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 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 CARTO™ 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO™ 3 System V8.1 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 V8.1 are the same as those found in the predicate device.

AI/ML Overview

The provided FDA 510(k) clearance letter for the CARTO™ 3 EP Navigation System V8.1 does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device (CARTO™ 3 EP Navigation System V8.0) and outlines the V&V testing performed at a high level.

Specifically, the document does not report specific quantitative acceptance criteria or reported device performance metrics in a readily extractable table format. It states that "All tests were successfully completed and met the acceptance criteria" for various testing phases, but the acceptance criteria themselves are not provided. Similarly, actual performance metrics (e.g., accuracy values, false positive rates, etc.) are not listed.

Regarding the "study that proves the device meets the acceptance criteria," the document describes verification and validation testing, but this is not presented as a single, comprehensive "study" with a specific design (like an MRMC study or a standalone performance study) and reported results in the same way one might describe a clinical trial. Instead, it's a summary of different types of engineering and software testing.

Given these limitations, I will extract and infer information where possible based on the provided text, and explicitly state when information is not available in the document.

Overview of Device Acceptance and Performance (Based on Available Information)

The acceptance of the CARTO™ 3 EP Navigation System V8.1 is broadly based on the successful completion of various verification and validation (V&V) tests, ensuring the device meets its design specifications and performs as intended, especially with new features and existing functionalities. The primary "proof" of acceptance is the statement that "All tests were successfully completed and met the acceptance criteria," even if those criteria are not quantitatively detailed.

Since quantitative acceptance criteria and reported numerical performance are not explicitly provided, a table with specific metrics cannot be generated. The document focuses on conceptual and functional "acceptance."

Detailed Breakdown of Available Information:

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

Not explicitly provided in the document in a quantitative, tabular format.

The document states:

"All tests were successfully completed and met the acceptance criteria" for "Proof of Design."
"All system features were found to perform according to specifications and met the tests acceptance criteria" for "Functional verification."
"All tests were successfully completed and met the acceptance criteria" for "Unit Tests."
"All testing performed were successfully completed and met the acceptance criteria" for "Retrospective Validation Tests."
"All test protocol steps were successfully completed and expected results were achieved" for "Animal Testing."

While these statements confirm the device met its internal acceptance criteria, the specific numerical values of these criteria (e.g., "accuracy > X mm," "sensitivity > Y%") and the actual measured performance values are not disclosed in this 510(k) letter.

Inferred Performance Claims:

The device maintains "identical magnetic location sensor and ACL location accuracy" as the predicate device (V8.0). However, the specific accuracy values are not stated for either version.

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

Test Set Sample Size: Not explicitly stated.
- For "Retrospective Validation Tests," it mentions "clinical recorded data from historic EP procedures." The number of procedures or specific data points is not provided.
- For "Animal Testing," it indicates "animal testing was conducted," but the number of animals or specific test cases is not provided.
Data Provenance:
- Country of Origin: Not explicitly stated. The company Biosense Webster has facilities in Irvine, CA, USA, and Yokneam, Israel. The data could originate from clinical sites globally.
- Retrospective or Prospective:
  - "Retrospective Validation Tests" explicitly used "clinical recorded data from historic EP procedures." This indicates retrospective data.
  - "Animal Testing" would be considered prospective in the context of controlled experimental animal studies.

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

Not explicitly stated. The document does not describe the process of establishing ground truth for any of the V&V tests, nor the involvement or qualifications of experts for this purpose.

4. Adjudication method for the test set

Not explicitly stated. Given that expert involvement for ground truth is not detailed, an adjudication method is also not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

No, an MRMC comparative effectiveness study was NOT done or reported. The document focuses on demonstrating substantial equivalence through technical V&V testing and software feature improvements, not on comparative effectiveness with human readers. The CARTO™ 3 System is a navigation system, not an AI for image interpretation that typically undergoes MRMC studies.

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

Yes, aspects of standalone performance were evaluated, though not explicitly labeled as such.

"Proof of Design" and "Unit Tests" would inherently involve evaluating the device's (or its software components') performance against design specifications in a standalone manner, without direct human-in-the-loop interaction beyond setup and execution of the tests.
The statement "identical magnetic location sensor and ACL location accuracy" implies a standalone assessment of the system's core navigational accuracy.

However, specific quantitative metrics for this standalone performance (e.g., location accuracy in mm, precision, etc.) are not provided.

7. The type of ground truth used

Not explicitly stated for specific tests.

Inferred types of ground truth based on the nature of the device and tests:

Engineering Specifications/Reference Standards: For "Proof of Design," "Functional verification," and "Unit Tests," the ground truth would likely be defined by internal engineering design specifications, simulated environments, and established reference measurements. For accuracy testing of location, highly precise physical measurement systems or phantoms would be used as ground truth.
Retrospective Clinical Data: For "Retrospective Validation Tests," ground truth would presumably come from existing clinical records of "historic EP procedures," although how this ground truth was established within those records (e.g., confirmed diagnoses, procedural outcomes, expert review) is not detailed.
Direct Observation/Measurement in Animal Models: For "Animal Testing," ground truth would be based on direct measurements and observations within the animal during the simulated procedures.

8. The sample size for the training set

Not applicable/Not mentioned. The CARTO™ 3 System is described as a navigation system with improved software features (e.g., catheter support, legacy feature enhancements). It is not presented as an AI/ML model that undergoes a distinct "training set" development phase in the typical sense of deep learning models requiring large datasets for training. The changes appear to be more in line with traditional software development and feature integration.

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

Not applicable/Not mentioned (as it's not described as an AI/ML system with a training set).

Summary of Limitations of the Document for this Request:

The provided FDA 510(k) clearance letter serves its purpose of demonstrating substantial equivalence based on the provided V&V testing summary. However, it is not a detailed technical report or clinical study publication that would typically include the specific quantitative acceptance criteria, full performance metrics, detailed sample sizes, expert qualifications, or ground truth methodologies you are requesting for a comprehensive analysis of a device's proven performance. The document implies successful adherence to internal specifications without detailing those specifications or the resultant performance values.

Summary

FDA 510(k) Clearance Letter - CARTO™ 3 EP Navigation System V8.1

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 22, 2025

Biosense Webster, Inc.
℅ Eyal Hendel
Associate Director of Regulatory Affairs
Biosense Webster, Ltd.
4 Hatnufa Street
Yokneam, 2066717
Israel

Re: K252302
Trade/Device Name: CARTO™ 3 EP Navigation System V8.1
Regulation Number: 21 CFR 870.1425
Regulation Name: Programmable Diagnostic Computer
Regulatory Class: Class II
Product Code: DQK
Dated: July 24, 2025
Received: July 24, 2025

Dear Eyal Hendel:

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 (the 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 available 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.

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K252302 - Eyal Hendel Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252302 - Eyal Hendel Page 3

assistance/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

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K252302
Please provide the device trade name(s).

CARTO™ 3 EP Navigation System V8.1

Please provide your Indications for Use below.

Please select the types of uses (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, CA 92618, USA
Tel.: (800) 729-9010
Fax: (909) 839-8500

Contact Person: Eyal Hendel
Associate Director of Regulatory Affairs
Biosense Webster (Israel), Ltd.
Phone: +972-52-5246178

Authored by: Eyal Hendel
Associate Director of Regulatory Affairs
Biosense Webster (Israel), Ltd.

Hen Keren Lap
Sr. Regulatory Affairs Program Lead
Biosense Webster (Israel), Ltd.

Date: July 23, 2025

Device Trade Name: CARTO™ 3 EP Navigation System V8.1

510(k) Number: K252302

Device Common Name: Cardiac Mapping System

Manufacturing Number: FG-5400-00

Device Classification: Programmable diagnostic computer
Class II, 21 CFR 870.1425

Product Code: DQK

Predicate Device: CARTO® 3 EP Navigation System Version 8.0 510(k)#: K231207

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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 Dr, Irvine, CA 92618
USA

Device Description:

The CARTO™ 3 System V8.1 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 V8.1 are the same as those found in the predicate device.

Indications for Use:

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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 V8.1 are identical to the indications for use of the predicate device, the CARTO® 3 System, software V8.0.

Technological Characteristics:

The modified CARTO™ 3 EP Navigation System V8.1 has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate CARTO™ 3 EP Navigation System, software V8.0 (K231207). 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 new software features, improvements of the legacy modules.

1 CATHETERS SUPPORT

1.1 CARTO™ 3 SYSTEM SUPPORT OF FARAWAVE CATHETER VISUALIZATION

The Boston Scientific FARAWAVE catheter is supported by the CARTO™ 3 System through a validated XML file containing the catheter essential physical characteristics, such as shape, number of electrodes, and relative distances. This allows the system to recognize the catheter and accurately display its representation among other connected devices, maps and CT/MR imaging. Additionally, the CARTO™ 3 System provides Tissue Proximity Indication (TPI) for the FARAWAVE catheter, offering real-time feedback on electrode proximity to cardiac tissues.

1.2 SUPPORT WITH VARIPULSE™ CATHETER AND TRUPULSE™ GENERATOR

The PFA Support Module provides real-time display of the VARIPULSE™ Catheter in the CARTO™ 3 System. In addition, the

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catheter can be used for standard functionality such as FAM acquisition, Electro anatomical MEM point acquisition, pacing, and building the visualization matrix.

1.3 CARTO™ 3 SYSTEM SUPPORT OF SOUNDSTAR™ CRYSTAL ULTRASOUND CATHETER

When used with CARTO™ 3 EP Navigation System Version V8.1, the SOUNDSTAR™ Crystal Ultrasound Catheter provides location information and is compatible with the legacy CARTO™ 3 CARTOSOUND™ SW and CARTOSOUND FAM LA Modules.

2 LEGACY FEATURES ENHANCEMENTS

Minor enhancement to the following legacy features:

Complex Signal Identification,
VISITAG Module Stability+,
Confidense Module,
Multipolar Mapping,
Qdot Micro support,
CARTOSOUND™ 4D, and
CARTOSOUND™ FAM LA.

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Performance Data:

The CARTO™ 3 EP Navigation System V8.1 underwent 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.

Verification and Validation Testing

Software Verification and Validation testing completed for CARTO™ 3 System V8.1 included:

Proof of Design – Testing was performed to verify the CARTO™ 3 System V8.1 design meets its accuracy specifications. All tests were successfully completed and met the acceptance criteria.
Functional verification – Testing was performed to verify the functional requirements of CARTO™ 3 System V8.1, 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 V8.1 software aligns perfectly with the design specifications. All tests were successfully completed and met the acceptance criteria.
Retrospective Validation Tests – Testing was performed to validate the clinical functionality and quality of the introduced modules. Testing was performed retrospectively, on clinical recorded data from historic EP procedures performed with the CARTO™ 3 System. All testing performed were successfully completed and met the acceptance criteria.

Animal Testing:

Animal testing was conducted to evaluate the CARTO™ 3 System V8.1 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 the modified device did not raise new questions of safety or effectiveness.

Conclusions:

The CARTO™ 3 EP Navigation System V8.1 is substantially equivalent to the currently cleared CARTO™ 3 EP Navigation System with software version V8.0, 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).