(330 days)
No
The description focuses on the material and mechanical design of a surgical implant and associated instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for long bone fracture fixation and is an intramedullary nail designed to fix fractures and resections, which categorizes it as a therapeutic device.
No
The device is an intramedullary nail system used for long bone fracture fixation and tumor resections, not for diagnosing conditions.
No
The device description explicitly states the device is an intramedullary nail system made of stainless steel and titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Syntec Femoral Nail System is an implantable device made of metal (stainless steel and titanium) designed to fix bone fractures. It is surgically inserted into the bone.
- Intended Use: The intended use is for the fixation of long bone fractures and related conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a device used within the body for structural support and fixation, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone, femoral neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
According device test report of performance data demonstrate that the Syntec Femoral Nail is as safe and effective as K040462, K984543 and K161327.
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.
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.
Not Found
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.
0
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
1
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 by
Peter G. Allen -S |
|----------|------------------------------------------|
| Allen -S | Date: 2019.04.11
14:14:43 -04'00' |
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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 Summary | |
| Prepared: | 2018-05-11 |
| Contact person: | Nicole Tseng |
| Name of the device: | Syntec Femoral Nail System |
| Trade or proprietary | |
| name: | 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 |
4
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) | |
| and | ||
| Surgical 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 |
6
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) | |
| and | ||
| Surgical Titanium Alloy (Ti6AL-4V) | Surgical Stainless Steel (SUS316L) | |
| and | ||
| Surgical 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-sterile |
| Interlocking Nail System | ||
| Applicant | Syntec Scientific Corporation | Syntec Scientific Corporation |
| 510(k) | K181296 | K984543 |
| Material Comparison | Surgical Stainless Steel (SUS316L) | |
| and | ||
| Surgical Titanium Alloy (Ti6AL-4V) | Surgical Stainless Steel (SUS316L) | |
| and | ||
| Surgical 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 |
7
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.