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 7.1 is a catheter-based atrial and ventricular mapping diagnostic system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical diagnostic 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 system allows electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System V7.1 uses the same two distinct types of location technology as the predicate device - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO® 3 System V7.1 consists of the following hardware components:

Patient Interface Unit (PIU) and Cables
3D Graphics Workstation
Wide-Screen monitors, keyboard, and mouse
Intracardiac In Port
Intracardiac Out Port
Power Supply
Patches Connection Box and Cables
Pedals
Location Pad

All hardware components of the CARTO® 3 System V7.1 are identical to those described for the predicate device.

AI/ML Overview

The provided text is a 510(k) summary for the Biosense Webster CARTO® 3 EP Navigation System, Version 7.1. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific clinical study with acceptance criteria for an AI/algorithm-driven diagnostic device.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth adjudication, MRMC studies, standalone performance, and ground truth establishment for training data specifically for an AI/algorithm are not present in this document. The CARTO® 3 System is a navigation and mapping system for electrophysiological procedures, and its V7.1 update primarily involves software modifications to existing functions and usability improvements, rather than introducing a new AI diagnostic algorithm that requires a detailed validation study against ground truth as might be seen for an imaging AI.

However, I can extract the information that is available and clearly state what is not provided based on the document.

Analysis of Acceptance Criteria and Device Performance (based on provided text)

The document describes the CARTO® 3 EP Navigation System, Version 7.1 as having undergone "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 in the predicate and reference devices." It concludes that "All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness."

This indicates that the acceptance criteria were primarily related to functional verification, regression testing, and ensuring the modified device's performance was at least as good as, and did not negatively impact, the predicate device. Specific quantitative acceptance criteria or raw performance numbers are not provided in this 510(k) summary.

Therefore, a table of specific quantitative acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy) cannot be created from this document. The performance is generally stated as "all testing passed."

Details Noted from the Document:

A table of acceptance criteria and the reported device performance:
- Not provided in detail. The document states: "All testing passed in accordance with appropriate test criteria and standards." No specific quantitative metrics (e.g., % accuracy, sensitivity, specificity, or specific error tolerances) are listed as acceptance criteria, nor are corresponding numerical results. The performance is generally concluded as not negatively affecting existing features and not raising new safety/effectiveness questions.
Sample sizes used for the test set and the data provenance:
- Not specified. The document mentions "extensive bench and pre-clinical testing under simulated clinical conditions." It does not provide the number of cases, patients, or specific data provenance (e.g., country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. Given the nature of the device (navigation and mapping), ground truth for performance testing would likely involve physical accuracy measurements and functional verification against known standards, rather than expert interpretation of medical images. The document does not describe a process involving expert readers for ground truth establishment.
Adjudication method for the test set:
- Not applicable/Not specified. As there's no mention of expert interpretation or ground truth derived from multiple experts, an adjudication method is not described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:
- Not applicable/Not specified. This type of study is typically done for AI-assisted diagnostic imaging, where the AI provides interpretations or assists human readers. The CARTO® 3 System is a navigation and mapping system used during EP procedures, not a diagnostic imaging AI in the context of interpreting images or assisting human readers with a diagnostic task.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly described in terms of a standalone diagnostic algorithm performance. The testing encompassed "bench and pre-clinical testing" which implies functional verification of the system's capabilities (e.g., mapping accuracy, signal processing, display features). This is different from the standalone performance metrics (like AUC for classification) seen in diagnostic AI algorithms.
The type of ground truth used:
- Inferred to be functional measurements and physical verification. For a mapping and navigation system, ground truth would likely relate to the accuracy of 3D anatomical and electroanatomical mapping, catheter location, and signal acquisition. This would be established through precise physical measurements, calibration, and comparison against known standards in simulated environments, rather than expert consensus on medical images or pathology.
The sample size for the training set:
- Not applicable/Not specified. This device is described as a "programmable diagnostic computer" that processes signals and displays maps. The description of modifications primarily involves merging existing functions and improving user experience ("LAT Histogram," "Map Consistency Display," "Parallel Mapping," "Advanced Reference Annotation," "Power line noise rejection," "GUI improvement"). This suggests software development and refinement rather than a machine learning model that requires a distinct "training set" for model parameters. The document does not indicate the use of a machine learning or deep learning algorithm requiring a separate training set.
How the ground truth for the training set was established:
- Not applicable/Not specified. As no training set for an AI/ML model is mentioned, this information is not relevant to the document provided.

In summary: The provided 510(k) summary for the CARTO® 3 EP Navigation System, Version 7.1, focuses on demonstrating substantial equivalence through a series of functional and regression tests ("bench and pre-clinical testing") verifying new features and ensuring existing features were not negatively impacted. It does not present a detailed clinical study with quantitative performance metrics, specific acceptance criteria, or ground truth establishment methods typically associated with the validation of an AI/algorithm-driven diagnostic device. The device is a navigation and mapping system, not a diagnostic AI in the common sense addressed by the questions.

Summary

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July 20, 2019

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

Re: K191660

Trade/Device Name: CARTO 3 EP Navigation System, Version 7.1 and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 19, 2019 Received: June 21, 2019

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 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

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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,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: 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) K191660

Device Name

CARTO® 3 EP Navigation System Version 7.1 and Accessories

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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K191660 510(k) Summary

Applicant:	Biosense Webster, Inc.33 Technology DriveIrvine, CA 92618, USATel.: (800) 729-9010Fax: (909) 839-8500
Contact Person:	Phuong ChauSenior Regulatory Affairs Program LeadPhone: 949-923-4238Fax: 949-450-6886
Authored by:	Elena GoldinQuality and Regulatory Senior SpecialistBiosense Webster (Israel), Ltd.AndPhuong ChauSenior Regulatory Affairs Program LeadBiosense Webster, Inc.
Date:	June 19, 2019
Device Trade Name:	CARTO® 3 EP Navigation System Version 7.1 andAccessories
Device CommonName:	Cardiac Mapping System
ManufacturingNumber:	FG-5400-00/FG-5400-00U
DeviceClassification:	Programmable diagnostic computerClass II, 21 CFR 870.1425
Product Code	DQK
Predicate Device:	CARTO® 3 EP Navigation System Version 6.0 andAccessories with VISITAG SURPOINT510(k)#: K180238
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

Device Description: The CARTO® 3 EP Navigation System, Version 7.1 is a catheter-based atrial and ventricular mapping diagnostic system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical diagnostic 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 system allows electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System V7.1 uses the same two distinct types of location technology as the predicate device - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO® 3 System V7.1 consists of the following hardware components:

Patient Interface Unit (PIU) and Cables ●
3D Graphics Workstation
Wide-Screen monitors, keyboard, and mouse ●
Intracardiac In Port ●
Intracardiac Out Port ●
Power Supply
Patches Connection Box and Cables 0
Pedals ●
Location Pad o

All hardware components of the CARTO® 3 System V7.1 are identical to those described for the predicate device.

The intended use of the CARTO® 3 System is catheter-based Indications for Use: 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 modified CARTO® 3 EP Navigation System, Version 7.1 Technological has the same technological characteristics (i. e., design, Characteristics: material, chemical composition, energy source) as the predicate CARTO® 3 EP Navigation System device. A

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Page 3 of 4

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 0
o Have identical magnetic location mapping technology

The main difference between the predicate device and the modified device are the merging of previously cleared functions (CARTOFINDER K173978 and Coherent Mapping module K173977 reference devices) in a CARTO3 software version, new modifications, and the addition of Letter to File changes as described below:

Summary of Modifications

Mapping and Annotations:

LAT Histogram a graphical representation of the ● Local Activation Time (LAT) values of all points that contribute to the Active Map's LAT coloring, over a time interval (range) from the lowest to highest LAT value.

Letter To File Changes:

LAT Hybrid Maps
Improvements for displays (Map Consistency Display) ●
o Map filtering (Parallel Mapping)
Signals displays (previous beat overlay)
Signals annotations (Advanced Reference Annotation (ARA))
Signals filtering (Power line noise rejection) ●
GUI improvement to improve user experience ● (usability) such as high definition (HD) propagation style
Updated Visualization Setup window display
Increased limit of points in map
Backup time reduction
The CARTO® 3 EP Navigation System, Version 7.1 underwent Performance Data: extensive bench and pre-clinical testing under simulated

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K191660

Page 4 of 4

clinical conditions to verify the new and modified features and to demonstrate with regression testing that these modifications did not negatively affect existing features in the predicate and reference devices. All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness. The CARTO® 3 EP Navigation System, Version 7.1 and Conclusions: Accessories is substantially equivalent to the cleared CARTO® 3 EP Navigation System V6 based on the completion of nonclinical 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).