SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX

K993698 · Mogul Enterprises · DRF · Aug 16, 2000 · Cardiovascular

Device Facts

• Record ID: K993698
• Device Name: SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
• Applicant: Mogul Enterprises
• Product Code: DRF · Cardiovascular
• Decision Date: Aug 16, 2000
• Decision: SESE
• Submission Type: Abbreviated
• 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

Slim Cath-Dx™ is a cardiac electrophysiology diagnostic catheter. It functions as an electrode-tipped catheter inserted into the heart to record electrical signals (electrograms) and deliver electrical stimulation for diagnostic mapping. Used in clinical electrophysiology labs by cardiologists/electrophysiologists. The device provides real-time intracardiac electrical data to assist clinicians in diagnosing cardiac arrhythmias and conduction abnormalities. It facilitates precise placement within specific cardiac structures (high right atrium, right ventricular apex, His bundle, coronary sinus) to map electrical activity, aiding clinical decision-making regarding arrhythmia origin and treatment planning.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cardiac electrophysiology diagnostic catheter; electrode-tipped design for signal recording and stimulation. Materials and dimensions are consistent with standard diagnostic catheters used in electrophysiology studies. No software or active electronic processing components described.

Indications for Use

Indicated for patients undergoing diagnostic electrophysiology studies requiring electrogram recording and cardiac stimulation in the high right atrium, right ventricular apex, His bundle, and 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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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2000

Jamil Mogul CEO/Chairperson Mogul Enterprises, Inc 6387 San Ignacio Avenue San Jose, CA 95119

K993698 Re: R95099
Slim Cath-Dx™ Cardiac Electrophysiology Diagnostic Catheter Regulatory Class: II (two) Product Code: 74 DRF Dated: May 17, 2000 Received: May 18, 2000

Dear Mr. Mogul:

We have reviewed your Section 510(k) notification of intent to market the we have referenced above and we have determined the device is aubstantially equivalent (for the indications for use stated in the Subblancearly ogazian marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Comments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You ene proviefore, market the device, subject to the general controls may) choro 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 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 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 Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the

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Page 2 - Mr. Mogul

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.

proced to the manific 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 [phone] Also, please note the regulation entitled, "Misbranding [phone]. by reference to premarket notification" (21CFR 807.97). Other general by reference to promaibilities 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,

Mark M. Melkersen

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Device and Radiological Health

## Enclosure

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510(k) Number (if known): K993698

Device Name: Slim Cath-Dx™ Cardiac Electrophysiology Diagnostic Catheter

Indications For 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Manh n Melberm
Division of Cardiovascular & Respiratory Devices
510(k) Number K993698