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.

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.

AI/ML Overview

The provided 510(k) summary for the T20 Diagnostic Deflectable Tip Catheter does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way typically expected for an AI/ML or imaging device.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here are implicitly linked to showing that the new device performs "as well as" the predicate device and that any differences are not statistically significant in a way that would affect safety and effectiveness.

Here's an attempt to structure the information based on the provided text, while noting the absence of details typically found in AI/ML performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate performance)	Reported Device Performance (T20 Catheter)
Electrical Performance	Comparable to predicate device across relevant electrical characteristics.	No statistically significant differences in outcome compared to predicate.
Mechanical Performance	Comparable to predicate device across relevant mechanical characteristics (e.g., deflection, torqueability).	No statistically significant differences in outcome compared to predicate.
Biocompatibility	Comparable to predicate device.	Not explicitly detailed in performance data section, but generally implied for such devices.
Material/Design Integrity	Catheter maintains integrity and functionality during intended use.	No statistically significant differences in outcome compared to predicate.
Safety and Effectiveness	Device is as safe and effective as the predicate device.	Concluded to be substantially equivalent to the predicate device, implying comparable safety and effectiveness.

Note: The submission states that tests were performed according to FDA's "Electrode Recording Catheter Preliminary Guidance." This guidance would outline the specific tests and expected results (acceptance criteria) for such devices, but the specific numerical criteria and detailed results are not included in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "nonclinical performance testing" which typically involves a set number of devices tested under laboratory conditions.
Data Provenance: Non-clinical (bench testing/laboratory testing). No patient data is mentioned as this is a non-clinical submission for substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. This was non-clinical testing; "ground truth" in the context of clinical endpoints or diagnostic accuracy is not relevant here. The "truth" is based on the physical and electrical measurements of the device compared to the predicate.
Qualifications of Experts: Not applicable. Testing was likely performed by engineers/technicians in a laboratory setting.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No human interpretation of results requiring adjudication is described. Measurements would be objective and compared against pre-defined engineering specifications or predicate performance.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

MRMC Study Done? No. This type of study is typically for evaluating diagnostic accuracy with human readers, often relevant for AI/ML devices. This submission pertains to an electrophysiological catheter for mapping, not a diagnostic imaging or AI system that interprets data for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done? Not applicable in the context of an AI/ML algorithm. The performance testing was on the device's physical and electrical characteristics as manufactured.

7. Type of Ground Truth Used

Type of Ground Truth: "Ground truth" here refers to established engineering specifications and the measured performance of the predicate device. The performance of the T20 catheter was compared directly to these objective benchmarks and the predicate's performance.

8. Sample Size for the Training Set

Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Established: Not applicable. No training set for an AI/ML model.

Summary

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K040751

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

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.

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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 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

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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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Indications for Use

510(k) Number (if known): K040751

Device Name: Vanguard Reprocessed Diagnostic Ellectrophysiology Catheters

Indications for Use:

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

Page 1 of 1

Regulation Number and Section

§ 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).