(279 days)
The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
The Reprocessed CS Diagnostic Electrophysiology Catheter is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 7FR catheter with a usable length of 115 cm. The catheter has a high-torque shaft with a braided deflectable, Bi-Directional tip section containing platinum electrodes that can be used for recording and stimulation. Two curve types, D/F and F/J, for CS placement, are available. Specific to Reprocessed CS Diagnostic Electrophysiology Catheters with Auto ID Technology: Each catheter is equipped with EEPROM (Electronically Erasable Programmable Read Only Memory), which is used to save unique catheter identification information. CARTO® EP Navigation Systems equipped with Auto ID Technology can access the saved information and automatically recognize the catheter information. This device has been cleared for three (3) reprocessing cycles.
This document is a 510(k) premarket notification for a repurposed medical device, specifically a "Reprocessed CS Diagnostic Electrophysiology Catheter." It is NOT describing an AI/ML powered device, therefore, the information requested about acceptance criteria, study details, sample sizes, ground truth, and expert involvement for an AI/ML device is not applicable.
The document primarily focuses on establishing substantial equivalence to existing predicate devices based on modifications to the "Instructions for Use" by adding contraindications. It does not contain any performance studies or data comparing the reprocessed device's performance against specific acceptance criteria in the manner an AI/ML device would be evaluated.
Therefore, I cannot provide the requested information.
§ 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).