CARTO™ 3 EP Navigation System V8.1

{0} FDA U.S. FOOD & DRUG ADMINISTRATION 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} 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- {2} 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 {3} | 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. | | ? | | 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. | | | | 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) | ? | {4} 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 Result: Eyal Hendel Person: 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 Classifications: 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 1 of 5 {5} 2 of 5 # 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 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. # Indications for Use: 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 {6} 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 3 of 5 {7} 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 SOUNDSTART™ CRYSTAL ULTRASOUND CATHETER When used with CARTO™ 3 EP Navigation System Version V8.1, the SOUNDSTART™ 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: 1. Complex Signal Identification, 2. VISITAG Module Stability+, 3. Confidence Module, 4. Multipolar Mapping, 5. Qdot Micro support, 6. CARTOSOUND™ 4D, and 7. CARTOSOUND™ FAM LA. 4 of 5 {8} 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. 5 of 5