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The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The H-Curve TV catheters are to be used to map the atrial regions of the heart.

The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop which is parallel to catheter body. The loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

The provided document K082061 does not describe the acceptance criteria, the study that proves the device meets the acceptance criteria, or any related details such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

This document is a 510(k) summary for a medical device (Inquiry™ H-Curve TV Steerable Diagnostic Catheter) and primarily focuses on establishing substantial equivalence to a predicate device. It briefly mentions nonclinical tests but does not provide details on their methodology, results, or how they relate to specific acceptance criteria.

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