The KMedic® Internal/External Fixation Devices are non-sterile, single-use; internal/external fixation devices intended to be used for unilateral internal/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 internal/external fixation modality.

Device Description

The KMedic® Internal/External Fixation Devices consist of various fixation pins and wires for use in unilateral internal/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® Internal/External Fixation Devices included in this submission are manufactured from stainless steel and will be offered non-sterile.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the KMedic® Internal/External Fixation Devices. This is a submission for a medical device and not for a software or AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert involvement, and multi-reader multi-case studies, which are typically relevant for AI/ML device evaluations, are not applicable here.

The document primarily focuses on establishing substantial equivalence to a predicate device based on material, design, and performance characteristics, and compliance with voluntary standards.

Here's a breakdown of the information that can be extracted or inferred from the provided text, related to the device's assessment:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ASTM F136-03 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)"	The KMedic® Internal/External Fixation Devices comply with this standard.
ASTM F366-04 "Standard Specification for Fixation Pins and Wires"	The KMedic® Internal/External Fixation Devices comply with this standard.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing an AI/ML device's performance on a dataset. The "testing" refers to device material and mechanical testing to ensure compliance with industry standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML studies is not relevant here. The "ground truth" for this device's performance relates to its material composition and mechanical properties meeting specified standards for surgical implants.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical implant, not an AI/ML software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" implicitly used for this device is the established specifications and requirements outlined in the ASTM standards (ASTM F136-03 and ASTM F366-04). Compliance with these standards indicates the device's suitability for its intended use.

8. The sample size for the training set: Not applicable. This is not a machine learning device.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "Summary of Testing" in Section H. It states that "The KMedic® Internal/External Fixation Devices comply with ASTM F138-03 'Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)' and ASTM F366-04 'Standard Specification for Fixation Pins and Wires'."

This means that the manufacturer conducted tests (likely mechanical, material composition, and possibly dimensional checks) to ensure that their fixation pins and wires meet the specific requirements set forth in these two ASTM industry standards. These standards define the material properties, performance characteristics, and testing methods for such devices. By stating compliance, the manufacturer is asserting that their testing demonstrated the device adhered to all relevant criteria within these standards. The 510(k) submission relies on this compliance, along with a detailed device description, to establish substantial equivalence to predicate devices.

Summary

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K010561

Teleflex Medical KMedic@ Internal/External Fixation Devices Abbreviated PreMarket Notification (510(k)) Submission

MAY 2 5 2007

SECTION 5 - 510(K) SUMMARY

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS KMedic® Internal/External Fixation Devices

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: 847-572-8002 Fax: 847-572-8001

B. Contact Person

Lori Hays Director, Regulatory Affairs

C. Date Prepared

February 22, 2007

D. Device Name

Trade Name: KMedic® Internal/External Fixation Devices

Common Name: Internal/External Fixation Devices

Classification Name: Smooth or threaded metallic bone fixation fastener

Product Code: HTY, JDW, and HWC

Regulation Number: 21 CFR § 888.3040

Class: II

E. Device Description

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Teleflex Medical KMedic® Internal/External Fixation Devices Abbreviated PreMarket Notification (510(k)) Submission

F. Indications for Use

The KMedic® Internal/External Fixation Devices are non-sterile, single-use; internal/external fixation devices intended to be used for unilateral internal/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 internal/external fixation modality.

G. Substantial Equivalence

The device is similar in intended use, materials, design, and performance characteristics to the Zimmer K-Wires, Steinmann Pins and Schanz Screws (Pre-Amendment). The determination of substantial equivalence for this device was based on a detailed device description and conformance with voluntary standards.

H. Summary of Testing

The KMedic® Internal/External Fixation Devices comply with ASTM F138-03 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F366-04 "Standard Specification for Fixation Pins and Wires".

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Teleflex Medical c/o Ms. Daphne D. Maurer Vice President, Regulatory Affairs 2345 Waukegan Road Suite 120 Bannockburn, Illinois 60015

MAY 2 5 2007

Re: K070561

Trade/Device Name: KMedic® Internal/External Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HTY, JDW, and HWC Dated: May 3, 2007 Received: May 4, 2007

Dear Ms. Maurer:

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 commercc 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 gencral 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Daphnc D. Maurer

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence 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 (240) 276-0120. 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, Intcrnational and Consumer Assistance at its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark M Milliken

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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Teleflex Medical KMedic® Internal/External Fixation Devices Abbreviated PreMarket Notification (510(k)) Submission

SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KO7056 Device Name: __ KMedic® Internal/External Fixation Devices

Indications for Use:

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 OF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millenson

(Division Sign-Off) Division of General, Restorative, and Neurological De

510(k) Number

Page of

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.