(84 days)
The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
The IntellaMap Orion™ High Resolution Mapping Catheter (Orion catheter) is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bidirectional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.
This 510(k) summary states that no performance data was applicable for changes proposed in this special 510(k). This is because the new device is substantially equivalent to a previously cleared device, the IntellaMap Orion High-Resolution Mapping Catheter (K192360). The proposed changes were limited to labeling modifications and updated contraindications. Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).