Ilizarov Drill Tip Wires are intended to be used for the following indications:
Post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; and infected fractures or nonunions.
Ilizarov Drill Tip Wires are for single use only.

Device Description

The subject Ilizarov Drill Tip Wires are comprised of implantable anchorage elements designed for use in a multilateral (i.e. a circular) fixator assembly comprised of a structurally purposeful arrangement of simple or complex bridge elements, connection elements and anchorage elements. The subject devices are manufactured from implant grade stainless steel material. Compared to the predicate devices, the subject devices will be available in the following configurations:
Ilizarov Drill Tip Wire, 1.8mm x 400mm
Ilizarov Drill Tip Wire with Stopper, 1.8mm x 400mm

AI/ML Overview

Acceptance Criteria and Study for Ilizarov Drill Tip Wires (K130479)

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Ilizarov Drill Tip Wires (K130479) to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify explicit numerical acceptance criteria for the "cutting performance of the wire." Instead, it states that "Mechanical test results were compared against predicate devices." The implicit acceptance criterion is that the subject device's performance in these mechanical tests should be comparable to or not worse than those of the predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Cutting performance (number of start/stops prior until failure) comparable to predicate devices	Mechanical test results were compared against predicate devices. (Specific quantitative results are not provided in the summary)
Cutting performance (time to insertion) comparable to predicate devices	Mechanical test results were compared against predicate devices. (Specific quantitative results are not provided in the summary)
Cutting performance (insertion temperature) comparable to predicate devices	Mechanical test results were compared against predicate devices. (Specific quantitative results are not provided in the summary)

Note: The provided 510(k) summary is high-level and does not include the detailed quantitative results of the specific mechanical tests. A full engineering report or test protocol would typically contain these specific values and their comparison to established thresholds or predicate device performance.

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not explicitly state the sample size (number of wires tested) for the preclinical bench testing.
Data Provenance: The preclinical testing was conducted by Smith & Nephew, Inc., implying it was internal testing. The country of origin of the data is not specified but is implicitly the manufacturing/testing location of Smith & Nephew, Inc. (Memphis, TN, USA is listed as their address). The nature of the testing (pre-clinical bench testing) indicates it was prospective for the purpose of this submission.

3. Number and Qualifications of Experts for Ground Truth Establishment

This submission primarily relies on bench testing for substantial equivalence. Therefore:

Number of Experts: Not applicable in the context of human expert review for establishing ground truth on a test set, as the ground truth is based on physical mechanical properties measured in a lab setting.
Qualifications of Experts: Not applicable, as expert consensus on a test set (e.g., medical image interpretation) was not performed. The testing would have been conducted by engineers or technicians qualified in materials testing and mechanical analysis.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to physical devices undergoing mechanical tests, not a set of clinical cases requiring expert interpretation and adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a surgical wire, and its performance is evaluated through mechanical bench testing, not clinical imaging or diagnostic interpretation where MRMC studies are typically employed.

6. Standalone (Algorithm Only) Performance Study

No. A standalone performance study of an algorithm was not conducted. This device is a physical medical implant, not a software-based algorithm or AI system.

7. Type of Ground Truth Used

The ground truth used for the device's evaluation was physical mechanical properties measured through preclinical bench testing. This includes objective measurements of "cutting performance including: number of start/stops prior until failure, time to insertion and insertion temperature." The performance was then compared against the observed mechanical properties of legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The data generated was for verification and validation of the physical product's performance.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical medical device like this.

Summary

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

K130479 510(k) Summary of Safety and Effectiveness

	Ilizarov Drill Tip Wires	MAY 14 2013
Submitted By:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	May 10, 2013
Contact Person:	David Henley, Regulatory Affairs Project ManagerTel: (901) 399-6487 Fax: (901) 566-7079
Proprietary Name:	Ilizarov Drill Tip Wires
Common Name:	Multilateral Fixators and Accessories
Classification Name and Reference:	21 CFR 888.3030, single/multiple component metallic bone fixation appliance and accessories - Class II
Device Product Code and Panel Code:	KTT / Orthopedics / 87

Device Description:

Device Type	Diameter	Length
Ilizarov Drill Tip Wire, 1.8mm x 400mm	1.8mm	400mm
Ilizarov Drill Tip Wire with Stopper,1.8mm x 400mm	1.8mm	400mm

Intended Use:

Ilizarov Drill Tip Wires are intended to be used for the following indications:

Post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; and infected fractures or nonunions.

Ilizarov Drill Tip Wires are for single use only.

Technological Characteristics:

Ilizarov Drill Tip Wires are very similar to legally marketed predicate devices listed below in that they share identical or very similar indications for use, are manufactured from stainless steel material and incorporate identical or very similar technological design characteristics.

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

Substantial Equivalence Information:

When compared to the predicate devices listed below, substantial equivalence is based on identical or very similar design features, overall indications for use, and raw material composition.

. Smith & Nephew Smooth and Olive Wires - K994143
Ilizarov Drill Tip Wires K093047 .
. Richards Transfixation Wires - K870961
Smith & Nephew Drill Tip Kirschner Wires (K-wires) K090675 .
. llizarov External Fixation System – Titanium Wires and Washers – K962808

Preclinical Testing:

To further support a determination of substantial equivalence, pre-clinical bench testing was conducted on the subject Ilizarov Drill Tip Wires. Mechanical test results were compared against predicate devices. The specific type of pre-clinical testing conducted is described as:

. Cutting performance of the wire including: number of start/stops prior until failure, time to insertion and insertion temperature

Conclusion:

Based on similarities in design and on the results of mechanical testing, the subject device is substantially equivalent to predicates.

5-2

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble a human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

Letter dated: May 14, 2013

Smith and Nephew, Incorporated % Mr. David Henley Regulatory Affairs Project Manager 1450 Brooks Road Memphis, Tennessee 38116

Re: K130479

Trade/Device Name: Ilizarov Drill Tip Wires Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: March 15, 2013 Received: March 18, 2013

Dear Mr. Henley:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Mr. David Henley

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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark Nigeljierson -S

Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Premarket Notification Indications for Use Statement

510(k) Number (if known): K130479

Device Name: Ilizarov Drill Tip Wires

Indications for Use:

llizarov Drill Tip Wires are intended to be used for the following indications:

Post-traumatic joint contracture which has resulted in loss of range of motion .
Fractures and disease which generally may result in joint contractures or loss of . range of motion and fractures requiring distraction
. Open and closed fracture fixation
. Pseudoarthrosis of long bones
Limb lengthening by epiphyseal or metaphyseal distraction �
Correction of bony or soft tissue deformities �
Correction of bony or soft tissue defects
Joint arthrodesis
Infected fractures or nonunions

Ilizarov Drill Tip Wires are for single use only.

Prescription Use AND/OR Over-the-Counter Use י (Part 21 CFR 801 Subpart D) י (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic:Devices

4- |

Regulation Number and Section

§ 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.