PERFORMR SERIES EP DIAGNOSTIC CATHETERS

K964272 · Medtronic Cardiorhythm · DRF · Jan 23, 1997 · Cardiovascular

Device Facts

• Record ID: K964272
• Device Name: PERFORMR SERIES EP DIAGNOSTIC CATHETERS
• Applicant: Medtronic Cardiorhythm
• Product Code: DRF · Cardiovascular
• Decision Date: Jan 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.

Device Story

Performr Series diagnostic electrophysiology catheters; closed-lumen design; 2-11 platinum alloy electrodes fixed to shaft. Physician-operated; used in clinical EP labs. Manipulator handle allows tip curve angle adjustment; some models feature radius of curvature control or lateral deflection. Catheter connects to external stimulator/recorder equipment; transmits analog cardiac electrical signals for recording and delivers stimulation pulses. Enables assessment of arrhythmia prognosis, therapy guidance, and intervention evaluation.

Clinical Evidence

No clinical data. Non-clinical and in-vivo testing conducted per GLP and FDA guidance to confirm electrical and mechanical performance. Biocompatibility fulfilled via predicate device comparison.

Technological Characteristics

Closed-lumen catheter; 5-7 French diameter; 60-125 cm length. Platinum alloy electrodes. Manipulator handle for tip deflection/curve radius control. Analog signal transmission. Biocompatible materials identical to predicate.

Indications for Use

Indicated for patients undergoing electrophysiology (EP) diagnostic studies to record cardiac electrical activity and provide cardiac stimulation for arrhythmia prognosis, therapy selection, and evaluation of therapeutic interventions.

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

• Medtronic CardioRhythm Marinr EP catheter
• Bard EP-XT Steerable catheter
• Elecath Genesis catheter

Submission Summary (Full Text)

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1-13-1997 4:39PM
K964272
JAN 23 1997
P. 3

# SECTION 6. 510(k) SUMMARY

The following 510(k) Summary of Safety and Effectiveness information is provided per 21 CFR §807.92.

## Device Name

Performr Series of Diagnostic Electrophysiology Catheters

## Device Description

The Performr Series Catheter is a closed-lumen diagnostic electrophysiology catheter with a variable number of platinum alloy recording/stimulating electrodes (2-11) fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrode to the electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 5 to 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curve of the catheter tips. Some models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.

## Intended Use

A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.

## Substantial Equivalence

The Performr series of EP catheters is substantially equivalent to the Medtronic CardioRhythm Marinr EP catheter, as well as the Bard EP-XT Steerable and Elecath Genesis catheters.

## Catheter Testing Results and Conclusion

The Performr catheter is constructed of similar materials to those found in the Medtronic CardioRhythm Marinr catheter. All materials in the Performr that are patient contacting are identical to those similarly exposed in the Marinr. Therefore, all biocompatibility testing was fulfilled via the predicate device.

The non-clinical and in-vivo testing were conducted in accordance with applicable FDA guidance and per GLP. The tests quantified and confirmed the adequacy of electrical and mechanical performance and reliability of the Performr catheters. These tests support the substantial equivalence of the Performr catheters with the predicate device.