(55 days)
Not Found
No
The 510(k) summary describes a mechanical implant for vertebral body replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a vertebral body replacement system intended for use in the thoracolumbar spine due to tumor or trauma, which implies it is used to treat a medical condition.
No
The device, Novel™ VBR Spinal System, is a vertebral body replacement device intended for implantation to improve spinal stability, not to diagnose a condition.
No
The device description explicitly states that the system components are manufactured from titanium alloy and are implanted into the vertebral body space, indicating a physical hardware device.
Based on the provided information, the Novel™ VBR Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma." This describes a surgical implant used to treat a physical condition within the body.
- Device Description: The description details a "vertebral body replacement device that is implanted into the vertebral body space." This further confirms it's an implantable medical device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Novel™ VBR Spinal System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Novel™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR Spinal System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR Spinal System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Additionally, the Novel™ VBR Spinal System is intended for use with bone graft.
Product codes
MQP
Device Description
The NOVEL™ VBR Spinal System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. System components are offered in three footprints of varying lengths, widths and heights to meet individual patient anatomy. System components are manufactured from titanium alloy (ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Static and dynamic testing of the NOVEL™ VBR Spinal System was performed. The test results demonstrated that the NOVEL™ VBR Spinal System is at least comparable to, in not better than those of the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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
NOVEL™ VBR Spinal System 510(k) SUMM August 200
l. Company: Alphatec Manufacturing, Inc. 6110 Corte Del Cedro Carlsbad, CA 92009, USA (760) 431-9286
OCT 7 - 2004
- II. Contact Person: Ellen Yarnall, Director of Regulatory Affairs
- III. Trade/Proprietary Name: NOVEL™ VBR Spinal System
- IV. Classification: MQP (888.3060) Vertebral Body Replacement Device
V. Product Description
The NOVEL™ VBR Spinal System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. System components are offered in three footprints of varying lengths, widths and heights to meet individual patient anatomy. System components are manufactured from titanium alloy (ASTM F136).
VI. Intended Use:
The Novel™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR Spinal System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR Spinal System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Additionally, the Novel™ VBR Spinal System is intended for use with bone graft.
VII. Substantial Equivalence:
The NOVEL™ VBR Spinal System is substantially equivalent to the following predicate devices
| Trade/Proprietary Name | Manufacturer | Clearance |
|---|---|---|
| Verte-Stack Spinal System | Medtronic Sofamor Danek | K021791 |
| DePuy AcroMed Stackable Cage | DePuy AcroMed | K990148 |
VIII. Performance Data:
Static and dynamic testing of the NOVEL™ VBR Spinal System was performed. The test results demonstrated that the NOVEL™ VBR Spinal System is at least comparable to, in not better than those of the predicate devices.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized emblem consisting of three wavy lines, which are meant to represent the human services provided by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JCT 2 - 2004
Ellen A. Yarnall Director of Regulatory Affairs Alphatec Manufacturing, Inc. 6110 Corte Del Cedro Carlsbad, California 92009
Re: K042201
Trade/Device Name: NOVEL™ VBR Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 12, 2004 Received: August 13, 2004
Dear Ms. Yarnall:
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 - Ms. Ellen A. Yarnall
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" (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,
Sincerely yours,
Mark A. Millerson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K041226 |
|---|---|
| --------------------------- | --------- |
Device Name: NOVEL™ VBR Spinal System
Indications for Use:
The Novel™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Furthermore, the Novel™ VBR System is intended for use with bone graft.
Prescription Use (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 Millesser
Division of General, Restorative, and Neurological Device
510(k) Number K04220
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