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The Cordis Webster Fixed Curve Catheter is indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; i.e. stimulation and recording only.

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The intended use of the Diagnostic Deflectable Tip Catheter is to map cardiac structures using stimulation and recording techniques. The Cordis Webster Diagnostic Deflectable Tip Catheter is indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; i.e. stimulation and recording only.

The Diagnostic Deflectable Tip Catheter (5 French size) modification is applicable only to the Instructions for Use. The function, component materials, and intended use of the Diagnostic Deflectable Tip Catheter as compared to the Predicate Device (of the same name - K892265) are identical. An additional indication for use and warning are added that allows the use of the catheter to not only be used in adults but in children 4 years of age and older. The additional warning is to alert the physician regarding the possibility of brachial plexus injury. These additions to the IFU were requested by FDA on behalf of P950005/S3, the pediatric indication approval for Cordis Webster's Diagnostic/Ablation Deflectable Tip Catheters, 6 and 7 French. They also apply to the 5 French diagnostic catheter. The safety or effectiveness of the subject device was not affected as the device itself has not been altered. The Diagnostic Deflectable Tip Catheter (5 French size) is essentially a smaller diameter version of the Premarket Notified 6. 7 French design. These catheters were designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing platinum electrodes that can be used for stimulation and recording. The 5 French Deflectable Catheter utilized the same design features that are in the present deflectable catheter with the exception of the tip electrode connection/termination method. The electrical connection is made in the same way as is done with the Predicate Device, however, the puller-wire which is normally anchored proximal to the tip is terminated (soldered) directly to the tip electrode. Since the puller-wire is attached to the tip electrode, the puller-wire replaces the safety wires that were in the 6 and 7 French Deflectable Catheters. This tip electrode connection/termination method is also utilized for the Crista Cath™ diagnostic catheter approved under K953768.

The intended use of the Modified Device is to provide stability and directional control during transcatheter ablation of endocardial tissue. PREFACE Braided Guiding Sheath - The intended use of the percutaneous Braided Guiding Sheath is for the introduction of intravascular electrophysiology catheters into any cardiac chamber. PERRY Exchange Dilator - The intended use of the PERRY Exchange Dilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascular electrophysiology catheters. The exchange dilator permits exchange of the guiding sheaths while maintaining transseptal left heart access and control of sheath location.

The components of the Predicate Device (K970264) consists of 1) a Guiding Sheath with posterior, anterior or multipurpose shaped distal tip section, 2) a conventional sheath vessel dilator (vessel dilator), 3) a dual-tapered long vessel dilator (exchange dilator), 4) a .032", 260cm guidewire, and 5) a guidewire funnel. The components of the Predicate Device are packaged in four configurations: 1) Guiding Sheath w/ posterior curve and vessel dilator, 2) Guiding Sheath w/ anterior curve and vessel dilator, 3) Guiding Sheath w/ multipurpose curve, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel, and 4) Posterior, Anterior and Multipurpose Guiding Sheaths, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel. The packaging configuration of the Predicate Device has been modified to offer the Guiding Sheath and Exchange System in two separate packages. The Guiding Sheath (PREFACE Braided Guiding Sheath) with posterior, anterior or multipurpose shaped distal tip sections is packaged with a vessel dilator and a short .032", 150cm guidewire. The Exchange System includes the exchange dilator (PERRY Exchange Dilator), .032", 260cm guidewire, and guidewire funnel. The distal end of the vessel dilator and both ends of the PERRY Exchange Dilator were modified by adding radiopaque tips with tungsten to improve visibility under fluoroscopy. The function and intended use of the Modified Device as compared to the Predicate Device are identical, as are all component materials with the exception of the tungsten dilator material. The addition of the tungsten material does not affect safety or effectiveness as demonstrated in the Verification Test Data provided in Appendix I. The PREFACE Braided Guiding Sheaths are intended to provide stability and directional control during catheter ablation. The PREFACE Braided Guiding Sheath is packaged with a vessel dilator with a radiopaque distal tip, and a .032", 150cm guidewire. The PERRY Exchange Dilator will be utilized by the physician to exchange the existing PREFACE Braided Guiding Sheath for an alternate PREFACE Braided Guiding Sheath without losing the established intracardiac position. The PERRY Exchange Dilator with radiopaque ends is packaged with a .032", 260cm guidewire and guidewire funnel.

The intended use of the New Device is to provide a reference location relative to the mapping/diagnostic catheter when used in conjunction with the CARTO and NOGA equipment. The Cordis Webster REF-STAR External Reference Patch is indicated for the use with the NAVI-STAR and NOGA-STAR catheters and the CARTO and NOGA systems to provide catheter tip location as well as electrogram information.

The REF-STAR External Reference Patch (ERP) is an integral part of a nonfluoroscopic catheter tip location and electrogram capture technology called CARTO and NOGA. When used with the CARTO and NOGA systems, the intracardiac location of the NAVI-STAR or NOGA-STAR mapping catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch, which is connected to an handle that houses the printed circuit board. The ERP, like the Predicate Device the Ex Surface Reference Device, is an external device placed on the patient's back by an adhesive patch. The adhesive patch is located on the distal end of the reference device and sandwiches a Biosensor in-between two hypoallergenic adhesive foam pads. The patch is permanently fixed to the shaft and acts as protection for the Biosensor in addition to providing a way to attach the sensor to the patient. The shaft is an Estane material which is radiolucent and houses the electrical cables for the Biosensor. The Biosensor is connected to a PC board which amplifies the electrical signal before it is transferred to the CARTO or NOGA system. The PC board also contains calibration data for the X, Y and Z axis of the sensor. The strain relief for the shaft as it enters the Barrel Cone is made up of two layers of Polyolefin heat shrink tubing. The Barrel Cone is made of Delrin and is attached to the Barrel Extension which is also made of Delrin. The Barrel Extension houses the PC board and connector. The PC board is surrounded by a Mu Metal Shield to protect it from electromagnetic interference.

The Cordis Webster REF-STAR Ex Surface Reference Device is indicated for use with the NAVI-STAR®, NOGA-STAR™, or REF-STAR catheters and the CARTO™ and NOGA ™ systems to provide catheter tip location.

The Cordis Webster REF-STAR Ex Surface Reference Device has been designed to be placed externally on the patient's back in order to compensate for movement during electrophysiological and electromechanical mapping of the heart. The Cordis Webster REF-STAR Ex Surface Reference is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology known as CARTO™ and NOGA ™. When used with the CARTO and NOGA system, the location of the mapping catheter tip, the NAVI-STAR, NOGA-STAR or REF-STAR is compared to the location of the reference device. This reference device consists of a sensor embedded in a polyurethane shaft, which is connected to a handle that houses the printed circuit board.

Introduction of intravascular electrophysiology catheters into any cardiac chamber.

The Cordis Webster Braided Guiding Sheath Exchange System consists of guiding sheaths with a sideport and valve, pre-shaped distal tip section with radiopaque brite tip, a guidewire, a conventional vessel dilator, and a long tapered exchange vessel dilator with a multipurpose curve at the distal end. The guiding sheaths have large non-tapered lumens that allow for intravascular passage of catheters and infusion of heparinized normal saline and/or contrast medium. The guiding sheaths feature a nylon body reinforced with a tightly wound stainless steel braid wire. The braid wire extends from the proximal hub through several flexible transition segments to the "brite tip" which is a low durometer Polyurethane with radiopaque filler at the distal end. The transition segments are comprised of several durometers of material designed to vary the stiffness along the entire length of the guiding sheath shaft. The higher durometer is used on the proximal segment of the shaft to yield a stiffer segment. This stiffer segment provides the added support required to manipulate the guiding sheath during cannulation. The distal transition segments utilize an increasingly softer durometer which provides the flexible atraumatic distal tip segment.

The Cordis Webster deflectable 720 electrode catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The preformed shape of the tip section is designed specifically for the tricuspid annulus.

The Cordis Webster deflectable 720 electrode catheter has been designed for electrophysiological mapping of the tricuspid annulus. The catheter has a high-torque shaft with a halo-shaped tip section containing ten pairs of platinum electrodes that can easily be seen under fluoroscopy. The tip section also contains a radiopaque marker in the center of the electrode array. The tip section of the catheter has a halo-shaped preformed loop which can be positioned around the atrial aspect of the tricuspid annulus. A piston in the handpiece is attached to an internal puller which changes the radius of curvature. When the piston is pushed forward, the radius of curvature of the preformed loop is reduced; when the thumbknob is pulled back, the radius of curvature is increased until the tip section returns to the preformed shape. The high-torque shaft allows the plane of the loop to be maneuvered in order to facilitate accurate positioning. The Cordis Webster deflectable T20 electrode catheter facilitates simultaneously local electrograms spanning the tricuspid annulus, from midseptal to anterior to lateral to posterolateral. Recordings of the entire annulus can be obtained without repositioning the catheter tip.

The Cordis Webster deflectable braided-tip electrode catheter is indicated for electrophysiological mapping of cardiac structures; i.e., endocardial stimulation and recording within the right side of the heart.

The Cordis Webster deflectable braided-tip electrode catheter has been designed for electrophysiological mapping of cardiac structures. The catheter has a high-torque shaft with an internal stainless steel braid and a tip section containing platinum electrodes that can easily be seen under fluoroscopy. The tip section also employs an internal braid to provide additional lateral stability during mapping procedures. A piston in the handpiece is attached to an internal puller which changes the radius of curvature of the tip section. When the piston is pushed forward, the radius of curvature of the tip section is reduced; when the thumbknob is pulled back, the radius of curvature is increased until the tip section returns to its original state. The high-torque shaft allows the tip section to be maneuvered in order to facilitate accurate positioning within the heart.