The CARTO® 3 V1.0 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 V1.0 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 mgn munication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V1.0 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 yolumes 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 Description

The CARTO® 3 V1.0 EP Navigation System is a catheter-based atrial and ventrioular 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 V1.0 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. ACL was previously referred to as "Active Current Localization" in the CARTO" III 510(k) submission (K072202). Following clearance of K072202, the acronym "ACL" was changed to Advanced Catheter Location for marketing purposes. 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 V1.0 System was implemented on the same hardware and software platform as the predicate CARTO® III System, cleared on November 17, 2007 via the CARTO® III 510(k) K072202.. The purpose of this 510(k) is to expand functionalities on the base CARTO® III System. The information presented below details the system's enhanced or additional functionality.

There are three basic categories of added functionality for the CARTO® 3 V1.0 system:

a) Enhanced base model features: These are features that were included in the previously cleared CARTO® III System. However, the features have been enhanced for the CARTO® 3 V 1.0 System.
The enhanced base model features discussed in this submission include:
Improved Magnetic Location Algorithm. ...
ii. Improved ECG signal quality.
iii. Catheter visualization using an enhanced ACL algorithm.
iv. Gated and Non-gated catheter visualization.
b) Features acquired from predicate devices: These are CARTO® 3 features that have been adopted from previously cleared CARTO® Systems.

The features acquired from predicate CARTO® Systems discussed in this submission include:

Integration with Stereotaxis Niobe® Catheter Magnetic Navigation System - Remote Magnetic Technology (RMT)
ii. Integration with Ultrasound (ULS) Systems CARTOSOUND™ Module.
iii. Fusion of CT and MRI images CARTOMERGE® PLUS Image Integration Module with Image Processing Package.
iv. Impedance mapping.
c) Features new to the CARTO® platform: These are new features not yet reviewed and cleared by the FDA.

The new features discussed in this submission include:

i. Fast Anatomical Mapping (FAM).
ii. Complex Fractionated Atrial Electrogram (CFAE) mapping tool.
iii. Window of interest templates.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CARTO® 3 V1.0 EP Navigation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify quantitative acceptance criteria. Instead, it makes a general statement about the device passing tests.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative thresholds.	The System passed all intended criteria in accordance with appropriate test criteria and standards.
No new questions of safety or effectiveness raised.	No new questions of safety or effectiveness were raised.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The document states "bench and electrical testing" and "simulated use conditions in animals" but does not provide numbers for these tests.
Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. The testing involved "simulated use conditions in animals."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for this device's performance evaluation appears to be based on engineering and preclinical testing standards, not expert clinical assessment of images or data.

4. Adjudication Method

Not applicable. The evaluation methods described (bench testing, electrical testing, simulated animal use) do not typically involve human adjudication in the context of diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study involving human readers comparing performance with and without AI assistance was not mentioned or described. This type of study is more common for diagnostic imaging AI.

6. Standalone (Algorithm Only) Performance Study

Yes, this appears to be the primary mode of performance evaluation described. The "bench and electrical testing" and "simulated use conditions in animals" are evaluations of the device's inherent functionality, independent of human interpretation or use in a clinical reader study. The purpose of the 510(k) is to "expand functionalities on the base CARTO® III System," and the testing aims to confirm these expanded functionalities meet appropriate standards.

7. Type of Ground Truth Used

The ground truth appears to be based on engineering standards, specifications, and preclinical physiological measurements in simulated animal models. For example, "Improved Magnetic Location Algorithm" and "Improved ECG signal quality" would be evaluated against established electrical and positional accuracy benchmarks.

8. Sample Size for the Training Set

Not applicable. This device is a navigation system that provides real-time mapping data. There is no mention of a training set as would be found in a machine learning or AI algorithm development, where data is used to train a model. The "algorithms" mentioned (e.g., "Improved Magnetic Location Algorithm," "enhanced ACL algorithm") are likely deterministic or model-based, rather than learned from a large dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for machine learning.

Summary

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K090017 pg 1 of 4

5. 510(K) SUMMARY

Applicant:	Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765USAPhone: 800-729-7272Fax: 909-839-8804OCT 1 3 2009
Date:	December 31, 2008
Contact Person:	Balaka DasSenior Specialist, Regulatory Affairs
Proprietary Device Name:	CARTO® 3 V1.0 EP Navigation System and Accessories
Common Device Name:	Cardiac mapping system
Classification Name:	Programmable diagnostic computer(per 21 CFR 870.1425, Product Code DQK)
Predicate Device:	CARTO® III EP Navigation System (K072202)CARTO® RMT V8 EP Navigation System (K060047)CARTO® V9 XP EP Navigation System (K070240)
Manufacturing Facilities:	System & System CablesBiosense Webster (Israel) Ltd.POB 2009Tirat HaCarmel, 39120IsraelAccessories (Accessory Cables and Patches)Biosense Webster, Inc.15715 Arrow HighwayIrwindale, CA 91706 USA

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5.1 Substantially Equivalent To:

The CARTO 3 V1.0 EP Navigation System is substantially equivalent to the predicate devices shown in Table 1 below:

Table 1: Predicate Devices for CARTO® 3 V1.0 EP navigation System
Submission Name	510(K) Number	Equivalence Criteria
CARTO® III EP Navigation System	K072202	System hardware, accessories,magnetic location technology,ACL Technology
CARTO® XP V9 EP Navigation System	K070240	CARTOSOUND™ andCARTOMERGE® PLUSfunctionalities, impedancemapping
CARTO® RMT V8 EP Navigation System	K060047	Stereotaxis Niobe® systemintegration and compatibility,impedance mapping

Description of the Device Subject to Premarket Notification: 5.2

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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.

There are three basic categories of added functionality for the CARTO® 3 V1.0 system:

a) Enhanced base model features: These are features that were included in the previously cleared CARTO® III System. However, the features have been enhanced for the CARTO® 3 V 1.0 System.
The enhanced base model features discussed in this submission include:
Improved Magnetic Location Algorithm. ...
ii. Improved ECG signal quality.
iii. Catheter visualization using an enhanced ACL algorithm.
iv. Gated and Non-gated catheter visualization.
b) Features acquired from predicate devices: These are CARTO® 3 features that have been adopted from previously cleared CARTO® Systems.

The features acquired from predicate CARTO® Systems discussed in this submission include:

Integration with Stereotaxis Niobe® Catheter Magnetic Navigation System -ﻨــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ Remote Magnetic Technology (RMT)
ii. Integration with Ultrasound (ULS) Systems CARTOSOUND™ Module.
iii. Fusion of CT and MRI images CARTOMERGE® PLUS Image Integration Module with Image Processing Package.
iv. Impedance mapping.
c) Features new to the CARTO® platform: These are new features not yet reviewed and cleared by the FDA.

The new features discussed in this submission include:

i. Fast Anatomical Mapping (FAM).
ii. Complex Fractionated Atrial Electrogram (CFAE) mapping tool.
iii. Window of interest templates.

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1690017 Pay of

Indications for Use: 5.3

The CARTO® 3 V1.0 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 V1.0 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 mgn munication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V1.0 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 yolumes 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.

Performance Data and Conclusion: 5.4

The CARTO® 3 V1.0 EP Navigation System underwent bench and electrical 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.

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Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Biosense Webster, Inc c/o Ms. Bakala Das Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

OCT 1 3 2009

Re: K090017

Trade/Device Name: CARTO 3 V1.0 EP Navigation System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: July 10, 2009 Received: July 14, 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.

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Page 2 - Ms. Bakala Das

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 (OS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

W.M.A.

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 4.

510(k) No (if known): K090017

Device Name: CARTO 3 V1.0 EP Navigation System

Indications for Use:

The CARTO® 3 V1.0 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 V1.0 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 mgir necation channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V1.0 System includes CARTOMERGE® PLUS functionality to import, register CARTO - VT.0 System mondes 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 yolumes using catheters with magnetic location sensors. The system's CARTOSOUND™ image integration functionality enables integration of intracardiac echo (ICE) to enable wisualization 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) M. Jo Willilre

(Division Simi-Off) Division of Cardiovascular Devices

6690017 510(k) Number

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).