MODIFICATION TO CARTO EP NAVIGATION SYSTEM

K993729 · Biosense Webster, Inc. · DQK · Dec 3, 1999 · Cardiovascular

Device Facts

• Record ID: K993729
• Device Name: MODIFICATION TO CARTO EP NAVIGATION SYSTEM
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Dec 3, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The intended use of the CARTO EP Navigation System is catheter-based cardiac mapping. The CARTO EP Navigation 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; utilizes locatable-tip catheters with magnetic location sensors to integrate intracardiac electrograms with endocardial location data. Replaces/augments traditional fluoroscopy-based mapping to reduce ionizing radiation exposure. Used in clinical settings by physicians; provides real-time visualization of electrical activation, propagation, potential, chamber geometry, and impedance maps. System displays body surface ECG and intracardiac electrograms. Enables precise navigation and mapping during cardiac procedures, potentially improving procedural efficiency and reducing radiation risk to patients and staff.

Clinical Evidence

Non-clinical bench and animal testing provided. No clinical data presented.

Technological Characteristics

Magnetic location sensing technology; integrates intracardiac electrograms with spatial coordinates. Complies with EN 60601-1 (general safety), EN 60601-1 A1/A2, and EN 60601-2-27 (ECG monitoring). System includes locatable-tip catheters, computerized mapping workstation, and display interface.

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 (K992968)

Submission Summary (Full Text)

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DEC - 3 1999

Image /page/0/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized heart shape on the left, followed by the text "Biosense Webster" in a serif font. Below the company name, in a smaller, cursive font, is the text "a Johnson & Johnson company."

Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters and numbers. The sequence is K993729. The characters are written in a cursive style, with varying stroke thicknesses. The image is in black and white.

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 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: | CARTO™ EP Navigation 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. K992968 |

The CARTO EP Navigation 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 EP Navigation 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 EP Navigation 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 60601-1/1990 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 heart shape on the left, followed by the words "Biosense Webster" in a serif font. Below the company name, in a smaller, italicized font, is the text "a Johnson-Johnson company."

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.

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Image /page/2/Picture/1 description: The image shows the seal of 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 a stylized image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1999

Ms. Sandra Williamson Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re : K993729 CARTO™ EP Navigation System Requlatory Class: II (two) Product Code: DOK November 1, 1999 Dated: Received: November 4, 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 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 requlation (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 - 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 requlation (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/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Acting 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: 16993729

Device Name: CARTO™ EP Navigation System

Indications For Use:

The intended use of the CARTO EP Navigation System is catheter-based cardiac mapping.

The CARTO EP Navigation 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.

N. Deuk Tith

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