(248 days)
The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. The Rhythmia Catheter is an 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only.
The Rhythmia Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment. The catheter can be connected to commercially available EP diagnostic systems such as recording systems or 3D mapping systems.
The provided text describes a 510(k) summary for the Rhythmia Mapping Catheter, focusing on its substantial equivalence to a predicate device. It details a variety of bench and animal tests, and mentions a clinical evaluation, but it does not include acceptance criteria for those tests, nor does it present device performance against such criteria in a tabular format.
Therefore, I cannot populate the table or provide specific details for points 1-9 as requested, because the information is not present in the provided document.
The document discusses the following types of testing:
- Bench Tests (In vitro testing): Performed to assure reliable design and performance in accordance with ISO 10555-1:2004. These included Physical Dimensions, Essential Catheter Features, Array Stiffness, Handle Control Forces, Compatibility with Sheaths, Array Shape Reproducibility, Radiopacity, Flushing Flow Rate, Labeling Content, Surface Inspection, Leak and Fluid Ingress Resistance, Corrosion Resistance, Joint Strengths, Catheter Tip Flexibility, Catheter Torsion Resistance, Catheter Kink Resistance, Simulated Use Bench Test, Particulate Evaluation, Spling and Strength, Array Shape Resilience, Pigtail Performance, Labeling Durability, Handle Marking Content and Durability, Connector Mate Life, Connector Latch Holding Force, Catheter Electrical Performance, Catheter Memory Function, Compatibility with Third-Party Recording Systems, Catheter Defibrillation Survival, and Electrical Cross-Talk. The text states "The test results demonstrate that the Rhythmia Mapping Catheter meets the requirements in the applicable standards and specifications," but does not explicitly list those requirements or the specific performance results.
- In vivo testing (GLP animal study): Designed to determine the catheter's ability to safely access, maneuver, stimulate, and record electrical signals in the cardiac chambers as intended. It states "The GLP study met the predefined endpoints in terms of safety and performance," but does not detail these endpoints or the results.
- Clinical experience (outside the US): Involved 29 subjects across 3 sites. It states "There were no adverse events related to the Rhythmia Mapping Catheter, and the catheter performed as intended," but does not provide quantitative performance metrics or specific acceptance criteria for "performed as intended."
Without explicit acceptance criteria and corresponding performance data, detailed responses to your specific questions are not possible based solely 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).