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 Description

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

AI/ML Overview

The provided text does not contain a detailed study with acceptance criteria and reported device performance metrics in tabular format. It focuses on regulatory submission (510(k) summary) and device description rather than a comprehensive performance study report.

However, based on the available information, I can extract and infer some details:

1. A table of acceptance criteria and the reported device performance:

The document states, "The System passed all intended criteria in accordance with appropriate test criteria and standards and no new questions of safety or effectiveness were raised." However, the specific acceptance criteria and corresponding performance results are not detailed in the provided text. The document lists various functionalities of the device but doesn't provide quantitative performance metrics against specific criteria.

2. Sample size used for the test set and the data provenance:

The document mentions "bench testing" and "simulated use conditions in animals" for testing the CARTO® 3 V1.05 EP Navigation System.

Test Set Sample Size: Not specified.
Data Provenance: The testing was conducted internally as part of the device development and regulatory submission process. The locations of the manufacturing facilities are given (Israel for System & System Cables, USA for Accessories), but the specific country of origin for the animal study data or bench testing is not explicitly stated. The nature of the studies ("simulated use conditions in animals") indicates prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the given text. The document does not describe the methodology for establishing ground truth for any performance evaluations, or the involvement or qualifications of experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the given text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided in the given text. The CARTO® 3 V1.05 EP Navigation System is a cardiac mapping system, and the description does not suggest "human readers" interpreting images in a way that would be typical for an MRMC study related to AI assistance in diagnosis. The system aids EP procedures by displaying electroanatomical maps, not by interpreting diagnostic images with human readers in a comparative AI-assisted vs. non-assisted setup.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device described is an "EP Navigation System" that "allows real-time display of 3D anatomical and electroanatomical maps of the human heart." It is inherently a system where "human-in-the-loop" (the clinician) uses the information generated by the algorithm to perform a procedure. The document doesn't describe an "algorithm only" performance evaluation separate from its intended use in EP procedures. Its stated function is to "acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical maps," implying the output is for human interpretation and guidance during a procedure.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not provided in the given text. For a cardiac mapping system, ground truth might involve highly accurate invasive measurements or correlation with clinical outcomes, but the document does not specify.

8. The sample size for the training set:

The document describes performance testing (bench and animal studies). It does not mention a "training set" in the context of machine learning model development. The CARTO® system's functionality is based on established principles of magnetic and Advanced Catheter Location (ACL) technology to acquire and display electroanatomical information, rather than a machine learning model that would typically require a training set.

9. How the ground truth for the training set was established:

As no training set is mentioned (see point 8), this information is not applicable.

Summary

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15. 510(K) SUMMARY

K093455
p1/3

Applicant:	Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765,USAPhone: 800-839-8599Fax: 909-839-8804	DEC - 4 2009
Date:	November 4, 2009
Contact Person:	Balaka DasSenior Specialist, Regulatory Affairs
Proprietary Device Name,	CARTO® 3 V1.05 EP Navigation System andAccessories
Manufacturing Part Number:	FG-5400-00 (standard location pad)FG-5600-00 (RMT location pad)
Common Device Name:	Cardiac Mapping System
Classification Name:	Programmable Diagnostic ComputerClass II, 21 CFR 870.1425 Product code DQK
Predicate Device:	CARTO® 3 V1.0 EP Navigation System and Accessories(K090017)
Manufacturing Facilities:	System & System CablesBiosense Webster (Israel) Ltd.POB2009Tirat HaCarmel, 39120IsraelAccessories (Accessory Cables and Patches)Biosense Webster, Inc.15715 Arrow HighwayIrwindale, CA 91706

USA

ﭘ

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K0934555
p2/3

15.1 Description of Device

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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Image /page/2/Picture/1 description: The image shows handwritten text. The text at the top reads "K093455". The text at the bottom reads "P 3/3".

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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, which is a common symbol of the United States. The eagle is depicted in a minimalist style, with only a few lines used to create its form.

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 (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.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:

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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Page 1 of 1

CONFIDENTIAL

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).