(28 days)
No
The device description and intended use are solely focused on the physical characteristics and application of bone plates and screws for fracture treatment. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is intended to treat fractures, which is a therapeutic purpose.
No
The device is a bone plate and screw system intended to treat fractures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a bone plate and screw system made of physical materials (Stainless Steel and Titanium) with specific dimensions, indicating it is a hardware medical device.
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, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided description clearly states that the device is a bone plate and screws intended to treat fractures of various bones. These are implanted within the body to stabilize and support bone healing.
The device described is an implantable orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The bone plates and screws are provided non-sterile. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).
Product codes
HRS, HWC
Device Description
The plate is manufactured from commercially 316LS Stainless Steel which in conformance with ASTM F138 and an alternative material which is Pure Titanium. The plates designed are from 1.5mm to 6.5mm thickness, from 6.5mm to 17.5mm width, and are available variously in length from 24.0mm (2 holes) to 394.0mm (22 holes). It should assembly with the same screw that was the predicate device in concurrence by FDA, (K983495).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Syntec-Taichung Bone Plates and Screw Implant, K983495
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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510(K) SUMMARY
| Submitter's name | Syntec Scientific Corporation | APR 24 2005 |
|---|---|---|
| Address | 2, Kung San Rd, | |
| Chuan Shing Industrial Zone, | ||
| Shen Kang, | ||
| Chang Hua, Taiwan. | ||
| Telephone :886-4-7987099 | ||
| Fax: 886-4-7987077 | ||
| Contact person | Carol Chang | |
| Name of the device | Syntec-Taichung Bone Plates and Screw | |
| Implant | ||
| Trade or proprietary name | Syntec-Taichung Bone Plates and Screw | |
| Implant | ||
| Classification name | Plate, Fixation, Bone | |
| Prode Code | HRS | |
| Regulation Number | 888.3030 | |
| Class | II | |
| Predicate device: | Syntec-Taichung Bone Plates and Screw | |
| Implant |
Description of the Device:
The plate is manufactured from commercially 316LS Stainless Steel which in conformance with ASTM F138 and an alternative material which is Pure Titanium. The plates designed are from 1.5mm to 6.5mm thickness, from 6.5mm to 17.5mm width, and are available variously in length from 24.0mm (2 holes) to 394.0mm (22 holes). It should assembly with the same screw that was the predicate device in concurrence by FDA, (K983495).
Indications for Use:
The bone plates and screws are provided non-sterile. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).
Substantially Equivalence:
The predicate device information provided supports the substantially equivalence.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
AD
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Syntec Scientific Corporation % Ms. Carol Chang Regulatory Affairs Specialist 3F1. 96 Chung Hsaio E. Rd. Sec 3 Taipei China (Taiwan) 106
APR 2 4 2009
Re: K090839
Trade/Device Name: Syntec-Taichung Bone Plates and Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: March 27, 2009 Received: March 27, 2009
Dear Ms. Chang:
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.
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
2
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For Pdo/m
De
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090839
Device Name: Syntec-Taichung Non-Sterile Bone Plate and Screw Implant
Indications for Use:
The bone plates and screws are provided non-sterile. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number