(29 days)
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a Cervical Plate System intended for anterior interbody fixation and temporary stabilization of the cervical spine during fusion for various conditions like degenerative disc disease, trauma, and tumors, indicating a therapeutic purpose.
No
The VERTEBRON SSP™ Cervical Plate System is described as an implantable device intended for temporary stabilization of the anterior spine during fusion, not for diagnosing conditions.
No
The device description explicitly states it is comprised of non-sterile, single-use, titanium alloy components, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for anterior interbody fixation and temporary stabilization of the cervical spine during fusion. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as a system of titanium alloy components (plates and screws) that attach to the vertebral body. This is a physical implant.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples and provide diagnostic information. This device is an in vivo (in the living body) surgical implant.
N/A
Intended Use / Indications for Use
The 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 spine 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, 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
KWO
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, self drilling or rigid 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 rigid cervical screw.
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
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)
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 (K062110 and K051815) and VERTEBRON SCP™ Cervical Plate System (K043181 and K040003) which have received market clearance by the FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062110, K051815, K043181, K040003
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.
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- 510(k) Summary or 510(k) Statement
JUL - 3 2008
- SUBMITTER: VERTEBRON Inc. 80 Hathaway Drive Stratford, CT 06615 (203) 380-9340
- CONTACT PERSON: Luis Nesprido Senior Manager Requlatory and Quality Affairs
- May 23, 2008 DATE PREPARED:
- CLASSIFICATION NAME: 21 CFR §888.3060 Spinal Intervertebral Fixation Orthosis
- COMMON NAME: Cervical Plating System
- PROPRIETARY NAME: VERTEBRON SSP Cervical Plating System
- PREDICATE DEVICES: VERTEBRON SSP System K062110 and K051815 VERTEBRON SCP System K043181 and K040003
- The modified VERTEBRON SSP™ Cervical Plate System is comprised of DEVICE DESCRIPTION: non-sterile, single-use, titanium alloy components, The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping, self drilling or rigid 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 rigid cervical screw.
- The VERTEBRON SSP™ Cervical Plate System is intended for anterior INTENDED USE: 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 spine 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
MATERIALS:
The material used is titanium Alloy material that conforms to ASTM F136.
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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 (K062110 and K051815) and VERTEBRON SCP™ Cervical Plate System (K043181 and K040003) which have received market clearance by the FDA.
.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2008
Vertebron , Inc. % Mr. Luis Nesprido Senior Manager, Regulatory and Quality Affairs 80 Hathaway Drive Stratford, Connecticut 06615
Re: K081567
Trade/Device Name: VERTEBRON SSP™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal vertebral body fixation device Regulatory Class: II Product Code: KWO Dated: May 29, 2008 Received: June 04, 2008
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.
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Page 2 - Mr. Luis Nesprido
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 vours.
Mark M. Milliman
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 Statement
510(k) Number (if known):
VERTEBRON SSP™ Cervical Plate System Device Name: Indications For Use:
The 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 spine 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, 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: AND / OR X (Per 21 CFR 801 Subpart D)
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)
Pedro Romero
(Division Sign-Off) Division of General. Restorative. and Neurological De
510(k) Number 108135