CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER

K955817 · Cordis Webster, Inc. · DRF · Mar 25, 1996 · Cardiovascular

Device Facts

• Record ID: K955817
• Device Name: CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER
• Applicant: Cordis Webster, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Mar 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

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.

Device Story

Electrophysiology catheter for cardiac mapping, stimulation, and recording. Features high-torque shaft with internal stainless steel braid and platinum electrodes visible under fluoroscopy. Tip section includes internal braid for lateral stability. Handpiece piston/thumbknob mechanism controls tip curvature radius via internal puller. Used by physicians in clinical settings during electrophysiological studies. Provides stable contact within beating heart; facilitates accurate positioning. Output consists of electrical signals for recording or stimulation. Benefits include improved contact stability compared to standard deflectable catheters.

Clinical Evidence

Bench testing only. Comparison of electrical and mechanical characteristics against predicate devices. Side load capability testing performed. Testing conducted in accordance with FDA's 'Electrode Recording Catheter Preliminary Guidance'. No clinical data presented.

Technological Characteristics

Materials: Polyurethane tip, stainless steel internal braid, platinum electrodes. Dimensions: 8 French shaft, 6.5 French tip, 90 cm length. Sensing/Actuation: Manual mechanical puller for tip deflection. Connectivity: None. Sterilization: Identical to predicate Cordis Webster catheters.

Indications for Use

Indicated for electrophysiological mapping, endocardial stimulation, and recording within the right side of the heart. Contraindicated for left-sided cardiac applications.

Regulatory Classification

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.

Predicate Devices

• Cordis Webster Diagnostic 7F Deflectable Tip Catheter (K955817)
• Cordis Webster Fixed Curve Catheter (K955817)
• Cordis Webster Coronary Sinus Flow Catheter (K955817)

Reference Devices

• Mansfield deflectable curve catheters
• Bard deflectable curve catheters
• Elecath deflectable curve catheters

Submission Summary (Full Text)

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K955817

# 510(k) Summary

## Classification

Common/Usual Name: Electrophysiology catheter

Proprietary Name: Deflectable braided-tip electrode catheter

## Name of Predicate Device

Cordis Webster Diagnostic 7F Deflectable Tip Catheter (primary)

Cordis Webster Fixed Curve Catheter (secondary)

Cordis Webster Coronary Sinus Flow Catheter (tertiary)

## Device Description

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.

## Intended Use

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.

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510(k) Summary (Continued)

## Technological Characteristics

The braided-tip electrode catheter is technologically similar to currently marketed Cordis Webster deflectable catheters and to other manufacturers' deflectable curve catheters; e.g., Mansfield, Bard and Elecath. The design of the braided-tip electrode catheter, the subject device, includes a polyurethane tip section that contains an internal braid, as compared to the Cordis Webster deflectable catheter which has a polyurethane tip section without an internal braid. The catheter shaft is 8 French while the tip section is 6.5 French which is within the existing range of tip sizes for the currently marketed devices (6 and 7 French). The tip section internal braid design is identical to that of the currently marketed Cordis Webster fixed curve catheter. The number of electrodes and type of interface connectors are the same as currently marketed devices.

## Performance Data (Non-clinical Testing)

Non-clinical performance testing was done to compare the braided-tip electrode catheter to the predicate devices indicated above and there were no significant differences in device performance. Basic electrical and mechanical characteristics are comparable and tip stiffness is no greater that that of other currently marketed devices. The side load capability of the braided-tip catheter is greater than that of the standard deflectable catheter and, as such, should provide a greater degree of stability in a beating heart during electrophysiological studies. Applicable tests were performed in accordance with the FDA's "Electrode Recording Catheter Preliminary Guidance".

## Sterilization and Packaging

The sterilization and packaging of the braided-tip deflectable catheter is identical to that of the Cordis Webster standard deflectable and fixed curve catheters.

## Conclusions

The results of the non-clinical performance tests indicate that the braided-tip electrode catheter performs as well as the predicate device, the standard Cordis Webster Deflectable Catheter. The braided-tip construction exhibits greater side load capability and thus may provide improved contact stability (as compared to the standard deflectable catheter) during use. Cordis Webster fixed curve catheters use the same braided tip construction; therefore, Cordis Webster concludes that the braided-tip catheter is substantially equivalent to the predicate devices. Because the 8 French shaft of the braided-tip catheter has greater pushability, it was deemed appropriate that it be contraindicated for left-sided applications; the catheter is available only in a 90 cm length which effectively precludes its use in other than the right side of the heart.