(72 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, image processing, or AI/ML capabilities.
Yes
Explanation: The device is intended to provide stabilization as an adjunct to fusion for various spinal conditions, which is a therapeutic function.
No
The device, the Caspian Spinal System, is a spinal fixation system designed to provide stabilization as an adjunct to fusion for various spinal conditions. It consists of physical components like screws, rods, and hooks, and its function is to immobilize parts of the spine. It does not analyze patient data or provide information for diagnosis.
No
The device description explicitly lists hardware components such as pedicle screws, rods, locking set screws, hooks, and rod connectors, and describes their materials and function as a physical fixation system.
Based on the provided text, this device 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: The Caspian Spinal System is a physical implantable device (screws, rods, hooks, etc.) used to stabilize the spine during fusion surgery. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to provide mechanical stabilization as an adjunct to fusion, not to perform diagnostic tests on biological samples.
The description clearly indicates a surgical implant for structural support, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Caspian Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history . and radiographic studies)
- . Spondylolisthesis
- Spinal stenosis
- . Fracture/dislocation
- Revision of previous cervical spine surgery
- . Tumors
- Atlantoaxial fracture with instability .
- Occipitocervical dislocation
The occipital bone screws are limited to occipital fixation only.
The rod and hook components are intended for use in the cervical/upper thoracic (CI-T3) spine. The pedicle screws are limited to placement in T 1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
Product codes
KWP
Device Description
The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.
Materials: The devices are manufactured from Ti6AI4V Eli and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the posterior cervical and thoracic spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipito-cervico-thoracic junction (occiput-T3), Occipital, cervical/upper thoracic (C1-T3) spine, T1-T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The Caspian Spinal System was mechanically tested and compared to predicate devices. The Caspian Spinal System performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081107, K092640, K093534, K101084, K033961, K042508
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
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