CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM

K012089 · Catheffects, LLC · DQK · Jan 28, 2002 · Cardiovascular

Device Facts

• Record ID: K012089
• Device Name: CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM
• Applicant: Catheffects, LLC
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The CATHEFFECTS Desai VectorCath™ Mapping System is intended to aid in the determination and analysis of abnormal heart activity. The device is used in conjunction with a 5-electrode catheter to record endocardial potentials to aid in the determination of the direction of the cardiac wavefront and the possible location of the wavefront's source.

Device Story

Desai VectorCath Mapping System records endocardial potentials via 5-electrode catheter; processes electrical signals to determine cardiac wavefront direction and source location; aids clinicians in analyzing abnormal heart activity; used in clinical settings by medical professionals; output provides diagnostic information regarding electrical activation patterns in heart; assists in identifying arrhythmia sources.

Technological Characteristics

Programmable diagnostic computer; utilizes 5-electrode catheter input for endocardial potential recording; class II device; product code DQK.

Indications for Use

Indicated for patients requiring analysis of abnormal heart activity; used to record endocardial potentials to determine cardiac wavefront direction and source location.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2002

Mr. Shawn Fojtik Chief Operating Officer CathEffects, L.L.C. 1100 Melody Lane, Suite 108 Roseville, CA 95678

Re: K012089

> Trade Name: Desai VectorCath Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer. Regulatory Class: II (two) Product Code: DQK Dated: October 17, 2001 Received: November 5, 2001

Dear Mr. Fojtik:

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. Shawn Fojtik

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 or any 1 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

K. Don Miller

Bram D. Zuckerman, M.D. Acting 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Desai VectorCath™ Mapping System

- The CATHEFFECTS Desai VectorCath™ Mapping System is intended Indications For Use: to aid in the determination and analysis of abnormal heart activity. The device is used in conjunction with a 5-electrode catheter to record endocardial potentials to aid in the determination of the direction of the cardiac wavefront and the possible location of the wavefront's source.
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use /

OR

Over-The-Counter Use __

(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012089

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