ELECTRODE RECORDING CATHETER

K954651 · Boston Scientific Corp · DRF · Oct 22, 1996 · Cardiovascular

Device Facts

• Record ID: K954651
• Device Name: ELECTRODE RECORDING CATHETER
• Applicant: Boston Scientific Corp
• Product Code: DRF · Cardiovascular
• Decision Date: Oct 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The electrode catheter is intended for temporary use in electrophysiologic procedures for intracardiac stimulation and/or recording potentials.

Device Story

Electrode recording catheter; percutaneously inserted via femoral or jugular access; navigated through vasculature to cardiac chambers. Device features wire-reinforced polyurethane shaft; soft distal tip with three ring electrodes and one tip electrode. Used by physicians during electrophysiologic procedures to stimulate heart tissue or record electrical potentials. Output consists of electrical signals for diagnostic or therapeutic mapping. Benefits include temporary access for cardiac electrophysiology assessment.

Clinical Evidence

Bench testing only. Structural strength of bonds verified; biocompatibility testing confirmed suitability for short-term human intravascular use; ethylene oxide residuals within acceptable limits.

Technological Characteristics

Wire-reinforced polyurethane shaft; soft distal tip; three ring electrodes and one tip electrode. Sterilization via ethylene oxide gas. Packaging: Tyvek-lidded blister pack and Tyvek/mylar pouch.

Indications for Use

Indicated for patients undergoing electrophysiologic procedures requiring temporary intracardiac stimulation or recording of potentials.

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

• Polaris catheter (Boston Scientific)
• CardioRhythm Voyager catheter (Medtronic)

Submission Summary (Full Text)

{0}

OCT 22 1996
K954651

# SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.

## A. GENERAL INFORMATION

Submitter's Name: Boston Scientific Corporation
Address: One Boston Scientific Place
Natick, MA 01760-1537 U.S.A.
Date of Preparation: October 6, 1995
Contact Person: Wanda M. Carpinella
Device Generic Name: Electrode Recording Catheter
Device Classification: 74DRF Catheter, Electrode Recording

## B. INDICATIONS

The electrode catheter is intended for temporary use in electrophysiologic procedures for intracardiac stimulation and/or recording potentials.

## C. DESCRIPTIVE CHARACTERISTICS

The catheters are typically placed percutaneously through femoral or jugular access sites and directed through the vasculature into the cardiac chambers. The catheter is composed of a wire-reinforced, polyurethane shaft and a soft, distal tip. The distal end of the catheter is fitted with three ring electrodes and one tip electrode. No new electrode geometries are introduced. Catheters with various tip lengths are available to meet anatomical constraints as well as physician preference and technique.

Substantial equivalence for the proposed catheter is based on similarities in design, materials and dimensions to Boston Scientific's currently-marketed Polaris catheter and Medtronic's CardioRhythm Voyager catheter.

## D. PERFORMANCE CHARACTERISTICS

The structural strength of each bond in the catheter was determined. The results demonstrated functional integrity and performance characteristics that were substantially equivalent and acceptable for the device's intended use and do not affect safety and effectiveness. Biocompatibility tests demonstrated that materials used in the proposed device are suitable for short-term, human intravascular use.

## E. STERILIZATION, PACKAGING and PYROGENICITY

The electrode recording catheter is packaged in an inner Tyvek-lidded blister pack and an outer Tyvek®/mylar pouch. The device is sterilized using ethylene oxide gas. Ethylene oxide gas residuals were shown to be less than the acceptable maximums. All testing was performed on sterilized samples and no detrimental effects from the sterilization process were noted.

## F. CONCLUSIONS

Mechanical, electrical and biological tests verify that the electrode recording catheter meets the essential requirements that are considered necessary for its intended use.

000137