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The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic EP Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic Electrophysiology (EP) Catheters are radiopaque, flexible, insulated catheters with a polymer shaft. The catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. The document is a 510(k) premarket notification clearance letter from the FDA for reprocessed electrophysiology catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a study with acceptance criteria.

The "Functional and Safety Testing" section (page 5-6) lists the types of tests conducted (e.g., Biocompatibility, Cleaning Validation, Functional Testing, Electrical Safety Testing, Shelf-life Validation), but it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, ground truth establishment, or expert involvement for any specific performance study.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

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