ORTHOGONAL EP CATHETERS

K990958 · Irvine Biomedical, Inc. · DRF · Jun 3, 1999 · Cardiovascular

Device Facts

• Record ID: K990958
• Device Name: ORTHOGONAL EP CATHETERS
• Applicant: Irvine Biomedical, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

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

Device Story

The ORTHOGONAL™ Steerable Electrophysiology Catheter System consists of a multiple-electrode recording catheter (5-8 French diameter) and connecting cables. Used in clinical electrophysiology labs by physicians to perform diagnostic electrophysiologic studies. The catheter is positioned within the heart (high right atrium, right ventricular apex, His bundle) to record cardiac electrical signals (electrograms) and deliver cardiac stimulation. Accessory cables connect the catheter to an external recording/stimulation system. The device facilitates the mapping of cardiac electrical activity and the assessment of conduction pathways, aiding in the diagnosis of cardiac arrhythmias. The system is designed for biocompatibility and uses conventional cabling compliant with UL 544 standards.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Multiple-electrode steerable catheter; 5-8 French diameter; biocompatible materials; accessory cables compliant with UL 544 standard for safety; validated sterilization process.

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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## SUMMARY OF SAFETY AND EFFECTIVENESS

The Irvine Biomedical, Inc. ORTHOGONAL™ 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 ORTHOGONAL™ Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.

The components of the ORTHOGONAL™ 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 ORTHOGONAL™ Steerable Electrophysiology Catheter has passed the performance tests. Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process. Therefore, we believe the ORTHOGONAL™ Steerable Electrophysiology Catheter on this submission to be safe and effective.

the ORTHOGONAL™ The accessory cables used to connect 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

JUN 3 1999

Roger Tu, Ph.D. Vice President Quality Assurance and Regulatory Affairs Irvine Biomedical, Inc. 2146A Michelson Drive Irvine, CA 92612

Re: K990958/S1 ORTHOGONAL™ EP Catheters Requlatory Class: II Product Code: DRF Dated: May 4, 1999 Received: May 6, 1999

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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and

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Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.

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 regulation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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.gov/cdrh/dsma/dsmamain.html".

Sincerely vours,

Thomas J. Callehan

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

Enclosure

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## 510(k) Number (if known): K990958

| Device Name: | ORTHOGONAL ^TM EP Catheters |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The ORTHOGONAL ^TM Electrophysiology Catheters are used for<br>electrogram recording and cardiac stimulation during diagnostic<br>electrophysiologic studies. The electrophysiology catheters are<br>commonly placed at the high right atrium, right ventricular apex,<br>and His bundle. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Valkell

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1990958 510(k) Number __

Prescription Use (Per 21 CFR 801.109)

Or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________