(154 days)
Webb-Morley Spine System, TSRH® Spinal System, Dyna-Lok® Spine System, Isola® Spine System, KSF Spinal Fixator, VSP® Plating System
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a spinal fixation system, indicated for surgical stabilization of the spine, not for therapy in the sense of actively treating a condition without surgical intervention.
No
Explanation: The document describes the EBI SpineLink™ System as a "spinal fixation device." Its stated purpose is for "reduction, alignment or stabilization" of the spine, and it consists of components like screws and connectors. This functionality is therapeutic and structural, not diagnostic.
No
The device description explicitly states it consists of physical components like screws, links, lock nuts, and washers, 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 clearly describes a spinal fixation device used for surgical implantation to stabilize the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description lists components like screws, links, nuts, and washers, which are all physical components for surgical fixation. There is no mention of reagents, assays, or anything used to test biological samples.
- Lack of Diagnostic Function: The device's function is to provide mechanical support and stability to the spine. It does not perform any tests on biological samples to diagnose a condition or provide information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The EBI SpineLink™ System, a spinal fixation device for the noncervical spine, is indicated for (a) anterior fixation, (b) posterior hook and sacral/iliac screw fixation and (pedicle screw fixation.
When used as an anterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.
When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.
Product codes
Not Found
Device Description
The EBI SpineLink™ System is a spinal fixation device for the noncervical spine consisting of fixed and polydirectional pedicle/sacral screws (available in diameters from 5,5 to 7.5 mm), various types of interconnecting links, lock nuts, and different types of washers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical spine, thoracic, lumbar and sacral segments of the spine, L5-S1 vertebral joint, L3-S1
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)
Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Webb-Morley Spine System, TSRH® Spinal System, Dyna-Lok® Spine System, Isola® Spine System, KSF Spinal Fixator, VSP® Plating System
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
Image /page/0/Picture/1 description: The image shows the logo for Electro Biology Inc. The logo consists of the letters "EBI" in a large, bold font, with the words "Electro Biology" in a smaller font to the right of the letters. The word "Electro" is above the word "Biology". There are horizontal lines above and below the letters "EBI".
2 1997
Inhancing Bone Healing through Applied Science
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI SpineLink™ System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.
-
- Submitter: Electro-Biology, Inc. 6 Upper Pond Road Parsippany, NJ 07054
Contact Person: Jon Caparotta Telephone: (201) 299-9022
- Submitter: Electro-Biology, Inc. 6 Upper Pond Road Parsippany, NJ 07054
Date prepared: April 23, 1997
-
- Proprietary Name: Common Name: Classification Names:
EBI SpineLink™ System Spinal Fixation System for the Noncervical Spine Spondylolisthesis Spinal Fixation Device System (Proposed) Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis
- Proprietary Name: Common Name: Classification Names:
3. Predicate or legally marketed devices that are substantially equivalent:
- Webb-Morley Spine System Electro-Biology, Inc.
- TSRH® Spinal System Sofamor Danek
- Dyna-Lok® Spine System Sofamor Danek
- Isola® Spine System AcroMed Corporation
- · KSF Spinal Fixator Tornier SA
- · VSP® Plating System AcroMed Corporation
-
- Description of the device: The EBI SpineLink™ System is a spinal fixation device for the noncervical spine consisting of fixed and polydirectional pedicle/sacral screws (available in diameters from 5,5 to 7.5 mm), various types of interconnecting links, lock nuts, and different types of washers.
- Intended Use: The EBI SpineLink™ System, a spinal fixation device for the noncervical spine, is 5. indicated for (a) anterior fixation, (b) posterior hook and sacral/iliac screw fixation and ® pedicle screw fixation.
When used as an anterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.
1
When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only, ® who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.
-
- Materials: The components of the system are manufactured from Ti-6Al-4V ELI per ASTM F136, The components will be available with and without TiN coating.
-
- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between EBI SpineLink™ System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements.
- Any statement made in conjunction regarding a decemination of substanial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not intended to be interpred as an admission or any other type of evidence in patent infringement lifeastion and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.))