(146 days)
The MAGiC Sweep™ EP Mapping Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the heart.
The MAGiC Sweep™ EP Mapping Catheters are biocompatible, flexible, radiopaque fixed catheters that are 130cm in length and available in multiple electrode spacing configurations and multiple magnet spacings. They have magnets encapsulated in the device shaft to allow manipulation through the vasculature and placement by a physician controlled robotic magnetic navigation system. Each device consists of 19 electrodes plus one tip electrode and come in three (3) different electrode spacings. In addition there are twenty (20) different magnet spacings for each electrode spacing configuration. The catheters are 8F diameter tapering to 5F at the distal end of the device shaft. The variety of configurations facilitate the navigation of the device to specific areas of the heart and facilitate recording of intracardiac signals and/or stimulation in the atrial and ventricular regions of the heart during electrophysiology studies.
The MAGiC Sweep™ EP Mapping Catheter is designed to be positioned in various endocardial and intravascular sites utilizing the Stereotaxis magnetic navigation system (MNS) along with the Stereotaxis catheter advancement system (CAS). The MAGiC Sweep™ EP Mapping Catheter is designed for recording intracardiac signals when connected to a recording system and for cardiac stimulation when connected to a stimulation system.
The MAGiC Sweep™ EP Mapping Catheter is comprised of a Pebax catheter shaft, platinum-iridium ring electrodes, platinum-iridium electrode tip, Neodymium Boron Magnets attached to a safety cable, and Redel electrical connectors. The Neodymium Boron Magnets are encapsulated within the catheter shaft.
The provided 510(k) clearance letter and summary describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the Stereotaxis MAGiC Sweep™ EP Mapping Catheter.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance/Conclusion |
|---|---|---|
| Visual Inspection | Visual | Met specifications |
| Dimensional Conformance | Dimensional | Met specifications |
| Electrical Performance | Continuity | Met specifications |
| Leakage Impedance | Met specifications | |
| Dielectric Strength | Met specifications | |
| Mechanical Performance | Tensile Strength | Met specifications |
| Torque | Met specifications | |
| Deflection | Met specifications | |
| Shaft Buckling | Met specifications | |
| Radio-detectability | Met specifications | |
| Corrosion Resistance | Met specifications | |
| Biocompatibility | Short Term ( |
§ 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).