K Number
K041722
Device Name
MODIFICATION TO VBR SPINAL SYSTEM
Manufacturer
Date Cleared
2004-09-23

(91 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).
Device Description
Additional components in various sizes and footprints. The VBR Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
More Information

Not Found

No
The summary describes a mechanical spinal implant system and associated surgical instruments, with no mention of AI or ML capabilities.

Yes
The device is used to replace diseased vertebral bodies, achieve decompression, restore height, and treat fractures, all of which are actions intended to treat or alleviate a medical condition.

No

The device description indicates that the VBR Spinal System is designed for surgical intervention (to replace diseased vertebral bodies, treat fractures, and restore biomechanical integrity) and explicitly mentions "manual surgical instruments." There is no mention of diagnostic functions or capabilities.

No

The device description explicitly mentions "Additional components in various sizes and footprints" and "Class 1 manual surgical instruments and cases," indicating it is a hardware-based medical device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description and Intended Use: The provided text describes a surgical implant (VBR Spinal System) used to replace or support vertebral bodies in the spine. It is a physical device implanted into the body during surgery.
  • Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its purpose is structural support and restoration within the body.

Therefore, based on the provided information, the VBR Spinal System is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the of tumors, to achieve anterior treatment decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).

Product codes

MQP

Device Description

Additional components in various sizes and footprints. The VBR Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracolumbar spine (i.e., T1-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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data were submitted to characterize the additional components of the VBR Spinal System.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K030833, K031635, K990148, K020522, K023835

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

SEP 2 3 2004

K 641722

IX. 510(k) Summary

SUBMITTER: DePuv Spine, Inc. 325 Paramount Drive Raynham, MA 02780

Lisa A. Gilman CONTACT PERSON:

June 18, 2004 DATE PREPARED:

CLASSIFICATION NAME: Implant, Fixation Device Spinal Intervertebral Body Fixation Orthosis Device

VBR Spinal System PROPRIETARY NAME:

  • DePuv AcroMed VBR System (K030833) PREDICATE DEVICES: DePuv AcroMed VBR System (K031635) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522) Devex Mesh System (K023835)
  • DEVICE DESCRIPTION: Additional components in various sizes and footprints.

The VBR Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

  • The VBR Spinal System is indicated for use in the INTENDED USE: thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the of tumors, to achieve anterior treatment decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
    The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.

The VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

1

The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).

MATERIALS: Carbon-fiber reinforced polymer

PERFORMANCE DATA:

Performance data were submitted to characterize the additional components of the VBR Spinal System.

2

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

SEP 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Gilman Regulatory Affairs Associate Depuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K041722

Trade/Device Name: VBR Spinal System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 23, 2004 Received: August 24, 2004

Dear Ms. Gilman:

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. Lisa Gilman

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) 594-4692. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 A. Millman

Celia 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

Indications for Use

510(k) Number (if known): ূK041722

Device Name: VBR Spinal System

Indications For Use:

The indications for use for the modified devices described in this submission are the same as those for the DePuy AcroMed VBR System. The indications are as follows:

The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve a nerior decompression of the spinal cord and neural tissues, and to restore the height nf a allensed vertebral body.

The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.

The VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged pneriod.

The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, II SULA, VSP, Moss Miami, TiMX, MONARCH, and Profile).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millheuser

Division Sign-Off

neral. Restorative. and Neurological Devices

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510(k) Number K041722