(101 days)
The Biosense Webster PENTARAY® NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY® NAV High-Density Mapping Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 3.0.)
The PENTARAY® NAV High-Density Mapping Catheter is a 7 Fr, multi-electrode, electrophysiological diagnostic mapping catheter that consists of an array of five flexible ences that support a total of 20 Platinum/Iridium ring mapping electrodes (four electrodes per spine). The five spines converge at a multi-lumen soft tip section of the catheter that is deflectable (a minimum of 160°) and maneuverable by the user. These features permit positioning the flexible electrode-bearing spines against the heart wall to monitor positioning the nemore is an electromagnetic location sensor location sensor located within the soft tip of the shaft. Two new ring electrodes are positioned on the exterior of the shaft in this same area. The electrical wires from the 22 electrodes, the sensor, the puller wires that effect deflection, and a plastic tube for heparinized saline run through the length of the catheter shaft to the handle. The handle is used to advance or retract the catheter, torque the catheter, and/or deflect the catheter to optimize positioning of the multi-spined tip. The catheter is connected via appropriate cables to the CARTO® 3 EP Navigation System and/or appropriate recording equipment.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the PENTARAY® NAV High-Density Mapping Catheter, detailing its description, indications for use, technical characteristics, and its substantial equivalence to predicate devices.
While it mentions "extensive Bench Testing that included simulated use conditions" and claims the catheter "passed all intended criteria in accordance with appropriate test criteria and standards," it does not provide any specific details regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance. The testing appears to be bench testing, not clinical studies with patients.
- Number or qualifications of experts used to establish ground truth. Given it's bench testing, this concept likely doesn't apply in the clinical sense.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on establishing substantial equivalence to previously cleared devices based on technological comparison and general performance testing, rather than presenting a detailed study with specific acceptance criteria and detailed quantitative results.
§ 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).