MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

K982232 · Irvine Biomedical, Inc. · DRF · Jul 25, 1998 · Cardiovascular

Device Facts

• Record ID: K982232
• Device Name: MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
• Applicant: Irvine Biomedical, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Jul 25, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.

Device Story

The IBI-1100 Bi-directional Steerable Electrophysiology Catheter System is a diagnostic tool used by physicians during electrophysiologic studies. The system consists of a steerable catheter (5-8 French diameter) and accessory connecting cables. The catheter is inserted into the patient's heart, specifically positioned at the high right atrium, right ventricular apex, or HIS bundle. It functions by recording cardiac electrograms and providing cardiac stimulation. The device connects to an external recording system via conventional cables. By enabling precise placement and signal acquisition, the catheter assists clinicians in diagnosing cardiac electrical activity, which informs clinical decision-making regarding heart rhythm management.

Clinical Evidence

Bench testing only. The device underwent biocompatibility and performance testing to ensure safety and effectiveness, with patient contact materials verified against predicate device standards.

Technological Characteristics

Bi-directional steerable catheter, 5-8 French diameter. Patient contact materials are biocompatible. Accessory cables comply with UL 544 Standard for Safety. Sterilization is performed via a validated process. System is designed for use with conventional external recording equipment.

Indications for Use

Indicated for patients undergoing diagnostic electrophysiologic studies requiring electrogram recording and cardiac stimulation. Catheters are placed 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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JUL 25 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS (K982232)

The Irvine Biomedical, Inc. 181-1100" Bi-directional Steerable Electrophysiology Catheter System is a multiple 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 apex, and HIS bundle. The IBI-1100" ventricular Bi-directional Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.

The components of the IBI-1100" Bi-directional 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 a Electrophysiology Catherer has passed the blocompatibility and performance thet. Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process. Therefore, we believe the 191-1100 Bidirectional Steerable Electrophysiology Catheter on this submission to be safe and effective.

The accessory cables used to connect the IBI-1100" Bi-directional 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 1998

Roger Tu, Ph.D. Vice President - QA/RA Irvine Biomedical, Inc. 2146A Michelson Drive Irvine, CA 92612

K982232 Re: IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System Regulatory Class: II (two) Product Code: DRF Dated: June 23, 1998 Received: June 25, 1998

Dear Dr. Tu:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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07/16/1998 11:03 7148513062 LEI PAGE 04

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510(k) NUMBER (IF KNOWN): K982232

DEVICE NAME: IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System

INDICATIONS FOR USE:

Electrogram recording and cardiac stimulation during diagnostic
electrophysiologic studies. The catheters are commonly placed in
the high right atrium, right ventricular apex, and the HIS bundle.