(54 days)
As the proximal component for CSF drainage or monitoring from the lateral ventricles of the brain.
The External Drainage Ventricular Catheter consists of a barium impregnated silicone tubing with flow holes at the distal end and a luer lock connector for attachment to an external drainage system. It is provided sterile for single use only.
The provided text is a 510(k) summary for the Radionics XDC Ventricular Catheter. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study to prove the device meets specific acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The provided text primarily addresses regulatory classification, intended use, description of the device, and a comparison to predicate devices, which are typical components of a 510(k) submission. There is no mention of performance studies with specific statistical outcomes against acceptance criteria.
§ 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).