IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

K961924 · Irvine Biomedical, Inc. · DRF · Apr 11, 1997 · Cardiovascular

Device Facts

• Record ID: K961924
• Device Name: IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
• Applicant: Irvine Biomedical, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Apr 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The IBI-1100™ Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.

Device Story

System consists of steerable multi-electrode catheter (5-8 French) and connecting cable; used for electrogram recording and cardiac stimulation. Operated by physicians in clinical electrophysiology settings. Catheters placed in high right atrium, right ventricular apex, and HIS bundle. Output consists of electrical signals for recording/stimulation; aids physician in diagnosing cardiac arrhythmias. Benefits include precise electrode positioning via steerable mechanism.

Clinical Evidence

Bench testing only; biocompatibility and performance testing conducted. No clinical data provided.

Technological Characteristics

Steerable multi-electrode catheter; 5-8 French diameter; biocompatible materials; accessory cables compliant with UL 544. Sterilization process validated.

Indications for Use

Indicated for patients undergoing diagnostic electrophysiologic studies requiring electrogram recording and cardiac stimulation via placement in the high right atrium, right ventricular apex, and HIS bundle.

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.

Submission Summary (Full Text)

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-03-97 THU 02:01 PM 14:11

APR 11 1997

K9601924

# SUMMARY OF SAFETY AND EFFECTIVENESS

The Irvine Biomedical, Inc. IBI-1100™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.

The electrophysiology catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle. The IBI-1100™ Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.

The components of the IBI-1100™ Steerable Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. Specifically, the patient contact materials are the same as the predicate devices and have been approved by the FDA. The sterilized, finished IBI-1100™ Steerable Electrophysiology Catheter has passed the biocompatibility and performance tests. Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process. Therefore, we believe the IBI-1100™ Steerable Electrophysiology Catheter on this submission to be safe and effective.

The accessory cables used to connect the IBI-1100™ Steerable Electrophysiology Catheters to a recorder are conventional and comply with Section 12A of the Underwriters Laboratories UL 544 Standard for Safety.

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