(73 days)
The ORTHOGONAL TM Electrophysiology Catheters are used forelectrogram recording and cardiac stimulation during diagnosticelectrophysiologic studies. The electrophysiology catheters arecommonly placed at the high right atrium, right ventricular apex,and His bundle.
The Irvine Biomedical, Inc. ORTHOGONAL™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the ORTHOGONAL™ Steerable Electrophysiology Catheter System. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the way a medical device typically would for a de novo or PMA submission.
Therefore, the information requested in the prompt, such as specific acceptance criteria, a detailed study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text.
The document states: "The components of the ORTHOGONAL™ Steerable Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. Specifically, the patient contact materials are the same as the predicate devices and have been approved by the FDA. The sterilized, finished ORTHOGONAL™ Steerable Electrophysiology Catheter has passed the performance tests."
This indicates that various performance tests were conducted, but the specific details, acceptance criteria, and results are not included in this summary. The FDA's 510(k) process relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, meaning that the new device is as safe and effective as the predicate. The "performance tests" mentioned are likely related to demonstrating this equivalence through bench testing (e.g., biocompatibility, sterilization validation, electrical performance, physical integrity) rather than a clinical study with statistical acceptance criteria for diagnostic accuracy as might be found in AI/imaging devices.
Based on the provided text, I cannot complete the table or answer the specific questions about the study design, sample sizes, or ground truth establishment. The document does not contain the level of detail required for these points.
§ 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).