(78 days)
- The Perf (Ommaya Style) Reservoir is intended as a means of gaining access to the cerebral ventricles by hypodermic puncture. It may be used for ventricular drainage.
- The Perf (Ommaya Style) Reservoir may be used to access the ventricles for the administration of chemotherapeutic agents and/or radioisotopes.
Not Found
This document is a 510(k) premarket notification letter from the FDA to Phoenix Biomedical Corporation regarding their "Perf (Ommaya Style) Reservoir." It is a regulatory approval document and does not contain information about acceptance criteria, device performance, or study details.
Therefore, I cannot provide the requested information from the provided text. The document outlines the FDA's decision that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing, subject to general controls provisions of the Act.
§ 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).