(90 days)
The Cordis Ventricular Antechamber (VA) is a component of a central nervous system (CNS) fluid shunt. It connects the ventricular catheter to the valve's integral tubing. In this configuration, it serves to conduct cerebrospinal fluid (CSF) from this catheter to the valve. It may also be used with a ventricular catheter alone. In either configuration, the VA facilitates CSF sampling.
The Cordis Ventricular Antechamber is manufactured from silicone elastomer (with/without barium sulfate), polysulfone and polypropylene impregnated with barium sulfate.
This submission describes a medical device, the Cordis Ventricular Antechamber (VA), which is a component of a central nervous system (CNS) fluid shunt. The document focuses on establishing substantial equivalence to predicate devices and detailing biocompatibility.
Critically, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or any study design involving statistical analysis, sample sizes, expert ground truth, or comparative effectiveness with or without AI assistance.
Therefore, I cannot fulfill your request for the specific information points you've outlined. The text provided is a regulatory submission for a Class II medical device, primarily addressing its intended use, description, classification, and substantial equivalence to existing predicate devices based on design, materials, and manufacturing methods, along with biocompatibility. It does not include performance study data in the context you've described.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).