(408 days)
Cordis Webster Diagnostic 7F Deflectable Tip Catheter, Cordis Webster Orthogonal Catheter
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No
The description focuses on the mechanical and electrical properties of the catheter for electrophysiological mapping, with no mention of AI or ML for data analysis or interpretation.
No.
Explanation: The device is indicated for "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only," which describes a diagnostic rather than a therapeutic function.
Yes
The intended use explicitly states "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only," which are diagnostic procedures to understand cardiac electrical activity.
No
The device description clearly details a physical catheter with electrodes, a shaft, a handpiece, and a piston, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "electrophysiological mapping of cardiac structures; i.e., stimulation and recording only." This describes a procedure performed within the body (in vivo) to assess electrical activity.
- Device Description: The description details a catheter designed to be inserted into the body and positioned within the heart. It focuses on its physical characteristics and how it is used for mapping in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro), such as blood, urine, or tissue. The device is used directly on the patient.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used for direct physiological measurement within the body.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures; tricuspid annulus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The nonclinical performance testing performed on the 720 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.
The results of the nonclinical performance tests indicate that the 720 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cordis Webster Diagnostic 7F Deflectable Tip Catheter, Cordis Webster Orthogonal Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
K953663
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
1
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 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.
Intended Use
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.
2
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 720 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 720 is 0.7mm compared to 1.3mm for the standard deflectable catheter. The distal tip of the 720 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 720 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 720 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.