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

CARTO® The 3 EP Navigation System with CARTOSOUND™ 4D, software V7.4, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals 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 specialized mapping catheters and reference devices. The CARTO® 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO® 3 System with CARTOSOUND™ 4D consists of the following hardware components:

. Patient Interface Unit (PIU)
Workstation with Graphic User Interface (GUI)
. Wide-Screen monitors, keyboard, and mouse
. Intracardiac In Port
Intracardiac Out Port ●
. Power Supply
Patches Connection Box and Cables (PU)
Pedals ●
Location Pad (LP) ●
Signal Processing Unit (SPU) ●

All hardware components of the CARTO® 3 system with CARTOSOUND™ 4D are the same to those found in the predicate device.

AI/ML Overview

The provided document focuses on the 510(k) summary for the CARTO® 3 EP Navigation System with CARTOSOUND™ 4D version 7.4. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the specific details required to answer all parts of your request, particularly regarding detailed acceptance criteria with performance values, sample sizes for test and training sets, expert qualifications, or multi-reader, multi-case (MRMC) comparative effectiveness studies.

The document primarily describes functional and performance verification rather than a study validating a specific AI algorithm's diagnostic performance against ground truth (as would be typical for an AI/ML medical device). The "CARTOSOUND™ 4D" module appears to be a feature that combines and processes ultrasound and mapping data, not a standalone diagnostic AI algorithm.

Based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria and corresponding numerical performance results for the device's diagnostic accuracy or AI performance. Instead, it states that:

Acceptance Criteria Category	Reported Device Performance
Proof of Design (POD)	"All testing performed were successfully completed and met the acceptance criteria." (Related to connecting the CARTO® 3 System to the NUVISION™ NAV Ultrasound catheter and GE Healthcare's Vivid S70N Ultrasound System)
Functional Verification	"All system features were found to perform according to specifications and met the tests acceptance criteria." (Including new CARTOSOUND™ 4D features, improvements, and regression testing for legacy features and Letter To File modifications)
Image Quality Assessment	"Assessment was successfully completed and expected results were achieved." (Evaluated ULS image quality displayed in the CARTO® 3 System)
Animal Testing (Functionality)	"All test protocol steps were successfully completed and expected results were achieved." (Evaluated CARTO® 3 System with CARTOSOUND™ 4D functionality under simulated clinical workflow and conditions)
Usability Testing	"operation of the CARTOSOUND™ 4D Module has been found to be safe and effective for the intended users, uses and use environments." (Validated ease of use of the CARTOSOUND™ 4D Module User Interface)
Overall Conclusion	"All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness." and "The CARTO® 3 EP Navigation System with CARTOSOUND™ 4D software version V7.4 is substantially equivalent to the currently cleared CARTO® 3 EP Navigation System. Version 7.2 based on the completion of verification and validation testing."

Important Note: The document describes engineering and system verification tests, not a clinical study involving diagnostic AI performance metrics like sensitivity, specificity, or AUC, which would typically have specific numerical acceptance criteria.

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

Sample Size for Test Set: Not specified. The document mentions "Bench testing," "Animal Testing," and "Summative Usability testing" but does not give specific numbers of cases, patients, or animals used in these tests.
Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. Animal testing is mentioned, which is by nature prospective for the animal portion.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It is implied that qualified personnel conducted and assessed the engineering and animal tests, but no details are given. This device processes and displays information for a human user (physician) to interpret; it does not itself make a diagnostic decision that requires establishing a "ground truth" through expert consensus in the typical AI sense.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified. Given the nature of the described tests (functional, image quality, animal functionality, usability), there's no mention of a traditional expert adjudication process for establishing ground truth for diagnostic accuracy, as the device's primary function is data acquisition and display, rather than automated diagnosis.

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

MRMC Study: No. The document does not describe any MRMC study comparing human readers with and without AI assistance. The device is a navigation system that provides information, not an assistive AI diagnostic tool for image interpretation.
Effect Size of Human Reader Improvement: Not applicable, as no such study was performed or described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document implies that the "performance data" refers to the device's functional performance in acquiring and processing data to specification. It does not describe a standalone study of an AI algorithm making diagnostic interpretations without human intervention. The device is a "Navigation System" that "provides information" to the user, not an autonomous diagnostic AI.

7. Type of Ground Truth Used

Type of Ground Truth: The concept of "ground truth" in the traditional sense of a diagnostic outcome (e.g., pathology, clinical outcome, expert consensus on a diagnosis) is not explicitly discussed for the device's performance validation. The "truth" in this context refers to whether the system functions according to its engineering specifications and accurately displays the acquired data. For instance:
- Bench Testing: Verification against internal system specifications and accurate data display.
- Animal Testing: Verification of functionality in a simulated physiological environment.
- Usability Testing: Assessment of the user interface's safety and effectiveness.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. The document describes a medical device upgrade, not a de novo AI model that requires a distinct "training set" in the machine learning sense. The software updates described are improvements to an existing system, including a new module (CARTOSOUND™ 4D) and various other enhancements, for which "training data" is not a relevant concept as it would be for a deep learning model.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Was Established: Not applicable. As there's no mention of an AI model with a training phase, the concept of establishing ground truth for a training set does not apply.

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 & 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.

February 16, 2023

Biosense Webster, Inc. Phuong Park Associate Director. Regulatory Affairs 31 Technology Drive, Suite 200 Irvine, California 92618

Re: K223733

Trade/Device Name: CARTO® 3 EP Navigation System with CARTOSOUND 4D version 7.4 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: December 13, 2022 Received: December 13, 2022

Dear Phuong Park:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223733

Device Name

CARTO® 3 EP Navigation System with CARTOSOUND 4D version 7.4

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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510(K) SUMMARY

Applicant:	Biosense Webster, Inc.31 Technology Drive, Suite 200Irvine, CA 92618, USATel.: (800) 729-9010Fax: (909) 839-8500
Contact Person:	Phuong ParkAssociate Director, Regulatory AffairsPhone: 949-923-4238Fax: 949-450-6886
Authored by:	Eyal HendelRegulatory Affairs ManagerBiosense Webster (Israel), Ltd.andPhuong ParkAssociate Director, Regulatory AffairsBiosense Webster, Inc.
Date:	February 15, 2023
Device TradeName:	CARTO® 3 EP Navigation System with CARTOSOUND 4D version 7.4
Device CommonName:	Cardiac Mapping System
ManufacturingNumber:	FG-5400-00
DeviceClassification:	Programmable diagnostic computer
	Class II, 21 CFR 870.1425
Product Code	DQK
Predicate Device:	CARTO® 3 EP Navigation System Version 7.2 510(k)#: K213264

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Manufacturing	Biosense Webster (Israel), Ltd.
Facilities:	a Johnson & Johnson Company
	4 Hatnufa Street
	Yokneam. ISRAEL 2066717

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

Device Description:

Image /page/4/Picture/3 description: The image shows a medical device on a wheeled stand. The device has a monitor at the top displaying medical images. Below the monitor is a control panel with various buttons and ports. The device is white and has a modern design. The stand has four wheels for easy mobility.

The CARTO® 3 System with CARTOSOUND™ 4D consists of the following hardware components:

. Patient Interface Unit (PIU)
Workstation with Graphic User Interface (GUI)
. Wide-Screen monitors, keyboard, and mouse
. Intracardiac In Port
Intracardiac Out Port ●
. Power Supply
Patches Connection Box and Cables (PU)
Pedals ●
Location Pad (LP) ●
Signal Processing Unit (SPU) ●

All hardware components of the CARTO® 3 system with CARTOSOUND™ 4D are the same to those found in the predicate device.

The intended use of the CARTO® 3 System is catheter-based cardiac Indications for Use: electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location

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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 indications for use for the CARTO® 3 System with CARTOSOUND™ 4D are identical to the indications for use of the predicate device, the CARTO® 3 System V7.2.

The modified CARTO® 3 EP Navigation System with CARTOSOUND™ 4D, Technological Characteristics: software V7.4 has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate CARTO® 3 EP Navigation System. Version 7.2 (K213264). A summary of the technological characteristics of the new device compared to the predicate device is as follows:

. Have identical intended use.
Use the same fundamental scientific technology.
. Have the same hardware platform
. Have identical magnetic and ACL location mapping technology.
. Have identical magnetic location sensor and ACL location accuracy.

The differences between the predicate device and the modified device are the addition of a new software feature, CARTOSOUND™ 4D, improvements of the legacy CARTOSOUND™ Module and the addition of Letter to File changes as described below.

Note: The CARTOSOUND™ module was cleared with the CARTO® 3 System V1, K090017.

Description of Modifications

CARTOSOUND™ 4D

The addition of the CARTOSOUND™ 4D Module combines 3D real-time ultrasound image data with CARTO® 3 System Maps. 4D (real-time volumetric imaging with a field of view of up to 90° x 90°) multi-planar, and 2D ultrasound images are acquired with the compatible NUVISION™ NAV Ultrasound Catheter (K223766). The catheter includes an ultrasound transducer and a location sensor. The NUVISION™ Nav catheter has a bifurcated 'tail' originating from the handle. One part terminates in a connector receptacle which mates with a NUVISION Connector Cable to connect the catheter to a compatible ultrasound system. The other part enables connection to the CARTO® 3 Navigation System with CARTOSOUND™ 4D Module via an extension cable. A steering mechanism controls orientation of the image plane by rotating both the NUVISION Nav Catheter's tip and providing variable bi-directional deflection. The real-time ultrasound images are displayed in the CARTO® 3 System and the compatible GE

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Healthcare's Vivid S70N Ultrasound System (Vivid S70N, SW version 206.zz, K223832), which is specialized for use with cardiac images.

This module also enables acquisition of clips from the ultrasound system, transferred with a digital communication protocol over an Ethernet connection (LAN) cable. The user can draw contours of the required anatomy on any frame of the ultrasound clip and add this information to a 3D anatomical map reconstruction. The ultrasound clip can be saved with these contours, and the frames containing the contours are marked for easy identification. The ultrasound clip can be also stored to the CARTO® 3 system for future contouring. Contour data contributes anatomical information to the map. Contours and Ultrasound clips are listed in the Map Point List.

The CARTOSOUND™ 4D Module 4D advanced feature presents a 4D rendered reconstruction on the CARTO main map viewer and additional windows in a realtime fashion.

CARTOSOUND™ Module Improvements

Improvements were implemented to the user interface of the legacy CARTOSOUND™ module while maintaining the same functionality. The user interface change includes layout and controls for assigning contours to maps and an updated toolbar.

Video Over LAN

Improvement was implemented to the CARTO® 3 System, by replacing the Analog interface with a digital communication protocol over an Ethernet connection (LAN) cable with the compatible ultrasound system, by enabling transmitting compressed videos from the GE Healthcare's Vivid S70N Ultrasound System (Vivid S70N, SW version 206.z) to CARTO® 3 System with CARTOSOUND™ 4D using industrial standard compressing protocol H.264 format.

Note: To maintain compatibility with all other Ultrasound Systems, the CARTO® 3 System with CARTOSOUND™ 4D also supports the legacy solution in which data is sent in an analog format (typically VGA) and images are grabbed via a Frame Grabber in the CARTO® 3 System workstation.

Letter to File changes

Improvement to OCTARAY DX catheter support through Signal Processing Unit

Updated coefficients of the Dynamic Threshold (Catheter XML Change) ● to receive the optimal S2 electrode detection in/out of the sheath
Signal Processing Unit (SPU) enhancements

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. Improvement to SPU Build in Test (BIT) mechanism to run the BIT only at SPU startup, to avoid possible delays during the clinical procedure.
Tissue Proximity Indicator (TPI) Card update: ●
- . HW change: removal of non-functional amplifiers in the TPI card, to decrease the total current (load and self-consumption) of the -5 Volt voltage supply, assembled on the Power Card, in order to reduce the possibility of saturation in extreme conditions.
- . HW change: replacement of 4 resistors in the TPI card to 0 [ohm], to reduce open loop noise due to the removal of the amplifiers. Note: these TPI changes have no impact on the TPI performance.
Firmware update: ●
- . FPGA Firmware update: updating the calibration multiplier factor with an overflow protected multiplier to address an observed ECG visualization artifact.

Note: The SPU has an analog amplifier (ASIC) followed by an A/D converter and a calibration multiplier. When a full-scale signal is set to the SPU, it may seldom cause an overflow at the multiplier and an ECG visualization artifact

Security Enhancements

Secure login mode is disabled by default, although selectable by the user ●
Security and drivers update .

Support removal

. The support for the Siemens Sequoia Ultrasound system was removed due to end of life of the ULS system.
The CARTO® 3 EP Navigation System with CARTOSOUND™ 4D underwent Performance Data: verification and validation testing under simulated clinical conditions to verify the new features and to demonstrate with regression testing that the modifications performed did not negatively affect existing features.

Bench Testing:

Bench testing completed for CARTO® 3 System with CARTOSOUND™ 4D included:

Proof of Design (POD) - Testing was performed to verify the CARTO® 3 System specifications while connecting it to the NUVISIONT™ NAV Ultrasound catheter and GE Healthcare's Vivid S70N Ultrasound System (Vivid S70N, SW version 206.z). All testing performed were successfully completed and met the acceptance criteria.

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Functional verification Testing was performed to verify the functional ● requirements of CARTO® 3 System with CARTOSOUND™ 4D, including testing of the new CARTOSOUND™ 4D features and CARTOSOUND™ improvements as well as regression testing to verify continued functionality of CARTO® 3 System legacy features and Letter To File modifications. All system features were found to perform according to specifications and met the tests acceptance criteria.
Image Quality assessment Testing was conducted to evaluate the ULS . image quality as displayed in the monitor of the CARTO® 3 System with CARTOSOUND™ 4D. The test was conducted under simulated clinical workflow and conditions. Assessment was successfully completed and expected results were achieved.

Animal Testing:

Animal testing was conducted to evaluate the CARTO® 3 System with CARTOSOUND™ 4D functionality under simulated clinical workflow and conditions. All test protocol steps were successfully completed and expected results were achieved.

All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.

Usability Testing:

Summative Usability testing was conducted to validate that CARTOSOUND™ 4D Module User Interface ease of use. In light of the usability validation study results, it was concluded that the operation of the CARTOSOUND™ 4D Module has been found to be safe and effective for the intended users, uses and use environments.

The CARTO® 3 EP Navigation System with CARTOSOUND™ 4D software Conclusions: version V7.4 is substantially equivalent to the currently cleared CARTO® 3 EP Navigation System. Version 7.2 based on the completion of verification and validation testing.

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).