(157 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and design of a physical implant (plates and screws) for spinal fusion, with no mention of software, algorithms, or data processing.
Yes
The device is described as an "anterior cervical plate system" intended for "immobilization and stabilization of the spine as an adjunct to fusions" for various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device is described as an anterior cervical plate system intended for "anterior screw fixation to the cervical spine (C2-C7)" and for "immobilization and stabilization of the spine as an adjunct to fusions." This indicates a therapeutic or supportive function, not a diagnostic one.
No
The device description explicitly states it is composed of plates and screws made from titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The VAN GOGH Anterior Cervical Plate System is a physical implantable device (plates and screws) made of titanium alloy. It is surgically implanted into the cervical spine.
- Intended Use: The intended use is for anterior screw fixation to the cervical spine to immobilize and stabilize it as an adjunct to fusions. This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant used to treat conditions of the cervical spine, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The VAN GOGH Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin . withdegeneration of the disc confirmed by patient history and radiographic studies).
- . spondylolisthesis,
- . trauma (i.e. fractures or dislocations),
- . tumors,
- . deformity (defined as kyphosis, lordosisor scoliosis),
- . pseudarthrosis.
- . failed previous fusion,
- . spinal stenosis.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The VAN GOGH Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6AI-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates range in length to accommodate one, two, three, and four level procedures. The screws in the VAN GOGH Anterior Cervical Plate System are 3.5mm and 4.0mm diameter bone screws. They are fixed self-tapping, variable self-tapping, fixed self-drilling, variable self-drilling and are available in lengths ranging from 12 to 20mm.
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)
Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the VAN GOGH Anterior Cervical Plate System performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061002, K031276, K994239, K030327, K113509, K103491
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 13 2012
CAccessPINE
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| Submitter: | Accel SPINE LLC |
|---|---|
| 14850 Quorum Dr. Suite 220 | |
| Dallas, TX 75254,USA | |
| Contact Person: | Daniel Chon |
| Phone.800.713.9489 | |
| Fax.888.831.4892 | |
| E-mail.dchon@accelspine.com | |
| Date prepared: | April 5, 2012 |
2. Device Identification
| Trade Name | VAN GOGH Anterior Cervical Plate System |
|---|---|
| Common Name | Anterior Cervical Plate |
| Regulation Name | Spinal intervertebral body fixation orthosis |
| Regulation Number | 21 CFR 888.3060 |
| Product Code | KWQ |
| Regulatory Class | Class II |
Predicate or legally marketed devices which are substantially equivalent 3.
- U&I Corporation: Maxima™ Anterior Cervical Plate System (K061002)
- Synthes: Synthes Anterior Cervical Locking Plate(ACLP) System (K031276)
- Medtronic: ZEPHIR™ Anterior Cervical Plate System(K994239, K030327)
- L&K BIOMED: LEXUS Anterior Cervical Plate System (K113509)
- DepuySpine:SKYLINE Anterior Cervical Plate System (K103491)
4. Description of the Device
The VAN GOGH Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6AI-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates range in length to accommodate one, two, three, and four level procedures. The screws in the VAN GOGH Anterior Cervical Plate System are 3.5mm and 4.0mm diameter bone screws. They are fixed self-tapping, variable self-tapping, fixed self-drilling, variable self-drilling and are available in lengths ranging from 12 to 20mm.
VAN GOGH Anterior Cervical Plate System
1
K121078
5. Intended use
The VAN GOGH Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
degenerative disc disease (as defined by neck pain of discogenic origin . withdegeneration of the disc confirmed by patient history and radiographic studies).
- . spondy lolisthesis,
- . trauma (i.e. fractures or dislocations),
- . tumors,
- . deformity (defined as kyphosis, lordosisor scoliosis),
- . pseudarthrosis.
- . failed previous fusion,
- . spinal stenosis.
6. Comparison of the Technology Characteristics
The VAN GOGH Anterior Cervical Plate System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials, substantially equivalent performance characteristics and the same intended use.
7. Discussion of the Non-Clinical Testing
Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the VAN GOGH Anterior Cervical Plate System performs as well as the predicate device.
8. Conclusion
The VAN GOGH Anterior Cervical Plate System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.
2
Image /page/2/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 symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Accel SPINE, LLC % Mr. Daniel Chon Vice President 14850 Quorum Drive, Suite 220 Dallas, Texas 75254
Re: K121078
Trade/Device Name: VAN GOGH Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 31, 2012 Received: September 4, 2012
Dear Mr. Chon:
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
SEP 13 2012
3
Page 2 - Mr. Daniel Chon
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
AccesSPINE
Indications for Use Statement
510(k) Number (if known): K121078
Device Name: VAN GOGH Anterior Cervical Plate System
Indications For Use:
The VAN GOGH Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,
(Part 21 CER801 Subpart D)
- deformity (defined as kyphosis, lordosisor scoliosis),
- pseudarthrosis,
- failed previous fusion, .
- spinal stenosis.
AND/OR Prescription Use
(21 CER801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OED)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K/2/078
VAN GOGH Anterior Cervical Plate S
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