(23 days)
No
The summary describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for temporary stabilization during degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis, and failed previous fusions, all of which are medical conditions that the device aims to treat or mitigate.
No
The device is a cervical plate system for stabilization during spinal fusion, which is a treatment, not a diagnostic process.
No
The device description explicitly states it is comprised of "non-sterile, single-use, titanium alloy components" and "attaches to the vertebral body by means of self tapping and self drilling cervical screws," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior interbody fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical soins fue tempor patients with degenerative disc disease... trauma... tumors... deformity... pseudoarthriosis, and/or failed previous fusions." This describes a surgical implant used in vivo (within the body) to provide structural support and stabilization.
- Device Description: The description details "non-sterile, single-use, titanium alloy components" that "attaches to the vertebral body by means of self tapping and self drilling cervical screws." This further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is implanted directly into the body.
N/A
Intended Use / Indications for Use
The Modified VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical soins fue tempor patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic shudies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordnois, ar scoliosis), pseudoarthriosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
Product codes
KWQ
Device Description
The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, sub-axial cervical spine from C3 through C7 levels
Indicated Patient Age Range
skeletally mature patients
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)
Substantial Equivalence: Testing in accordance with ASTM F1717 was performed and demonstrated that the modified VERTEBRON SSP™ Cervical Plate System is substantially equivalent to the VERTEBRON SSP™ Cervical Plate System (K051815) which have received market clearance by the FDA.
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
VIII. Summary of Safety and Effectiveness
| SUBMITTER: | VERTEBRON Inc.
400 Long Beach Blvd.
Stratford, CT 06615
(203) 380-9340 | AUG 16 2006 |
| ------------ | --------------------------------------------------------------------------------- | ------------- |
|---|
CONTACT PERSON: Luis Nesprido Regulatory Affairs, Manager
July 21, 2006 DATE PREPARED:
CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis
COMMON NAME: Cervical Plating System
PROPRIETARY NAME: VERTEBRON SSP™ Cervical Plate System
PREDICATE DEVICES: VERTEBRON SSP™ Cervical Plate System - K051815
DEVICE DESCRIPTION:
The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.
INTENDED USE: The modified VERTEBRON SSP™ Cervical Plate System is intended for non pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed bv history and radiographic studies): spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON SSP™ Cervical Plate System is intended for non cervical pedicle fixation for for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
MATERIALS: The material used is titanium Alloy material that conforms to ASTM F136.
1
Substantial Equivalence: Testing in accordance with ASTM F1717 was performed and demonstrated that the modified VERTEBRON SSP™ Cervical Plate System is substantially equivalent to the VERTEBRON SSP™ Cervical Plate System (K051815) which have received market clearance by the FDA.
2
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 stylized emblem. The emblem consists of three abstract human figures, possibly representing health, hope, and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2006
Vertebron, Inc. % Mr. Luis Nesprido Manager, Regulatory Affairs 400 Long Beach Boulevard Stratford, Connecticut 06615
Re: K062110
Trade/Device Name: VERTEBRON SSP™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: July 21, 2006 Received: July 24, 2006
Dear Mr. Nesprido:
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA
3
Page 2 - Mr. Luis Nesprido
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtains, 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 vours.
for P.J. Pma
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
V. Indications for Use
510(k) Number (if known):
Device Name:
VERTEBRON SSP™ Cervical Plate System
Indications For Use:
The Modified VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical soins fue tempor patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic shudies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordnois, ar scoliosis), pseudoarthriosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
Prescription Use: X (Per 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P. Mthme
(Division Sign-O Division of General, Restorative, and Neurological Devices
Kob2110 510(k) Number