WIN Nails (for use in pediatric patients) are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

This device is intended for osteosynthesis.

The WIN Flexible Nail System is to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

Device Description

The subject WIN Flexible Nail System is made of titanium alloy, which has been continuously made commercially available since the 1950s. This device is to be implanted by insertion into long bones for fixation of fractures.

AI/ML Overview

This document is a 510(k) premarket notification for the "WIN Flexible Nail System" and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of AI/software performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, ground truth, and MRMC studies is not applicable to this type of submission.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance

Not Applicable. This document does not describe performance metrics for a diagnostic or AI device with specific acceptance criteria. It's for a physical medical device (bone fixation nails) and focuses on mechanical properties and material equivalence to a predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No test set or data provenance details are relevant for this type of device submission. The submission relies on demonstrating equivalence through comparison of materials, design features, and intended use, rather than a clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There is no "ground truth" establishment in the context of an AI/diagnostic device performance study mentioned in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No adjudication method for a test set is discussed.

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 is not an AI/software device, so no MRMC study was conducted or is relevant.

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

Not Applicable. This is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. There is no ground truth concept as defined for AI/diagnostic devices in this submission. The "ground truth" in this context is established by the known properties and clinical history of the predicate device and the materials used.

8. The sample size for the training set

Not Applicable. No training set is involved as this is not a machine learning/AI device.

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

Not Applicable. No training set or ground truth for it is relevant.

Information provided in the document related to the device and its assessment:

Device Name: WIN Flexible Nail System
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: JDS
Indications for Use: To be used for treatment of long-bone fractures (including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures) in pediatric patients.
Predicate Device: Pediatric Fixation Rods (K000764) and 2mm Pediatric Flex Nail (K022531)
Basis for Substantial Equivalence:
- Intended Use: Identical to predicate
- Indications for Use: Identical to predicate
- Materials: Identical to predicate (titanium alloy, commercially available since the 1950s)
- Design Features: Similar to predicate
- Sterilization: Identical to predicate
Non-Clinical Tests: "None provided" - The document explicitly states no non-clinical tests were provided in this section of the summary. This implies reliance on the equivalence to the predicate and the established properties of the materials.
Clinical Tests: "None provided" - No clinical tests were provided for this submission.

Conclusion from document: The submission concludes that the differences between the subject device and the predicate do not raise new questions of safety and effectiveness, and the subject device is at least as safe and effective as the legally marketed predicate devices. This is a common approach for Class II devices demonstrating substantial equivalence.

Summary

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February 20, 2020

Biomet Inc. Dominique Dompor Regulatory Affairs Specialist 56 East Bell Drive, PO Box 587 WARSAW IN 46581

Re: K193533

Trade/Device Name: WIN Flexible Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDS Dated: December 19, 2019 Received: December 20, 2019

Dear Dominique Dompor:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193533

Device Name WIN Flexible Nail System

Indications for Use (Describe)

WIN Flexible Nail System

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K193533

510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the WIN Flexible Nail System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number:1825034
Primary Contact Person:	Dominique DomporRegulatory Affairs SpecialistTelephone: (877) 652-0830 ext. 169
Secondary Contact Person:	Stacy HutchensScientific Affairs ManagerTelephone: (574) 371-9671
Date:	December 19, 2019
Subject Device:	Trade Name: WIN Flexible Nail SystemCommon Name: Nail, Fixation, Bone
	Classification Name:Single/multiple component metallic bonefixation appliances and accessories.
	• JDS - Nail, Fixation, Bone(21 CFR §888.3030)

Predicate Device(s):

Primary Predicate	510(k) Number
Pediatric Fixation Rods	K000764
Alternate Predicate	510(k) Number
2mm Pediatric Flex Nail	K022531

Purpose and Device Description:

The subject WIN Flexible Nail System is made of titanium alloy, which has been continuously made commercially available since the 1950s. This device is to

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Intended Use and Indications for Use:

Summary of Technological Characteristics:

Summary of Performance Data: (Nonclinical and/or Clinical)

be implanted by insertion into long bones for fixation of fractures.

The purpose of this submission is:

. To further identify and clarify cumulative changes made to the system since original clearance:
- o An extension to the WIN Flexible Nail product line offering;
- Added surface treatment to o aid in visual differentiation of nail sizes:
- A change to the o manufacturing location;
- o A change to the sterilization vendor site;
. To update labeling in order to bring the Instructions for Use up to current practices.

This device is intended for osteosynthesis.

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: Identical to predicate
Indications for Use: Identical to ● predicate
Materials: Identical to predicate ●
Design Features: Similar to predicate
Sterilization: Identical to predicate

Non-Clinical Tests:

None provided .

Clinical Tests:

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Substantial Equivalence Conclusion:

None provided
The subject WIN Flexible Nail System has identical intended use and indications for use as the predicate devices. The subject device has similar technological characteristics to the predicates, and the information provided herein demonstrates that:
. any differences do not raise new questions of safety and effectiveness; and
the subject devices are at least as . safe and effective as the legally marketed predicate devices.

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.