(86 days)
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No
The 510(k) summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for "fusion, reduction, alignment or stabilization of the cervical segments of the spine," which are therapeutic purposes.
No
The device is described as an "anterior cervical spine system" intended for fusion, reduction, alignment, or stabilization of spinal segments, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of spinal implant components (plates, screws, locking screws) and instruments, which are physical hardware.
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 "fusion, reduction, alignment or stabilization of the cervical segments of the spine." This describes a surgical implant used directly on the patient's body.
- Device Description: The device consists of "spinal implant components and various instruments used during the implantation procedure." These are physical devices used in surgery.
- 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 about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The EBI Anterior Cervical Spine System is a single use device, intended for anterior cervical spine applications only Specific indications include the fusion, reduction, alignment or stabilization of the cervical segments of the spine in cases of degenerative disc disease (spondylosis of the cervical spine, cervical spondylotic myelopathy and cervical spondylosis neuropathy), trauma, and tumors.
Product codes
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Device Description
The EBI Anterior Cervical Spine System consists of spinal implant components and various instruments used during the implantation procedure. The spinal implants consist of plates, screws and locking screws. Materials: Ti-6AI-4V ELI alloy with or without Titanium nitride coating
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical segments of the spine
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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Image /page/0/Picture/1 description: The image shows the logo for EBI Electro Biology. The letters "EBI" are in a large, bold, sans-serif font. To the right of "EBI" are the words "Electro Biology" in a smaller, serif font. The words "Electro Biology" are stacked on top of each other. There is a line underneath the entire logo.
through Applied Science
Finhancing Bone Healing
Summary of Safety & Effectiveness for EBI Anterior Cervical Spine System
This Safety and Effectiveness Summary for the EB1 Anterior Cervical Spine System line extension to include TiN coating is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
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Contact Person: Sharon A. Starowicz 1. Submitter: Electro-Biology Inc. Telephone: 201-331-3904 6 Upper Pond Road Parsippany, NJ 07054
Date prepared: December 15, 1995 -
Proprietary Name: EBI Anterior Cervical Spine System 2. Common Name: Spinal Fixation System
Classification Name: Spinal Intervertebral Body Fixation Orthosis -
- Predicate or legally marketed devices with TiN coating that are substantially equivalent:
- "Cervical Spine Locking Plate distributed by Synthes ·Songer Titanium Cable System distributed by Sofamor Danek ■Buechel-Pappas™ Total Hip Replacement System distributed by Endotec, Inc.
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- Description of the device: The EBI Anterior Cervical Spine System consists of spinal implant components and various instruments used during the implantation procedure. The spinal implants consist of plates, screws and locking screws.
Materials: Ti-6AI-4V ELI alloy with or without Titanium nitride coating
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- Intended Use: The EBI Anterior Cervical Spine System is a single use device, intended for anterior cervical spine applications only Specific indications include the fusion, reduction, alignment or stabilization of the cervical segments of the spine in cases of degenerative disc disease (spondylosis of the cervical spine, cervical spondylotic myelopathy and cervical spondylosis neuropathy), trauma, and tumors.
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- Comparison of the technological characteristics of the device to predicate and legally marketed devices:
There are no significant differences between the TiN coating of the EBI" Anterior Cervical Spine System and the other currently marketed TiN coated orthopedic implants which would adversely affect the use of the product. It is substantially equivalent* to these other devices in function, material and chemical composition.
" Any statement made in conunction with this submission of substantial 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 interpreted as an admission or any other infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble August 23, 1977, FR 42520 (Docket No. 76N-0355.))
Image /page/0/Picture/16 description: The image shows the number 35. The number is written in a simple, slightly rounded font. The number is in black and is set against a white background.