(157 days)
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 with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,
- deformity (defined as kyphosis, lordosis or scoliosis),
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis.
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.
The provided text describes a medical device, the VAN GOGH Anterior Cervical Plate System, and its clearance through the FDA's 510(k) process. This process focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. It does not involve a study that evaluates device performance against specific acceptance criteria for AI/ML based devices, nor does it typically include details like human reader studies, training set data, or expert ground truth adjudication as would be relevant for such systems.
Therefore, many of the requested sections below cannot be populated from the provided text because the submission is for a physical medical device (an implantable plate system), not an AI/ML-based diagnostic or prognostic tool.
Here's an attempt to answer the questions based only on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on "substantial equivalence" to predicate devices, rather than meeting specific performance criteria. The acceptance criteria for the mechanical tests were implicitly met by performing "as well as the predicate device."
| Acceptance Criteria (Not explicit as numerical values) | Reported Device Performance |
|---|---|
| Performance "as well as" predicate devices | "The mechanical test results demonstrated that the VAN GOGH Anterior Cervical Plate System performs as well as the predicate device (U&I Corporation: Maxima™ Anterior Cervical Plate System, Synthes: Synthes Anterior Cervical Locking Plate (ACLP) System, Medtronic: ZEPHIR™ Anterior Cervical Plate System, L&K BIOMED: LEXUS Anterior Cervical Plate System, DepuySpine: SKYLINE Anterior Cervical Plate System)." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The "test set" in this context refers to mechanical testing of physical implants, not data for an AI/ML model. The study was non-clinical mechanical testing, not involving human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This was a non-clinical mechanical test, not dependent on expert interpretation of data or images.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical mechanical test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic or interpretive AI systems, not a physical implantable device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
For the mechanical tests, the "ground truth" would be the direct physical measurements and compliance with ASTM F1717 standards, compared against the predicate device's performance. It is based on engineering standards and comparative mechanical properties.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML training set.
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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
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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.
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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
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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
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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
Page 24/ 63
§ 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.