CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM

K020863 · Biosense Webster, Inc. · DQK · Jan 9, 2003 · Cardiovascular

Device Facts

• Record ID: K020863
• Device Name: CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The CARTO XP EP Navigation System with QWIKMAP software is intended to acquire real time catheter based cardiac electrophysiogical maps in patients who are eligible for a conventional electrophysiological study. There are no special contraindications when using the CARTO XP with OWIKMAP software. The intended use of the CARTO XP EP Navigation System is catheter-based atrial and ventricular mapping. The CARTO XP 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 electro-anatomical maps of human heart; inputs include intracardiac electrograms and location data from magnetic sensors on catheters; body surface ECG also displayed. Magnetic location technology replaces/augments fluoroscopy to determine catheter tip position; reduces ionizing radiation exposure. Used in clinical settings by physicians during cardiac EP procedures. Output displayed on screen as activation, propagation, potential, chamber geometry, or impedance maps. Assists physicians in visualizing cardiac electrical activity and anatomy to guide clinical decision-making during mapping procedures.

Clinical Evidence

No clinical data. Safety and effectiveness supported by non-clinical bench and animal testing.

Technological Characteristics

Cardiac mapping system using magnetic location technology. Integrates intracardiac electrograms with endocardial location data. Displays real-time ECG and electrograms. Complies with UL 2601-1, IEC 60601-2-25, and IEC 60601-2-27 standards.

Indications for Use

Indicated for patients eligible for conventional electrophysiological studies requiring catheter-based atrial and ventricular mapping. No specific contraindications.

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™ XP mapping system (K013083)

Submission Summary (Full Text)

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K020863

Image /page/0/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized graphic to the left of the company name, "Biosense Webster," written 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]

# 510(k) summary for the CARTO™ XP EP Navigation 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] | JAN 09 2003 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact person: | Marcia Yaross<br>Vice President, Regulatory and Clinical Affairs | |
| Proprietary device name: | CARTO™ XP EP Navigation System with<br>QWIKMAP™ software | |
| Classification name: | Programmable diagnostic computer<br>(per 21 CFR 870.1425) | |
| Common device name: | Cardiac Mapping System | |
| Predicate device: | CARTO™ XP mapping system<br>510(k) No. K013083 | |
| Manufacturer: | Biosense Webster (Israel) Ltd.<br>POB 2009<br>Tirat HaCarmel, 39120<br>Israel | |

### Indications For Use

The CARTO XP EP Navigation System with QWIKMAP software is intended to acquire real time catheter based cardiac electrophysiogical maps in patients who are eligible for a conventional electrophysiological study. There are no special contraindications when using the CARTO XP with OWIKMAP software.

### General Device Description

The CARTO XP EP Navigation system with QWIKMAP software is designed to acquire, analyze, and display electro-anatomical 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. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, chamber geometry maps, and impedance maps. In the CARTO XP with OWKMAP mapping system the location information needed to create the cardiac maps is acquired using catheters equipped with magnetic proximal and distal location sensors. The

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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 graphic to the left of the company name, "Biosense Webster," which is written in a serif font. Below the company name, in a smaller, cursive font, is the phrase "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]

acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

Cardiac EP mapping procedures are generally 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 XP with QWIKMAP mapping system enables cardiac mapping using a magnetic location technology, and may reduce exposure to dangerous ionizing radiation.

#### Safety and Effectiveness

The CARTO™ XP EP Navigation System with QWIKMAP™ software complies with the following safety standards:

- UL 2601-1: 97/CSA C22.2 No. 601.1 ●
- IEC 60601-2-25: 93 and A1(99) .
- IEC 60601-2-27: 94 ●

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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or birds in flight, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 9 2003

Biosense Webster, Inc. c/o Mr. William Welch, RAC Regulatory Affairs Project Manager 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

Re: K020863

Trade Name: Carto™ XP EP Navigation System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: August 9, 2002 Received: August 12, 2002

Dear Mr. Welch:

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. William Welch

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 comply 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), 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,

R.Z. MD

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for use statement

510(k) No: K020863

Device Name: CARTO XP EP Navigation System

Indications For Use:

The intended use of the CARTO XP EP Navigation System is catheter-based atrial and ventricular mapping.

The CARTO XP 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.

Della Teth

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