4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX

K030852 · Mogul Enterprises · DRF · Jul 10, 2003 · Cardiovascular

Device Facts

• Record ID: K030852
• Device Name: 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX
• Applicant: Mogul Enterprises
• Product Code: DRF · Cardiovascular
• Decision Date: Jul 10, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study.

Device Story

EP Diagnostic Catheters (Astra 1 and Astra II) are diagnostic tools used by electrophysiologists during cardiac electrophysiology studies. The catheters are inserted into the heart to record electrical signals (electrograms) and provide cardiac stimulation. These inputs allow clinicians to map cardiac electrical activity and diagnose arrhythmias. The device is used in a clinical or hospital setting. By facilitating precise signal acquisition and stimulation, the catheters assist in identifying the origin and mechanism of cardiac rhythm disorders, enabling targeted clinical decision-making and therapeutic planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrode recording catheter; 4 French and 5 French diameters; used for electrogram recording and cardiac stimulation. No specific materials or software algorithms described.

Indications for Use

Indicated for patients undergoing diagnostic electrophysiology studies requiring electrogram recording and cardiac stimulation via placement in the high right atrium, right ventricular apex, His bundle, or coronary sinus.

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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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 0 2003

Mogul Enterprises, Inc. c/o Mr. Jamil Mogul CEO/Chairperson 6387 San Ignacio Avenue San Jose, CA 95119

Re: K030852

> Trade Name: EP Diagnostic Catheters, Models Astra™ 1 and Astra™ II Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: DRF Dated: June 9, 2003 Received: June 10, 2003

Dear Mr. Mogul:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Jamil Mogul

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

1. XQeTeh

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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030852

## 3.0 Intended Use

The modified device has the same intended use as that of the FDA-cleared (unmodified) device, which is as follows: "The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study."

Prescription Use \$\checkmark\$

Ndelettm

Special 510(k): Device Modification Application 4 French & 5 French Electrophysiology Diagnostic Catheters MOGUL ENTERPRISES, Inc.

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