(90 days)
No
The description focuses on the mechanical and electrical properties of a catheter for electrophysiological mapping, with no mention of AI or ML capabilities.
No
The device is indicated for "electrophysiological mapping of cardiac structures" which is a diagnostic purpose, not a therapeutic one.
Yes
The intended use explicitly states "electrophysiological mapping of cardiac structures; i.e., endocardial stimulation and recording within the right side of the heart," which is a diagnostic procedure.
No
The device description clearly details a physical catheter with a shaft, electrodes, and a handpiece with a piston and puller mechanism for deflection. This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states the device is a catheter used for "electrophysiological mapping of cardiac structures; i.e., endocardial stimulation and recording within the right side of the heart." This is an in vivo procedure, meaning it is performed inside the living body.
The device is used for direct interaction with and measurement within the heart, not for testing samples taken from the body.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures; i.e., endocardial stimulation and recording within the right side of the heart.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 stiffess is no greater that that of other currently marketed devices. The side load capability of the braidedtip 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".
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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510(k) Summary
Classification
Common/Usual Name: | Electrophysiology catheter |
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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.
1
510(k) Summary (Continued)
I echnological Characteristics
The hraided-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 stiffess is no greater that that of other currently marketed devices. The side load capability of the braidedtip 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.