(148 days)
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No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The EBI SpineLink™ System is intended for surgical implantation to treat severe spondylolisthesis and facilitate spinal fusion. It is a medical device designed to directly intervene and improve a patient's health condition.
No
The device description indicates it is a posterior pedicle system with screws, links, and nuts, used for spinal fusion, not for diagnosing conditions.
No
The device description clearly states it is a "posterior pedicle system consisting of fixed and polydirectional pedicle/sacral screws, various types of interconnecting links, lock nuts, and different types of washers," which are all hardware components.
Based on the provided information, the EBI SpineLink™ System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The EBI SpineLink™ System is a surgical implant designed to stabilize the spine during fusion procedures for severe spondylolisthesis. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The description clearly indicates it's a system of screws, links, nuts, and washers used for spinal fixation. This falls under the category of a surgical device or implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The EBI SpineLink™ System (severe spondylolisthesis indication) is intended for patient: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-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 screws of the system are limited to L3- S1 or iliac screw fixation.
Product codes
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Device Description
The EBI SpineLink™ System is a posterior pedicle system 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fifth lumbar - first sacral (LS-S1) vertebral joint, lumbar and sacral spine, L3- S1 or iliac screw fixation
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)
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.)
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Predicate Device(s)
Webb-Morley Spine System Electro-Biology, Inc., TSRH® Spinal System Sofamor Danek, Dyna-Lok® Spine System Sofamor Danek, Isola® Spine System AcroMed Corporation, VSP® Plating System AcroMed Corporation, KSF Spinal Fixator Tornier SA
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/3 description: The image shows the logo for EBI Electro Biology. The letters "EBI" are in a large, bold, sans-serif font, with the word "Electro" above the word "Biology" in a smaller, serif font. There are horizontal lines above and below the entire logo.
through Applied Science
Enhancing Bone Healing
APR - 9 1997
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.
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- 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 4, 1997
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- Proprietary Name: EBI SpineLink™ System Posterior pedicle spinal system Common Name: Classification Name:Spondylolisthesis Spinal Fixation Device System (Proposed)
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- 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
- · VSP® Plating System AcroMed Corporation
- · KSF Spinal Fixator Tornier SA
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- Description of the device: The EBI SpineLink™ System is a posterior pedicle system 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 (severe spondylolisthesis indication) is intended for patient: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-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 screws of the system are limited to L3- S1 or iliac screw fixation.
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- Materials: The components of the system are manufactured from Ti-SAI-4V ELI per ASTM F136. The components will be available with and without TiN coating.
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- 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 sulement made in conjunction with this submission of subseanial equivalence to any other product is intended only Io relate to whether the product can be lawfully market approval or reclassification and is not intended to be interpreted as an idmission or any other you of crident infringement liggstion . [Esablishment Registration and Permsiter Notices Frink Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]