(94 days)
NuVasive Mesh System
Not Found
No
The summary describes a mechanical vertebral body replacement device and does not mention any AI or ML components or functionalities.
Yes
The device is used to treat diseased or damaged vertebral bodies caused by tumor or fracture and to restore height and achieve decompression of the spinal cord, indicating a therapeutic purpose.
No
Explanation: The device is a vertebral body replacement device, designed to replace a diseased or damaged vertebral body, not to diagnose a condition.
No
The device description clearly states it includes physical components like "adjustable height core and endplates" which are hardware, not software.
Based on the provided information, the NuVasive Adjustable VBR System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The NuVasive Adjustable VBR System is a physical implant designed to replace a damaged vertebral body in the spine. Its function is mechanical and structural, not analytical or diagnostic based on bodily fluids or tissues.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples.
Therefore, the NuVasive Adjustable VBR System falls under the category of a surgical implant or device, not an IVD.
N/A
Intended Use / Indications for Use
The NuVasive Adjustable VBR System is a 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 NuVasive Adjustable VBR 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 Adjustable VBR System includes different sized adjustable height core and endplates to suit the individual pathology and anatomical conditions of the patient. The cores can extend in height to properly match the anatomy and the endplates come in three major types: symmetric, asymmetric, and round.
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
Mechanical testing was presented.
Key Metrics
Not Found
Predicate Device(s)
NuVasive Mesh System
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
APR 2 7 2009
K090176
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Image /page/0/Picture/16 description: The image contains the logo for NUVASIVE, a medical device company. The logo features the company's name in a bold, sans-serif font. Below the name is the tagline "Curative Spine Technology" in a smaller, italicized font. The logo is simple and modern, reflecting the company's focus on innovation in spine surgery.
Special 510(k) Premarket Notification Adjustable VBR System
VII. 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92, the following summary of information is provided:
A. Submitted by:
Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3338 Fax: (858) 909-3438
Device Name B.
Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Classification: Product Code:
NuVasive Adjustable Vertebral Body Replacement System Spinal Intervertebral Body Fixation Orthosis Spinal Intervertebral Body Fixation Orthosis Class II 888.3060 MQP
C. Predicate Devices
The subject Adjustable Vertebral Body Replacement System is substantially equivalent to the NuVasive Mesh System currently distributed commercially in the U.S. by NuVasive.
D. Device Description
The NuVasive Adjustable VBR System includes different sized adjustable height core and endplates to suit the individual pathology and anatomical conditions of the patient. The cores can extend in height to properly match the anatomy and the endplates come in three major types: symmetric, asymmetric, and round.
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E. Intended Use
The NuVasive Adjustable VBR System is a 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 NuVasive Adjustable VBR 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.
Comparison to Predicate Devices F.
The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.
- Summary of Non-Clinical Tests G. Mechanical testing was presented.
- H. Summary of Clinical Tests (Not Applicable).
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nuvasive, Inc. % Han Fan 7475 Lusk Boulevard San Diego, California 92121
APR 2 7 2009
Re: K090176
Trade/Device Name: Adjustable Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: April 9, 2009 Received: April 10, 2009
Dear Ms. Fan:
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 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 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. Han Fan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
t-a
Mark N. Melkerson
Mark N. Me. Director Division of General, Restorative, And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K090176
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Indications for Use
K090176 510(k) Number (if known):
Device Name:____Adjustable VBR System
Indications For Use:
The NuVasive Adjustable VBR System is a 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 NuVasive Adjustable VBR 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.
Perh
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L050176
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)
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