The NCB Plating System is an extramedullary internal fixation plate system to be used for either distal femoral or proximal tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.

AI/ML Overview

The provided text is a 510(k) summary for the Zimmer GmbH NCB® Plating System. This document describes a medical device, specifically a bone fixation system, and its premarket notification to the FDA.

Based on the content of the document, the device described is a mechanical implant, not an AI/software-based medical device. The "Performance Data (Nonclinical and/or Clinical)" section explicitly states:

Non-Clinical Performance and Conclusions: "Class II: Amendment of Design Controls with verification of mechanical integrity and resistance."
Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

This means the clearance for this device was based on mechanical testing and verification of design controls, not on a study proving performance against acceptance criteria for an AI or software algorithm. There is no mention of an algorithm, AI assistance, human readers, or ground truth establishment in the context of device performance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details for an AI/software device, as this document is about a physical orthopedic implant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

September 13, 2019

Zimmer GmbH Tiana Steinhoff Regulatory Affairs Specialist Sulzerallee 8 Winterthur, 8404 CH

Re: K192217

Trade/Device Name: NCB Plating System Distal Femur and Proximal Tibia Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 12, 2019 Received: August 15, 2019

Dear Tiana Steinhoff:

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

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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) 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,

Shumaya Ali. MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192217

Device Name

NCB® Plating System, Distal Femur and Proximal Tibia

Indications for Use (Describe)

The NCB Plating System is indicated for temporary internal fixation of fractures and osteotomies of long bones.

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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Image /page/3/Picture/2 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. Below the company name is the tagline "Your progress. Our promise".

510(k) SUMMARY

Sponsor:	Zimmer GmbHSulzerallee 8, P.O. Box8404 Winterthur, Switzerland
Contact Person:	Tiana SteinhoffSpecialist, Regulatory AffairsTelephone: +41 58 854 82 96Fax: +41 52 244 86 58
Date:	August 12th, 2019
Trade Name:	NCB® Plating System, Distal Femur and its line extensionProximal Tibia
Classification Product Code :	Plate SystemHRSHWC
Device Classification Name:	Plate, fixation, boneScrew, fixation, bone
Regulation Number / Description:	21 CFR § 888.3030 Single/multiple component metallic bonefixation appliances and accessories21 CFR § 888.3040 Smooth or threaded metallic bone fixationfastener
Predicate Device:	NCB® Plating System, Distal Femur, manufactured by ZimmerGmbH, K042695, cleared in October 2004 (primary predicate)NCB® Plating System, Proximal Tibia, manufactured by ZimmerGmbH, K061211, cleared in June 2006 (line extension ofK042695)
Device Description:	The NCB Plating System is an extramedullary internal fixationplate system to be used for either distal femoral or proximal tibiafractures. It is intended to be implanted either percutaneously orby a traditional open method.
Intended Use:	The NCB Plating System is indicated for temporary internalfixation and stabilization of fractures and osteotomies oflong bones.
Comparison to Predicate Device:	The intended use of the modified devices, as described in itslabeling, has not changed as a result of the modifications
proposed in the present submission.
The proposed packaging configuration and the methods to supportthe package integrity have been previously cleared for ZimmerGmbH products. Zimmer GmbH is furthermore seeking clearancefor certain system-specific Class II instruments - these instrumentsthat have previously considered Class I exempt and correction ofclassification to Class II is proposed within present submission.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Class II: Amendment of Design Controls with verification ofmechanical integrity and resistance.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.
Conclusion:	The subject devices have the same intended use and sameindications for use as the predicate devices. The subject devicesuse the same operating principle, incorporate the same basicdesign and labeling and are manufactured and sterilized using thesame materials and processes as the predicate devices.Except for the modifications described in this submission thesubject devices are identical to the predicate devices, and theperformance data and analyses demonstrate that:any differences do not raise new questions of safety andeffectiveness as established with performance testing; and the subject devices are at least as safe and effective asthe legally marketed predicate devices.

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510(K) SUMMARY

Image /page/4/Picture/2 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. Below the company name is the tagline "Your progress. Our promise." in a smaller font.

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.