RHYDER DIAGNOSTIC CATHETER

K962307 · Fidus Medical Technology Corp. · DRF · Sep 17, 1996 · Cardiovascular

Device Facts

• Record ID: K962307
• Device Name: RHYDER DIAGNOSTIC CATHETER
• Applicant: Fidus Medical Technology Corp.
• Product Code: DRF · Cardiovascular
• Decision Date: Sep 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Fidus Rhyder Diagnostic Catheter is intended to simultaneously pace and record monophasic action potentials (MAPs) from the endocardial surface of the heart. The combined capabilities of this catheter obviate the need to insert a separate catheter for stimulation in MAP studies.

Device Story

Flexible diagnostic catheter; two electrode pairs at distal tip; one pair for ECG signal recording; one pair for cardiac pacing. Used in electrophysiology studies; enables simultaneous pacing and MAP recording from endocardial surface; eliminates need for secondary stimulation catheter. Operated by physicians in clinical settings. Output: electrical signals for cardiac monitoring/analysis. Benefits: reduced procedural complexity by combining pacing and recording functions.

Clinical Evidence

Bench testing only. Testing included thermal cycling, impedance, tensile strength, tip buckling, deflection, torsional, connector, leakage current, joint seal, radiopacity, and biocompatibility testing.

Technological Characteristics

Flexible catheter; two electrode pairs (one for ECG, one for pacing); three distal tip designs. Materials biocompatible. Connectivity: standard electrical connector for interface with external electrophysiology recording/pacing equipment.

Indications for Use

Indicated for patients undergoing electrophysiology studies requiring simultaneous endocardial pacing and monophasic action potential (MAP) recording.

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

• EP Technologies, Inc. Franz™ Combination Map Catheter (K900452)
• Daig Response™ Electrophysiology Catheter (K894500, K942379)

Submission Summary (Full Text)

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K962307

SEP 17 1998

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## CONTACT PERSON

Ted Ormsby
VP Engineering and Product Development
Fidus Medical Technology Corporation
47929 Fremont Blvd.
Fremont, CA 94538

## DEVICE NAME

Rhyder Diagnostic Catheter; Class II

## DEVICE DESCRIPTION

The Fidus Rhyder Diagnostic Catheter is a flexible catheter with two pairs of electrodes at the distal tip. One pair of electrodes consisting of tip (active) and side (indifferent) electrodes is used for recording ECG signals. The second pair of electrodes, located adjacent to the catheter's tip, are used for pacing. The Rhyder Diagnostic Catheter is available with three distal tip designs.

## INDICATIONS FOR USE

The Fidus Rhyder Diagnostic Catheter is intended to simultaneously pace and record monophasic action potentials (MAPs) from the endocardial surface of the heart. The combined capabilities of this catheter obviate the need to insert a separate catheter for stimulation in MAP studies.

## PREDICATE DEVICES

- EP Technologies, Inc. Franz™ Combination Map Catheter (K900452)
- Daig Response™ Electrophysiology Catheter (K894500, K942379)

Rhyder Diagnostic Catheter 510(k)

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# TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION

The results of bench testing (thermal cycling test, impedance testing, tensile test, tip buckling test, deflection test, tortional test, connector test, leakage current test, joint seal test, radiopacity) and biocompatibility testing support the substantial equivalence claims of the Rhyder Diagnostic Catheter for its intended use in the coronary vasculature. Results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the Rhyder Diagnostic Catheter's substantial equivalence to the predicate device.

# SUBSTANTIAL EQUIVALENCE CONCLUSIONS

Substantial equivalence is based on the fact that the Rhyder Diagnostic Catheter is substantially equivalent in regard to intended use and technological characteristics as the predicate devices. In instances where the technological characteristics are different, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the Rhyder Diagnostic Catheter. Therefore, it can be concluded that the Rhyder Diagnostic Catheter is substantially equivalent to the predicate devices.

Rhyder Diagnostic Catheter 510(k)