(89 days)
The Medtronic CardioRhythm StableMapr Catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
The StableMapr Series of EP Diagnostic Catheters are used to record electrical activity from within the heart and its vasculature and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.
The StableMapr Catheters are closed-lumen diagnostic electrophysiology catheters with a variable number of platinum allov recording/stimulating electrodes fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The StableMapr Catheters include addition mapping electrodes and a preformed distal tip section, as well as other minor modifications for improved manufacturability. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrode to the electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curvature of the catheter tip. All models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.
The provided text describes the Medtronic StableMapr Steerable Intracardiac Electrode Catheters. However, it does not contain the specific information required to complete the detailed acceptance criteria and study analysis requested.
Here's a breakdown of why the requested information cannot be fully provided:
- Acceptance Criteria and Reported Device Performance: The document states that "The non-clinical testing were conducted in accordance with applicable FDA guidance. The tests quantified and confirmed the adequacy of electrical and mechanical performance and reliability of the Marinr catheters." And "These tests support the substantial equivalence of the StableMapr catheters with the predicate device." However, it does not provide specific numerical acceptance criteria (e.g., "electrical resistance must be
§ 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).