PLATINUM SERIES EP DIAGNOSTIC CATHETERS

K953185 · Medtronic Cardiorhythm · DRF · Apr 15, 1996 · Cardiovascular

Device Facts

• Record ID: K953185
• Device Name: PLATINUM SERIES EP DIAGNOSTIC CATHETERS
• Applicant: Medtronic Cardiorhythm
• Product Code: DRF · Cardiovascular
• Decision Date: Apr 15, 1996
• 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 coronary vessels 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

Electrophysiology diagnostic catheter; 2-10 platinum electrodes at distal end; Pebax tip; 5-6 French diameter; 60-125 cm length. Connects to external physician stimulator/recorder equipment. Transmits analog electrical signals from heart/coronary vessels; delivers stimulation pulses. Used by physicians in clinical EP studies. Facilitates arrhythmia assessment, therapy guidance, and intervention evaluation.

Clinical Evidence

Non-clinical and in-vivo testing performed to confirm electrical and mechanical performance and reliability. Biocompatibility testing fulfilled based on material equivalence to predicate.

Technological Characteristics

Materials: Platinum electrodes, Pebax tip. Dimensions: 5-6 French OD, 60-125 cm length. Sensing/Actuation: Analog electrical signal recording and stimulation. Connectivity: Wired connection to external stimulator/recorder. Construction: Welded electrode bands to internal wiring.

Indications for Use

Indicated for patients undergoing electrophysiology 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 Torqr catheter
• Bard Intracardiac Electrode catheter

Submission Summary (Full Text)

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K953185

# Attachment VII
## 510(k) SUMMARY
As of July 7, 1995

## Device Name
Platinum™ Series of Diagnostic Electrophysiology Catheters

## Device Description
The Platinum Series EP Diagnostic Catheter is an electrophysiology catheter with a range of two to ten platinum recording/stimulating electrodes arranged on its distal end. The distal band electrode is approximately .050" from the spherically molded Pebax tip. The distal band electrode serves as the tip electrode. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each platinum electrode to the electrical connector in the proximal end. The outside diameter of the catheter is 5 to 6 French and the usable length ranges from 60 to 125 cm.

## Intended Use
A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and coronary vessels 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 Platinum series of EP catheters is substantially equivalent to the Medtronic CardioRhythm Torqr catheter and the Bard Intracardiac Electrode catheter.

## Catheter Testing Results and Conclusion
The Platinum catheter is constructed of similar materials to those found in Medtronic CardioRhythm's Torqr catheter. All materials in the Platinum that are patient contacting are identical to those similarly exposed in the Torqr, therefore all biocompatibility testing was fulfilled.

The results of non-clinical and in-vivo testing quantitated and confirmed the adequacy of electrical and mechanical performance and reliability of the Platinum catheters. These tests support the equivalence of the Platinum catheters with the predicate device.

Platinum 510(k) Medtronic® CardioRhythm CONFIDENTIAL Page 69