ARRHYTHMIA MAPPING SYSTEM (8100/8300)

K965066 · Cardiac Pathways Corp. · DRF · Aug 11, 1997 · Cardiovascular

Device Facts

• Record ID: K965066
• Device Name: ARRHYTHMIA MAPPING SYSTEM (8100/8300)
• Applicant: Cardiac Pathways Corp.
• Product Code: DRF · Cardiovascular
• Decision Date: Aug 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Arrhythmia Mapping System is intended to be used to record, view, and analyze intracardiac electrogram (EGM) and surface electrocardiograph (EKG) signals. By performing these functions, the Mapping System assists in the collection and presentation of signal information necessary for the diagnosis and localization of cardiac arrhythmias. The system is intended to be used by a Cardiologist (subspecialty Cardiac Electrophysiology) during electrophysiology studies.

Device Story

System records, displays, and analyzes intracardiac electrograms (EGM) and surface ECG signals; used by cardiac electrophysiologists in clinical electrophysiology studies. Device processes electrical signals to assist in diagnosing and localizing cardiac arrhythmias. Output presented to physician for clinical decision-making regarding arrhythmia management. Benefits include improved visualization and analysis of cardiac electrical activity to guide diagnostic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

System for acquisition and display of intracardiac and surface ECG signals. Operates as a signal processing and visualization workstation for electrophysiology studies.

Indications for Use

Indicated for use by cardiac electrophysiologists to record, view, and analyze intracardiac electrograms and surface ECGs to assist in the diagnosis and localization of cardiac arrhythmias during electrophysiology studies.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Mr. Earle L. Canty
Cardiac Pathways Corporation
995 Benecia Avenue
Sunnyvale, California 94086

AUG 11 1997

Re: K965066
Arrhythmia Mapping System (8100/8300)
Regulatory Class: II (two)
Product Code: 74 DRF
Dated: July 29, 1997
Received: July 30, 1997

Dear Mr. Canty:

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 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 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 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 - Mr. Earle L. Canty

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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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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CARDIAC PATHWAYS CORPORATION
Premarket Notification
Model 8100/8300 Arrhythmia Mapping System

# Indications

The Arrhythmia Mapping System is intended to be used to record, view, and analyze intracardiac electrogram (EGM) and surface electrocardiograph (EKG) signals. By performing these functions, the Mapping System assists in the collection and presentation of signal information necessary for the diagnosis and localization of cardiac arrhythmias. The system is intended to be used by a Cardiologist (subspecialty Cardiac Electrophysiology) during electrophysiology studies.


December 16, 1996
CONFIDENTIAL