(29 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a traditional intramedullary nail system, with no mention of AI or ML capabilities.
Yes.
It is indicated for long bone fracture fixation and tumor resections, which are conditions that require therapeutic intervention.
No
Explanation: The device is an intramedullary nail system used for fracture fixation, which is a therapeutic intervention, not a diagnostic one. Its description focuses on its materials, dimensions, and surgical application, not on identifying diseases or conditions.
No
The device description explicitly states it 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:
- Intended Use: The intended use clearly states that the device is for "long bone fracture fixation" and lists various types of fractures and bone conditions. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant (intramedullary nail, screws, end cap) made of metal, designed to be surgically inserted into the bone. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The information provided describes a medical device used for surgical treatment of bone fractures, which falls under a different regulatory category than In Vitro Diagnostics.
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; Supracondy lar 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 Extended System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 5deg proximal bend allows the nail to be inserted through the tip of the greater trochanter for an easier surgical approach. These nails have a 135deg 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 Extended 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, Femur shaft, 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)
Clinical data and conclusions were not needed for these devices. The Syntec Femoral Nail Extended System was considered for conformance to dimensional and material mechanical property standards ASTM F138-13 and F136-13. Those nails in the scope of this submission were in conformance with those standards and are therefore substantially equivalent to the predicate devices. In addition, mechanical strength comparison, analysis of results, engineering justifications, dimensional and material comparisons were conducted to determine substantial equivalence to the predicates.
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
November 23, 2020
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Syntec Scientific Corporation Nicole Tseng Senior Regulatory Affairs Specialist Syntec Scientific Corporation - Taipei Office 3f ., No.96, Sec. 3, Zhongxio East Road Da'An Dist., Taipei, R.O.C. 10652 Taiwan
Re: K202935
Trade/Device Name: Syntec Femoral Nail Extended System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB
Dear Nicole Tseng:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 28, 2020. Specifically, FDA is updating this SE Letter due to an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Michael Owens, OHT6: Office of Orthopedic Devices, 301-796-5650, Michaelc.Owens@fda.hhs.gov.
Sincerely,
Farzana
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2020.11.23
11:58:17-05'00'
For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
October 28, 2020
Image /page/1/Picture/1 description: The image shows 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 consists of 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.
Syntee Scientific Corporation Nicole Tseng Senior Regulatory Affairs Specialist Syntec Scientific Corporation - Taipei Office 3f ., No.96, Sec. 3, Zhongxio East Road Da'An Dist., Taipei, R.O.C. 10652 Taiwan
Re: K202935
Trade/Device Name: Syntec Femoral Nail Extended System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 26, 2020 Received: September 29, 2020
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/cfpm1/pmn.cfm 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,
2
including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2020.10.28
For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name Syntec Femoral Nail Extended 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; Supracondy lar 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Image /page/4/Picture/1 description: The image shows the logo and contact information for SYNTEC SCIENTIFIC CORPORATION. The logo consists of the letters 'OS' in orange and blue, with the words 'SYNTEC SCIENTIFIC' below. The contact information includes the address 'No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C.', the telephone number '+886-4-798-7099', and the email address 'fda@eagleseye.com.tw'.
This summary of 510(k) information is being submitted in accordance with the requirement of SMDA 1990 and 21CFR 807.92.
Special 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: | 2020-09-26 |
| Contact Person: | Nicole Tseng |
| Name of the Device: | Syntec Femoral Nail Extended System |
| Trade or Proprietary Name: | Syntec Femoral Nail Extended System |
| Common or Usual Name: | Intramedullary Nail |
| Classification name: | Intramedullary Fixation Rod and Accessories |
| Product Code: | HSB |
| Regulation Number: | 21 CFR §8888.3020 |
| Device Classification: | Class II |
| Classification Panel: | 87- Division of Orthopedic Devices |
| Primary Predicate: | K181296 - Syntec Femoral Nail System |
| Additional Predicates: | K984543 - Syntec-Taichung Non-Sterile Interlocking Nail |
| System (FEMUR:274-000/870) | |
| Modification of a Legally | |
| Marketed Device: | K181296 - Syntec Femoral Nail System |
| Prior Submission: | None |
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Image /page/5/Picture/1 description: The image shows a logo for Syntec Scientific. The logo features a large orange circle to the left, and a stylized blue "S" to the right. Below these elements, the text "SYNTEC SCIENTIFIC" is written in a serif font.
SYNTEC SCIENTIFIC CORPORATION
No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kanq Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Specialist
1. Description of the Device
The Syntec Femoral Nail Extended 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 Extended 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 Extended 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 Previous Device
Syntec Femoral Nail Extended System is identical to the Syntec Femoral Nail System and Syntec-Taichung Non-Sterile Interlocking Nail System (FEMUR:274-000/870) cleared for market in 510(k) K181296. K984543 and essentially Equivalent (SE) to the predicate. The indications for use for the Syntec Femoral Nail Extended System are patterned after the predicate devices and supported by an extensive collection of literature references for a long time.
The modified nails are fabricated from stainless steel (SUS316L) per ISO 5832-1:2007/ASTM F 138-13 and Titanium-6 Aluminum-4 Vanadium Eli (Extra Low Interstitial) Alloy per ISO
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Image /page/6/Picture/1 description: The image shows the logo for Syntec Scientific. The logo consists of a large orange circle overlapping a blue letter 'S'. Below the graphic is the text 'SYNTEC SCIENTIFIC' in a simple sans-serif font. The logo is clean and professional, suggesting a company involved in science or technology.
SYNTEC SCIENTIFIC CORPORATION 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
5832-3:1996/ASTM F136-13 as same as previous devices. The design feature for the nail is same to the predicate devices including shape, style and type. Also, the final finished form is identical to Syntec (K181296) in formulation, processing, and sterilization and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). Even though the global geometry in dimensions is 1 mm less in revised K181296 nail type for better anatomical fit , the material and manufacturing process is identical in formulation, processing and sterilization. Also, the modified nail's diameter and length are between K984543's femur nail type.
| Subject device | Predicate Device | Add. Predicate Device | |
|---|---|---|---|
| Device | |||
| Name | Syntec Femoral Nail | ||
| Extended System | Syntec Femoral Nail | ||
| Extended System | Syntec-Taichung | ||
| Non-Sterile Interlocking | |||
| Nail System | |||
| (FEMUR:274-000/870) | |||
| Applicant | Syntec Scientific | ||
| Corporation | Syntec Scientific | ||
| Corporation | Syntec Scientific | ||
| Corporation | |||
| 510(k) | K202935 | K181296 | K984543 |
| Material | |||
| Comparison | Surgical Stainless Steel | ||
| (SUS316L) and Surgical | |||
| Titanium Alloy (Ti6AL-4V) | Surgical Stainless Steel | ||
| (SUS316L) and Surgical | |||
| Titanium Alloy (Ti6AL-4V) | Surgical Stainless Steel | ||
| (SUS316L) | |||
| Nail | |||
| Diameter | ø9 | ø10 , ø11 , ø12 , ø13 , ø14 | ø 8 , ø9 , ø10 , ø11 , ø12 , |
| ø13 , ø14, ø15 , ø16 | |||
| Nail Length | From 260 mm to 400 mm | ||
| (in 20 mm increments) | From 320 mm to 460 mm | ||
| (in 20 mm increments) | From 240 mm to 480 mm | ||
| (in 20 mm increments) | |||
| Nail Type | Left and Right | Left and Right | Standard |
Syntec Femoral Nail Extended System and Two type of Syntec Femoral Nail System
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Image /page/7/Picture/1 description: The image shows a logo for Syntec Scientific. The logo features a large orange circle overlapping a blue stylized letter 'S'. Below the graphic, the words 'SYNTEC SCIENTIFIC' are printed in a serif font, with 'SYNTEC' appearing above 'SCIENTIFIC'.
SYNTEC SCIENTIFIC CORPORATION 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. Summary of Performance Data (Nonclinical and/or Clinical)
*Clinical Test
Clinical data and conclusions were not needed for these devices.
*Non-Clinical Test
The Syntec Femoral Nail Extended System was considered for conformance to dimensional and material mechanical property standards ASTM F138-13 and F136-13. Those nails in the scope of this submission were in conformance with those standards and are therefore substantially equivalent to the predicate devices.
In addition, mechanical strength comparison, analysis of results, engineering justifications, dimensional and material comparisons were conducted to determine substantial equivalence to the predicates.
5. Substantial Equivalence
The Syntec Femoral Nail System has the same intended uses and indications, technological characteristics, and principles of operation to the predicate device. Stress analysis result, risk analysis and design control activities including verification activities were conducted to demonstrate the subject device does not raise any different questions of safety or effectiveness associated with smaller diameter devices. Thus, the Syntec Femoral Nail System is substantially equivalent in design, configuration, and indications for use to the Predicate Device.