/o M. Frank Lewis President InnerVision, Inc. 6258 Shady Grove Road East Memphis, Tennessee 38120
Re: K023241
Trade/Device Name: Telegraph Humeral Nail Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 5, 2002 Received: September 30, 2002
Dear Mr. Lewis:
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
3
Page 2 -- Mr. M. Frank Lewis
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.
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Alan Watt
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
4
.
INTENDED USES / INDIC TIONS
510 K Number (if known):
Device Name:
.
- 1
TELEGRAPH® Humeral Nail With Locking Screws
.
Indications For Use:
Telegraph® Humeral nail is indicated for proximal and/or diaphyseal fractures of the humerus.
Wha witts
(Division Sign-Off) (Division of General, Restorative and Neuron of General, Resto
510(k) Number K023241