(155 days)
Not Found
No
The document describes a mechanical vertebral body replacement device and its materials. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is described as a "vertebral body replacement device" used to "replace a diseased or damaged vertebral body" and "restore height of a collapsed vertebral body," which directly relates to treating a medical condition and restoring normal function.
No
Explanation: The device is a vertebral body replacement device used for structural support, not for diagnosing medical conditions.
No
The device description explicitly states the device is manufactured from carbon-fiber PEEK and titanium alloy, which are hardware materials. The summary also describes physical testing performed on the 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 a vertebral body in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and design of a physical implant and its inserter, not a test or reagent used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for structural support and replacement within the body.
N/A
Intended Use / Indications for Use
The NuVasive® Lateral VBR System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, 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 Lateral VBR System is a vertebral body replacement device manufactured from carbon-fiber PEEK (polyetheretone) and titanium alloy conforming to industry recognized standards that is available in a variety sizes to suit the individual pathology and anatomical conditions of the patient. The Lateral VBR System vertebral body replacement device is designed to address thoracolumbar pathologies utilizing implant placement though a lateral approach. This implant inserter is specifically designed to place and expand the implant device. Allograft or autograft material may be used to facilitate fusion. The subject device components are manufactured from Carbon-Fiber Reinforced PEEK-Optima® LT1CA30 (CFRP) and titanium alloy conforming to ASTM F136 and ISO 5832-3.
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
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
Nonclinical testing was performed to demonstrate that the subject Lateral VBR System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression, compression shear, and torsion per ASTM F2077
- Wear debris testing per ASTM F1714 and ASTM F1877
- Expulsion testing
- Cadaver testing
The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate. No non-clinical or clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
NuVasive Ti Mesh System (K032476), SpineWave StaXx XD System (K052670 and K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254), NuVasive CoRoent System (K071795), Aesculap Hydrolift VBR System (K083186)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Nuvasive, Incorporated Mr. Jeremy Markovich Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K140563
Trade/Device Name: NuVasive® Lateral VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: July 3. 2014 Received: July 7, 2014
Dear Mr. Markovich:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm_ Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald�@Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name NuVasive® Lateral VBR System
Indications for Use (Describe)
The NuVasive® Lateral VBR System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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Form Approved: OMB No, 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray, and the words "Speed of Innovation" in purple below. The logo is simple and modern, and the colors are eye-catching.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Jeremy Markovich Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: February 28, 2014
B. Device Name
| Trade or Proprietary Name: | NuVasive® Lateral VBR System |
|---|---|
| Common or Usual Name: | Spinal Vertebral Body Replacement Device, |
| Classification Name: | Spinal Vertebral Body Replacement Device, |
| Spinal Intervertebral Body Fixation Orthosis | |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3060 |
MOP
C. Predicate Devices
Product Code:
The subject Lateral VBR System is substantially equivalent to the following predicate devices: NuVasive Ti Mesh System (K032476), SpineWave StaXx XD System (K052670 and K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254), NuVasive CoRoent System (K071795), and Aesculap Hydrolift VBR System (K083186).
D. Device Description
The NuVasive Lateral VBR System is a vertebral body replacement device manufactured from carbon-fiber PEEK (polyetheretone) and titanium alloy conforming to industry recognized standards that is available in a variety sizes to suit the individual pathology and anatomical conditions of the patient. The Lateral VBR System vertebral body replacement device is designed to address thoracolumbar pathologies utilizing implant placement though a lateral approach. This implant inserter is specifically designed to place and expand the implant device. Allograft or autograft material may be used to facilitate fusion. The subject device components are manufactured from Carbon-Fiber Reinforced PEEK-Optima® LT1CA30 (CFRP) and titanium alloy conforming to ASTM F136 and ISO 5832-3.
4
E. Intended Use
The NuVasive® Lateral VBR System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, 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. Technological Characteristics
As was established in this submission, the subject Lateral VBR System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
Performance Data G.
Nonclinical testing was performed to demonstrate that the subject Lateral VBR System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression, compression shear, and torsion per ASTM ● F2077
- Wear debris testing per ASTM F1714 and ASTM F1877
- Expulsion testing
- Cadaver testing
The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate. No non-clinical or clinical studies were conducted.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Lateral VBR System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.