CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2

K112007 · Biosense Webster, Inc. · DQK · Oct 5, 2011 · Cardiovascular

Device Facts

• Record ID: K112007
• Device Name: CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 5, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The CARTO® 3 V2.2 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 V2.2 System is also intended to support EP procedures maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 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, nonnavigational, electrophysiology catheters without magnetic location sensors.

Device Story

System acquires/analyzes intracardiac electrograms and body surface ECG signals; utilizes magnetic sensor technology and Advanced Catheter Location (ACL) technology for real-time 3D anatomical/electroanatomical mapping. Used in clinical EP labs by physicians; provides visualization of cardiac activation, propagation, potential, impedance, and geometry. Integrates CT/MRI structural images (CARTOMERGE® Plus), intracardiac echo (CARTOSOUND®), and enables rapid volume creation (Fast Anatomical Mapping). Supports high-metallic environments and magnetic fields up to 0.1 T; provides data link to Stereotaxis Niobe® system. Output displayed on screen to guide catheter navigation and clinical decision-making during cardiac procedures; benefits patient through enhanced visualization and procedural guidance.

Clinical Evidence

Bench and animal pre-clinical testing performed to verify new features and ensure no negative impact on existing functionality. No clinical data provided.

Technological Characteristics

Cardiac mapping system using magnetic sensor and Advanced Catheter Location (ACL) technology. Hardware includes ECG board and extension cables. Supports specialized magnetic navigation catheters and conventional non-navigational catheters. Integrates with external imaging (CT/MRI/ICE). Operates in magnetic fields up to 0.1 T.

Indications for Use

Indicated for catheter-based atrial and ventricular mapping in patients undergoing electrophysiology procedures. Supports use of specialized magnetic navigation catheters and conventional non-navigational catheters.

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 V2.0 EP Navigation System (K103746)

Reference Devices

• Stereotaxis Niobe® Catheter Navigation System

Submission Summary (Full Text)

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#### 16 510(k) SUMMARY

16.1

General Information

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# Applicant: Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765 USA Phone: [phone] Fax: [phone] July 8, 2011 Date: Wayne R. Hohman Contact Person: Project Manager Regulatory Affairs Trade/Proprietary Device CARTO® 3 V2.2 EP Navigation System and Accessories Name: Manufacturing Part FG-5400-00 (with standard location pad) Numbers: FG-5600-00 (with RMT location pad) Common Device Name: Cardiac mapping system Programmable diagnostic computer Classification Name: Device Classification: Class II, 21 CFR 870.1425 Product Code DQK CARTO® 3 V2.0 EP Navigation System and Accessories Predicate Device: 510(k) K103746, January 21, 2011 Manufacturing Facility: Biosense Webster (Israel) Ltd. 4 Hatnufa Street, POB 275 Yokneam 20692 Israel

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CONFIDENTIAL

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# Description of Device 16.2

The CARTO® 3 V2.2 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 catheters and reference devices. The system allows real-time display of electrograms and cardiac maps based on the received intra cardiac signals in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the display screen. The CARTO® 3 V2.2 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

### 16.3 New Features

The new features in this Special 510(k) Notification were software additions of Fluoro Effect Reduction (FER), support of Biosense Webster PENTARAY® Catheter, and support of SOUNDSTAR® eco Catheters with Split Handle, and hardware modification of an ECG board and addition of an Extension Cable. In addition, all modifications cleared via documentation since the prior predicate version were described.

#### 16.4 Indications for Use

The Indications for Use for the modified device are identical to the predicate device:

The CARTO® 3 V2.2 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 V2.2 System is also intended to support EP procedures maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 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

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Biosense Webster, Inc. CARTO® 3 x 7 2 Snecial 510/k) CONFIDENTIAL

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K112007

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, nonnavigational, electrophysiology catheters without magnetic location sensors.

# Summary of Non-Clinical Performance Testing 16.5

The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing to verify the new and enhanced features and to demonstrate with regression testing that the new features did not negatively affect existing features. The CARTO® 3 V2.2 EP Navigation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.

# Substantial Equivalence 16.6

The Carto® 3 EP Navigation System, Version 2.2, is substantially equivalent to the legally marketed Carto® 3 EP Navigation System, Version 2.0, 510(k) K103746, cleared on January 21, 2011.

#### 16.7 Conclusions

The bench and animal pre-clinical testing demonstrated that the CARTO® 3 V2.2 EP Navigation System is safe, effective, and performs as well as or better than the predicate device. This testing program supports the determination of substantial equivalence to the predicate device.

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Biosense Webster, Inc. CARTO® 3 v 7 7 Snerial SIN/k) CONFIDENTIAL

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20903-0002

Biosense Webster, Inc. c/o Mr. Wayne R. Hohmann Project Manager Regulatory Affairs 3333 Diamond Canyon Road. Diamond Bar, CA 91765

2.11

Re: [510(k)] K112007 [210(W)] Trade/Device Name: CARTO 3 V2.2 EP Navigation System (Version 2.2) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: September 8, 2011 Received: September 9, 2011

Dear Mr. Hohmann:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Wayne R. Hohmann

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 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/About/DA/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/ReportalProblem/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,

Bram D. Zuckerman, M.D.

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

510(k) No (if known): K112007

Device Name: CARTO® 3 V2.2 EP Navigation System

# Indications for Use:

The CARTO® 3 V2.2 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 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 V2.2 System is also intended to support EP procedures, maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 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 (Division Sign-Off) Device Evaluation (ODE)
Division of Cardiovascular Devices

| 510(k) Number | 1/1/2007 |
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