(85 days)
Telegraph® Humeral nail with locking screws is intended to be used for proximal and/or diaphyseal fractures of the humerus.
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.
Here's an analysis of the provided text regarding the Telegraph® Humeral Nail, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Conformity to ASTM F-1264 | Performance characteristics tested and approved through mechanical tests according to standard ASTM F-1264. |
| Safety and Effectiveness: | |
| General safety and effectiveness (as per predicate device) | Verification, validation, and design control activities demonstrate the safety and effectiveness of the Telegraph® Humeral Nail. |
| Substantial Equivalence to Predicate Device | Concluded to be substantially equivalent to predicate devices in terms of intended use, safety, and effectiveness. |
| Intended Use: Used for proximal and/or diaphyseal fractures of the humerus. | The device is intended to be used for proximal and/or diaphyseal fractures of the humerus. |
| Material: Constructed from stainless steel (ISO 5832/1). | Constructed from stainless steel (ISO 5832/1). |
| Dimensions: Lengths 150 mm (short) or 210-310 mm (long); Diameters 7, 8, 9 mm. | Length 150 mm for short, or 210 to 310 mm for long; all models in three diameters: 7, 8 and 9 mm. |
| Fixation Holes: Three proximal and two distal holes for 4.0 mm screws. | Three proximal and two distal holes for 4.0 mm diameter, fully-threaded screws. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a mechanical testing study performed according to a recognized standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of humeral nails) used in the mechanical testing.
- Data Provenance: Not specified, but generally, mechanical testing data for device submissions like this would be generated in a lab setting rather than from patient data. The manufacturer is based in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study described is a mechanical performance test against an engineering standard, not a clinical study requiring expert assessment of ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is a mechanical performance test, not a clinical study requiring adjudication of findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission focuses on mechanical equivalence and safety/effectiveness based on predicate device comparison and engineering testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical medical device (intramedullary nail), not a software or AI product.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is adherence to the ASTM F-1264 standard for intramedullary rods. This standard defines the required mechanical properties and test methods.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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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 KernevezQUIMPER, 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: | PolarusAcumed Inc.K 951740Fixion™™ Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Inc.K 010901 |
| Device description: | The Telegraph® Humeral nail is designated to be inserted in theproximal extremity of the humerus. It is constructed from stainless steel(ISO 5832/1), length 150 mm for the short humeral nail or 210 to 310mm length for the long humeral nail, all models are available in threediameters : 7, 8 and 9 mm. It has three proximal and two distal holes for4.0 mm diameter, fully-threaded screws suitable for cancellous fixationof small bone fragments.The two distal holes can if necessary be used for locking. But itsadvantages result mainly from the possibilities afforded by the treeproximal screwholes. |
| Intended use: | Telegraph® Humeral nail with locking screws is intended to be used forproximal and/or diaphyseal fractures of the humerus. |
| Device TechnologicalCharacteristics andComparison to PredicateDevices: | The Telegraph® Humeral Nail has the same intended use, is made ofthe same material, is available in similar diameters and lengths, andhas a similar design as the predicate devices. |
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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INTENDED USES / INDIC TIONS
510 K Number (if known):
Device Name:
.
- 1
TELEGRAPH® Humeral Nail With Locking Screws
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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
§ 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.