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The Cardiac Pathways Tracking System catheters are indicated for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli. In addition, the Tracking catheters are used with the Arrhythmia Mapping and Tracking System to provide catheter location information. The Cardiac Pathways Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Arrhythmia Mapping and Tracking System to provide catheter location information.

The Cardiac Pathways Arrhythmia Mapping and Tracking System allows the recording, viewing, and analysis of intracardiac electrograms and EKG signals to aid in the diagnosis and localization of cardiac arrhythmias. The System also allows the recording, viewing, and annotation of diagnostic electrophysiology (EP) catheter positions and electrode positions. The system facilitates the simultaneous recording of signals through connections to standard EP mapping catheters, specialized EP mapping catheters, and a 12-lead EKG. The Cardiac Pathway Arrhythmia Mapping and Tracking System is intended for use in applications of diagnostic EP mapping and consists of the following: - a signal recording computer system for interpreting mapping signals and documenting . locations of catheters and catheter electrodes, - . electrogram signal amplifier electronics, - ultrasound transmit and receive electronics, - . a set of diagnostic electrophysiology reference catheters containing ultrasound ranging transducers and mapping electrodes (referred to as Reference Catheters, RV Reference Catheters, and CS Reference Catheters), - one or more diagnostic electrophysiology tracking catheters containing ultrasound ranging transducers and mapping electrodes (referred to as Tracking Catheters, Steerable Catheters, and Radii Catheters with Tracking), - . cabling to connect transducers and electrodes to recording equipment, and - . software for interfacing the electronics and displaying catheter locations to the operator.

The Mercator Atrial High Density Array Catheter is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). When used in conjunction with electrogram recording equipment and stimulators, the system is used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure. The Mercator Atrial High Density Array Catheter can be used with: - the Cardiac Pathways' Model 8100 Arrhythmia Mapping System and the Model 8300 . Signal Acquisition Module in conjunction with a stimulator, and - Cardiac Pathways' EGM Adapter Cables (Models 2036, 2043, and 2044) in conjunction . with intracardiac electrogram recording equipment. **Prescription Use** (Per 21 CFR 801.109)

The Mercator High Density Array Catheter has an 8.5F catheter shaft with a collapsible, spheroid-shaped. 32-bipole-electrode array (64 electrodes) on the distal end, and an integrated cable/connector assembly on the proximal end. The device is designed to connect/mate directly with the Cardiac Pathways' Arrhythmia Mapping System and with Cardiac Pathways' EGM Adapter Cables. The EGM Adapter Cables can be connected to electrogram recording equipment. The Mercator High Density Array Catheter has been described previously in the 510(k) Summary and the Device Description section in the 510(k) submission file number K982540. There are three different EGM Adapter Cables for use with the Mercator Catheter. The distal end of the cable is identical in each of the three cable types and defined as the end that connects to the Mercator High Density Array Catheter. The proximal end connects to electrogram recording equipment. The distal end of the EGM Adapter Cables is a threaded-body style connector that has contacts for each of the 64 electrodes of the Mercator High-Density Array Catheter and a contact for a shield wire. The proximal end of the cable distinguishes the three EGM Adapter Cables. The Model 2036 EGM Adapter Cable allows for general connection of individual electrodes to electrogram recorders and stimulators. This cable has 64 independent connectors on the proximal end. Model 2043 and Model 2044 EGM Adapter Cables have connector configurations that can mate with Prucka CardioLab recording systems. These cables have two connectors on the proximal end. On each of these two connectors, 33 contacts connect 32 electrodes and 1 shield wire from the Mercator High-Density Array Catheter to the inputs on the Prucka system. The two Prucka connector cable models differ in that one model has pin-type contacts and the other model has socket-type contacts to adapt to suitable models of the Prucka recording system. The EGM Adapter Cables are not sterilized since they are not in the sterile field during a procedure.

The Mercator Atrial High-Density Array Catheter, used in conjunction with the Cardiac Pathways' Model 8100 Arrhythmia Mapping System and the Model 8300 Signal Acquisition Module, is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The system is used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.

The Mercator High Density Array Catheter has an 8.5F catheter shaft with a collapsible, spheroidal-shaped, 32 bipole electrode array on the distal end, and an integrated cable/connector assembly on the proximal end. The device is designed to interface with the Cardiac Pathways' Arrhythmia Mapping System. There are three sizes of arrays for the right atrium based on the atrial volume derived from transthoracic echocardiograms: 70 cc, 100 cc, and 130 cc. The electrode array consists of eight equidistant arms fixed at each end to form a spheroid. The arms terminate into an atraumatic tip on the distal end, and transition into the catheter shaft on the proximal end. The arms are made of a compliant material that maintains contact against the atrial walls during the cardiac cycle. The arms are labeled A through H in a clockwise direction. The array orientation is ascertained using three radiopaque markers positioned on arms A (distal), B (mid) and C (proximal). Each arm has four electrode pairs spaced equidistant from each other along the length of each arm. Each electrode is 0.75 mm wide by 0.25 mm high. The electrode spacing is the same for all three sizes of catheters: 1 mm between electrodes in a bipole and 8 mm between bipoles when measured center to center. The electrical connections between the electrodes on the array and the connector on the proximal end of the catheter are made via cables. The cables run the length of the catheter shaft and connector bump tubing. The catheter shaft terminates at the proximal end at the Y-arm assembly. The center lumen of the catheter is contiguous with the luer fitting on the straight arm of the Y-arm assembly and is used for flushing the catheter. The angled arm on the Y-arm assembly provides the interface for the connector bump tubing. The connector has 79 pins, and interfaces with a mating receptacle on the Arrhythmia Mapping System. The terminations of the cables at the connector are housed inside a backshell that provides a smooth transition from the connector to the connector burnp tubing. The 11 F Guiding Sheath and the 30° Angled Guiding Sheath have an 11 F braided catheter shaft that terminates into a short, atraumatic tip on the distal end and a luer fitting on the proximal end. On the 30° Angled Guiding Sheath, the distal 4.5 cm of the catheter shaft is angled 30° from the proximal shaft of the catheter. The 11 F Guiding Sheath and the 30° Angled Guiding Sheath are used in conjunction with the 8.5 F Pigtail Catheter and the 30° Angled 8.5 F Pigtail Catheter, respectively, to position the High Density Array Catheter in the right atrium. The 11 F Guiding Sheaths have a large inside diameter through which the High Density Array Catheter is inserted into and withdrawn from the cardiovascular system. The shaft of the Guiding Sheath is radiopaque. The Guiding Sheath terminates into a female luer fitting on the proximal end. This luer fitting is used to flush the Guiding Sheath and to introduce the High Density Array Catheter into the Guiding Sheath. The working length of the Guiding Sheath is 110 cm. The purpose of the Guiding Sheath is to "guide" the High Density Array Catheter to a position in the right atrium found using the 8.5 F Pigtail Catheter. The Guiding Sheath is also used to collapse and withdraw the electrode array on the High Density Array Catheter when mapping is complete The 8.5 F Pigtail Catheter and the 30° Angled 8.5 F Pigtail Catheter have an 8.5 F braided catheter shaft on the proximal end attached to a soft distal extrusion that is necked down and formed into a radius known as a " pigtail". The 8.5 F Pigtail Catheter and the 30° Angled 8.5 F Pigtail Catheter are used in conjunction with the 11 F Guiding Sheath to position the High Density Array Catheter in the right atrium. The Pigtail Catheters have an open center lumen and 12 side holes positioned equidistant from each other in the distal extrusion, proximal to the pigtail. These holes can be used to deliver contrast media into the right atrium for visualization of catheter position and to assess the size of the atrium. The center lumen is accessible for flushing using a female luer lock fitting on the proximal end of the Pigtail Catheter. The braided shaft is radiopaque and gives the catheter good torque transmission. The diameter of the pigtail tip is 1.3 cm. The purpose of this large diameter tip is to facilitate atraumatic placement into the right atrium. It also helps to avoid prolapsing of the High Density Array Catheter through the tricuspid valve into the right ventricle. The working length of the Pigtail Catheter is 135 cm. A pigtail stylet is packaged in the Deployment Kit to straighten out the distal radius of the pigtail when inserting it inside the Guiding Sheath. The stylet is a stainless steel mandrel with a ball on the end to prevent advancing it all the way into the center lumen of the Pigtail Catheters. The pigtail stylet is used only in the preparation of the Guiding Sheath/Pigtail Catheter assembly and is not intended to be inserted into a patient. It is removed after the Pigtail Catheter is positioned inside the Guiding Sheath.

The Radii Diagnostic Electrophysiology Catheter is intended to be used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.

The Radii Diagnostic Electrophysiology Catheter is a 7 F steerable, deflectable, quadrapolar catheter. It has a 4 mm tip electrode and three 1 mm ring electrodes in the flexible distal tip and a handle at the proximal end. The catheter is available in several curve sizes, two shaft stiffnesses, and two electrode spacings. The four electrodes at the distal end of the catheter include one 4 mm electrode at the distal tip, and three 1 mm ring electrodes placed at specified distances proximal to the tip electrode. One interelectrode spacing configuration is 2 mm, 5 mm, and 2 mm (2,5,2) and the other interelectrode spacing configuration is 2 mm, 2 mm, and 2 mm (2,2,2). Each of the electrodes is attached to a conductor that extends from the electrode to a specific pin in the connector in the handle. The shaft has two lumens, one for the electrode wires and the other for the pull-wire. To facilitate the transmission of rotational force, the shaft includes braiding sandwiched between layers of tubing. At the proximal end of the handle (i.e., farthest from the shaft), there is a connector for connecting the device to an external stimulator and electrophysiologic recorder. The knob utilized to deflect the tip is on the distal end of the handle (i.e., nearest to the shaft). This knob is connected to the tip by the pull-wire. Pulling the knob toward the connector causes the tip to deflect, with the extent of deflection controlled by the extent of movement of the knob. Pushing the knob toward the shaft causes the tip to straighten. Rotating the handle to the right rotates the catheter tip counterclockwise or clockwise, respectively (as viewed from the handle). The Radii Catheter connects to an electrophysiologic recorder using an EGM Cable designed specifically for the connector configuration on the recorder. Each cable has a connector on one end that mates to the connector on the Radii Catheter and a connector on the other end that mates to the recorder. Within the insulated cable bundle, each conductor is insulated. A separate cable is utilized for connecting the Radii Catheter to an external stimulator. Like the EGM Cables, this cable has a connector on one end that mates to the connector on the Radii Catheter and a connector on the other end that mates to the stimulator. Each conductor within the insulated cable bundle is insulated. Because many pacing stimulators do not contain protected-pin attachments (these are designed into the Cardiac Pathways cable), a Pin Adaptor is provided with the cable to allow for a variety of connection situations.

The Arrhythmia Mapping System is intended to be used to record, view, and analyze intracardiac electrogram (EGM) and surface electrocardiograph (EKG) signals. By performing these functions, the Mapping System assists in the collection and presentation of signal information necessary for the diagnosis and localization of cardiac arrhythmias. The system is intended to be used by a Cardiologist (subspecialty Cardiac Electrophysiology) during electrophysiology studies.

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