CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
K953663 · Cordis Webster, Inc. · DRF · Sep 18, 1996 · Cardiovascular
Device Facts
| Record ID | K953663 |
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| Device Name | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER |
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| Applicant | Cordis Webster, Inc. |
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| Product Code | DRF · Cardiovascular |
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| Decision Date | Sep 18, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 870.1220 |
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| Device Class | Class 2 |
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Intended Use
The Cordis Webster deflectable T20 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.
Device Story
Diagnostic electrophysiological catheter; halo-shaped tip with 20 platinum electrodes; high-torque shaft; handpiece with piston-actuated puller to adjust loop radius of curvature. Used in clinical electrophysiology labs by physicians. Input: cardiac electrical signals via electrodes. Output: simultaneous local electrograms spanning tricuspid annulus (midseptal to posterolateral). Facilitates mapping entire annulus without repositioning; aids clinical diagnosis of cardiac arrhythmias; enables targeted stimulation/recording.
Clinical Evidence
Bench testing only. Testing performed per FDA 'Electrode Recording Catheter Preliminary Guidance'. Results indicate no statistically significant differences in performance compared to predicate devices.
Technological Characteristics
Diagnostic electrophysiological catheter; 20 platinum ring electrodes (0.7mm width); halo-shaped preformed distal tip; high-torque shaft; mechanical puller-wire deflection mechanism; manual operation via handpiece; non-powered; sterile.
Indications for Use
Indicated for electrophysiological mapping, stimulation, and recording of cardiac structures, specifically the tricuspid annulus.
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
- Cordis Webster Orthogonal Catheter
Related Devices
- K040751 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS · Vanguard Medical Concepts, Inc. · Mar 10, 2005
- K171788 — Reprocessed Halo XP Diagnostic Electrophysiology Catheter · Innovative Health, LLC · Nov 3, 2017
- K012520 — GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E · Cardiac Assist Devices, Inc. · Mar 27, 2002
- K201750 — Pentaray Nav eco High-Density Mapping Catheter · Biosense Webster, Inc. · Aug 6, 2020
- K101623 — INQUIRY AFOCUSII DIAGNOSTIC CATHETER · St Jude Medical · Aug 13, 2010
Submission Summary (Full Text)
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K953663
SEP 18 1995
510(k) SUMMARY
August 4, 1995
Prepared by: Cordis Webster, Inc.
4750 Littlejohn Street
Baldwin Park, CA 91706
(818) 813-1290
(818) 813-1443 (fax)
Contact Person: Mary Adams
Sr. Regulatory Affairs Specialist
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# 510(k) Summary
## Classification Name
Common/Usual Name: Diagnostic electrophysiological catheter
Proprietary Name: T20 Diagnostic Deflectable Tip Catheter
## Name of Predicate Device
Cordis Webster Diagnostic 7F Deflectable Tip Catheter (primary)
Cordis Webster Orthogonal Catheter (secondary)
## Device Description
The Cordis Webster deflectable T20 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.
## Intended Use
The Cordis Webster deflectable T20 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.
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# 510(k) Summary (Continued)
## Technological Characteristics
The subject device is technologically similar to the predicate device, the Cordis Webster Diagnostic Deflectable catheter. The design of the T20 electrode catheter, the subject device, includes a greater number of ring electrodes, 20, as compared to the Cordis Webster Diagnostic Deflectable catheter which has 4 and the Cordis Webster Orthogonal catheter which has 12 poles. The nominal width of each ring electrode used in the T20 is 0.7mm compared to 1.3mm for the standard deflectable catheter. The distal tip of the T20 electrode catheter has a “halo” shape as compared to A - F curve availability for distal tip deflection of the standard deflectable catheter. The differences indicated do not affect the safety or effectiveness of the device.
## Performance Data (Nonclinical Testing)
The nonclinical performance testing performed on the T20 electrode catheter compared to the predicate device indicated that there were no statistically significant differences in the outcome of the tests for each of the devices that would affect the safety and effectiveness of the device. The tests on the following table were performed according to FDA’s “Electrode Recording Catheter Preliminary Guidance”. Certain tests were not applicable to this device and justifications are given for the absence of those particular tests.
## Conclusions Drawn from the Nonclinical Tests
The results of the nonclinical performance tests indicate that the T20 electrode catheter performs as well as the predicate device (the standard Cordis Webster Diagnostic 7F Deflectable Catheter) and that the differences in testing outcome are not statistically significant; therefore, Cordis Webster concludes that the T20 catheter is substantially equivalent to the predicate device.
