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 System Version 5.2 and Accessories 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. 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 electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System V5.2 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology. The CARTO® 3 EP Navigation System Version 5.2 is a modification to the CARTO® 3 EP Navigation System Version 4.2 to add the CARTOFINDER™ Module and workstation as an accessory to the CARTO® 3 System. The CARTOFINDER™ Module sends recorded electrical signals collected from multi-connector electrode catheters to the CARTOFINDER™ workstation, which generates new visual format maps to be displayed in the CARTO® 3 EP Navigation System.

AI/ML Overview

The provided text describes a 510(k) summary for the CARTO® 3 EP Navigation System, Version 5.2 and Accessories with the CARTOFINDER Module. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel claims with specific acceptance criteria. Therefore, the information requested regarding acceptance criteria, study design, and quantitative performance metrics is largely not available in this type of regulatory document.

However, based on the information provided, here's what can be inferred and stated:

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

The document does not specify quantitative acceptance criteria or provide a table of reported device performance values in relation to such criteria. The performance data section broadly states: "The CARTO® 3 EP Navigation System, Version 5.2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness." This indicates that predefined criteria were met for functional safety and effectiveness, but the specific metrics are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document mentions "Biosense Webster sponsored studies, published literature, and manuscripts" were used for clinical data to support the performance of the new maps. However, it does not specify the sample size for these studies or for any dedicated test set.
Data Provenance: The provenance (country of origin, retrospective/prospective) of the clinical data is not specified.

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 document. For diagnostic devices, expert review is often part of establishing ground truth, but the details are absent here.

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

The document does not specify any adjudication method for establishing ground truth in a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size for human reader improvement with AI assistance. The CARTOFINDER™ Module is an enhancement to a mapping system, generating "new visual format maps," but the document doesn't frame its evaluation as an AI-assisted interpretation study for human readers.

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

The document states that the new maps produced by the CARTOFINDER™ Module are for "diagnostic purposes only" and that "Therapeutic treatment should rely on all available information in the EP lab." This implies that the output of the CARTOFINDER™ Module is intended to be used by a clinician as part of a larger diagnostic and treatment workflow, rather than as a standalone diagnostic device. The "performance data" section focuses on verification of functionality and integration rather than standalone diagnostic accuracy metrics. Therefore, a standalone (algorithm-only) diagnostic performance study is not explicitly described or quantified.

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

The document does not explicitly state the type of ground truth used for the clinical data from the "Biosense Webster sponsored studies, published literature, and manuscripts." For cardiac electrophysiology, ground truth often involves a combination of clinical assessment, catheter ablation outcomes, and consensus among experienced electrophysiologists, but this is not detailed here.

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of regulatory submission typically focuses on validation and verification rather than detailing the development (training) phase of the algorithms.

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

Since a training set is not mentioned, the method for establishing its ground truth is also not provided.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 24, 2018

Biosense Webster, Inc. Phuong Chau Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618

Re: K173978

Trade/Device Name: CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK. Dated: July 31, 2018 Received: August 1, 2018

Dear Phuong Chau:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mude Jellm
for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K173978

Device Name

CARTO® 3 EP Navigation System Version 5.2 and Accessories with CARTOFINDER Module

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

Applicant:	Biosense Webster, Inc.33 Technology DriveIrvine, CA 92618, USAPhone: 909-839-8500Fax: 909-839-8804
Contact Person:	Phuong ChauSenior Regulatory Affairs Program LeadPhone: 949-923-4238Fax: 949-450-6886
Authored by:	Moshe HochmitzAssociate Director, Quality and RegulatoryBiosense Webster (Israel), Ltd.AndPhuong ChauSenior Regulatory Affairs Program Lead
Date:	July 27, 2018
Device TradeName:	CARTO® 3 EP Navigation System Version 5.2 and Accessories withCARTOFINDER™ Module
Device CommonName:	Cardiac Mapping System
ManufacturingNumber:	FG-5400-00
DeviceClassification:	Programmable diagnostic computer
Classification:	Class II, 21 CFR 870.1425
Product Code	DQK
Predicate Device:	CARTO® 3 EP Navigation System Version 4.2 and Accessories510(k)#: K133916
ManufacturingFacilities:	Biosense Webster (Israel), Ltd.a Johnson & Johnson Company4 Hatnufa StreetYokneam ISRAEL 2066717

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Biosense Webster, Inc. 15715 Arrow Hwy Irwindale, CA 91706

The CARTO® 3 EP Navigation System Version 5.2 and Accessories is Device Description: 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. 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 electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System V5.2 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO® 3 EP Navigation System Version 5.2 is a modification to the CARTO® 3 EP Navigation System Version 4.2 to add the CARTOFINDER™ Module and workstation as an accessory to the CARTO® 3 System. The CARTOFINDER™ Module sends recorded electrical signals collected from multi-connector electrode catheters to the CARTOFINDER™ workstation, which generates new visual format maps to be displayed in the CARTO® 3 EP Navigation System. The new visual format maps generated by the CARTOFINDER™ Workstation are divided into two categories:

1. Dynamic mapping algorithms: Wherein the physiological scoring is changing over time after inspecting the input signals in a certain window of interest.
1. Static mapping algorithms: These maps set a single physiological scoring per electrode, after analyzing the input signals during the full recording time.

The CARTOFINDER™ Workstation creates the following Dynamic and Static Maps:

1. 4D LAT: Dynamic map of the Local Activation Time.
1. Cycle Length (CL) Unipolar Signal: Static map showing the dominant cycle length measured on each recorded channel per recording/data acquisition set.
1. Cycle Length (CL) Variation: Static map showing the standard deviation cycle length measured on each recorded channel.
1. CARTOFINDER™ Region of Interest (ROI) Focal: This map will identify the area with OS morphology on the unipolar electrograms that are activated early compared to the

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surrounding multi-connector (MC) electrode catheter recorded channels.

1. CARTOFINDER™ (ROI) Rotational: This map will identify rotational activation patterns that occupy at least 50% of the cycle length map (this condition requires sufficient spatial and temporal resolution).
  CARTO® 3 EP Navigation System Version 5.2 and Accessories consists of the following components:
Patient Interface Unit (PIU) ●
3D graphical Workstation that serves as the Graphic User Interface (GUI), Wide-Screen monitors, keyboard, and mouse
Intracardiac In Port
Intracardiac Out Port ●
Power Supply ●
. Patches Connection Box and Cables
Pedals
Location Pad ●
CARTOFINDER™ Workstation ●
Non-Biosense Webster basket catheter interface cable (CA-● 5400-61)

Because CARTOFINDER™ is only available on this version, the CARTO® 3 System V5.2 will be marketed in parallel with the CARTO® 3 System V6.0 software. Future software releases may incorporate this functionality pending company business decisions

Indications for Use: 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.
The proposed CARTO® 3 EP Navigation System, Version 5.2, has the Technological same technological characteristics as the predicate CARTO® 3 EP Characteristics: Navigation System, Version 4.2. A summary of the technological characteristics of the new device compared to the predicate device is provided in the following table.

	CARTO 3 System V4.2(K133916)	CARTO® 3 EP NavigationSystem Version 5.2 withCARTOFINDER™ Module(K173978)
Indications for Use	The intended use of theCARTO® 3 System is catheter-based cardiacelectrophysiological (EP)	Same
	procedures. The CARTO® 3System provides informationabout the electrical activity of theheart and about catheter locationduring the procedure. The systemcan be used on patients who areeligible for a conventionalelectrophysiological procedure.The system has no specialcontraindications.
System	Patient Interface Unit (PIU)Workstation Computer withstandard keyboard andmouseSingle monitor displayIntracardiac PortIntracardiac Out PortPower SupplyPatch Connections Box andCablesPedalsLocation Pad	Addition of theCARTOFINDER™ Workstation(Workstation specifications aresame as CARTO 3 SystemWorkstation specifications)
Sensors catheterssupport	Mapping and visualization basedon Basic triangulation ofMagnetic Location algorithm	Same
Non-Sensorscatheters support	Mapping and visualization basedon Current based location (ACL)algorithm	Same
Interface for DatatransferCARTOFINDERTMModule	Interfacing with compatibledevices (such as Ultrasoundsystems, EP recording systems,Fluoroscopic systems, RFGenerators)	Extended interface abilities tosupport the CARTOFINDERTMWorkstation data.
Offers DisplayOptions for Reviewof ProcessedSignals	LAT (including propagation ofsingle beat)AnatomicalUnipolar & Bipolar VoltagemapsImpedance	4D LATenhanced to review signalpropagation over thecomplete periods of time ofsignal recordingCL StabilityCL VariationROI - FocalROI - Rotational
Supports MultiElectrode CatheterRecordings	Yes	MEM capability was expandedto high number of electrodes,including interface cable (CA-5400-61) to support basketcatheter

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The CARTO® 3 System V5.2 is substantially equivalent to the CARTO® 3 System V4.2, as the mechanism of the diagnostic maps of both devices remains the same. Both devices use IC annotated signal in a known location and present them in a sequence that determines the propagation direction of the signal in the tissue allowing the physician to diagnose the arrhythmia pattern. Except for the CARTOFINDER™ Workstation, the hardware components of the CARTO® 3 System V5.2

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are identical to those described for the predicate CARTO® 3 System V4.2.

The CARTO® 3 EP Navigation System, Version 5.2 underwent Performance Data: extensive bench and pre-clinical testing under simulated clinical conditions to verify the new and modified features and to demonstrate with regression testing that these modifications did not negatively affect existing features. The CARTO® 3 EP Navigation System, Version 5.2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.

Bench Testing:

Non-clinical performance testing completed for the CARTO® 3 EP Navigation System, Version 5.2 included:

CARTO® 3 System Version 5.2 verify the functional . requirements and hardware configurations with the new CARTOFINDER™ Module and Workstation, regression testing of all CARTO® 3 System legacy features, verify system functionality for all supported catheters, and usability testing.
. CARTOFINDERTM Workstation testing - verify the signal preprocessing and annotation detection, maps and catheter generation and coloring, CARTOFINDER™ functionality (including MC catheter support), stimulation detection and blanking, coloring projection and interpolation, power reject algorithm performance, and usability testing.
CARTOFINDER™ integration verify that the new module . interface with the CARTOFINDER™ Workstation meets requirements and functions as intended when integrated with the CARTO® 3 system.
. Interface cable - verification testing was completed for the interface cable connected to a non-Biosense Webster basket catheter with the CARTO® 3 System.

Animal Testing:

Animal testing was performed to evaluate the CARTO® 3 System Version 5.2 and CARTOFINDER™ Workstation workflow under simulated clinical workflow.

Clinical Data:

Clinical data from Biosense Webster sponsored studies, published literature, and manuscripts were used to support the clinical performance of the new maps for their respective intended use. The data also supported the clinical performance of the compatible catheters with the new maps. The information provided by these maps

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are for diagnostic purposes only. Therapeutic treatment should rely on all available information in the EP lab.

The CARTO® 3 EP Navigation System, Version 5.2 is substantially Conclusions: equivalent to the currently cleared CARTO® 3 EP Navigation System, Version 4.2 based on the completion of non-clinical bench testing, preclinical testing, and clinical data as well as similar principles of design, operation and indications for use.

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).