CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

K953750 · Boston Scientific Corp · DRF · Mar 11, 1996 · Cardiovascular

Device Facts

• Record ID: K953750
• Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Applicant: Boston Scientific Corp
• Product Code: DRF · Cardiovascular
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The electrode catheter is intended for intracardiac electrogram recording and pacing for the purpose of determining conduction times from one cardiac location to another, to localize aberrant conduction pathways and to test for the susceptibility of the cardiac chambers to arrhythmias.

Device Story

Electrode recording catheter used for intracardiac electrogram recording and pacing; percutaneously inserted via femoral or jugular access; directed through vasculature to cardiac chambers. Device features stainless steel braid for torque control, soft atraumatic tip, and up to ten platinum electrodes. Operated by physicians in clinical settings. Provides electrical signals for conduction time determination, pathway localization, and arrhythmia testing. Bench testing confirms mechanical integrity, torque performance, and electrical functionality. Biocompatibility verified per Tripartite/ISO guidelines for short-term intravascular use.

Clinical Evidence

Bench testing only. Evaluated tensile strength of joints (tip electrode/tubing, shaft/tip tubing, connector/shaft), rotational failure, recording/pacing capabilities, and torque performance. Biocompatibility testing performed per Tripartite and ISO guidelines for short-term human intravascular use. No clinical data presented.

Technological Characteristics

Materials: Polyurethane shaft with stainless steel wire braid, platinum electrodes. Dimensions: 6F French size, 100 cm length, 1-10 mm electrode spacing. Energy: Electrical (pacing/recording). Sterilization: Ethylene oxide gas. Design: Soft, non-braided atraumatic tip; various curve styles (Cournand, Josephson, Damato, Multipurpose, Special Procedure, Conduction Study).

Indications for Use

Indicated for patients requiring intracardiac electrogram recording and pacing to determine conduction times, localize aberrant conduction pathways, and test cardiac chamber susceptibility to arrhythmias.

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

• Elecath's Investigator (K953750)
• Daig's Response (K953750)

Submission Summary (Full Text)

{0}

K953750/3001

# 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: August 9, 1995
Contact Person: Wanda M. Carpinella
Device Generic Name: Electrode Recording Catheter
Device Classification: 74DRF Catheter, Electrode Recording

MAR 1 1996

## B. INDICATIONS

The electrode catheter is intended for intracardiac electrogram recording and pacing for the purpose of determining conduction times from one cardiac location to another, to localize aberrant conduction pathways and to test for the susceptibility of the cardiac chambers to arrhythmias.

## 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 reinforced with a stainless steel braid to enhance torque control and allow easier maneuverability and has a soft tip to reduce the potential for vessel trauma during placement of the catheter. The tip of the catheter is fitted with up to ten platinum electrodes. No new electrode geometries are introduced. Catheters with various curve styles are also available to meet anatomical constraints as well as physician preference and technique.

The catheters described in this submission are substantially equivalent to Elecath's Investigator and Daig's Response electrophysiology catheters. Descriptive characteristics between the proposed catheter and the Investigator and Response catheters are compared in Table 1.

## D. PERFORMANCE CHARACTERISTICS

The strength of each bond in the catheter was determined. Tensile testing evaluated the strength of the following joints: tip electrode/tubing; shaft/tip tubing and connector/shaft. In addition, the tip electrode was fixed in a chuck and the catheter was rotated until failure occurred. Other testing included an evaluation of recording and pacing capabilities and torque performance testing conducted in bench top models. The testing 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 conducted according to the Tripartite and ISO Guidelines for Medical Devices demonstrated that materials used in the proposed device are suitable for short-term, human intravascular use.

## E. STERILIZATION, PACKAGING and PYROGENICITY

The electrode recording catheters are 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 and bacterial endotoxin levels are monitored for compliance to maximum releasable limits. 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.

000108

{1}

SUMMARY OF SAFETY AND EFFECTIVENESS
page 2 of 2

Submitter's Name: Boston Scientific Corporation
Address: One Boston Scientific Place
Natick, MA 01760-1537 U.S.A
Date of Preparation: August 9, 1995
Contact Person: Wanda M. Carpinella
Device Generic Name: Electrode Recording Catheter
Device Classification: 74DRF Catheter, Electrode Recording

| TABLE 1. SUBSTANTIAL EQUIVALENCE COMPARISON CHART | | | |
| --- | --- | --- | --- |
| CHARACTERISTIC | PROPOSED ELECTRODE CATHETER | ELECATH'S INVESTIGATOR SERIES | DAIG'S RESPONSE SERIES |
| Distal Tip Design | Soft, non-braided atraumatic tip | Soft, non-braided atraumatic tip | Soft, non-braided atraumatic tip |
| Tip Curve Styles | Cournand
Josephson
Damato
Multipurpose
Special Procedure
Conduction Study | Cournand
Josephson
Damato | Cournand
Josephson
Damato
CRD-1
JSN-1
DAO-1 |
| Shaft Materials | Polyurethane/Wire Braid Construction | Nylon/Wire Braid Construction | Not Specified |
| Electrode Material | Platinum | Platinum | Platinum |
| Useable Length | 100 cm | 105 cm | 120 cm
65 cm |
| French Size | 6F | 6F | 6F |
| Electrode Spacing | 2 to 10 mm | 1 to 5 mm | 2 to 10 mm |
| Connector Type | Quick | Quick | Quick Connect |
| Tip Electrode Length | 1 mm | 2 mm | Not Specified |
| Electrode Number | 2, 4, 6, 8, 10 | 4 | 2, 4, 6, 8, 10 |
| Proximal Electrode Length | 1 mm | 2 mm | Not Specified |

000103