(84 days)
Not Found
No
The summary describes a mechanical implant and surgical tools, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is described as an implantable system intended for anterior interbody fixation of the cervical spine, used in the temporary stabilization of the anterior spine during the development of cervical spine fusions for conditions such as degenerative disc disease, trauma, tumors, and deformity. This clearly indicates a therapeutic purpose.
No
The device is described as an implantable system of metal plates and screws intended for spinal fusion and stabilization, not for diagnosing conditions.
No
The device description explicitly states it consists of implantable metal plates and screws, which are hardware components. It also includes hand tools for implantation.
No, 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, tissue) to provide information about a person's health.
- Device Description: The Vertebron SCP™ Cervical Plate System is described as a system of implantable metal plates and screws used for spinal fusion. It is a surgical implant.
- Intended Use: The intended use is for anterior interbody fixation of the cervical spine, which is a surgical procedure.
- No Mention of Samples or Testing: The description and intended use do not involve analyzing samples from the body or performing diagnostic tests.
This device is a surgical implant used to stabilize the spine, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Vertebron SCP™ 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), pseudoarthriosis, and/or failed previous fusions. The SCP Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
Product codes (comma separated list FDA assigned to the subject device)
KWO
Device Description
The device consists of a system of implantable metal plates and screws intended the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, 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)
The device has been tested in accordance with the requirements prescribed in ASTM F1717. The device was found to perform comparably to other cervical plate systems.
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
MAR 2 6 2004
VERTEBRON. Inc. 510(k) Notilitation
K040003
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | Vertebron, Ltd.
Stratford, CT 06614 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Bruce Khalili
Vice President, Research & Development |
| DATE PREPARED | December 23, 2003 |
| CLASSIFICATION | Spinal Interlaminal Fixation Orthosis; KWQ
Class II |
| COMMON NAME | Anterior Cervical Plate |
| PROPRIETARY NAME | Vertebron SCP™ Cervical Plate System |
| PREDICATE DEVICES | Centerpulse Spine-Tech K022344
Theken Surgical K010466
Blackstone Medical K030595 |
| DEVICE DESCRIPTION | The device consists of a system of implantable metal plates
and screws intended the purpose of aiding in spinal fusion.
The system also includes various hand tool used to assist in
implantation of the system. Implantable components are
composed of titanium alloy meeting the requirements of
ASTM F136-98. The device is supplied non-sterile and is
intended for sterilization by hospital personnel. |
| TESTING | The device has been tested in accordance with the
requirements prescribed in ASTM F1717. The device was
found to perform comparably to other cervical plate systems. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
MAR 2 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bruce Khalili Vice President, Research & Development Vertebron, Inc. 136 Albert Avenue Stratford, Connecticut 06614
Re: K040003
Trade/Device Name: Vertebron SCP™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: December 30, 2003 Received: January 2, 2004
Dear Mr. Khalili:
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
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark N. Millican
Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT FOR INDICATIONS FOR USE
510(k) Number:
Device Name: Vertebron SCP™ Cervical Plate System
Indications for Use:
The Vertebron SCP™ 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), pseudoarthriosis, and/or failed previous fusions. The SCP Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
Prescription Use: Yes
DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office
/ Mark H. Milhusan
(Division Engineer)
Vertebran SCPM C 510(K