(351 days)
Not Found
Not Found
No
The description focuses on the mechanical design and function of the catheter for electrophysiological mapping, with no mention of AI or ML capabilities.
No
The device is described for "electrophysiological mapping," "recording," and "evaluation of arrhythmias or cardiac mapping," which are diagnostic functions, not therapeutic. While it mentions "intracardiac pacing," this is for temporary use during studies, not as a primary therapeutic intervention.
Yes
The Intended Use / Indications for Use section explicitly states that the catheter is for "temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping," which are diagnostic procedures. Additionally, the Device Description mentions "electrophysiological mapping" and "recordings of the entire annulus," further supporting its diagnostic function. The predicate device is also explicitly named as a "Diagnostic Catheter".
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 information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping." This describes a procedure performed within the body (in vivo) to diagnose and evaluate heart conditions.
- Device Description: The description details a catheter designed to be inserted into the heart to record electrical signals and potentially pace the heart. This is an invasive medical device used directly on a patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or treatment. This device does not process or analyze biological specimens in this manner.
Therefore, this device falls under the category of an invasive medical device used for diagnostic and therapeutic procedures within the body, not an in vitro diagnostic device.
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.
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. In addition, the preformed shape of the Halo XP catheter's tip section is designed particularly for the tricuspid annulus.
Product codes (comma separated list FDA assigned to the subject device)
NLH
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 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.
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 (primary), Cordis Webster Orthogonal Catheter (secondary)
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
MAR 1 0 2005
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.
1
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 720 is 0.7mm compared to 1.3mm for the standard deflectable catheter. The distal tip of the 720 electrode catheter has a "balo" 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 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 720 catheter is substantially equivalent to the predicate device.
12-075
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
MAR 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vanguard Medical Concepts Inc. c/o Ms. Heather Crawford, RAC Director of Regulatory Affairs 5307 Great Oak Drive Lakeland, FL 33815
Re: K040751
K040731
Trade Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (see enclosed list) Regulation Number: 21 CFR 870.1220 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: NLH Dated: December 28, 2004 Received: December 29, 2004
Dear Ms. Crawford:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We nave reviewed your Section 970(x) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard) to regard date of the Medical Device American Council Ford. Brya commerce provided in accordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMAA devices that have been recarsined in accerdance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval oppor and Costliere Act (Act) that do not require subject to the general controls provisions of the Act. The You may, merelove, market the device, basjer to the may be annual registration, listing of general controls provisions of the rest labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (500 above) into existing major regulations affecting your device can may be subject to such additional controlions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
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Page 2 -- Ms. Heather Crawford, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fill I DA s issualled of a band a mind other requirements of the Act
that FDA has made a determination that your device complies with one and that FDA has made a determination that your are read by other Federal agencies. You must be or any Federal statutes and regulations administer of rot limited to: registration and listing comply with all the Act s requirements, meddly, good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing the electron (21 CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); voys Section S product radiation control provisions (Sections of 1 5 in Jerse as described in your Section 510(k)
This letter will allow you to begin marketing your device of your douice to I his letter will allow you to begin makemig your article equivaler of your device to a legally
premarket notification. The FDA finding of substantial enad thus, permits vou premarket notification. The PDA inding of succitation of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac now as a more the regulation entitled, and the increases attain contact the Office of Complance at (216) 276-67607 (21CFR Part 807.97). You may obtain "Misbranding by relefence to premarket notificanses in the Act from the Division of Small
other general information on your responsibilities under the Act from the 1990s (28. other general information on your responsion.cos and its toll-free number (800) 638-2041 or 1011) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
Bhimmar for
Brain D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Ms. Heather Crawford, RAC
List of Models:
| Halo XP – 7F Diameter, 110 cm long, 20 electrodes, Tricuspid/Halo XP Curve | ||
|---|---|---|
| Catalog Number | Electrode Spacing | Connector Type |
| D7-T20-P15-FS | 2-13-2mm (no tip electrode) | 15-pin molded (2) |
| D7-T20-P15-RT | 2-13-2mm (no tip electrode) | 10-pin Redel (2) |
| D7-T20-282-FS | 2-8-2mm w/20mm leader (no tip electrode) | 15-pin molded (2) |
| D7-T20-282-RT | 2-8-2mm w/20mm leader (no tip electrode) | 10-pin Redel (2) |
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5
Indications for Use
510(k) Number (if known): K040751
Device Name: Vanguard Reprocessed Diagnostic Ellectrophysiology Catheters
Indications for Use:
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. In addition, the preformed shape of the Halo XP catheter's tip section is designed particularly for the tricuspid annulus.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhimmer
ion Sign-Off
{{ Sign-Off Division of Cardiovascular Devices 510(k) Number
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