MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM by IRVINE BIOMEDICAL, INC.

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 Description

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.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than a clinical study proving device performance against specific acceptance criteria.

Therefore, the document does not contain details about acceptance criteria, a study proving the device meets those criteria, or information related to AI/algorithm performance. The submission relies on the device being "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile.

Here's why the requested information cannot be extracted from this document:

Acceptance Criteria & Reported Device Performance: Not mentioned. The focus is on substantial equivalence, not a direct performance comparison against predefined metrics in a clinical study.
Sample size for test set & data provenance: Not applicable. This isn't a clinical trial with a test set of patient data.
Number of experts for ground truth & qualifications: Not applicable for a 510(k) that isn't a clinical study.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable. This device is not an AI-assisted diagnostic tool.
Standalone algorithm performance: Not applicable. This is a physical medical device, not an algorithm.
Type of ground truth: Not applicable.
Sample size for training set & how ground truth was established for training set: Not applicable, as this is not an AI/ML device.

Instead, the document states:

"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 Catheter has passed the biocompatibility and performance test."
"Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process."
"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..."

This indicates that the "proof" for this submission is biocompatibility testing, performance testing (likely bench testing or non-clinical trials demonstrating functionality), adherence to manufacturing standards, and comparison to existing, legally marketed predicate devices. It is not a clinical study with detailed acceptance criteria as one would expect for a novel diagnostic algorithm.

Summary

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JUL 25 1998

SUMMARY OF SAFETY AND EFFECTIVENESS (K982232)

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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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.

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
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.(b)
Classification. Class II (performance standards).