The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTOTM 3 System provides information about the electrical activity of the heart and about catheter location 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 CARTOTM 3 EP Navigation System V8.0, 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 CARTOTM 3 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTOTM 3 System V8.0 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 V8.0 are the same as those found in the predicate device.

AI/ML Overview

The provided document describes the CARTO™ 3 EP Navigation System Software V8.0 and its modifications. It details the various tests performed (software verification and validation, bench testing, animal testing, and clinical testing) to demonstrate the device's safety and effectiveness and its substantial equivalence to the predicate device. However, the document does not provide specific acceptance criteria or detailed study results in the format requested. It generally states that "All testing performed were successfully completed and met the acceptance criteria" and "All system features were found to perform according to specifications and met the tests acceptance criteria" without listing the metrics or the numerical outcomes.

Therefore, for aspects like "Table of acceptance criteria and the reported device performance," "Effect size of how much human readers improve with AI vs without AI assistance," and specific numerical results for performance, the information is not present in the provided text.

Based on the available text, here's a breakdown of what can be extracted:

Device: CARTO™ 3 EP Navigation System Software V8.0

No AI/ML Specific Performance Study (MRMC or Standalone) provided in the document for the new AI/ML features that show a quantitative acceptance criteria and the actual performance. The document broadly states that tests met acceptance criteria and performs as expected.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document broadly states that all tests successfully met acceptance criteria without providing specific performance metrics or numerical thresholds for acceptance. It is a general statement of compliance.

Acceptance Criteria (General Statement from Document)	Reported Device Performance (General Statement from Document)
CARTO™ 3 System V8.0 design meets specifications.	All testing performed were successfully completed and met the acceptance criteria.
Functional requirements of CARTO™ 3 System V8.0, including new features and improvements, perform according to specifications.	All system features were found to perform according to specifications and met the tests acceptance criteria.
Design implementation in CARTO™ 3 V8.0 software is compatible with the design.	All testing performed were successfully completed and met the acceptance criteria.
Clinical functionality and quality of new introduced modules are validated.	All testing performed were successfully completed and met the acceptance criteria (on clinical recorded data).
CARTOTM 3 System V8.0 User Interface is safe and effective for use.	CARTOTM 3 System V8.0 has been found to be safe and effective for the intended users, uses and use environments. (summative usability testing).
Functionality under simulated clinical workflow and conditions.	All test protocol steps were successfully completed and expected results were achieved. (animal testing).
Safety and acute effectiveness for Paroxysmal Atrial Fibrillation ablation with a zero/low fluoroscopy workflow.	The primary safety and secondary acute effectiveness endpoints were met in the REAL AF Registry population. Comparable cumulative incidences of the secondary safety endpoint between the zero/low fluoroscopy group and the conventional fluoroscopy group. (Clinical Study).

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

Complex Signals Identification (CSI) module:
- Data Provenance: Medical Centers in Europe and the United States of America.
- Data Type: Control database created using input from multiple stable atrial typical and atypical flutter cases. Included data from different catheters, with complex signals, single activations, noisy signals, and so on.
- Sample Size: Not specified.
- Retrospective/Prospective: "Retrospective Validation Tests Testing was performed retrospectively, on clinical recorded data from historic EP procedures performed with the CARTOTM 3 System." This applies to all new modules including CSI.
CARTOSOUND™ FAM Module:
- Data Provenance: Diverse locations and populations.
- Data Type: Collected using a variety of ultrasound system settings, scanners, and Catheters.
- Sample Size: Not specified.
- Retrospective/Prospective: "Retrospective Validation Tests Testing was performed retrospectively, on clinical recorded data from historic EP procedures performed with the CARTOTM 3 System." This applies to all new modules including CARTOSOUND™ FAM.
Clinical Testing (REAL AF Registry Sub-Study):
- Sample Size: The "REAL AF Registry population" is mentioned, but the specific number of patients is not provided.
- Data Provenance: Not explicitly stated beyond "REAL AF Registry Sub-Study."
- Retrospective/Prospective: Not explicitly stated, but "Registry Sub-Study" often implies a prospective or retrospective observational study on existing patient data.

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

For the Complex Signals Identification (CSI) module, it states that "a control database was created using input from multiple stable atrial typical and atypical flutter cases." It does not specify the number or qualifications of "experts" if involvement extends beyond clinical data collection.
For the CARTOSOUND™ FAM Module, no information provided about experts involved in ground truth establishment for the test set.
For the Clinical Testing (REAL AF Registry Sub-Study), the ground truth is clinical outcomes and safety endpoints, which are typically established by clinical professionals as part of the study protocol, but specific numbers or qualifications of adjudicators are not provided.

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

No specific adjudication method for establishing ground truth is described for any of the modules or studies.

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 to evaluate human reader improvement with AI assistance. The AI/ML algorithms are described as components of the system to aid specific tasks (e.g., automatically tagging fractionated IC ECG signals, reconstructing 3D volumes) rather than an AI-assisted interpretation by human readers.

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

The document indicates that the "Complex Signals Identification (CSI) module is a machine learning locked algorithm that automatically tags fractionated IC ECG signals." Similarly, "The CARTOSOUND™ FAM Module incorporates a Deep Learning (DL) algorithm" for automatic reconstruction and segmentation.
"Retrospective Validation Tests Testing was performed retrospectively, on clinical recorded data from historic EP procedures" for newly introduced modules. This suggests standalone performance evaluation on historic data, but specific performance metrics (e.g., accuracy, sensitivity, specificity) for these algorithms are not provided in the document. The document only states that "All testing performed were successfully completed and met the acceptance criteria."

7. The type of ground truth used:

Complex Signals Identification (CSI) module: "Control database created using input from multiple stable atrial typical and atypical flutter cases." This implies clinical ground truth based on real patient data.
CARTOSOUND™ FAM Module: Training and validation data collected from diverse clinical settings with ultrasound systems. Ground truth for 3D segmentation would likely be based on expert manual segmentation or a consensus method, though not explicitly stated.
Clinical Testing (REAL AF Registry Sub-Study): Clinical outcomes (safety and acute effectiveness endpoints) based on patient data.

8. The sample size for the training set:

Complex Signals Identification (CSI) module: Not specified.
CARTOSOUND™ FAM Module: Not specified, only mentioned that "Data for training and validation of the DL algorithm was collected from diverse locations and populations."

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

Complex Signals Identification (CSI) module: "a control database was created using input from multiple stable atrial typical and atypical flutter cases." This suggests the ground truth was derived from the characteristics of these cases, likely based on established clinical criteria or expert review of the EP data. The exact method (e.g., expert consensus, independent review) is not detailed.
CARTOSOUND™ FAM Module: Not specified. For 3D segmentation, ground truth is typically established by manual annotation by trained professionals or a consensus of multiple annotators, but this is not confirmed in the document.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through various V&V activities and broad statements of meeting acceptance criteria. It introduces new AI/ML components but does not delve into detailed quantitative performance metrics for these AI components or comparative studies with human readers.

Summary

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September 7, 2023

Biosense Webster, Inc. Caleb Lau Senior Regulatory Affairs Program Lead 31 Technology Drive, Suite 200 Irvine, California 92618

Re: K231207

Trade/Device Name: CARTO™ 3 EP Navigation System Software V8.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DOK Dated: August 8, 2023 Received: August 8, 2023

Dear Caleb Lau:

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) K231207

Device Name

CARTOTM 3 EP Navigation System Software V8.0

Indications for Use (Describe)

The system has no special contraindications.

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 200 Irvine, CA92618, USATel.: (800) 729-9010Fax: (909) 839-8500
ContactPerson:	Caleb LauSenior Regulatory Affairs Program Lead Phone: 949-704-1584Fax: 949-450-6886
Authored by:	Dorit EizenbergSenior Regulatory Affairs Program Lead BiosenseWebster (Israel), Ltd.and Caleb LauSenior Regulatory Affairs Program Lead BiosenseWebster, Inc.
Date:	August 8, 2023
Device TradeName:	CARTO™ 3 EP Navigation System V8.0
DeviceCommonName:	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 with CARTOSOUND™ 4DVersion 7.4 510(k)#: K223733

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Manufacturing Facilities:

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

Biosense Webster, Inc. 23 Hubble Drive Irvine, CA 92618 USA

Device Description:

Image /page/4/Picture/4 description: The image shows a medical device with a monitor on top. The monitor displays two images of what appears to be a heart. The device has several buttons and ports on the front, and it is mounted on a wheeled base.

magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTOTM 3 System V8.0 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 V8.0 are the same as those found in the predicate device.

The intended use of the CARTOTM 3 System is catheter-based cardiac Indications for Use: electrophysiological (EP) procedures. The CARTOTM 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on

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patients who are eligible for a conventional electrophysiological procedure.

The system has no special contraindications.

The indications for use for the CARTO™ 3 System V8.0 are identical to the indications for use of the predicate device, the CARTO® 3 System with CARTOSOUND™ 4D, software V7.4.

The modified CARTOTM 3 EP Navigation System V8.0 has the same Technological characteristics (i.e., design, material, Characteristics: technological chemical composition, energy source) as the predicate CARTO® 3 EP Navigation System with CARTOSOUND™ 4D, software V7.4 (K223733). 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 features, improvements of the legacy modules.

DESCRIPTION OF MODIFICATIONS:

MULTIPOLAR MAPPING 1.1

The Multipolar Mapping provides an additional annotation to the Wavefront Annotation mechanism, designed to enable a better discrimination between local activation and far-field potentials, and results in an improved consistency of the LAT annotation and Voltage measurements.

AUTO PATTERN ACQUISITION 1.2

Auto Pattern Acquisition automatically acquires BS ECG or IC EGMs patterns for either ventricular or atrial mappings. Automatic acquisition is achieved through a clustering mechanism using incoming beats, grouped based on similar morphology, to create different maps for the patterns of interest.

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COMPLEX SIGNALS IDENTIFICATION 1.3

The Complex Signals Identification (CSI) module is a machine learning locked algorithm that automatically tags fractionated IC ECG signals. This module allows the identification and visualization of complex signals during continuous mapping mode or retrospectively. In addition, tools for viewing the identified complex signals in specific regions of interest are provided.

For developing and validating the algorithm, a control database was created using input from multiple stable atrial typical and atypical flutter cases. This data was sourced from Medical Centers in Europe and the United States of America. It included data from different catheters, with complex signals, single activations, noisy signals, and so on.

CARTOSOUND™ FAM 1.4

The CARTOSOUND™ FAM Module is used to automatically reconstruct an editable 3D volume with automatic 3D segmentation of the Left Atrium (LA) anatomies, based on a series of 2D ultrasound gated input frames acquired from the Right Atrium (RA, Fossa Ovalis) and/or the Right Ventricular Outflow Tract (RVOT).

The CARTOSOUND™ FAM Module incorporates a Deep Learning (DL) algorithm. Data for training and validation of the DL algorithm was collected from diverse locations and populations, using a variety of ultrasound system settings, scanners, and Catheters.

1.5 LAT VELOCITY VECTORS (LVV)

The LAT Velocity Vectors (LVV) enables a visual display of the conduction mechanism in the chamber via velocity vectors on top of the 3D map, indicating the speed and direction of the activation wave as it propagates through the chamber.

1.6 CATHETERS SUPPORT

CARTO™ 3 system improved support of QDOT Micro™ Catheter:

CARTO™ 3 system V8.0 includes the following QDOT Module Improvements on the CARTO software version that was part of PMA P210027: enhanced ECG channels filters, addition of nGEN PUMP

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real-time flow rate display, display improvement, reflection of irrigation changes for focal ablation and during ablation only.

CARTO™ 3 system support of OPTRELL™ Mapping Catheter through SPU:

Visualization and mapping capabilities for the OPTRELL TM Mapping catheter. OPTRELL support includes Local Conduction Vectors (LCV), showing visualization of the wave propagation through the OPTRELL™ Catheter, indicating direction and speed.

CARTO™ 3 system support of LASSOSTAR NAV:

Visualization and mapping capabilities for LASSOSTAR NAV Circular Mapping Catheter.

1.7 LEGACY FEATURES MODIFICATIONS

VISITAG Module - Compensated VISITAG Stability Algorithm:

The VISITAG stability indication in the predicate device CARTO® 3 System V7.4 is based on the ACCURESP™ algorithm that provides the ablation catheter end-expirium locations, meaning that stability indication is updated once every respiration cycle. A modified respiration decomposition ("Compensated") algorithm was developed that estimates the catheter motion in real-time based on the respiration originated motion and subtracting it from the measured location. The Compensated Stability algorithm enables faster feedback to user at the beginning of ablation ensuring VISITAG early appearance, when the stability conditions are maintained.

Late Annotation Mapping (LAM):

Late Annotation Mapping provides an additional mapping criterion that allows a Late Boundary (LB) annotation line to be placed within the standard LAT Window of Interest (WOI).

CONFIDENSE Module - SmartMap:

In the legacy CONFIDENSE™ Module design, the map is colored according to the first point that passed the CONFIDENSE™ filter thresholds and was acquired in every specific location, and such that new potential points will be filtered out if the position is already occupied, even if they also passed the CONFIDENSETM filter thresholds (first comes, first stays).

With SmartMap, each potential point in the study is rated with a Smart Index, indicating its relative quality based on quality parameters

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(Pattern matching, Respiration, LAT stability, Position stability, Tissue proximity, Signal sharpness). SmartMap prioritizes high Smart Index score points over low Smart Index score points when building maps, by swapping points in the map according to their Smart Index score (best comes, best stays even if not first).

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The CARTOTM 3 EP Navigation System V8.0 underwent verification and Performance validation testing under simulated clinical conditions to verify the new Data: features and to demonstrate with regression testing that the modifications performed did not negatively affect existing features.

Verification and Validation Testing

Software Verification and Validation testing completed for CARTO™ 3 System V8.0 included:

Proof of Design Testing was performed to verify the ● CARTOTM 3 System V8.0 design meets specifications. All testing performed were successfully completed and met the acceptance criteria.
Functional verification - Testing was performed to verify the functional requirements of CARTOTM 3 System V8.0, including testing of the new features and improvements as well as regression testing to verify continued functionality of CARTO® 3 System legacy features. All system features were found to perform according to specifications and met the tests acceptance criteria.
Unit Tests Testing was performed to verify the design . implementation in CARTO™ 3 V8.0 software is compatible with the design. All testing performed were successfully completed and met the acceptance criteria.
Retrospective Validation Tests Testing was performed to ● validate the clinical functionality and quality of new introduced modules. Testing was performed retrospectively, on clinical recorded data from historic EP procedures performed with the CARTOTM 3 System. All testing performed were successfully completed and met the acceptance criteria.

Bench Testing:

Bench Testing completed for CARTO™ 3 System V8.0 included Usability Testing: Summative Usability testing was conducted to validate that CARTOTM 3 System V8.0 User Interface is safe and effective for use. In light of the usability validation study results, it is concluded that CARTOTM 3 System V8.0 has been found to be safe and effective for the intended users, uses and use environments.

Animal Testing:

Animal testing was conducted to evaluate the CARTOTM 3 System V8.0 functionality under simulated clinical workflow and conditions. All test protocol steps were successfully completed and expected results were achieved.

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

Clinical Testing:

A Real-World Evidence study (REAL AF Registry Sub-Study) evaluating the safety and acute effectiveness of Paroxysmal Atrial Fibrillation ablation with a zero/low fluoroscopy workflow was performed. The data from the study demonstrated the safety and effectiveness of zero/low fluoroscopy workflow. The primary safety and secondary acute effectiveness endpoints were met in the REAL AF Registry population. The safety of the zero/low fluoroscopy workflow was further corroborated by the comparable cumulative incidences of the secondary safety endpoint between the zero/low fluoroscopy group and the conventional fluoroscopy group.

The CARTO™ 3 EP Navigation System V8.0 is substantially equivalent Conclusions: to the currently cleared CARTO® 3 EP Navigation System with CARTOSOUND™ 4D, software version V7.4, 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).