The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Device Description

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for a medical device called the "Normandy VBR System." This document describes the device's indications for use, its mechanical characteristics, and its substantial equivalence to predicate devices based on mechanical performance testing.

It is crucial to understand that this document does not describe a study involving an artificial intelligence (AI) device or a study involving human readers/interpreters of medical images. Therefore, I cannot provide information on acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details as requested in your prompt. These elements are typically associated with studies evaluating diagnostic or prognostic AI algorithms, not with physical implantable medical devices like the Normandy VBR System.

The "Performance Data" section explicitly states: "Mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices. Static and Dynamic Axial Compression, Static and Dynamic Torsion, Subsidence, and Expulsion (per internal protocol) testing was performed in accordance with ASTM F2077 and ASTM F2267."

This refers to physical, biomechanical testing of the device's structural integrity and function, not evaluation of a diagnostic algorithm's accuracy or interpretation by human readers.

Therefore, I must state that the requested information (points 1-9) about acceptance criteria and study proving device performance cannot be extracted from the provided text because the device and the associated testing are not related to an AI/diagnostic imaging context.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

Zavation Medical Products LLC Frankie Cummins Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

Re: K180673

Trade/Device Name: Normandy VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR, MQP Dated: June 11, 2018 Received: June 14, 2018

Dear Mr. Cummins:

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 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.

July 13, 2018

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Melissa Hall -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) K180673

Device Name

Normandy VBR System

Indications for Use (Describe)

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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510K Summary

Date:	July 9, 2018
Submitter:	Zavation Medical Products LLC220 Lakeland ParkwayFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302
Contact person:	Frankie Cummins
Trade name:	Normandy VBR System
Classification:	Regulation Number: 21 CFR 888.3060Regulation Name: Spinal Intervertebral Body FixationOrthosisRegulatory Class: Class IIProduct Code: PLR, MQP
Predicates:	Primary: K162315 Globus FORTIFY Corpectomy SpacersAdditional: K060416 Ulrich Medical ObeliscK012254 Osteotech VBRK172032 Aesculap Modulift VBR	Reference: K112664 Zavation IBF

Device Description:

Intended Use:

The Normandy VBR System is indicated for use in the cervical spine (C2-C7) and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased,

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collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

Technological Characteristics:

The Normandy VBR System implants have the same technological characteristics as the predicate devices including, design, intended use, material composition, function, and range of sizes.

Performance Data:

Mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices. Static and Dynamic Axial Compression, Static and Dynamic Torsion, Subsidence, and Expulsion (per internal protocol) testing was performed in accordance with ASTM F2077 and ASTM F2267.

Conclusion:

The Normandy VBR System is substantially equivalent to the predicate device referenced above.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.