LUMA-CATH FIXED CURVE EP CATHETERS

K991025 · Irvine Biomedical, Inc. · DRF · Oct 15, 1999 · Cardiovascular

Device Facts

• Record ID: K991025
• Device Name: LUMA-CATH FIXED CURVE EP CATHETERS
• Applicant: Irvine Biomedical, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Oct 15, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Luma-Cath™ Fixed Curve Electrophysiology Catheters are used for measurement of electrical activity in the heart.

Device Story

Luma-Cath™ Fixed Curve Electrophysiology Catheter is a multi-electrode catheter used for cardiac electrogram recording and stimulation. Device features 5-8 French diameter catheter and electrodes, with a 0.036-inch internal lumen for guidewire insertion. Operated by physicians in clinical settings during diagnostic electrophysiologic studies. Catheter is placed at high right atrium, right ventricular apex, or His bundle to capture electrical signals. Signals are transmitted via accessory cables to an external recorder. Output allows clinicians to map cardiac electrical activity and perform stimulation, aiding in the diagnosis of cardiac arrhythmias.

Clinical Evidence

Bench testing only. Device passed performance tests; all components are biocompatible.

Technological Characteristics

Multi-electrode catheter; 5-8 French diameter; 0.036-inch internal lumen for guidewire; biocompatible materials; fixed curve design; connects to external recording equipment via accessory cables compliant with UL 544 standards.

Indications for Use

Indicated for use in patients undergoing diagnostic electrophysiologic studies requiring electrogram recording and cardiac stimulation. Used for placement at 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.

Reference Devices

• Accessory cables (K946333)

Submission Summary (Full Text)

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Special 510(k): Luma-Cath™Fixed Curve EP Catheters/K991025

OCT 1 5 1999

## SUMMARY OF SAFETY AND EFFECTIVENESS

1991025/53

The Irvine Biomedical, Inc. Luma-Cath™ Fixed Curve Electriophysiology 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 electrodes is between 5 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch for insertion of a guidewire.

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

The components of the Luma-Cath™ Fixed Curve Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. The sterilized, finished Luma-Cath™ Fixed Curve 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 Luma-Cath™ Fixed Curve Electrophysiology Catheter on this submission to be safe and effective.

The accessory cables used to connect the Luma-Cath™ Fixed Curve Electrophysiology Catheters to a recorder are conventional and are cleared in the 510(k) K946333. which comply with Section 12A of the Underwriters Laboratories UL 544 Standard for Safety,

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

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

Re: K991025 Luma-Cath™ Fixed Curve EP Catheters Requlatory Class: II (two) Product Code: DRF September 9, 1999 Dated: September 16, 1999 Received:

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 aqainst 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 Regulation (QS) for Medical Devices: General requlation (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 requlation 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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Page 2 - Roger Tu, Ph.D.

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 regulation 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 yours,

Thomas J. Callehan

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): K991025

Device Name:

Luma-Cath™ Fixed Curve EP Catheters

Indications For Use:

The Luma-Cath™ Fixed Curve Electrophysiology Catheters are used for measurement of electrical activity in the heart.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K. Day Ve Tich

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Division of Cardiovascular, Respiratory
510(k) Number_________________________________________________________________________________________________________________________

Prescription Use V (Per 21 CFR 801.109)

Or

Over-The-Counter Use