(95 days)
ProCath® Electrophysiology (EP or Electrode) Catheters are indicated for temporary use in electrophysiology studies (mapping), intracardiac pacing, stimulation, sensing and ECG recording of the heart only.
ProCath® Electrophysiology Catheter
The provided text is an FDA 510(k) clearance letter for the ProCath Electrophysiology Catheter. This document indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, this document does NOT contain the acceptance criteria, details of a study demonstrating device performance, or any of the specific information requested in your prompt regarding a study (e.g., sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance, training set details).
The letter primarily focuses on:
- Confirming the substantial equivalence determination.
- Indicating the regulatory class (Class II).
- Listing the product code (DRF).
- Stating the intended use/indications for use for the device.
- Explaining the general controls and provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device.
To answer your questions, additional documentation, specifically related to the performance data submitted by ProCath Corporation for their 510(k) application, would be required. This letter merely confirms the FDA's decision based on that submission, but does not detail the submission's contents.
§ 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).