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U.S. Department of Health and Human Services

Product Classification

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Device catheter remote control system
Regulation Description Steerable cardiac ablation catheter remote control system.
Definition A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.
Physical State Consists of non-sterile, reusable components including the remote catheter system (sled, track, and turret), a hard-wired remote control, a bridge support with rail and frame, as well as a sterile, single use docking station and spreader to interface with compatible, commercially available ablation catheters. Additional sterile, single-use accessory items (sterile cover and track kits) are used to maintain a sterile field during device use.
Technical Method Uses electronic stepper motors to operate the manual handle of a steerable cardiac ablation catheter to remotely control its advancement, retraction, rotation, and deflection. The system does not use software or decision logic to control the catheter and does not provide any diagnostic or visual information or therapy by itself. Physicians use standard fluoroscopy to visualize the movement and placement of the catheter in the same way they would for a manual catheter procedure. However, remote control of the catheter allows the physician the choice to be positioned outside of the fluoroscopy radiation field.
Target Area Right atrium
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePJB
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.5700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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