(60 days)
The APT Map-It™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Map-iTTM Diagnostic Mapping Catheters are biocompatible, flexible, radiopaque fixed and steerable catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, including a guidewire tip configuration to aid the physician in accessing and mapping a patient's heart. They are available in fixed curve and steerable configurations. The fixed curve catheters are available in 4/3.3F (4F tapering to 3.3F), 4F, 5F and 6F sizes with a 0.026'' floppy guidewire tip configuration in the 4/3.3F and 4F sizes for access into smaller anatomies. The steerable catheters are available in 4F, 5F, 6F and 7F sizes. There is a tip electrode on all models except the guidewire tip and PV loop configuration: the band electrodes are set at predetermined distances along the catheter shaft. The catheters can be used for recording intracardiac signals in the atrial and ventricular regions of the heart and for cardiac stimulation during electrophysiology studies. The Map-iT™ Diagnostic Mapping Catheters are comprised of a Pebax catheter shaft, platinum-iridium electrodes and electrical connectors that are either shrouded pin for the bipolar configurations or industry standard Redel connectors. The distal end of the fixed catheters is preformed into industry standard shapes with a variety of electrodes spacing to reach specific areas in the targeted chamber of the heart. The steerable catheters are available in a variety of curves that are controlled to the precise location in the heart by pulling or pushing the plunger on the handle.
The provided document is an FDA 510(k) premarket notification for the Map-it™ Diagnostic Mapping Catheters. The document states that the device is "substantially equivalent" to a legally marketed predicate device (St. Jude Medical Livewire™ Diagnostic Mapping Catheter). This means the FDA determined that the new device is as safe and effective as the predicate device, and thus does not require a new premarket approval (PMA).
Crucially, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way one might expect for a new, de novo device or a clinical AI/ML device. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.
Here's an breakdown based on your request, highlighting what is and isn't present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the document as specific performance metrics and acceptance thresholds. Instead, the performance is implicitly demonstrated by meeting existing standards and test methods as discussed in the "TESTING PERFORMED" section.
The document states:
"The Map-iT™ Diagnostic Mapping Catheters were thoroughly tested based on existing standards and test methods. These tests included visual, dimensional, electrical performance - continuity, leakage impedance, dielectric; mechanical performance - tensile, torque, deflection, shaft buckling, radio-detectability, corrosion; biocompatibility (short term
§ 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).