CARTO EP NAVIGATION SYSTEM

K992968 · Biosense Webster, Inc. · DQK · Sep 29, 1999 · Cardiovascular

Device Facts

• Record ID: K992968
• Device Name: CARTO EP NAVIGATION SYSTEM
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 29, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The intended use of the CARTO mapping system is catheter-based cardiac mapping. The CARTO mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

Device Story

System acquires, analyzes, and displays electroanatomical maps of human heart; inputs include intracardiac electrograms and location data from locatable-tip catheters with magnetic location sensors; system integrates electrogram data with endocardial location to reconstruct maps; displays activation, propagation, potential, geometry, and impedance maps; also displays body surface ECG and intracardiac electrograms in real-time; used in clinical settings by physicians; replaces or supplements fluoroscopy-based mapping to reduce ionizing radiation exposure; provides real-time visualization to assist in cardiac diagnostic procedures.

Clinical Evidence

No clinical data. Evidence provided via non-clinical bench and animal testing.

Technological Characteristics

Cardiac mapping system utilizing magnetic location technology; integrates intracardiac electrograms with endocardial location data; complies with EN 60601-1 (1990), EN 60601-1 A1/1993, EN 60601-1 A2/1995, and EN 60601-2-27/1994 safety standards.

Indications for Use

Indicated for catheter-based cardiac mapping in patients requiring electroanatomical mapping of the heart.

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.

Predicate Devices

• CARTO mapping system (K954395)

Submission Summary (Full Text)

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Kg92968

Image /page/0/Picture/2 description: The image shows the Biosense Webster logo. The logo consists of a stylized letter "B" made up of four squares, followed by the word "Biosense" in a bold, sans-serif font. Below the word "Biosense" is a horizontal line, and below that is the text "a Johnson & Johnson company" in a smaller, italicized font.

Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: [phone] Fax: [phone] e-mail: [e-mail]

## 510(k) summary for the CARTO Mapping System

| 510(k) Notification submitted<br>by: | Biosense Webster, Inc.<br>3333 Diamond Canyon Rd.<br>Diamond Bar, CA 91765<br>USA<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Sandra Williamson<br>Senior Regulatory Affairs Associate |
| Proprietary device name: | CARTOTM Mapping System |
| Classification name: | Programmable diagnostic computer<br>(per 21 CFR 870.1425) |
| Common device name: | Cardiac mapping system |
| Cleared unmodified device | CARTO mapping system<br>510(k) No.K954395 |

The CARTO mapping system is designed to acquire, analyze, and display electroanatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. In the CARTO mapping system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a magnetic location sensor.

Currently, cardiac mapping is performed using a roving mapping catheter, a computerized mapping system, and fluoroscopy to determine the location of the tip of the mapping catheter. In the conventional procedure both the patient and the physician are exposed to harmful ionizing radiation during the course of the lengthy procedure. The CARTO mapping system enables cardiac mapping using a magnetic location technology, and may reduce exposure to dangerous ionizing radiation.

The CARTO mapping system complies with the following safety standards:

EN 60601-111990 EN 60601-1 A1/1993 EN 60601-1 A2/1995 EN 60601-2-27/1994

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Image /page/1/Picture/0 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized letter "B" made up of black squares, followed by the word "Biosense" in a bold, sans-serif font. Below the word "Biosense" is the phrase "a Johnson & Johnson company" in a smaller, serif font. A horizontal line is placed under the word "Biosense".

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Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: [phone] Fax: [phone] e-mail: [e-mail]

The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness.

## 000786

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Image /page/2/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1999

Ms. Sandra Williamson Senior Regulatory Affairs Associate Cordis Webster, Inc. 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

K992968 Re : Carto™ EP Navigation System Requlatory Class: II (two) Product Code: DQK Dated: Auqust 30, 1999 Received: September 3, 1999

Dear Ms. Williamson:

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 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 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 - Ms. Sandra Williamson

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 Also, please note the regulation entitled, [phone]. "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. Callahan

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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## Indications for use statement

510(k) No:

Device Name: CARTO mapping system

Indications For Use:

The intended use of the CARTO mapping system is catheter-based cardiac mapping.

The CARTO mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

Dan Va Hill

(Division Signand Neur 510k) N

**Prescription Use**
**(Per 21 CFR 801.109)**

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