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.

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.

AI/ML Overview

This submission describes Kirschner Wires and Steinmann Pins, which are mechanical devices for bone fixation. The provided text is a 510(k) summary for these devices. For mechanical devices, acceptance criteria and performance are typically evaluated through bench testing (e.g., material strength, fatigue, bending), biocompatibility testing, and sometimes cadaveric studies, rather than through clinical studies with metrics like sensitivity, specificity, or reader agreement that are common for AI/diagnostic devices.

Based on the provided 510(k) document, there is no information about acceptance criteria or specific studies that 'prove' the device meets certain performance metrics in the way a diagnostic algorithm would. The 510(k) process for this type of device relies on demonstrating substantial equivalence to a legally marketed predicate device.

However, I can extract the information that is present concerning the device and its regulatory clearance:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as specific performance criteria in the provided document. For this type of device, typical acceptance criteria would involve
- Material Composition: Conforming to 316 LS stainless steel standards.
- Dimensions: Within specified ranges for length and diameter.
- Mechanical Properties: (e.g., tensile strength, bending strength, fatigue resistance, torsional strength) necessary for their intended use in fracture fixation. These would be compared against the predicate device or established standards.
- Biocompatibility: Demonstrated non-toxicity and compatibility with human tissue.
- Sterilization Compatibility: Ability to withstand recommended sterilization parameters.
Reported Device Performance:
- Material: Manufactured from commercially 316 LS stainless steel.
- Dimensions:
  - Kirschner Wires: Length from 101.6 to 300 mm, diameter from 0.7 to 1.6 mm.
  - Steinmann Pins: Length from 70 to 400 mm, diameter from 0.8 to 4.8 mm.
  - Available with "four-point style: diamond, trocar, both ends diamond and both ends trocar."
- Sterilization: Provided non-sterile, with recommended steam sterilization parameters (Vacuum cycle, 6 min, 132-135°C).

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. This document pertains to a medical device (Kirschner Wires and Steinmann Pins) which is a physical implant, not a diagnostic or AI-based device that would typically involve a "test set" of data or patient cases. Performance is generally evaluated through bench testing (materials, mechanical properties) and comparison to a predicate device. The 510(k) process itself doesn't require a clinical "test set" in the context of data for an algorithm.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. See point 2. Ground truth in this context would relate to engineering specifications, material standards, and surgical usage, rather than expert-labeled diagnostic data.

4. Adjudication Method for the Test Set:

Not Applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is not relevant for this type of physical medical device. These studies are typically performed for diagnostic devices (especially imaging-based ones) to assess the impact of an AI algorithm on human reader performance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not Applicable in the traditional sense of an AI/diagnostic device. For this mechanical device, "ground truth" implicitly relies on:
- Engineering Specifications and Standards: Conformance to material standards (e.g., 316 LS stainless steel), dimensional specifications, and mechanical performance requirements (which would be derived from predicate devices and historical clinical use).
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance and safety profile of the legally marketed predicate device.

8. The Sample Size for the Training Set:

Not Applicable. This device does not involve a "training set" in the context of machine learning or algorithms.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. See point 8.

Summary of Device Clearance:

The device (Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins) received 510(k) clearance (K983121) on October 5, 1998, indicating that the FDA determined it was substantially equivalent to legally marketed predicate devices for the specified indications for use. This regulatory pathway does not typically involve clinical trials or performance studies as described for AI or diagnostic devices, but rather relies on non-clinical testing (material, mechanical) and a comparison to an already cleared device.

Summary

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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 :

A Description of the Device :

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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 ℃

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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.

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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 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

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Page _ _ of __________________________________________________________________________________________________________________________________________________________________

510(K) Number (if known): __K983121 Device Name: Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins

Indications for use:

(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)

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K9831

Regulation Number and Section

§ 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.