Device Dossier

Standard Integra CSF reservoir - Reservoir, cerebrospinal fluid

Device Dossier for Standard Integra CSF reservoir - Reservoir, cerebrospinal fluid (Reservoir, cerebrospinal fluid, Class III, sponsor Integra…

Intended purpose

The Integra CSF Reservoir provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injection of chemotherapeutic agents and/or radio-isotopes.

Functional description

The reservoir is designed for subcutaneous placement and attaches to the ventricular catheter at the straight connector. The reservoir is made with a suture flange at its base for attachment to the periosteum. Access is obtained by penetrating the reservoir dome with a 25-gauge or smaller needle. In this manner, cerebrospinal fluid may be withdrawn or other fluid injected into the reservoir. A ventricular catheter is supplied with the larger standard but not the mini reservoir.

TGA Public Summary