C-Wires are single use devices. They are intended to be used by trained professionals for the purpose of bone fracture fixation. The C-Wires should only be used with wire drivers that are designed to drive wires having longitudinal flats.

Device Description

The C-Wires are single use devices. They are intended to be used by trained professionals for the purpose of bone fracture fixation. The C-Wires should only be used with wire drivers that are designed to drive wires having longitudinal flats.

The C-Wire Double Ended Orthopedic Wires are single-use devices that are indicated for surgical repair of small bone trauma. The C-Wires provide mechanical stability during the natural bone healing process. Each wire is 5" (127mm) long, with each end ground to either a spade or trocar shaped tip. C-Wires are available in four different diameters (0.7mm, 0.89mm, 1.14mm and 1.57mm). The wires are made of 316LVM stainless steel.

AI/ML Overview

The provided document describes the CONMED Corporation's C-Wire Double Ended Orthopedic Wires and its substantial equivalence to a predicate device (SMT Schilling Kirschner/Guide Wires, K100736). As such, this document does not contain information about acceptance criteria and a study proving a new device meets those acceptance criteria in the typical sense of a performance study for, for example, an AI/ML device.

Instead, the submission argues for substantial equivalence based on:

Long-term market history: The device has been in continuous use for 38 years with few complaints. This serves as a form of "real-world evidence" demonstrating safety and effectiveness over a very long period.
Similarity to predicate devices: The C-Wire is very similar to other FDA-cleared wires in terms of intended use, engineering drawings, material, method of operation, and shape/size.
Conformance to FDA standards: The device conforms to FDA standards related to pins and wires and other recognized standards.
Completed testing: Transportation, biocompatibility, sterilization, and shelf-life testing were completed.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device demonstrating substantial equivalence rather than a diagnostic device relying on specific performance metrics established through a clinical or algorithmic study.

However, I can extract the information that is present and indicate where requested information is not available.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The C-Wire Double Ended Orthopedic Wires are demonstrated to be substantially equivalent to the predicate device, SMT Schilling Kirschner/Guide Wires (K100736). The "acceptance criteria" in this context are not quantitative performance metrics of a novel diagnostic algorithm, but rather the qualitative and quantitative similarities to the predicate device, along with a long history of safe use and compliance with relevant standards. The "study" proving the device meets these criteria is a substantial equivalence comparison and a review of post-market surveillance data.

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

Acceptance Criteria Category	Specific Criteria (Implicitly Met for SE)	Reported Device Performance/Evidence Provided
Intended Use	Match or be acceptably similar to the predicate device.	Proposed Device: "C-Wires are single use devices. They are intended to be used by trained professionals for the purpose of bone fracture fixation. The C-Wires should only be used with wire drivers that are designed to drive wires having longitudinal flats."Predicate Device: "Orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system."Note: The proposed device has a slightly narrower intended use (no guidance function).
Material	Biocompatible and similar to predicate device.	Proposed Device: 316LVM stainless steelPredicate Device: 316L stainless steelBiocompatibility testing was completed.
Conditions of Use	Similar to predicate device.	Proposed Device: Operating Room in Hospital or Ambulatory Surgical Center for fracture fixation.Predicate Device: Operating Room in Hospital or Ambulatory Surgical Center for fracture fixation or guide for implant.
Scientific Technology	Similar fundamental technology.	Proposed Device: Metal rods inserted using powered handpieces.Predicate Device: Metal rods inserted using powered hand pieces.
Sterilization Method	Validated and similar to predicate device for sterility assurance level (SAL).	Proposed Device: Gamma Sterilization at a SAL of 10-6.Predicate Device: Gamma Sterilization at a SAL of 10-6.Sterilization testing was completed.
Safety and Effectiveness	Demonstrated by long-term safe market history, similarity to cleared devices, and conformance to standards. No new issues of safety or effectiveness should be raised.	Evidence:- Continuous use for 38 years with few complaints regarding breakage, insertion, or pull-out (based on Post Market Surveillance Reports).- Very similar to other FDA-cleared wires (including the predicate) in intended use, engineering drawings, material, method of operation, and shape/size.- Conformance to FDA standards (e.g., related to pins and wires) and other FDA-recognized standards.- Completed Transportation, Biocompatibility, Sterilization, and Shelf-life testing.
Physical Characteristics	(e.g., diameter, length, tips) Similar range or scope as predicate.	Proposed Device: Diameter: 0.7mm, 0.89mm, 1.14mm, 1.57mm; Length: 5" (127mm); Tips: spade or trocar. Made of 316LVM stainless steel.Predicate Device: Diameter: 0.6 - 6.35mm; Length: 60 - 500mm; Tips: diamond or trocar point, round, flat, with or without 3- or 4-shank ends, with or without spherical shape. Made of 316L.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable in the context of a traditional device substantial equivalence based on long market history and comparison to a predicate device. Performance is not measured on a specific test set of cases. The "test" is the comparison analysis and the review of 38 years of post-market surveillance.
Data Provenance: The 38 years of "continuous use" and "Post Market Surveillance Reports" indicate retrospective real-world data, likely from various unspecified regions where the device was marketed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Experts and Qualifications: Not applicable. Ground truth in the context of diagnostic AI/ML evaluation is not relevant here. The evidence for substantial equivalence relies on device design, materials, manufacturing controls, and historical safety data.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. No "test set" in the traditional sense, and thus no adjudication of expert interpretations for ground truth.

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:

MRMC Study: Not applicable. This document is for a physical medical device (orthopedic wires), not an AI/ML diagnostic system. No human readers or AI assistance are involved in its primary function.

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

Standalone Performance Study: Not applicable. This is not an algorithm.

7. The type of ground truth used:

Type of Ground Truth: In this context, the "ground truth" for the safety and effectiveness claim is primarily based on:
- Historical Performance/Outcomes Data: 38 years of continuous use with few complaints from post-market surveillance.
- Engineering and Material Standards: Conformance to established FDA and recognized standards for physical properties, device design, and biocompatibility.
- Direct Comparison to Predicate: Demonstrating substantial equivalence in design, materials, intended use, and technology to a legally marketed device.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are connected by a flowing line.

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

September 12, 2014

CONMED Corporation Ms. Joy Lovett Regulatory Affairs Specialist 11311 Concept Blvd Largo, Florida 33773

Re: K142134

Trade/Device Name: C-Wire Double Ended Orthopedic Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: July 31, 2014 Received: August 6, 2014

Dear Ms. Lovett:

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

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Page 2 - Ms. Joy Lovett

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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.

Lori A. Wiggins -S

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

Enclosure

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Indications for Use

510(k) Number (if known): K142134

Device Name: C-Wire Double Ended Orthopedic Wires

Intended Use / Indications for Use:

Prescription Use × (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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510(k) Summarv

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CONMED Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K142134

Date Prepared: 5 September 2014

A. Submitter

ConMed Corporation, Largo 11311 Concept Boulevard Largo, FL Establishment Registration Number:

B. Company Contact
Joy Lovett Requlatory Affairs Specialist Phone: 727-399-5137 Fax: 727-399-5264
C. Device Name

Trade Name:	C-Wire Double Ended Orthopedic Wires
Common Name:	Fixation Wire
Classification Name:	Pin, Fixation, Smooth
Proposed Class:Device:	Class II
Product Codes:	HTY
Regulation:	21 CFR Part 888.3040

D. Predicate/Legally Marketed Devices

Device Name:	SMT Schilling Kirschner/Guide Wires, K100736
Company Name:	SMT Schilling Metalltechnik GmbH
510(k) #:	K100736

E. Device Description

The intended use / indications statement for the C-Wires materially differs from that of the Schilling Kirschner/Guide Wires in that the C-Wire statement does not include a guidance function for insertion of implants into the skeletal system. CONMED manufactures a separate line of quidewires for this function. The

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separation of these functions does not have an impact on the safety and effectiveness of the device.

Intended Use / Indications F.
The C-Wires are single use devices. They are intended to be used by trained professionals for the purpose of bone fracture fixation. The C-Wires should only be used with wire drivers that are designed to drive wires having longitudinal flats.

The intended use / indications statement for the C-Wires materially differs from that of the Schilling Kirschner/Guide Wires in that the C-Wire statement does not include a quidance function for insertion of implants into the skeletal system. CONMED manufactures a separate line of guide wires for this function. The separation of these functions does not have an impact on the safety and effectiveness of the device.

G. Summary of Technological Characteristics
The following table represents a summary of the technological characteristics of the ConMed C-Wire Double Ended Orthopedic Wires and the SMT Schilling Kirschner/GuideWires

	Proposed DeviceCONMED C-Wire DoubleEnded Orthopedic Wires	Predicate DeviceSMT SchillingKirschner/Guide Wires(K100736)
Brief Description	C-Wire Double EndedOrthopedic Wires are single-use devices that are indicatedfor surgical repair of smallbone trauma. The C-Wiresprovide mechanical stabilityduring the natural bonehealing process. Each wire is5" (127mm) long, with eachend ground to either a spadeor trocar shaped tip. C-Wiresare available in four differentdiameters (0.7mm, 0.89mm,1.14mm and 1.57mm). Thewires are made of 316LVMstainless steel.	Orthopaedic fixation pins andwires are metal pins for use infixation of bone fractures, forbone reconstructions, as guidepins for insertion of other implantsor implantation through the skinso that traction may be applied tothe skeleton system. To ensurethe multi-use of these devices,many different models areavailable. This differences canbe as follows:Diameter: from 0.6 - 6.35mmLength, from 60 up to 500mmTips: diamond or trocar point,round, flat, with or without 3- or 4-shank ends, with or withoutspherical shape.Surface: complete or partialsmooth and/or threaded, with orwithout threading cutter.

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	Proposed DeviceCONMED C-Wire DoubleEnded Orthopedic Wires	Predicate DeviceSMT SchillingKirschner/Guide Wires(K100736)
IntendedUse/Indications forUse	C-Wires are single use devices. They are intended to be used by trained professionals for the purpose of bone fracture fixation. The C-Wires should only be used with wire drivers that are designed to drive wires having longitudinal flats.	Orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
Material	316LVM	316L
Conditions of Use	Operating Room in Hospital orAmbulatory Surgical Center forfracture fixation	Operating Room in Hospital orAmbulatory Surgical Center forfracture fixation or guide forimplant
ScientificTechnology	Metal rods inserted using powered handpieces	Metal rods inserted using powered hand pieces
SterilizationMethod and SAL	Gamma Sterilization at a SAL of 10-6	Gamma Sterilization at a SAL of 10-6

Completed testing includes the following:

Transportation 0
Biocompatibility �
® Sterilization
ø Shelf-life

Functional testing on the C-Wires is not required as safety and effectiveness has been established through the following:

The device has been in continuous use for thirty-eight (38) years with few 1. complaints regarding breakage, insertion or pull-out as detailed in Post Market Surveillance Reports.
1. The C-Wire is very similar to other wires cleared by FDA based on a comparison of intended use, engineering drawings, material, method of operation and shape/size. This similarity is documented in the Comparison Chart of Section 13 and summarized below for the predicate device, SMT Schilling Kirschner/Guide Wires (K100736).
1. Conformance to FDA standards related to pins and wires as well as other FDA recognized Standards governing aspects of product development and total life cycle.

H, Substantial Equivalence

The C-Wire Double Ended Orthopedic Wires have intended use, conditions of use, sterilization method, sterility assurance level and utilizes the same fundamental scientific technology as the predicate device, while raising no new issues of safety or effectiveness. Similarities of the two devices are demonstrated in

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a comparison of the engineering drawings as well. Refer to Attachment 14-1. The C-Wire Double Ended Orthopedic Wires are therefore substantially equivalent to the SMT Schilling Kirschner/GuideWires cleared under K100736.

I. CONCLUSION

Based upon the testing and analysis performed, the C-Wire Double Ended Orthopedic Wire is as safe, as effective, and performs as well as the SMT Schilling Kirschner/Guide Wires (K100736)..

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.