(330 days)
The Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following: Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondylar and ipsilateral fractures; Delayed union fractures; Open and closed femur shaft fractures; Combined inter and subrochanteric fractures; High subtrochanteric fractures; Pseudoarthrosis and correction osteotomy; Pathological fractures, impending pathologic and tumor resections; Pertrochanteric fractures; and Nonunions and malunions.
The Syntec Femoral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 5° proximal bend allows the nail to be inserted through the tip of the greater trochanter for an easier surgical approach. These nails have a 135° recon screw angle for easier placement of two 6.3 mm Recon Screws into the femoral neck and ø5mm internal hex captured screws in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø13 in 3, 5, 10, 15mm lengths is available for proximal closing of the nail. The Syntec Femoral Nail System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.
This document describes the Syntec Femoral Nail System, an intramedullary fixation rod. The information provided outlines the system's design, intended use, and a comparison to predicate devices, but it contains limited details regarding specific acceptance criteria and study outcomes.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document mentions that "The procedure of evaluating the device tests was according to the standard of ASTM-F1264-16." It also states, "According device test report of performance data demonstrate that the Syntec Femoral Nail is as safe and effective as K040462, K984543 and K161327."
However, the document does not provide a table of specific acceptance criteria (e.g., minimum bending strength, torsional stiffness, fatigue life) or the actual reported device performance values against those criteria. It only states that the testing was performed and demonstrated substantial equivalence to the predicate devices. To fulfill this request, concrete numerical values for both acceptance criteria and the device's performance would be needed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states, "The testing was done to our Syntec Femoral Nail System device to demonstrate substantial equivalence."
The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective study design). Given that the testing was "to our Syntec Femoral Nail System device," it's likely referring to a bench testing study on the device itself, rather than a clinical study with human patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable to the type of study described. The document refers to "device tests" according to a standard like ASTM-F1264-16, which are typically mechanical or material property tests performed in a lab setting, not evaluations requiring expert interpretation of medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reasons as point 3. Adjudication methods are relevant for studies involving human interpretation or clinical endpoint assessments, which are not detailed here.
5. 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:
This information is not applicable. The device described is an intramedullary fixation rod, a physical implant for fracture fixation. It is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a physical medical implant, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the "device tests" mentioned (which are presumed to be mechanical testing), the "ground truth" would be established by the specific test methods and measurement standards outlined in ASTM-F1264-16. For example, force exerted, displacement measured, or cycles to failure. These are objective, measurable physical properties, not ground truth established by expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This information is not applicable as the device is a physical product and does not involve machine learning or AI that would require a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
In summary, the provided text describes the regulatory clearance of a physical medical device (Syntec Femoral Nail System) based on substantial equivalence and performance testing to an industry standard (ASTM-F1264-16). It lacks the detailed information typically found in documentation for AI/software medical devices regarding acceptance criteria, study design, expert involvement, and ground truth establishment. The context of your questions seems to overlap with requirements for AI/ML-based medical devices, which the Syntec Femoral Nail System is not.
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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 11, 2019
Syntec Scientific Corporation % Nicole Tseng Regulatory Affairs Specialist Syntec Scientific Corporation - Taipei Office 3F., No.96, Sec.3, Zhongxio East Road Da'An Dist. Taipei, 10652 Taiwan R.O.C.
Re: K181296
Trade/Device Name: Syntec Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: March 8, 2019 Received: March 13, 2019
Dear Nicole Tseng:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
| Peter G. | Digitally signed byPeter G. Allen -S |
|---|---|
| Allen -S | Date: 2019.04.1114:14:43 -04'00' |
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K181296
Device Name
SYNTEC FEMORAL NAIL SYSTEM
Indications for Use (Describe)
The Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following: Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondylar and ipsilateral fractures; Delayed union fractures; Open and closed femur shaft fractures; Combined inter and subrochanteric fractures; High subtrochanteric fractures; Pseudoarthrosis and correction osteotomy; Pathological fractures, impending pathologic and tumor resections; Pertrochanteric fractures; and Nonunions and malunions.
| 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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Image /page/3/Picture/1 description: The image shows the logo for Syntec Scientific. The logo consists of a gray circle overlapping a black letter 'S'. Below the logo, the words 'SYNTEC SCIENTIFIC' are written in a simple, sans-serif font. The logo is simple and professional.
No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Specialist
This summary of 510(k) information is being submitted in accordance with the requirement of SMDA 1990 and 21CFR 807.92.
510(k) SUMMARY
| Submitted By: | Syntec Scientific Corporation |
|---|---|
| Address: | No.2, Kung San Road |
| Chuan Shing Industrial Zone, | |
| Shen Kang, Chang Hua Hsien, Taiwan R.O.C. | |
| TEL: +886-4-798-7099 | |
| FAX: +886-4-798-7077 | |
| Date SummaryPrepared: | 2018-05-11 |
| Contact person: | Nicole Tseng |
| Name of the device: | Syntec Femoral Nail System |
| Trade or proprietaryname: | Syntec Femoral Nail System |
| Common or usual name: | Intramedullary Nail |
| Classification name: | Intramedullary Fixation Rod |
| Produce code: | HSB |
| Regulation number: | 21CFR888.3020 |
| Class: | Class II |
| Predicate devices: | Trigen Trochanteric Antegrade Nail (K040462) |
| Syntec Humeral Nail System (K161327) | |
| Syntec-Taichung Non-sterile Interlocking Nail System(K984543) | |
| Prior Submission: | None |
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Image /page/4/Picture/1 description: The image shows the logo for Syntec Scientific. The logo consists of a large, gray circle overlapping with a stylized letter 'S'. Below the symbol, the words 'SYNTEC SCIENTIFIC' are printed in a simple, sans-serif font, with 'SYNTEC' appearing above 'SCIENTIFIC'.
No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Requlatory Affairs Specialist
1. Description of the Device
The Syntec Femoral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 5° proximal bend allows the nail to be inserted through the tip of the greater trochanter for an easier surgical approach. These nails have a 135° recon screw angle for easier placement of two 6.3 mm Recon Screws into the femoral neck and ø5mm internal hex captured screws in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø13 in 3, 5, 10, 15mm lengths is available for proximal closing of the nail. The Syntec Femoral Nail System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.
2. Intended Use
The Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following: Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondylar and ipsilateral fractures; Delayed union fractures; Open and closed femur shaft fractures; Combined inter and subrochanteric fractures; High subtrochanteric fractures: Pseudoarthrosis and correction osteotomy: Pathological fractures. impending pathologic and tumor resections; Pertrochanteric fractures; and Nonunions and malunions.
3. Technological Characteristics, comparison to predicate device
Syntec Femoral Nail System is identical to the Trigen Trochanteric Antegrade Nail, Syntec-Taichung Non-sterile Interlocking Nail System, and Syntec Humeral Nail System cleared for market in 510(k) K040462, K984543 and K161327 and essentially Equivalent (SE) to the predicate. The indications for the Syntec Femoral Nail System are patterned after the predicate devices and supported by an extensive collection of literature references.
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Image /page/5/Picture/1 description: The image shows the logo for Syntec Scientific. The logo consists of a gray circle with the letter 'S' superimposed on it. Below the circle and 'S' is the text 'SYNTEC SCIENTIFIC' in capital letters.
No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Specialist
Syntec Femoral Nail System and Trigen Trochanteric Antegrade Nail
| Subject device | Predicate Device | |
|---|---|---|
| Device Name | Syntec Femoral Nail System | Trigen Trochanteric Antegrade Nail |
| Applicant | Syntec Scientific Corporation | SMITH & NEPHEW, INC. |
| 510(k) | K181296 | K040462 |
| Material Comparison | Surgical Stainless Steel (SUS316L)andSurgical Titanium Alloy (Ti6AL-4V) | Surgical Titanium Alloy (Ti6AL-4V) |
| Nail Diameter | ø10 , ø11 , ø12 , ø13 , ø14 | ø10 , ø11.5 , ø13 |
| Nail Length | From 320 mm to 460 mm(in 20 mm increments) | From 300 mm to 500 mm(in 20 mm increments) |
| Nail Type | Left and Right | Left and Right |
| Screw Dia. | ø5.0 mm Internal Hex Captured | ø5.0 mm Internal Hex Captured |
| Screw Length | From 30 mm to 100 mm(in 5 mm increments) | From 25 mm to 110 mm(in 5 mm increments) |
| Recon Screw Dia. | ø6.3 mm Recon Screw | ø6.4mm Recon Screw |
| Actual size of Recon Screw Dia. | ø6.3mm | ø6.3mm |
| Recon Screw Length | From 65mm to 120 mm(in 5 mm increments) | From 65mm to 125 mm(in 5 mm increments) |
| Nail Caps Diameter | ø 13 | ø 13 |
| Nail Cap Length | in 3.5, 10.15 mm lengths | in 0.5, 10.15, 20 mm lengths |
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Image /page/6/Picture/1 description: The image shows the logo for Syntec Scientific. The logo consists of a gray circle overlapping the letter "S", with the words "SYNTEC SCIENTIFIC" written in a smaller font below the symbol. The logo is simple and modern, with a focus on the company name.
No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Specialist
| Subject device | Predicate Device | |
|---|---|---|
| Device Name | Syntec Femoral Nail System | Syntec Humeral Nail System |
| Applicant | Syntec Scientific Corporation | Syntec Scientific Corporation |
| 510(k) | K181296 | K161327 |
| Material Comparison | Surgical Stainless Steel (SUS316L)andSurgical Titanium Alloy (Ti6AL-4V) | Surgical Stainless Steel (SUS316L)andSurgical Titanium Alloy (Ti6AL-4V) |
| Nail Caps Diameter | ø 13 | ø 8 and ø 9 |
| Nail Cap Length | in 3,5, 10,15 mm lengths | in 9 mm lengths |
Syntec Femoral Nail System and Syntec Humeral Nail System
Syntec Femoral Nail System and Syntec-Taichung Non-sterile Interlocking Nail System
| Subject device | Predicate Device | |
|---|---|---|
| Device Name | Syntec Femoral Nail System | Syntec-Taichung Non-sterileInterlocking Nail System |
| Applicant | Syntec Scientific Corporation | Syntec Scientific Corporation |
| 510(k) | K181296 | K984543 |
| Material Comparison | Surgical Stainless Steel (SUS316L)andSurgical Titanium Alloy (Ti6AL-4V) | Surgical Stainless Steel (SUS316L)andSurgical Titanium Alloy (Ti6AL-4V) |
| Screw Dia. | ⌀5.0 mm Internal Hex Captured | ⌀5.0 mm Internal Hex Captured |
| Screw Length | From 30 mm to 100 mm(in 5 mm increments) | From 20 mm to 90 mm(in 5 mm increments) |
| Recon Screw Dia. | ⌀6.3 mm Recon Screw | ⌀6.4mm Screw |
| Recon Screw Length | From 65mm to 120 mm(in 5 mm increments) | From 30mm to 90 mm(in 5 mm increments) full thread |
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Image /page/7/Picture/1 description: The image shows a logo for Syntec Scientific. The logo consists of a gray circle to the left of a stylized letter "S". The words "SYNTEC SCIENTIFIC" are written in a sans-serif font below the circle and the "S".
No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Specialist
4. Performance Data
The procedure of evaluating the device tests was according to the standard of ASTM-F1264-16. The testing was done to our Syntec Femoral Nail System device to demonstrate substantial equivalence.
5. Substantial Equivalence
We believe that Syntec Femoral Nail System does not add new or increased risks and complications, based on current engineering technology and clinical results published about intramedullary rods as well as based on what has been previously cleared by FDA.
According device test report of performance data demonstrate that the Syntec Femoral Nail is as safe and effective as K040462, K984543 and K161327. In addition, the Syntec Femoral Nail System has the same intended uses and indications, technological characteristics, and principles of operation to the predicate device. Thus, the Syntec Femoral Nail System is substantially equivalent in design, configuration, and indications for use to the Predicate Device.
§ 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.