VERTE-STACK SPINAL SYSTEM by MEDTRONIC SOFAMOR DANEK

The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

Device Description

The VERTE-STACK™ device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK ™ device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA I.T) along with a tantalum marker. Alternatively the device may be manufactured from titanium alloy.

The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK™ device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK 1M Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK™ constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK™ constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to include titanium components to the VERTE-STACK™ Spinal System.

AI/ML Overview

This appears to be a 510(k) premarket notification document for a medical device, specifically the VERTE-STACK™ Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with acceptance criteria and performance metrics of the new device itself in the way that an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in the provided document.

Here's why and what can be extracted from the provided text:

Device Type: The VERTE-STACK™ Spinal System is a physical medical implant (spinal intervertebral body fixation orthosis), not an AI/ML diagnostic or prognostic software. Substantial equivalence for physical implants typically relies on mechanical testing, material compatibility, and engineering design comparisons to predicate devices, rather than clinical performance metrics in the way AI algorithms are evaluated.
Submission Type: A 510(k) submission, as indicated by "K040167" and the FDA letter, aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process generally does not require new efficacy or comparative effectiveness studies with human readers, especially for a device of this nature. The FDA letter explicitly states, "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...".

Information that can be extracted from the document related to the device and its regulatory context:

Device Name: VERTE-STACK™ Spinal System
Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060)
Regulatory Class: II
Product Code: MQP
Manufacturer: Medtronic Sofamor Danek Company
Device Description: Stackable spacer made from PEEK OPTIMA I.T. (with a tantalum marker) or titanium alloy, designed for vertebral body replacement in the anterior thoracic and lumbar spine. It is not intended as a stand-alone device and must be used with additional anterior and/or posterior spinal instrumentation.
Indications for Use: Vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used with supplemental fixation systems (listed are Medtronic Sofamor Danek ZPLATE II, DYNALOK™ CLASSIC, VANTAGE™, TSRH®, CD HORIZON®, GDLH® Spinal System, or their successors) and bone graft.
Purpose of Submission K040167: To include titanium components to the VERTE-STACK™ Spinal System.

Conclusion:

The provided document (a 510(k) premarket notification) for the VERTE-STACK™ Spinal System does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods for demonstrating device performance. These types of detailed studies are not typically required for a 510(k) submission of a physical implant device demonstrating substantial equivalence.

Summary

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K040167

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Medtronic Sofamor Danek Company: I. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proprietary Trade Name: VERTE-STACK™ Spinal System II.

Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR III. 888.3060)

III. Product Description

The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The purpose of this submission is to include titanium components to the VERTE-STACK™ Spinal System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Public Health Service

FEB 1 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K040167

Trade/Device Name: VERTE-STACK™ Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral body replacement device Regulatory Class: II Product Code: MQP Dated: January 23, 2004 Received: January 26, 2004

Dear Dr. Treharne:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 docs 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); 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.

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Pagc 2 - Richard W. Treharne, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milliken

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K040167

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Device Name: VERTE-STACK™ Spinal System

Indications for Use:

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
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Over-The-Counter Use(Optional 1-2-96)
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Mark A. Mellken

(k) Number

510(k) Number.

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.