(254 days)
No
The summary describes a mechanical implant (humeral nailing system) and its materials and testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes.
The device is described as an intramedullary nailing system intended for the treatment of fractures of the humerus, making it a device used for treating a medical condition.
No
This device is an intramedullary nailing system used for the treatment of humerus fractures, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it includes physical components (nails, screws, washer) made of titanium alloy, which are implanted into the body. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this is a "Humeral Nailing System" which includes "intramedullary cannulated humeral nails, proximal screws and a washer." These are implants designed to be surgically placed inside the body to fix bone fractures.
- Intended Use: The intended use is for the "Fracture of the proximal extremity of the humerus. Fracture of the diaphysis of the humerus." This is a therapeutic use, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic tests.
This device is a surgical implant used for the treatment of bone fractures.
N/A
Intended Use / Indications for Use
Fracture of the proximal extremity of the humerus. Fracture of the diaphysis of the humerus.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The FH Industrie TELEGRAPH® EVOLUTION Humeral Nailing System includes short and long intramedullary cannulated humeral nails with right and left orientations, proximal screws and a washer. The nails, screws, and washer are intended for use in treatment of fracture of the proximal extremity of the humerus or fracture of the diaphysis of the humerus. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The nails that are the subject of this submission are cannulated.
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
Prescription Use
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)
Sterilization (ISO 11137), packaging (ISO 11607), and biocompatibility (ISO 10993-1) validations and rationales were conducted and provided to demonstrate substantial endotoxin levels were evaluated using LAL pyrogen testing.
Mechanical testing has been performed per ASTM F1264 and ASTM F543 on the subject TELEGRAPH® EVOLUTION Humeral Nailing System and the results have shown them to be substantially equivalent to the predicate device.
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.
K033510, K023241, K042332, K133376
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
October 1, 2020
FH Industrie % Kathy L. Remsen, MS, MBA, CTBS Principal Consultant MRC Global 9085 East Mineral Circle, Suite 110 Centennial, CO 80112 USA
Re: K200127
Trade/Device Name: TELEGRAPH® EVOLUTION Humeral Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 1, 2020 Received: September 1, 2020
Dear Kathy Remsen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200127
Device Name TELEGRAPH® EVOLUTION Humeral Nailing System
Indications for Use (Describe) Fracture of the proximal extremity of the humerus. Fracture of the diaphysis of the humerus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary FH Industrie TELEGRAPH® EVOLUTION Humeral Nailing System October 1, 2020
| Company: | FH INDUSTRIE
ZI DE KERNEVEZ-6 RUE NOBEL
QUIMPER Finistere, FRANCE 29000
Tel: +33 2 98 55 68 95 |
|-------------------------|-------------------------------------------------------------------------------------------------------------|
| Company Contact: | Patricia DONNARD -- FH Industrie
Naoual RAHIMI- FH Industrie |
| Official Correspondent: | Kathy L. Remsen -- MRC Global
9085 E. Mineral Circle, Suite110
Centennial, CO 80112
901-606-4856 |
| Secondary Contact: | Christine Scifert -- MRC Global
9085 E. Mineral Circle, Suite110
Centennial, CO 80112
901-831-8053 |
| Trade Name: | TELEGRAPH® EVOLUTION Humeral Nailing System |
| Common Name: | Rod, Fixation, Intramedullary and Accessories |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3020 (Intramedullary fixation rod) |
| Panel: | Orthopedic |
| Product Code: | HSB |
Device Description:
The FH Industrie TELEGRAPH® EVOLUTION Humeral Nailing System includes short and long intramedullary cannulated humeral nails with right and left orientations, proximal screws and a washer. The nails, screws, and washer are intended for use in treatment of fracture of the proximal extremity of the humerus or fracture of the diaphysis of the humerus. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The nails that are the subject of this submission are cannulated.
Indications for Use:
Fracture of the proximal extremity of the humerus. Fracture of the diaphysis of the humerus.
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Substantial Equivalence:
The subject TELEGRAPH® EVOLUTION Humeral Nailing System components are substantially equivalent with respect to indications for use, design, dimension, and materials to the following devices, previously cleared by the FDA:
Primary Predicate:
-
. FH Industrie: Modification to TELEGRAPH® HUMERAL NAIL – K033510
Secondary Predicates: -
. FH Industrie: TELEGRAPH® HUMERAL NAIL-K023241
-
FH Industrie: TITANIUM TELEGRAPH® HUMERAL NAIL – K042332
-
Tornier: AEQUALIS HUMERAL NAIL SYSTEM - K133376
Reference Devices (Biocompatibility predicates): -FH Industrie: CALCANAIL Orthopedic Nail - K150463 -FH Industrie: CALCANAIL Orthopedic Arthrodesis Nail -- K150471
Comparison of Technological Characteristics:
The Indications for Use, Materials, and Geometry for predicate devices are all similar to those of the subject device. The indication of both the subject and predicate devices include the treatment of proximal and diaphyseal fractures of the humerus. Although the material of the subject device is different than that of the primary predicate, it is identical to the material of the secondary predicates. The subject device is of similar geometry to the predicate devices and is offered in a range of sizes as that is within the size range of the predicate devices. However, unlike the primary predicate, the subject humeral nail is cannulated. Comparison of mechanical test results of the worst case subject cannulated nail to the worst case predicate device showed substantially equivalent results. Thus, it can be concluded that the subject device does not raise new questions about safety and effectiveness.
Performance Testing:
Sterilization (ISO 11137), packaging (ISO 11607), and biocompatibility (ISO 10993-1) validations and rationales were conducted and provided to demonstrate substantial endotoxin levels were evaluated using LAL pyrogen testing.
Mechanical testing has been performed per ASTM F1264 and ASTM F543 on the subject TELEGRAPH® EVOLUTION Humeral Nailing System and the results have shown them to be substantially equivalent to the predicate device.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.