(349 days)
The Reflexion HD™ High-Density Mapping Catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion HD™ High-Density Mapping Catheter is to be used to map the atrial regions of the heart.
The St. Jude Medical (SJM) Reflexion HD™ High Density Mapping Catheter is a flexible, bi-directional, fixed radius loop catheter constructed of a polymer shaft that incorporates platinum electrodes. The Reflexion HD™ High Density Mapping Catheter has a fixed loop and a proximal handle (the ComfortGrip™ handle) that contains: A shaft actuator mechanism for deflecting the distal portion of the shaft; and An electrical connector.
The provided document is a 510(k) Premarket Notification for the St. Jude Medical Reflexion HD™ High-Density Mapping Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through a comprehensive study with acceptance criteria.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria. This is because a 510(k) typically demonstrates equivalence based on design, materials, and non-clinical bench testing, rather than a clinical study with defined performance targets and human expert evaluation in the way you've described.
Specifically, the document states:
- "Summary of Non-Clinical Testing: Bench testing of the Reflexion HD" High Density Mapping Catheter was performed to support substantial equivalence. Results of the testing demonstrates that the Reflexion HD™ High-Density Mapping Catheter design meets product specifications and intended uses."
This indicates that the "study" conducted was bench testing, and the "acceptance criteria" were the product specifications, which are not detailed in this public summary.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, data provenance, expert qualifications, or MRMC studies for this device based on the provided text.
§ 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).