CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

K093455 · Biosense Webster, Inc. · DQK · Dec 4, 2009 · Cardiovascular

Device Facts

• Record ID: K093455
• Device Name: CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The CARTO® 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO® 3 V1.05 System is also intended to support EP procedures, maintaining CARTO® System capabilities, in the presence of a high metallic environment and magnetic field strengths upto 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V1.05 System includes CARTOMERGE® Plus functionality to import, register and merge CT or MRI structural images with CARTO map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND™ image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

Device Story

System acquires/analyzes intracardiac signals and location data to generate real-time 3D anatomical and electroanatomical maps of the heart. Inputs include intracardiac electrograms (IECG) and body surface ECG via catheters, plus magnetic sensor and Advanced Catheter Location (ACL) data using external reference patches on patient chest/back. System integrates with Stereotaxis Niobe for remote magnetic navigation, CARTOSOUND for intracardiac echo (ICE) visualization, and CARTOMERGE for CT/MRI image fusion. Fast Anatomical Mapping (FAM) creates cardiac volumes. Used in clinical EP labs by physicians to visualize catheter position, electrical activation, propagation, and potential maps. Output displayed on screen to guide catheter placement and clinical decision-making during cardiac ablation or diagnostic procedures. Benefits include enhanced visualization of cardiac geometry and electrical activity.

Clinical Evidence

Bench testing and simulated use in animal models. System met all pre-defined acceptance criteria; no new safety or effectiveness questions raised. No human clinical trial data presented.

Technological Characteristics

Uses magnetic sensor technology and Advanced Catheter Location (ACL) technology. Requires external reference patches. Integrates with Stereotaxis Niobe, ICE, and CT/MRI imaging. Supports both magnetic-navigational and conventional non-navigational catheters. Operates in magnetic fields up to 0.1 T.

Indications for Use

Indicated for catheter-based atrial and ventricular mapping in patients undergoing electrophysiology (EP) procedures. Supports use with specialized magnetic navigation catheters and conventional non-navigational EP catheters. Compatible with high metallic environments and magnetic fields up to 0.1 T.

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® 3 V1.0 EP Navigation System and Accessories (K090017)

Submission Summary (Full Text)

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## 15. 510(K) SUMMARY

K093455
p1/3

| Applicant: | Biosense Webster, Inc.<br>3333 Diamond Canyon Rd.<br>Diamond Bar, CA 91765,<br>USA<br>Phone: [phone]<br>Fax: [phone] | DEC - 4 2009 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date: | November 4, 2009 | |
| Contact Person: | Balaka Das<br>Senior Specialist, Regulatory Affairs | |
| Proprietary Device Name, | CARTO® 3 V1.05 EP Navigation System and<br>Accessories | |
| Manufacturing Part Number: | FG-5400-00 (standard location pad)<br>FG-5600-00 (RMT location pad) | |
| Common Device Name: | Cardiac Mapping System | |
| Classification Name: | Programmable Diagnostic Computer<br>Class II, 21 CFR 870.1425 Product code DQK | |
| Predicate Device: | CARTO® 3 V1.0 EP Navigation System and Accessories<br>(K090017) | |
| Manufacturing Facilities: | System & System Cables<br>Biosense Webster (Israel) Ltd.<br>POB2009<br>Tirat HaCarmel, 39120<br>Israel<br>Accessories (Accessory Cables and Patches)<br>Biosense Webster, Inc.<br>15715 Arrow Highway<br>Irwindale, CA 91706 | |

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K0934555
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### 15.1 Description of Device

The CARTO® 3 V1.05 EP Navigation System is a catheter-based atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical maps of the human heart in real-time. The location information needed to create the cardiac maps and the local electrograms are acquired using a specialized mapping catheter and reference device. The system allows real-time display of electrograms and cardiac maps based on the received intra cardiac signals from the catheters in a number of different formats. For example, maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms (IECG) may also be displayed on the display screen.

The CARTO® 3 V1.05 System uses two distinct types of location technology magnetic sensor technology and Advanced Catheter Location (ACL) technology. The system utilizes magnetic sensor technology to locate the magnetic location sensor housed within a navigational catheter. The system uses "ACL technology" in conjunction with the magnetic sensor technology to locate the catheter electrodes. External reference patches are needed for magnetic sensor-based as well as for ACL-based localization. The external reference patches are accessories to the system. Three patches are placed on the patient's chest and three are placed on the patient's back. Each patch connects to a location sensor mounted on the patch unit cables that extend from the CARTO® 3 System.

Magnetic sensor location is calculated in reference to an axis origin based on external references. In order to locate the magnetic location sensor of mapping (navigational) catheters (such as the NAVISTAR® catheter), the system compares the location of the mapping catheter sensor to the mean calculation obtained from the three sensors located on the patch cables attached to the patient's back.

In order to locate and visualize the electrodes on a catheter using ACL technology, three patch cables must be attached to the patches placed on the patient's chest and three patch cables must be attached to the patches placed on the patient's back.

The Carto 3 V1.05 System incorporates the following features:

- Visualization of multiple catheters using ACL technology
- Integration with Stereotaxis Niobe Catheter Magnetic Navigation System -. Remote Magnetic Technology (RMT)
- Integration with Ultrasound (ULS) systems CARTOSOUND™ Module .
- Fusion of CT and MRI images CARTOMERGE® PLUS Image Integration . Module with Image Processing Package
- . Fast Anatomocal Mapping
- Complex Fractionated Atrial Electrogram (CFAE) mapping tool
- . Impedance mapping

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#### 15.2 Indications for Use

The CARTO® 3 VI.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO® 3 V1.05 System is also intended to support EP procedures, maintaining CARTO® System capabilities, in the presence of a high metallic environment and magnetic field strengths upto 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V1.05 System includes CARTOMERGE® Plus functionality to import, register and merge CT or MRI structural images with CARTO map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND™ image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

#### 15.3 Summary of Testing

The CARTO® 3 V1.05 EP Navigation System underwent bench testing and was also tested under simulated use conditions in animals. The System passed all intended criteria in accordance with appropriate test criteria and standards and no new questions of safety or effectiveness were raised.

#### 15.4 Substantial Equivalence

The CARTO 3 V1.05 EP Navigation System is substantially equivalent to the CARTO® 3 V1.0 EP Navigation System in terms of intended use, operating principles, fundamental scientific technology, design and performance.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

DEC - 4 2009

Biosense Webster, Inc. c/o Balaka Das Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re: K093455

Trade/Device Name: Carto 3 V1.05 EP Navigation System Regulation Number: 21 CFR 870.1425 Regulation Name: Computer, Diagnostic, Programmable Regulatory Class: Class II Product Code: DQK Dated: November 4, 2009 Received: November 5, 2009

Dear Ms. Das:

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 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.

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); medical device reporting (reporting of medical

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Page 2 – Ms. Balaka Das

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W.M.C.

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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#### ട. INDICATIONS FOR USE

# 510(k) No (if known): K093455

Device Name: CARTO® 3 V1.05 EP Navigation System

#### Indications for Use:

The CARTO® 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO® 3 V1.05 System is also intended to support EP procedures, maintaining CARTO® System capabilities, in the presence of a high metallic environment and magnetic field strengths upto 0.1 T and provide a data communication channel to the Stereotaxis Niobe Catheter Navigation System. The CARTO 3 V1.05 System includes CARTOMERGE® PLUS functionality to import. register and merge CT or MRI structural images with CARTO map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND" image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

| 510(k) Number | K023455 |
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CONFIDENTIAL