(45 days)
Not Found
No
The device description and intended use focus on a mechanical implant for spinal fixation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are mechanical testing, not related to algorithmic performance.
Yes
The device is described as "Anterior Cervical Plate System" intended for "anterior screw fixation to the cervical spine C2-C7" for various medical conditions like "degenerative disc disease", "trauma", "tumors", etc., which are therapeutic interventions.
No
The device, VIP™ Anterior Cervical Plate System, is an implantable medical device for anterior screw fixation in the cervical spine. Its intended use is for treatment of various spinal conditions, not for diagnosing them.
No
The device description explicitly states the system consists of plates and screws made of titanium alloy, which are physical hardware components intended for surgical implantation.
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: The VIP™ Anterior Cervical Plate System is a surgical implant designed for fixation to the cervical spine. It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Intended Use: The intended use describes the surgical application of the device for treating various spinal conditions. This is a therapeutic use, not a diagnostic one.
Therefore, the VIP™ Anterior Cervical Plate System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VIP™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Product codes
KWQ
Device Description
The VIP™ Anterior Cervical Plate System consists of plates of various lengths to be used with either variable angle screws or fixed angle screws. Each VIP plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). VIP™ implants are composed of titanium alloy, as specified in ASTM F136, F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine C2-C7
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(K) Summary: VIP™ Anterior Cervical Plate System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 415-9000 | JUL - 3 2008 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Kelly J. Baker, Ph.D
Director, Clinical Affairs & Regulatory | |
| Device Name: | VIP™ Anterior Cervical Plate System | |
| Classification: | Per 21 CFR as follows:
§888.3060 Spinal Intervertebral Body Fixation Orthosis
Product Code KWQ.
Regulatory Class II and III, Panel Code 87. | |
| Predicate(s): | Globus Medical ASSURE® Anterior Cervical Plate System
K040721, SE date June 14, 2004, and PROVIDENCE™
Anterior Cervical Plate System K070775, SE date April 19, 2007 | |
Device Description:
The VIP™ Anterior Cervical Plate System consists of plates of various lengths to be used with either variable angle screws or fixed angle screws. Each VIP plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). VIP™ implants are composed of titanium alloy, as specified in ASTM F136, F1295.
Intended Use:
The VIP™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Basis of Substantial Equivalence:
VIP™ Anterior Cervical Plate System is similar to the predicate systems with respect to technical characteristics, performance, and intended use. Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is smaller than the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2008
Globus Medical, Inc. % Ms. Kelly J. Baker 2560 General Armistead Avenue Valley Forge Business Center Audubon, PA 19403
Re: K081391
Trade/Device Name: VIP Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 19, 2008 Received: June 23, 2008
Dear Ms. Baker:
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,
2
Page 2 - Ms. Kelly J. Baker
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) 638-2041 or (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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Indications for Use Statement
510(k) Number:
Device Name: VIP™ Anterior Cervical Plate System
INDICATIONS:
The VIP™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Prescription Use × OR (Per 21 CFR §801.109)
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
6081391 510/k) Number