(206 days)
Control Unit: The NMT Neurosciences Control Unit is a portable, programmable system, designed for use with the NMT Disposable Drainage Line Kit, that controls cerebrospinal fluid (CSF) external drainage at the programmed pressure. Unlike other external drainage devices, the pressure setting is not dependent upon the patient's position. The system also allows for CSF sampling, collection, and for CSF pressure monitoring.
Disposable Drainage Line Kit: The Disposable Drainage Line Kit is designed to be connected to the NMT Neurosciences Control Unit for cerebrospinal external drainage, sampling, collection and pressure monitoring.
Control Unit Disposable Drainage Line Kit
This document is a 510(k) clearance letter from the FDA for a medical device called "Control Unit Disposable Drainage Line Kit." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The input document is a regulatory approval letter and does not include performance data, study results, or detailed acceptance criteria for the device itself.
§ 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).