(80 days)
The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter and related accessory devices are indicated for catheter-based anatomic mapping of the esophagus. When used during an electrophysiology ablation procedure, the EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is not intended to provide absolute esophageal wall location information. The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is placed in the esophagus via the transpharyngeal or transnasal approach.
The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is a mapping catheter to be used exclusively for anatomically mapping points within the esophagus using CARTO™ Navigation System technology to indicate the relative anatomical relationship between the esophagus and posterior wall of the left atrium. The EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is introduced through the patient's nose or throat into the esophagus. Once in the desired position, the device's location sensor is used to "map" the 3-D position of the catheter in the esophagus, using Biosense Webster's location software and hardware system, as the device is slowly pulled towards the initial entry port.
The ESOPHASTAR™ Esophageal Mapping Catheter is 8 F in diameter and is 125 cm long. The catheter has a flexible polyurethane shaft with an atraumatic tip section. This catheter has a magnetic location sensor embedded in the tip and, therefore, is used with the CARTO™ EP Navigation System (a magnetic field location technology) and a REFSTAR™ with QWIKPATCH™ External Reference Patch to tag the esophagus.
The provided text describes a 510(k) summary for the ESOPHASTAR™ Esophageal Mapping Catheter. Unfortunately, the document is a regulatory submission for device clearance and does not contain the specific details about a clinical study with acceptance criteria and reported device performance in the format requested.
The document states:
- "The ESOPHASTAR™ underwent bench testing and was also tested under simulated use conditions in animals. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards."
This indicates that internal testing was performed, and the device met its pre-defined criteria. However, the specific acceptance criteria, a table of performance, sample sizes, data provenance, expert qualifications, ground truth methods, or details about comparative effectiveness studies (MRMC) or standalone algorithm performance are not provided in this summary.
Therefore, I cannot fulfill your request for the detailed table and study information based solely on the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices based on safety and effectiveness, rather than a detailed report of a clinical efficacy study against specific, quantified 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).