NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL

The RAUMEDIC NEUROMONITORING-SYSTEM is a family of intracranial pressure (ICP) monitoring catheters with various sensor configurations. Different models measure ICP alone, ICP with temperature, ICP with oxygen partial pressure, or provide cerebrospinal fluid drainage. The system includes surgical implantation kits (bolt, drill, and tunneling kits) to facilitate catheter placement in the brain.

The devices use the same materials and form as predicate devices, with equivalent lumen designs for drainage, pressure sensors for ICP measurement, temperature thermistors for thermal monitoring, and fiber optic sensors for tissue oxygen monitoring. All models are MR conditional under specified constraints varying by device type, implantation method, and magnetic field strength (1.5 or 3.0 Tesla).

ASTM F2052-15 (magnetically induced displacement force), ASTM F2213-06 (magnetically induced torque), ASTM F2119-07 (image artifacts), ISO/TS 10974:2018 (gradient-induced heating, malfunction, RF-induced heating, malfunction, and combined fields).

The devices have identical intended use and indications for use as the predicate devices (ICP monitoring, CSF drainage, temperature and oxygen monitoring). They are manufactured from the same or substantially equivalent materials with equivalent form, function, and features. Performance testing confirms MR safety equivalence under the same conditional constraints, and no new safety or effectiveness issues are raised compared to the predicate systems.