(258 days)
The Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
The Advisor HD Grid Mapping Catheter, Sensor Enabled, is a sterile, singleuse, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an introducer tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is compatible with the EnSite Velocity and EnSite Precision Cardiac Mapping Systems and other accessories, including the connecting cable and commercially available irrigation pumps.
The provided text describes the St. Jude Medical Advisor HD Grid Mapping Catheter, Sensor Enabled. It mentions several types of testing conducted to demonstrate substantial equivalence to predicate devices, including bench, in vivo, and biocompatibility testing. However, the document does NOT contain a study that establishes acceptance criteria and provides specific device performance data in the format requested.
The document lists various performance characteristics that were tested (e.g., irrigation pressure, electrical resistance, magnetic resistance, and compliance to various ISO and ANSI/AAMI/IEC standards), as well as a "GLP safety study" and an "Accuracy study" as part of in vivo testing. It states that "The resulting evidence obtained from the design verification and validation testing did not raise new questions of safety and effectiveness, and demonstrates that the subject device is as safe and effective as the predicate devices."
However, it does not provide the acceptance criteria for these tests, nor does it present the reported device performance against those criteria in a quantitative manner. Therefore, I cannot complete the table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.
Based on the provided text, I can only state that an "Accuracy study" was performed as an in vivo test, but no details about its methodology, results, or how it proved the device met specific acceptance criteria are given.
The information regarding acceptance criteria and a study proving their fulfillment is absent from the provided FDA 510(k) clearance letter and associated indications for use and device description.
§ 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).