(262 days)
The EKOS Ultrasound EVD System is intended to be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) as a means of reducing intracranial pressure and CSF volume.
Not Found
This is a 510(k) premarket notification for the EKOS Ultrasound EVD System, which is a ventricular catheter. The document does not describe the acceptance criteria or a study proving the device meets those criteria. It is a regulatory letter from the FDA confirming substantial equivalence to legally marketed predicate devices and outlining general controls and regulations.
Therefore, I cannot provide the requested information from the provided text.
§ 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).