(184 days)
- Percutaneous lumbo-peritoneal shunting may be utilized in the treatment of . communicating hydrocephalus. It is designed to shunt CSF from the subarachnoid space to the peritoneal cavity.
- The shunting may be used for evaluation or treatment of normal pressure ● communicating hydrocephalus.
- A percutaneous lumbo-peritnoeal shunt is also useful in the management of . persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and transient CSF absorption defects, e.g. post meningitic or post-hemorrhagic hydrocephalus.
- Lumbar Drainage System is intended for use as a means of temporary external Eumbar Drainage Cyclinage Cyonitoring and collection of cerebrospinal fluid from the diversion, proboute metesigned for use with the Phoenix Fifth Ventricle Collection Bag.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for Lumbar Drainage Systems and Lumbo-Peritoneal Shunts. It states that the devices are substantially equivalent to legally marketed predicate devices and can be marketed.
The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot provide the requested information.
§ 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).