(128 days)
Not Found
Not Found
No
The summary describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a supplemental fixation device intended to achieve fusion for various spinal conditions, indicating a therapeutic purpose.
No
Justification: The device description states it is a "posterior, non-pedicle supplemental fixation device" intended for "plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion." This describes a therapeutic or surgical device, not a device used to diagnose a medical condition.
No
The device description clearly describes physical plates with spikes, indicating a hardware implant, not a software-only device.
Based on the provided information, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The NuVasive® Spinous Process Plate System is a surgical implant intended for fixation in the spine to aid in fusion. It is a physical device implanted in the body, not a device used to analyze samples outside the body.
The description clearly indicates it's a surgical implant for structural support in the spine, which falls under the category of a surgical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The NuVasive® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand-alone use.
Product codes
KWP
Device Description
The NuVasive® Spinous Process Plate System features plates with spikes under the plate to help resist plate rotation after implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1 - S1)
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. Summary of Clinical Tests (Not Applicable).
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Nuvasive, a medical device company specializing in spine surgery. The logo features a stylized arc above the letters "NUVASIVE" in a bold, sans-serif font. Below the company name is the tagline "Creative Spine Technology" in a smaller, italicized font.
5. 510(K) SUMMARY
MAR 2 8 2008
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
A. Submitted by
Laetitia Cousin Director of Regulatory and Clinical Affairs, and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068
B. Device Name
| Trade or Proprietary Name: | NuVasive® Spinous Process Plate System |
|---|---|
| Common or Usual Name: | Spinal Implants |
| Classification Name: | Spinal Interlaminal Fixation Orthosis. |
| Device Class: | Class II |
| Classification: | §888.3050 |
| Product Code: | KWP |
C. Predicate Devices
The subject device is substantially equivalent to similar previously cleared devices.
D. Device Description
The NuVasive® Spinous Process Plate System features plates with spikes under the plate to help resist plate rotation after implantation.
E. Intended Use
The NuVasive® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand-alone use.
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F. Substantial Equivalence
Data was provided which demonstrated the NuVasive® Spinous Process Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.
- G. Summary of Non-Clinical Tests Mechanical testing was presented.
- H. Summary of Clinical Tests (Not Applicable).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle or bird-like figure. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2008
NuVasive, Inc. % Ms. Laetitia Cousin Director of Regulatory and Clinical Affairs and Quality Assurance 4545 Towne Centre Court San Diego, California 92121
Re: K073278
Trade/Device Name: NuVasive® Spinous Process Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 5, 2008 Received: March 6, 2008
Dear Ms. Cousin:
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. Laetitia Cousin
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: NuVasive® Spinous Process Plate System
Indications for Use:
The NuVasive® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand-alone use.
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)
(Division Sigh Division of General, Restorative, and Neurological Devices
510(k) Number K073278
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