K Number
K043405
Device Name
NUVASIVE COROENT SYSTEM
Manufacturer
Date Cleared
2005-02-07

(59 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Device Description
The NuVasive CoRoent System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
More Information

Not Found

No
The description focuses on the physical characteristics and intended use of an implantable device, with no mention of software, algorithms, or data processing that would suggest AI/ML.

Yes
The device is intended to treat a diseased, collapsed, damaged, or unstable vertebral body due to tumor or trauma, and to achieve decompression of the spinal cord and neural tissues, which constitutes a therapeutic use.

No
Explanation: The device is described as a "partial vertebral body replacement device" used to treat damaged vertebral bodies, not to diagnose a condition.

No

The device description explicitly states it is an "implantable PEEK vertebral body replacement device," which is a physical hardware component.

Based on the provided information, the NuVasive CoRoent System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens from the human body. The intended use and device description clearly state that the NuVasive CoRoent System is an implantable device used to replace a diseased vertebral body within the patient's spine.
  • The device is a physical implant. It is a PEEK vertebral body replacement device, not a test or reagent used to analyze biological samples.
  • The intended use is surgical. The device is used in a surgical procedure to treat a collapsed, damaged, or unstable vertebral body.

Therefore, the NuVasive CoRoent System falls under the category of an implantable medical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The NuVasive CoRoent System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues.

The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Product codes

MQP

Device Description

The NuVasive CoRoent System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues.

The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic and lumbar spine (i.e., T1 to L5) / thoracolumbar spine (T1 to L5)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Mechanical testing was presented.

Key Metrics

Not Found

Predicate Device(s)

K033517, K011037, K032476, K041939

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

VII. 510(k) Summary

K043405 Page 1 of 2

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of n decorantee with the 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

A. Submitted by

Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, CA 92121 Telephone: (858) 909-1868 Date Prepared: February 1, 2005.

B. Device Name

Trade or Proprietary Name:NuVasive CoRoent System
Common or Usual Name:Vertebral Body Replacement Device
Classification Name:Vertebral Body Replacement Device

C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

D. Device Description

The NuVasive CoRoent System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues.

The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

1

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The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

F. Comparison to Predicate Devices

As was established in this submission, the subject device is substantially equivalent to the following predicate devices:

K033517Spinal Concepts Cadence™Spinal concepts, Inc.
K011037Vertebral SpacerSynthes
K032476NuVasive MeshNuVasive, Inc.
K041939Blackstone VBR SystemBlackstone Medical, Inc.

Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.

G. Summary of Non-Clinical Tests

Mechanical testing was presented.

H. Summary of Clinical Tests

(Not Applicable).

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three wing-like shapes.

FEB - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Inc. 4545 Towne Centre Court San Diego, California 92121

Re: K043405

Trade/Device Name: NuVasive CoRoent System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 9, 2004 Received: December 10, 2004

Dear Ms. Cousin:

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 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); 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.

3

Page 2 - Ms. Laetitia Cousin

This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotel will and in your a 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 rr you abon't the Office of Compliance at (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Mark McMullen

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

4

V. Draft Labeling

A. Indications for Use

510(k) Number (if known): __ K0 4 3405

NuVasive CoRoent System Device Name:

Indications for Use:

The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Mark N. Milken

al. Resterative, and Neurological Devices

510(k) Number K043405

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)