(29 days)
Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
Synthes TFN System consists of a cannulated femoral nail, a cannulated helical blade and a cannulated nail end cap. Synthes Helical Blades will be available in three additional lengths, 75 mm, 125 mm, and 130 mm.
The provided text describes a 510(k) premarket notification for the "Synthes Trochanteric Fixation Nail (TFN) System, additional Helical Blades." This submission aims to demonstrate substantial equivalence to a predicate device, not to establish a new performance benchmark for a novel device through a clinical study with acceptance criteria.
Therefore, the document does not report acceptance criteria or a study proving that the device meets such criteria in the way medical device AI performance studies typically do. This is a regulatory filing for a physical medical device (an intramedullary fixation rod system) and its accessories, not a software or AI-based diagnostic tool.
Based on the provided text, the device is being cleared based on substantial equivalence to a predicate device, not on specific performance metrics established through a clinical trial or algorithm-only study.
Consequently, I cannot provide the requested information as it is not present in the given document.
To directly answer your numbered points based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable/Not provided. The submission is for substantial equivalence to a predicate device, not demonstrating performance against specific numerical acceptance criteria.
- Sample sized used for the test set and the data provenance: Not applicable/Not provided. No test set or data provenance for a performance study is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/Not provided. This is a physical device, not an AI or software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is a physical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
- The sample size for the training set: Not applicable/Not provided.
- How the ground truth for the training set was established: Not applicable/Not provided.
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Ko70294
MAR 0 1 2007
| 3.0 | 510(k) Summary | Page 1 of 1 | |
|---|---|---|---|
| Sponsor: | Synthes (USA)130 Goshen ParkwayWest Chester, PA 19380(610) 719-6940 | ||
| Device Name: | Synthes Trochanteric Fixation Nail (TFN) System, additionalHelical Blades | ||
| Classification: | 21 CFR 888.3020: Rod, Fixation, Intramedullary and Accessories | ||
| Predicate Devices: | Synthes Trochanteric Fixation Nail (TFN) System | ||
| Device Description: | Synthes TFN System consists of a cannulated femoral nail, acannulated helical blade and a cannulated nail end cap. SynthesHelical Blades will be available in three additional lengths, 75 mm,125 mm, and 130 mm. | ||
| Intended Use: | Synthes Trochanteric Fixation Nail (TFN) System is intended totreat stable and unstable fractures of the proximal femur includingpertrochanteric fractures, intertrochanteric fractures, basal neckfractures, and combinations thereof. The Long TFN is additionallyindicated for subtrochanteric fractures, pertrochanteric fracturesassociated with shaft fractures, pathologic fractures (includingprophylactic use) in both trochanteric and diaphyseal regions, longsubtrochanteric fractures, proximal or distal non-unions,malunions, and revisions. | ||
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
MAR C 1 2007
Re: K070294
Trade/Device Name: Synthes Trochanteric Fixation Nail (TFN) system, additional helical blades Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: January 30, 2007 Received: January 31, 2007
Dear Ms. Musgnung:
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
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Page 2 - Ms. Sheri L. Musgnung
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. 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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark Al-Mulla
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K070294
page 1 of
2.0
Indications for Use
702
Helical Blades
revisions.
510(k) Number (if known):
Device Name:
Indications for Use:
Mark H. Millikan
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number
X Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Synthes Trochanteric Fixation Nail (TFN) System, Additional
Synthes Trochanteric Fixation Nail (TFN) System is intended to
treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN
is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and
No
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.