(21 days)
K041722, K0522344
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No
The document describes a mechanical spinal implant system and its surgical instruments, with no mention of AI or ML capabilities.
Yes
The device is indicated for replacing a diseased vertebral body, treating tumors and fractures, achieving anterior decompression of the spinal cord, and restoring the height of a collapsed vertebral body, all of which are therapeutic interventions.
No
The provided text describes a spinal implant system used for treatment and restoration of the spine, not for diagnosing diseases or conditions.
No
The device description explicitly mentions "manual surgical instruments and cases" and "additional components in various sizes and footprints," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace or support vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description mentions surgical instruments and cases, further indicating a surgical device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information.
- Anatomical Site: The device is used directly on the spine, which is consistent with a surgical implant.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Concorde 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 Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.
The Concorde 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 Concorde 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, Expedium. Viper, and Profile).
Product codes
MQP
Device Description
Additional components in various sizes and footprints alternative minimally invasive surgical and an approach. The Concorde VBR Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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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 Concorde VBR Spinal System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041722, K0522344
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.
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- OCT 2 1 2005 510(k) Summary IX. SUBMITTER: DePuv Spine, Inc. 325 Paramount Drive Raynham, MA 02780 CONTACT PERSON: Lisa A. Gilman DATE PREPARED: September 29, 2005 CLASSIFICATION NAME: Implant, Fixation Device Spinal Intervertebral Body Fixation Orthosis Device Concorde VBR Spinal System PROPRIETARY NAME: VBR Spinal System (K041722) PREDICATE DEVICES: DEVICE DESCRIPTION: Additional components in various sizes and footprints alternative minimally invasive surgical and an approach. The Concorde VBR Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification. The Concorde VBR Spinal System is indicated for use INTENDED 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 Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The Concorde 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 Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the
1
Concorde VBR Spinal System
Concorde VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, T MX, MONARCH, Expedium, Viper, and Profile).
Carbon-fiber reinforced polymer MATERIALS:
PERFORMANCE DATA:
Performance data were submitted to characterize the additional components of the Concorde VBR Spinal System.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three stylized feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sharon Starowicz Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K052746
Trade/Device Name: Concorde VBR Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: September 29, 2005 Received: September 30, 2005
Dear Ms. Starowicz:
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.
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Page 2- Sharon Starowicz
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse of substantial equivalence of your device to a legally premaince notification - Theseification 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 desire specific acreoliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisoranding of Terefore to presessonsibilities under the Act from the Division of Small other golferal miorinational 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 Naff
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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lll. Indications for Use
| 510(k) Number (if known): | K052746 |
|---|---|
| --------------------------- | --------- |
Concorde VBR Spinal System Device Name:
Indications For Use:
The Concorde 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 Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.
The Concorde 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 Concorde 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, Expedium. Viper, and Profile).
× Prescription Use (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)
s
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
510(k) Number_K0522344