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 7.2 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 V7.2 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO® 3 System V7.2 consists of the following 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) ((510(k)#: K200484)

AI/ML Overview

The provided text describes the CARTO® 3 EP Navigation System Version 7.2 and its regulatory submission. It is a 510(k) summary, which means it primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study report for new functionalities or a de novo device.

Therefore, the document does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria in terms of a true "performance study" with a test set, ground truth experts, and MRMC studies as might be expected for an AI/ML diagnostic algorithm. The performance data presented is focused on non-clinical verification and validation to demonstrate that the new version maintains the safety and effectiveness of its predicate.

Based on the provided text, here's what can be extracted and what information is missing:

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

The document provides general statements about acceptance criteria being met, but it does not present a formal table with quantitative acceptance criteria and corresponding performance metrics from a clinical study on a patient test set.

Acceptance Criteria (General):
- Electrical Safety and Electromagnetic Compatibility per IEC 60601-1 and IEC 60601-1-2.
- Proof of Design: verified visualization of catheters, system behavior, location accuracy of catheters position, ECG channel characteristics and performance, load capacity, data synchronization, and verification of legacy re-enabled modules.
- Functional verification: functional requirements and hardware configurations, regression testing of CARTO® 3 System legacy features, system functionality for supported catheters, and interoperability with 3rd party compatible medical devices.
- Usability per IEC 60601-1-6.
- Animal testing: functionality under simulated clinical workflow and conditions, with successful completion of all protocol steps and achievement of expected results.
Reported Device Performance (General):
- "Test results were in compliance to the standards." (for electrical safety/EMC)
- "All testing performed met the acceptance criteria." (for Proof of Design)
- "All system features were found to perform according to specifications and met acceptance criteria." (for Functional verification and Usability)
- "All test protocol steps were successfully completed and expected results were achieved." (for Animal Testing)
- "All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness."

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

The document describes bench testing and animal testing. It does not describe a clinical "test set" of patient data in the sense of a diagnostic AI performance study.

Sample Size for Bench Testing: Not specified as a number of "samples" in the traditional sense of a test set. It refers to various engineering and functional tests.
Sample Size for Animal Testing: Not specified, but it implies a pre-clinical study involving animals. No indication of retrospective or prospective for non-human data.
Data Provenance: Not applicable for a clinical test set from human patients, as such a study is not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not present because the document does not describe a clinical study with a human-derived test set requiring expert ground truth.

4. Adjudication method for the test set

This information is not present for the same reason as above.

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

There is no mention of an MRMC study. This device is an EP navigation system, not a diagnostic AI intended to assist human readers in interpreting medical images in the manner that an MRMC study would evaluate. Its purpose is to guide catheter-based procedures and provide real-time information rather than perform diagnostic interpretation that humans would then re-read.

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

The device's core functionality is a navigation and mapping system that processes real-time electrical signals and catheter location. Its "performance" is inherently tied to its function in a procedure, not as a standalone diagnostic algorithm providing a final output without human intervention. The testing described is focused on the accuracy of its measurements and display capabilities.

7. The type of ground truth used

For the bench testing, the "ground truth" would be the known inputs, reference standards, and specifications against which the device's output (e.g., location accuracy, ECG channel characteristics) is compared.
For the animal testing, "expected results" were achieved, implying a predefined understanding of the physiological responses or system behavior under simulated clinical conditions.
There is no mention of expert consensus, pathology, or outcomes data as ground truth for a diagnostic performance study.

8. The sample size for the training set

This document describes a 510(k) submission for a software update (Windows 10 compatibility, re-enabling legacy modules, SPU inclusion). It is not a de novo submission for a new AI/ML algorithm that would typically involve a "training set." Therefore, information on a training set sample size is not applicable/not provided.

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

Not applicable, as it's not an AI/ML algorithm development as typically understood for training.

In summary: The provided document is a 510(k) summary for a software update to an existing EP navigation system. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench and animal testing designed to show that an updated version of a device maintains its safety and effectiveness and is substantially equivalent to predicate devices, rather than a clinical performance study of a diagnostic AI. The typical elements requested (e.g., test set sample size, expert ground truth, MRMC studies) are not part of this type of regulatory submission because they are not relevant to the nature of the device and the changes made.

Summary

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October 29, 2021

Biosense Webster, Inc. Khaled Hamad Senior Regulatory Affairs Specialist 31 Technology Drive, Suite 200 Irvine, California 92618

Re: K213264

Trade/Device Name: CARTO® 3 EP Navigation System Version 7.2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 27, 2021 Received: September 30, 2021

Dear Khaled Hamad:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 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) K213264

Device Name

CARTO® 3 EP Navigation System Version 7.2

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 — K213264

Applicant:	Biosense Webster, Inc.31 Technology Drive, Suite 200Irvine, CA 92618, USATel.: (800) 729-9010Fax: (909) 839-8500
Contact Person:	Khaled HamadSenior Regulatory Affairs SpecialistPhone: 949-453-6350Fax: 949-450-6886
Authored by:	Elena GoldinQuality and Regulatory Affairs Senior SpecialistBiosense Webster (Israel), Ltd.andKhaled HamadSenior Regulatory Affairs SpecialistBiosense Webster, Inc.
Date:	September 27, 2021
Device TradeName:	CARTO® 3 EP Navigation System Version 7.2
Device CommonName:	Cardiac Mapping System
ManufacturingNumber:	FG-5400-00, FG-5400-00U
DeviceClassification:	Programmable diagnostic computerClass II, 21 CFR 870.1425
Product Code	DQK
PredicateDevice:	CARTO® 3 EP Navigation System Version 7.1 510(k)#: K191660 (primarypredicate device) and CARTO® 3 EP Navigation System Version 7.61 with SPU(Signal Processing Unit) 510(k)#: K200484
Indications forUse:	The intended use of the CARTO® 3 System is catheter-based cardiacelectrophysiological (EP) procedures. The CARTO® 3 System providesinformation about the electrical activity of the heart and about catheter locationduring the procedure. The system can be used on patients who are eligible for aconventional electrophysiological procedure. The system has no specialcontraindications.

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Manufacturing Biosense Webster (Israel), Ltd. a Johnson & Johnson Company Facilities: 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 mobile cart. The device has a monitor at the top displaying medical images. Below the monitor is a control panel with various buttons and ports, followed by another smaller monitor and additional controls. The cart has wheels for mobility and is designed to be easily moved around a medical facility.

technology.

The CARTO® 3 System V7.2 consists of the following 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) ((510(k)#: K200484) ●

Indications for The intended use of the CARTO® 3 System is catheter-based cardiac Use: 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.

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The indications for use for the CARTO® 3 System are identical to the indications for use of the primary predicate CARTO® 3 System V7.1

Technological The modified CARTO® 3 EP Navigation System, V7.2 has the same technological Characteristics: characteristics (i. e., design, material, chemical composition, energy source) as the predicate CARTO® 3 EP Navigation System, Version 7.1 (K191660) and Version 7.61 with SPU (Signal Processing Unit) (K200484). 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 identical magnetic location mapping technology.
. Have identical magnetic location sensor accuracy.

The main difference between the predicate device and the modified device are the upgrade of the CARTO® 3 software operating system to Windows 10, while restoring support of all legacy software modules and interoperabilities, cleared under 510k K191660, that were blocked under K200484. The CARTO® 3 EP Navigation System V7.2 includes the Signal Processing Unit (SPU), cleared under 510k K200484, that provides support to multi-electrode catheters up to 48 electrodes, such as the OCTARAY DX catheter.

This release also includes minor improvements to several legacy modules, without adding any new software module.

Performance The CARTO® 3 EP Navigation System V7.2 with accessories underwent extensive bench and pre-clinical testing under simulated clinical conditions to Data: verify the new and modified features and to demonstrate with regression testing that these modifications did not negatively affect existing features.
Bench Testing:

·Electrical Safety and Electromagnetic Compatibility testing was performed per IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements. Test results were in compliance to the standards.

•Proof of Design - verified visualization of catheters, system behavior, location accuracy of catheters position, ECG channel characteristics and performance,

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load capacity, data synchronization, and the verification of legacy re-enabled modules. Tests were performed on a Windows 10 Operating System. All testing performed met the acceptance criteria.

•Functional verification – verified the functional requirements and hardware configurations, regression testing of CARTO® 3 System legacy features, system functionality for supported catheters, and interoperability with 3rd party compatible medical devices. Usability was tested per IEC 60601-1-6, Medical electrical equipment- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. All applicable functions on the CARTO® 3 V7.2 System were tested running on a Windows 10 Operating System. All system features were found to perform according to specifications and met acceptance criteria.

Animal Testing:

•Animal testing was conducted to evaluate the CARTO® 3 V7.2 System 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.

Conclusions: The CARTO® 3 EP Navigation System, V7.2 is substantially equivalent to the currently cleared CARTO® 3 EP Navigation System, Version 7.1 and Version 7.61 based on the completion of non-clinical bench testing and pre-clinical testing 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).