The KMedic External Fixation Devices are non-sterile, single-use, external fixation devices intended to be used for unilateral external fixation in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

Device Description

KMedic External Fixation Devices consist of various fixation pins and wires for use in unilateral external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. All KMedic external fixation devices included in this submission are manufactured of medical grade stainless steel. All KMedic external fixation devices included in this submission will be offered in a non-sterile condition. The following KMedic External Fixation Devices are included in this submission: Kirschner Wires, Steinmann Pins, Schanz Pins, Cerclage Wires.

AI/ML Overview

I am sorry, but based on the provided document, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) Pre-market Notification for the KMedic External Fixation Devices, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices.

The document includes:

Device description and intended use: This section describes the KMedic External Fixation Devices and their intended medical applications.
Comparison to predicate devices: The submission asserts that the KMedic devices are substantially equivalent in design and materials to previously marketed devices.
FDA clearance letter: This letter confirms the FDA's finding of substantial equivalence, allowing the device to be marketed.

However, it does not contain the following information you requested, which would typically be found in a performance study or validation report:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance, number of experts, or adjudication methods for any test set.
Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Information on ground truth types or how ground truth was established for training or test sets.
Sample size for a training set.

The 510(k) pathway for medical device clearance in the US relies on demonstrating substantial equivalence to a predicate device rather than requiring extensive clinical trials and performance studies as might be needed for a PMA (Pre-Market Approval) or for a device incorporating AI.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for TFX Medical Incorporated. The logo is black and white and features a stylized "T" and "FX" stacked on top of each other. To the right of "TFX" is the word "Medical" in a bold, sans-serif font. Above the "dical" in "Medical" is the word "INCORPORATED" in a smaller font.

030336
page 1 of

MAR 0 6 2003

510 (k) Summary

Submitter Name, Address, and Date of Submission: 1.

Rick Lykins Group RA Manager - US Teleflex Medical Group Tall Pines Park 03452 Jaffrey, NH Telephone Number: (603) 532-0204 Fax Number: (603) 532-6179

Same as above Contact:

Name of the Device, Common, Proprietary (if known), and 2. Classification:
Classification Name: Smooth or Threaded Metallic Bone Fixation Fasteners External Fixation Devices Common Name: KMedic External Fixation Devices Proprietary Name:

Identification of the legally marketed device to which the 3. submitter claims equivalence:

Fixation Devices are substantially External The KMedic equivalent in design and materials to:

George Tiemann & Co. Kirschner Wires, Steinmann Pins and ● Cerclage Wires - Preamendment
Kirschner Wires and Pins ● DuPuy, Inc. Steinmann Sterile (As referenced in DuPuy, Inc. Preamendment Kirschner Wires and Steinmann Pins K960385)
NewDeal K-Wire K022599 .

(603) 532-8211 or 6108

{1}------------------------------------------------

030336

Page 2 6x 2

Description of the Device: 4 .

KMedic External Fixation Devices consist of various The fixation pins and wires for use in unilateral external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. All KMedic external fixation devices included in this submission are manufactured of medical grade stainless steel. All KMedic external fixation devices included in this submission will be offered in a non-sterile condition.

The following KMedic External Fixation Devices are included in this submission:

Kirschner Wires Steinmann Pins Schanz Pins Cerclage Wires

5. Intended Use of the Device:

The KMedic External Fixation Devices are non-sterile, singleexternal fixation devices intended to be used for use, unilateral external fixation in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

Summary of Technological Characteristics: 6.

technological characteristics are the same as or The equivalent to the predicate devices previously listed.

Materials:

The KMedic External Fixation Devices are manufactured from 316 stainless steel which is identical to all of the identified predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 6 2003

Mr. Rick Lykins Group RA Manager - US Teleflex Medical Group 50 Plantation Drive Jaffrey, New Hampshire 03452

Re: K030336

Trade Name: KMedic External Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW and HTY Dated: January 29, 2003 Received: January 31, 2003

Dear Mr. Lykins:

We have reviewed your Section 510(k) premarket 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) 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 such 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); 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.

{3}------------------------------------------------

Page 2 - Mr. Rick Lykins

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milkman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known): KO30336

Device Name: KMedic External Fixation Devices

Indications for Use:

The KMedic External Fixation Devices are non-sterile, single-use, external fixation devices intended to be used for unilateral external fixation in the treatment of of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

(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)

Mr Milk
(Optional Format 1-2-
Division Sign-OM

e. Restorative

1021cal Devices

" " (k) Number -

(Optional Format 1-2-96)

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.