(28 days)
The Set Screw for Ti Trochanteric Fixation Nail (TFN) 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.
The Set Screw for Ti Trochanteric Fixation Nail (TFN) is an additional offering for use with the existing TFN System. The Set Screw prevents sliding and rotation of the head element (TFN Screw or helical blade) within the nail for fixation of proximal femur fractures.
The provided 510(k) summary (K120083) for the "Set Screw for Ti Trochanteric Fixation Nail (TFN)" describes a mechanical testing study to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic or prognostic performance. Therefore, many of the requested categories regarding clinical study design, expert evaluation, and ground truth are not applicable.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance (Test Result) |
|---|---|
| "demonstrate the comparable mechanical performance of the subject device... compared to the predicate." | "The mechanical testing was designed to assess the peak slip load of the proposed device." (The specific numerical results for peak slip load and how they compare to the predicate are not provided in this summary, only that the testing was conducted and supports substantial equivalence.) |
| (Implicit) The proposed set screw should have comparable "peak slip load" to the predicate. | The information presented supports substantial equivalence to the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified for the mechanical testing. Mechanical tests typically use a certain number of samples, but the exact count is not mentioned in this summary.
- Data Provenance: The data is likely from in-vitro mechanical testing conducted by the manufacturer, Synthes. The summary does not specify a country of origin for the data beyond being part of the manufacturer's submission. It is prospective in the sense that the tests were designed and executed to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This was a mechanical performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the objective measurement of mechanical properties, specifically "peak slip load," under controlled conditions.
4. Adjudication Method for the Test Set
- Not Applicable. As a mechanical test, there is no human adjudication process involved. The results are based on physical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not Applicable. This is a mechanical device study, not an AI-assisted diagnostic study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a mechanical device study, not an algorithm performance study.
7. The Type of Ground Truth Used
- Mechanical Measurement (Peak Slip Load): The ground truth for this study was the objectively measured mechanical characteristic of "peak slip load" under specified test conditions.
8. The Sample Size for the Training Set
- Not Applicable. This is a mechanical device study, not a machine learning study requiring a training set. If referring to the development of the device itself, the summary does not provide details on R&D processes beyond the final mechanical testing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set in the context of this mechanical performance study, this question is not relevant.
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FEB - 8 2012
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small registered trademark symbol is located to the right of the letter "S" in the word "SYNTHES".
| 3.0510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | SynthesThomas N. Shea1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6809 |
| Device Name: | Set Screw for Ti Trochanteric Fixation Nail (TFN) |
| Classification: | Product Code – HSB/HWC, Rod, Fixation, Intramedullary andAccessories, Class II, §888.3020 - (Intramedullary fixation rod.) |
| Predicate Devices: | Synthes Trochanteric Fixation Nail (TFN) Screw K092646Synthes Trochanteric Fixation Nail (TFN) K011857Smith & Nephew, Inc. TriGen InterTAN° K040212 |
| Device Description: | The Set Screw for Ti Trochanteric Fixation Nail (TFN) is anadditional offering for use with the existing TFN System. The SetScrew prevents sliding and rotation of the head element (TFN Screwor helical blade) within the nail for fixation of proximal femurfractures. |
| Intended Use: | The Set Screw for Ti Trochanteric Fixation Nail (TFN) 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 of the SetScrew for Ti Trochanteric Fixation Nail (TFN) to the predicatedevices, Synthes Trochanteric Fixation Nail, Synthes TrochantericFixation Nail Screw, and the Smith & Nephew, Inc. TriGenInterTAN°. The proposed set screw has the same indications for use,is similar in shape/design and incorporates the same fundamentaltechnology.Axial static testing was conducted to demonstrate the comparablemechanical performance of the subject device, Set Screw for Ti TFNcompared to the predicate. The mechanical testing was designed toassess the peak slip load of the proposed device. |
device is substantially equivalent to the predicate.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes % Mr. Thomas Shea Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
FEB - 8 2012
Re: K120083
Trade/Device Name: Set Screw for Ti Trochanteric Fixation Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod. Regulatory Class: Class II Product Code: HSB, HWC Dated: January 10, 2012 Received: January 12, 2012
Dear Mr. Shea:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Mr. Thomas Shea
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0
Indications for Use
510(k) Number (if known): _ K120083
Device Name:
Set Screw for Ti Trochanteric Fixation Nail (TFN)
Indications for Use:
The Set Screw for Ti Trochanteric Fixation Nail (TFN) 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.
Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
BAPinder
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
AND/OR
510(k) Number_K120083
§ 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.