(27 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is indicated for fracture fixation and healing of bone fragments, which aligns with the definition of a therapeutic device as it is used to treat a medical condition.
No
Explanation: The device is indicated for fracture fixation and as guide pins for other implants, which are therapeutic and procedural uses, not diagnostic.
No
The device description clearly states it is comprised of physical Kirschner Wires and Steinmann Pins, which are hardware components used in surgical procedures.
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 and Intended Use: The description clearly states that Kirschner Wires and Steinmann Pins are used for fracture fixation, healing of bone fragments, osteotomies, and as guide pins for implant insertion. These are all procedures performed directly on the patient's body during surgery or other medical interventions.
- No Mention of Samples or Testing: There is no mention of collecting samples from the body or performing any kind of laboratory test with this device.
Therefore, based on the provided information, this device is a surgical implant/instrument used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Kirschner Wires and Steinmann Pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
Product codes (comma separated list FDA assigned to the subject device)
HTY, JDI
Device Description
This system makes up of non-sterile, shank and threaded Kirschner Wires and Steinmann Pins. The Kirschner Wires ranges in length from 101.6 to 300 mm and ranges in diameter from 0.7 to 1.6 mm. The Steinmann Pins ranges in length from 70 to 400 mm and ranges in diameter from 0.8 to 4.8 mm. They are available with four-point style: diamond, trocar, both ends diamond and both ends trocar. The 9 "(230 mm) shank and threaded Kirschner Wires and Steinmann Pins are usually available with fracture fixation fasteners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
OCT 5 1998
510(k) Summary of Safety and effectiveness
- A 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
- Proprietary Name : Non-sterile Kirschner Wires and Steinmann Pins A
- A Common Name : Bone fixation fasteners
- ア Classification Name : Class II, CFR 888.3040
- A Device Product Code : 87 HTY and 87 JDW
- A Material: This device is manufactured from commercially 316 LS stainless steel.
- A Indication for Use :
The Kirschner Wires and Steinmann Pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
A Description of the Device :
This system makes up of non-sterile, shank and threaded Kirschner Wires and Steinmann Pins. The Kirschner Wires ranges in length from 101.6 to 300 mm and ranges in diameter from 0.7 to 1.6 mm. The Steinmann Pins ranges in length from 70 to 400 mm and ranges in diameter from 0.8 to 4.8 mm. They are available with four-point style: diamond, trocar, both ends diamond and both ends trocar. The 9 "(230 mm) shank and threaded Kirschner Wires and Steinmann Pins are usually available with fracture fixation fasteners.
1
Appendixes A
Sterilization Information-Non-sterile Device
These devices are provided non-sterile. The recommended sterilization parameters for nonsterile devices are as follows:
| Method | Cycle | Time | Temperature |
|---|---|---|---|
| Steam | Vacuum | 6 min | 132~135 ℃ |
Image /page/1/Picture/4 description: The image shows a black and white abstract pattern. The pattern is composed of small, irregular shapes and lines. The shapes are concentrated in the upper right corner of the image, and they become more sparse towards the bottom left corner. The overall effect is one of randomness and chaos.
12
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services (HHS). The seal features a stylized eagle with three legs, representing health, hope, and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
5 1998 OCT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ted Y. Shi Vice-Chairman Syntec-Taichung Medical Instruments Company Limited 2, Kung San Road Chuan Shing Industrial Zone, Shen Kanq Chang Hua, Taiwan 509
Re: K983121 Non-sterile Kirschner Wires and Steinmann Pins Regulatory Class: II Product Codes: HTY and JDI Dated: September 1, 1998 Received: September 8, 1998
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will werify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 requlations.
3
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 regulation (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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general 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
4
Page _ _ of __________________________________________________________________________________________________________________________________________________________________
510(K) Number (if known): __K983121 Device Name: Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins
Indications for use:
The Kirschner Wires and Steinmann Pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K9831