(70 days)
The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.
The interlocking system makes up of Humeral, Fibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nails have the same features such as: Proximal locking: Choice of two oval holes for static locking(only three holes for humerus) secures the rotational and axial stability. Anatomical design: Humerus: The curvature of 5° in the upper third of the Reamed Humeral Nail allows for easy insertion and good anatomical fit. Femur: The 1.88m radius of the Reamed Femoral Nail corresponds closely with the average anatomical curvature of the femur. Tibia: The curvature of 15° in the upper third of the Reamed Tibial Nail allows for easy insertion and good anatomical fit. Distal locking: Through two medial holes, additional locking is also possible in the anatomical seat. Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion. The dimension of the interlocking nail ranges in diameter from 7 to 16 mm and total length 200 to 480 mm. The locking bolt screws have high strength, no tapping necessary and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9 to 6.4 mm and total length 20 to 100 mm.
This document is a 510(k) summary for the Syntec-Taichung Non-sterile Interlocking Nail System. It describes the device and claims substantial equivalence to a predicate device. However, the document does not describe any specific acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) submission process for Class II devices like this one focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness against predefined acceptance criteria.
Therefore, I cannot provide the requested information from the provided text for the following reasons:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document states a "Basis of Substantial Equivalence" where it compares the Syntec-Taichung device to the Richards - Trimax Nail System in terms of design, sizes, material, and appliance, but no specific performance metrics or acceptance criteria are listed.
- Sample size used for the test set and the data provenance: There is no mention of a "test set" or a study involving such a set. The substantial equivalence claim is based on comparison to a predicate device's existing market data and characteristics.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable, as no such test set or adjudication process is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. The document is about an orthopedic implant, not an AI or imaging device where MRMC studies are typically performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable, as no study requiring ground truth is described.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, performance studies, or clinical trial data as would be found for novel devices or those undergoing a PMA (Premarket Approval) process. The FDA's letter confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed under the general controls provisions, without requiring new clinical performance studies outlined by specific acceptance criteria.
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510(k) Summary of Safety and effectiveness
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Sponsor: Syntec-Taichung Medical Instruments Co., Ltd. > 2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. 509 Phone / FAX: 886-4-7987099 / 886-4-7987077 Contact Person: Ted Y. Shi
984543 -
Proprietary Name : Syntec-Taichung Non-sterile Interlocking Nail System A
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A Common Name : Various Types of Intramedullary Fixation Implants
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Classification Status : Class II, CFR 888.3020
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Device Product Code : 87 HSB A
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A Material: This device is manufactured from commercially 316LS stainless steel.
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A Indication for Use :
The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.
Description of the Device : A
The interlocking system makes up of Humeral, Fibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nails have the same features such as:
- A Proximal locking: Choice of two oval holes for static locking(only three holes for humerus) secures the rotational and axial stability.
- A Anatomical design:
- Humerus: The curvature of 5° in the upper third of the Reamed Humeral Nail � allows for easy insertion and good anatomical fit.
- Femur: The 1.88m radius of the Reamed Femoral Nail corresponds closely � with the average anatomical curvature of the femur.
- � Tibia: The curvature of 15° in the upper third of the Reamed Tibial Nail allows for easy insertion and good anatomical fit.
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- Distal locking: Through two medial holes, additional locking is also possible in the > anatomical seat.
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Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion.
The dimension of the interlocking nail ranges in diameter from 7 to 16 mm and total length 200 to 480 mm.
The locking bolt screws have high strength, no tapping necessary and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9 to 6.4 mm and total length 20 to 100 mm.
> Basis of Substantial Equivalence :
A comparison of the non-sterile Interlocking Nail System described in this submission and Richards - Trimax Nail System has been commercial device that they are very similar or identical in terms of design, sizes, material and appliance. Based on this information, Syntec-Taichung (Taiwan) believes that the non-sterile Interlocking Nail System is substantially equivalent to Richards - Trimax Nail System.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 1999
Mr. Ted Y. Shi President Syntec-Taichung Medical Instruments Company Limited 2, Kung San Road, Chuan Shing Industrial Zone Shen Kang, Chang Hua, Taiwan 509
K984543 Re: Syntec-Taichung (Taiwan) Non-sterile Interlocking Nail System Requlatory Class: II нав Product Code: December 15, 1998 Dated: December 21, 1998 Received:
Dear Mr. Shi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may Existing major be subject to such additional controls. requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ted Y. Shi
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to Other general premarket notification" (21 CFR 807.97). information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ of ___________________________________________________________________________________________________________________________________________________________________
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for use:
The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription Use | + | OR | Over-The-Counter-Use_ |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| (Division Sign-Off) | |||
| Division of General Restorative Devices | |||
| 510(k) Number | K984543 |
§ 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.