(392 days)
Not Found
No
The device description and intended use are purely mechanical, describing an intramedullary nail system for fracture fixation. There is no mention of any software, image processing, or analytical capabilities that would suggest the use of AI/ML.
No.
The device is an intramedullary nail system used for stabilizing humeral fractures, which is a reconstructive device rather than one that treats or cures a disease or condition.
No
This device is an intramedullary nail system used for the mechanical fixation of humeral fractures, not for diagnosing medical conditions.
No
The device description clearly states the device is a physical implant (nail, screw, end cap) made of stainless steel and titanium alloy, and includes associated physical instrumentation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Syntec Humeral Nail System is an implantable medical device used to fix fractures of the proximal humerus. It is made of metal and is surgically inserted into the bone.
- Intended Use: The intended use is to treat bone fractures, not to analyze biological samples.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
THE SYNTEC HUMERAL NAIL SYSTEM IS INDICATED FOR FRACTURES OF THE PROXIMAL HUMERUS. INCLUDING 2-PART SURGICAL NECK FRACTURES, 3-PART FRACTURES, AND 4-PART FRACTURES, PROXIMAL HUMERAL FRACTURES WITH DIAPHYSEAL EXTENSION INTO THE SHAFT, AND IMPENDING PATHOLOGIC HUMERAL FRACTURES.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Syntec Humeral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) straight nail with a 5° proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over ø2.0 calibrated guide wires. Those nail accepts only an ø3.8mm Cortical Screw in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø8 ~ ø 9 in 9mm lengths is available for proximal closing of the nail. The Syntec Humeral 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
proximal humerus
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-F1264-14. The testing was done to our Syntec Humeral Nail System device to demonstrate substantial equivalence.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2017
Syntec Scientific Corporation Kavin Chu Regulatory Affairs Manager Syntec Scientific Corporation - Taipei Office 3F., No. 96, Sec. 3, Zhongxio East Road Da'an Dist., Taipei, 10652 TW
Re: K161327
Trade/Device Name: Syntec Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: April 21, 2017 Received: May 10, 2017
Dear Mr. Chu:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| r (if known) | |
|---|---|
| -------------- | -- |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number K161327
Device Name
SYNTEC HUMERAL NAIL SYSTEM
Indications for Use (Describe)
THE SYNTEC HUMERAL NAIL SYSTEM IS INDICATED FOR FRACTURES OF THE PROXIMAL HUMERUS. INCLUDING 2-PART SURGICAL NECK FRACTURES, 3-PART FRACTURES, AND 4-PART FRACTURES, PROXIMAL HUMERAL FRACTURES WITH DIAPHYSEAL EXTENSION INTO THE SHAFT, AND IMPENDING PATHOLOGIC HUMERAL FRACTURES.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
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FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Syntec, Taipei-Taiwan
3
Image /page/3/Picture/0 description: The image shows a logo for Syntec Scientific. The logo features a large orange circle overlapping a blue stylized "S". Below the graphic is the text "SYNTEC SCIENTIFIC" in a simple sans-serif font. The logo is clean and modern, using contrasting colors to make it visually appealing.
YNTEC 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 Manager
This summary of 510(k) information is being submitted in accordance with the requirement of SMDA 1990 and 21CFR 807.92.
K161327 - 1 of 3
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: | April 29, 2016 | |
| Contact person: | Kavin Chu | |
| Name of the device: | Syntec Humeral Nail System | |
| Trade or proprietary name: | Syntec Humeral Nail System | |
| Common or usual name: | Intramedullary Rod | |
| Classification name: | Intramedullary Fixation Rod | |
| Produce code: | HSB | |
| Regulation number: | 888.3020 | |
| Class: | Class II | |
| Predicate devices: | I.T.S. IM Nail Systems CFN-CTN-CHN (K132945 | |
| Prior Submission: | None |
1. Description of the Device
The Syntec Humeral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) straight nail with a 5° proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over ø2.0 calibrated guide wires. Those nail accepts only an ø3.8mm Cortical Screw in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø8 ~ ø 9 in 9mm lengths is available for proximal closing of the nail. The Syntec Humeral Nail System
4
Image /page/4/Picture/1 description: The image shows the logo for Syntec Scientific. The logo consists of a large red circle overlapping a blue letter 'S'. Below the graphic is the text 'SYNTEC SCIENTIFIC' in a serif font. The logo is simple and uses contrasting colors to make it visually appealing.
TEC 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 Manager
(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 Humeral Nail System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension into the shaft, and impending pathologic humeral fractures.
-
- Technological Characteristics, comparison to predicate device Syntec Humeral Nail System is identical to the I.T.S. IM Nail Systems CFN-CTN-CHN cleared for market in 510(k) K132945 and essentially Equivalent (SE) to the predicate.
The indications for use for the Syntec Humeral Nail System are patterned after the predicate devices and supported by an extensive collection of literature references.
- Technological Characteristics, comparison to predicate device Syntec Humeral Nail System is identical to the I.T.S. IM Nail Systems CFN-CTN-CHN cleared for market in 510(k) K132945 and essentially Equivalent (SE) to the predicate.
| Subject device | Predicate Device | |
|---|---|---|
| Device Name | Syntec Humeral Nail System | I.T.S. IM Nail Systems |
| CFN-CTN-CHN | ||
| Applicant | Syntec Scientific Corporation | I.T.S. GmbH |
| 510(k) | K161327 | K132945 |
| Material Comparison | Surgical Stainless Steel (SUS316L) | |
| and | ||
| Surgical Titanium Alloy (Ti6AL-4V) | Surgical Titanium Alloy (Ti6AL-4V) | |
| Nail Diameter | $\phi$ 7, $\phi$ 8, $\phi$ 9 | $\phi$ 7, $\phi$ 8, $\phi$ 9 |
| Nail Length | From 160mm to 240mm | |
| (in 20mm increments) | From 140mm to 320mm | |
| (in 10 and 20mm increments) | ||
| Nail Type | Standard | Left and Right |
5
Image /page/5/Picture/0 description: The image shows the logo for Syntec Scientific. The logo features a large orange circle to the left, partially overlapping a blue letter 'S'. Below the symbol, the words 'SYNTEC SCIENTIFIC' are printed in a simple, sans-serif font, with 'SYNTEC' appearing above 'SCIENTIFIC'.
TEC SCIENTIFIC CORPORATION No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang
K161327 - 3 of 3
Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Manager
| | From 20mm to 70mm
(in 5mm increments) | From 20mm to 70mm
(in 2mm and 5mm increments) |
|------------------|------------------------------------------|--------------------------------------------------|
| Screw Length | | |
| Screw Diameter | ø3.8mm Cortical Screw | ø3.5mm Cortical Screw |
| End Cap Diameter | ø 8 , ø 9 | No information provide |
| End Cap Length | 9mm | in +0,+5, +10,+15, +20, +25 & +30 lengths |
4. Performance Data
The procedure of evaluating the device tests was according to the standard of ASTM-F1264-14. The testing was done to our Syntec Humeral Nail System device to demonstrate substantial equivalence.
5. Substantial Equivalence
We believe that Syntec Humeral 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 Humeral Nail is as safe and effective as K132945. In addition, the Syntec Humeral Nail System has the same intended uses and indications, technological characteristics, and principles of operation to the predicate device. Thus, the Syntec Humeral Nail System is substantially equivalent in design, configuration, function, and indications for use to the I.T.S. IM Nail Systems CFN-CTN-CHN (K132945).