The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

Device Description

The CARTO®3 EP Navigation 3 System, Version 3.2 and Accessories is a catheterbased 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 intracardiac signals from the catheters in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms (IECG) may also be displayed on the display screen. The CARTO® 3 System V3.2 uses two distinct types of location technology magnetic sensor technology and Advanced Catheter Location (ACL) technology.

AI/ML Overview

The provided text describes a 510(k) submission for the CARTO® 3 EP Navigation System, Version 3.2. This submission focuses on software changes and the activation of a previously blocked module. It demonstrates substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving device performance in the typical sense of a new AI/ML device is not directly applicable or available in this document.

However, I can extract information related to the type of testing performed to support the substantial equivalence claim.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria in the format you requested (e.g., sensitivity, specificity, accuracy thresholds) because it is a 510(k) for a software update to an existing device, focusing on substantial equivalence. The "acceptance criteria" here implicitly refer to passing all tests designed to verify modified features and demonstrate regression testing, ensuring no negative impact on existing features.

Feature Tested/Modified	Acceptance Criteria (Implied)	Reported Device Performance
Modified Features (Software)	Meets design specifications; functions as intended.	Passed all tests.
Existing Features (Regression)	No negative impact on previously cleared functionalities.	Passed all tests; new features did not negatively affect existing ones.
Overall System Safety/Effectiveness	As safe and effective as predicate and reference devices.	Demonstrated to be as safe, as effective, and performs as well as or better than predicate and reference devices.
SMARTTOUCH™ Module Activation	Functions correctly and safely when activated.	Included in the demonstration of safety and effectiveness.
Advanced FAM improvements	Visual improvements are effective and do not degrade mapping.	Part of the overall system that passed testing.
RMT Improvements	Enhanced functionality without degradation of existing features.	Part of the overall system that passed testing.
Video Export to Recording System	Functions correctly.	Part of the overall system that passed testing.
PaSo™ Module Update	Improved functionality without degradation.	Part of the overall system that passed testing.

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

The document mentions Bench and Animal Testing, and an IDE Clinical Investigation. However, it does not provide specific sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the summary. For this type of electromechanical and software system, "ground truth" would likely be established through precise engineering measurements and physiological recordings in animal models, rather than expert consensus on images.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device (cardiac mapping system) and the testing type (bench, animal, clinical investigation), a formal adjudication method as typically applied to image-based AI diagnoses is not explicitly mentioned or clearly implied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided. The document focuses on demonstrating substantial equivalence of the modified device to a previous version and a reference device, not on comparing human reader performance with and without AI assistance. The CARTO® 3 system is a tool for EP procedures, not a diagnostic AI interpretation system in the typical sense that would involve human readers interpreting AI output.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The testing performed (Bench, Animal, IDE Clinical Investigation) would inherently evaluate the "standalone" performance of the system's functions. The system itself is designed to provide real-time information to a clinician (human-in-the-loop), but its underlying algorithms and functionality were tested independently to ensure they work as intended. The document doesn't explicitly frame it as a "standalone study" in the context of an AI diagnostic, but rather as verification and validation of the system's software and hardware.

7. The Type of Ground Truth Used

Based on the description of the device (catheter-based atrial and ventricular mapping system), the ground truth for performance testing would likely involve:

Engineering/Physical Measurements: During bench testing, this would involve highly accurate physical measurements to verify mapping accuracy, location accuracy, and signal integrity.
Physiological Data: In animal testing and clinical investigations, the "ground truth" would be the actual electrophysiological activity of the heart, as measured by reference devices or established physiological principles, and corresponding catheter locations.

The document does not detail specific methods for establishing ground truth, but these are the likely approaches given the device's function.

8. The Sample Size for the Training Set

This document describes a software update and activation of a module for an existing device. It is not a de novo AI/ML submission where a separate, distinct "training set" would typically be described. The "training" for such a system would involve software development and integration, followed by extensive testing, but not in the sense of training a machine learning model on a labeled dataset. Therefore, this information is not applicable/provided.

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

As explained above, this concept of a "training set" is not directly applicable to this submission in the way it would be for a typical AI/ML diagnostic algorithm. Therefore, how ground truth for a training set was established is not provided.

Summary

{0}------------------------------------------------

JAN 2 4 2014

14 510(K) SUMMARY

-" " ::

14.1 General Information

Applicant:	Biosense Webster, Inc.3333 Diamond Canyon RoadDiamond Bar, CA 91765 USAPhone: 909-839-8597Fax: 909-839-8804
Date:	September 3, 2013
Contact Person:	Wayne R. HohmanProject Manager Regulatory Affairs
Authored By:	Moshe HochmitzQuality and Regulatory ManagerBiosense Webster (ISRAEL), Ltd.
Trade/Proprietary Device Name:	CARTO® 3 EP Navigation System, Version 3.2 andAccessories
Manufacturing Part Number:	FG-5400-00
Common Device Name:	Cardiac mapping system
Classification Name:	Programmable diagnostic computerClass II, 21 CFR 870.1425, Product Code DQK
Predicate Device:	CARTO® 3 EP Navigation System, Version 3.0 andAccessories510(k) K120550, May 7, 2012
	Reference Device:CARTO® 3 XP EP Navigation, System Version 1.0510(k) K093566, June 18, 2010
Manufacturing Facilities:	Biosense Webster (Israel), Ltd.a Johnson & Johnson Company4 Hatnufa Street, POB 275Yokneam 20692ISRAELBiosense Webster, Inc.a Johnson & Johnson Company3333 Diamond Canyon RoadDiamond Bar, California 91765 USA

Biosense Webster, Inc.
CARTO® 3 EP Navigation System, V3.2

Traditional 510(k)
Page 5 of 268

{1}------------------------------------------------

14.2 Substantial Equivalence

ﺪ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

The CARTO® 3 EP Navigation System, Version 3.2 and Accessories are substantially equivalent to the legally marketed CARTO® 3 EP Navigation System, Version 3.0 and Accessories and the CARTO® XP EP Navigation System. Version 10 as shown in Table 7:

Table 7Predicate Devices for CARTO® 3 EP Navigation System, Version 3.2
Device Name	510(k)Number	Equivalence Criteria
CARTO® 3 EP Navigation System,Version 3.0 and Accessories	K120550	Legacy Functionality
CARTO XP EP NavigationSystem, Version 10	K093566	Pace Mapping Software (PaSo™)Module

14.3 Description of Device

14.4 Indications for Use

14.4a Technological Characteristics

The Proposed CARTO® 3 Electrophysiology Navigation System. Version 3.2, has the same technological characteristics (i. e., design, material, chemical composition, energy source) as the predicate CARTO® 3 Electrophysiology Navigation System, Version 3.0. A summary of the technological characteristics of the new device compared to the predicate device is as follows:

Biosense Webster, Inc. CARTO® 3 EP Navigation System, V3.2

Biosense Webster, Inc. CARTO® 3 EP Navigation System, V3.2 Traditional 510(k) Page 88 of 2538

Traditional 510(k) Page 6 of 268

{2}------------------------------------------------

. The hardware platform of the new Version 3.2 is identical to the predicate Version 3.0.
. The differences between Versions 3.2 and 3.0 involve only software as follows:
- The main change in this submission is to activate an installed but previously o blocked SMARTTOUCHTM Module.
- o The software of three other features of this system is enhanced (i. e., updated) in this submission: 1) Advanced FAM - Visual improvement of the V2 FAM Feature, 2) Remote Magnetic Technology (RMT) Improvements, and 3) Video Export to Recording System.
- o Finally, Biosense Webster is updating FDA on a feature that was incorporated via 510(k) Letter to File since the last submission: Improved Pace Mapping Software (PaSoTM) Module. The PaSoTM Module was originally cleared via in an earlier version of this device and this device is included in this Application as a Reference Device for the PaSo™ Module feature: CARTO® XP EP Navigation System, Version 10 (510(k) K093566, cleared June 18, 2010).

14.5 Summary of Non-Clinical Performance Testing

The CARTO® 3 EP Navigation System, Version 3.2 underwent extensive Bench and Animal Testing to verify the modified features and to demonstrate with regression testing that the new features did not negatively affect existing features. The CARTO® 3 EP Navigation System, Version 3.2 passed all tests in accordance with appropriate test criteria and standards, and the CARTO® 3 EP Navigation System, Version 3.2 and Accessories did not raise new questions of safety or effectiveness.

14.6 Conclusions

. ...

Extensive Non-Clinical (Bench) Testing, Animal Testing, and an IDE Clinical Investigation all demonstrated that the CARTO® 3 EP Navigation System, Version 3.2 and Accessories as used with the activated SMARTOUCH® Module are as safe, as effective, and performs as well as or better than the Predicate Device and the Reference Device. This testing program supports the determination of substantial equivalence of the CARTO® 3 EP Navigation System, Version 3.2 and Accessories to existing predicate devices.

Biosense Webster, Inc. CARTO® 3 EP Navigation System, V3.2

Biosense Webster, Inc. CARTO® 3 EP Navigation System, V3.2 Traditional 510(k) Page 89 of 2538

Traditional 510(k) Page 7 of 268

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 24, 2014

Biosense Webster, Inc. Wayne Hohman 3333 Diamond Canyon Rd Diamond Bar, CA 91765 US

K132782 Re:

Trade/Device Name: CARTO 3 EP Navigation System, version 3.2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 5, 2013 Received: November 6, 2013

Dear Mr. Hohman:

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 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.

{4}------------------------------------------------

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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Owen P. Faris -S

for

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

Enclosure

{5}------------------------------------------------

510(k) No (if known):

Device Name: CARTO® 3 EP Navigation System, Version 3.2

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)

Digitally signed by.
Owen P. Faris -S
Date: 2014.01.24
16:20:52 -05'00'

Biosense Webster, Inc. CARTO® 3 EP Navigation System, V3.2

Biosense Webster, Inc. CARTO® 3 EP Navigation System, V3.2 Traditional 510(k) Page 42 of 2538

Traditional 510(k) Page 9 of 268

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).