CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module

K173978 · Biosense Webster, Inc. · DQK · Aug 24, 2018 · Cardiovascular

Device Facts

• Record ID: K173978
• Device Name: CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Aug 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended 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 patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

Device Story

CARTO 3 EP Navigation System V5.2 is a catheter-based cardiac mapping system. It acquires intracardiac electrical signals and catheter location data using magnetic and Advanced Catheter Location (ACL) technologies. The system includes a new CARTOFINDER Module and workstation that processes multi-connector electrode catheter signals to generate 3D anatomical and electroanatomical maps. Maps include 4D Local Activation Time (LAT), Cycle Length (CL) Unipolar Signal, CL Variation, and Regions of Interest (ROI) for focal and rotational activation patterns. Used in EP labs by physicians to visualize arrhythmia patterns. Output is displayed on a 3D graphical workstation. The system assists in diagnosing cardiac arrhythmias by identifying signal propagation directions. It does not provide therapy; therapeutic decisions rely on all available clinical information. Benefits include enhanced visualization of complex cardiac electrical activity.

Clinical Evidence

Supported by bench testing, animal studies under simulated clinical conditions, and clinical data from Biosense Webster-sponsored studies and published literature. Bench testing verified functional requirements, signal preprocessing, annotation detection, and integration of the CARTOFINDER Module. Animal testing evaluated workflow. Clinical data supported the performance of new maps and compatible catheters for their intended diagnostic use.

Technological Characteristics

System comprises a Patient Interface Unit (PIU), 3D graphical workstation, wide-screen monitors, location pad, and CARTOFINDER workstation. Uses magnetic sensor technology and Advanced Catheter Location (ACL) for mapping. Supports multi-electrode catheter recordings via specialized interface cables. Software-based signal processing and mapping algorithms. Connectivity includes interfaces for ultrasound, EP recording, fluoroscopic, and RF generator systems.

Indications for Use

Indicated for patients eligible for conventional catheter-based cardiac electrophysiological (EP) procedures. No specific age or gender restrictions; no special contraindications.

Regulatory Classification

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.

Predicate Devices

• CARTO® 3 EP Navigation System Version 4.2 and Accessories (K133916)

Submission Summary (Full Text)

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August 24, 2018

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

Re: K173978

Trade/Device Name: CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK. Dated: July 31, 2018 Received: August 1, 2018

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Mude Jellm
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K173978

Device Name

CARTO® 3 EP Navigation System Version 5.2 and Accessories with CARTOFINDER Module

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="2" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

| Applicant: | Biosense Webster, Inc.<br>33 Technology Drive<br>Irvine, CA 92618, USA<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Phuong Chau<br>Senior Regulatory Affairs Program Lead<br>Phone: [phone]<br>Fax: [phone] |
| Authored by: | Moshe Hochmitz<br>Associate Director, Quality and Regulatory<br>Biosense Webster (Israel), Ltd.<br>And<br>Phuong Chau<br>Senior Regulatory Affairs Program Lead |
| Date: | July 27, 2018 |
| Device Trade<br>Name: | CARTO® 3 EP Navigation System Version 5.2 and Accessories with<br>CARTOFINDER™ Module |
| Device Common<br>Name: | Cardiac Mapping System |
| Manufacturing<br>Number: | FG-5400-00 |
| Device<br>Classification: | Programmable diagnostic computer |
| Classification: | Class II, 21 CFR 870.1425 |
| Product Code | DQK |
| Predicate Device: | CARTO® 3 EP Navigation System Version 4.2 and Accessories<br>510(k)#: K133916 |
| Manufacturing<br>Facilities: | Biosense Webster (Israel), Ltd.<br>a Johnson & Johnson Company<br>4 Hatnufa Street<br>Yokneam ISRAEL 2066717 |

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Biosense Webster, Inc. 15715 Arrow Hwy Irwindale, CA 91706

The CARTO® 3 EP Navigation System Version 5.2 and Accessories is Device Description: 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 V5.2 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

> The CARTO® 3 EP Navigation System Version 5.2 is a modification to the CARTO® 3 EP Navigation System Version 4.2 to add the CARTOFINDER™ Module and workstation as an accessory to the CARTO® 3 System. The CARTOFINDER™ Module sends recorded electrical signals collected from multi-connector electrode catheters to the CARTOFINDER™ workstation, which generates new visual format maps to be displayed in the CARTO® 3 EP Navigation System. The new visual format maps generated by the CARTOFINDER™ Workstation are divided into two categories:

- 1. Dynamic mapping algorithms: Wherein the physiological scoring is changing over time after inspecting the input signals in a certain window of interest.
- 2. Static mapping algorithms: These maps set a single physiological scoring per electrode, after analyzing the input signals during the full recording time.

The CARTOFINDER™ Workstation creates the following Dynamic and Static Maps:

- 1. 4D LAT: Dynamic map of the Local Activation Time.
- 2. Cycle Length (CL) Unipolar Signal: Static map showing the dominant cycle length measured on each recorded channel per recording/data acquisition set.
- 3. Cycle Length (CL) Variation: Static map showing the standard deviation cycle length measured on each recorded channel.
- 4. CARTOFINDER™ Region of Interest (ROI) Focal: This map will identify the area with OS morphology on the unipolar electrograms that are activated early compared to the

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surrounding multi-connector (MC) electrode catheter recorded channels.

- 5. CARTOFINDER™ (ROI) Rotational: This map will identify rotational activation patterns that occupy at least 50% of the cycle length map (this condition requires sufficient spatial and temporal resolution).
CARTO® 3 EP Navigation System Version 5.2 and Accessories consists of the following components:

- Patient Interface Unit (PIU) ●
- 3D graphical Workstation that serves as the Graphic User Interface (GUI), Wide-Screen monitors, keyboard, and mouse
- Intracardiac In Port
- Intracardiac Out Port ●
- Power Supply ●
- . Patches Connection Box and Cables
- Pedals
- Location Pad ●
- CARTOFINDER™ Workstation ●
- Non-Biosense Webster basket catheter interface cable (CA-● 5400-61)

Because CARTOFINDER™ is only available on this version, the CARTO® 3 System V5.2 will be marketed in parallel with the CARTO® 3 System V6.0 software. Future software releases may incorporate this functionality pending company business decisions

- 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 patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
The proposed CARTO® 3 EP Navigation System, Version 5.2, has the Technological same technological characteristics as the predicate CARTO® 3 EP Characteristics: Navigation System, Version 4.2. A summary of the technological characteristics of the new device compared to the predicate device is provided in the following table.

| | CARTO 3 System V4.2<br>(K133916) | CARTO® 3 EP Navigation<br>System Version 5.2 with<br>CARTOFINDER™ Module<br>(K173978) |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The intended use of the<br>CARTO® 3 System is catheter-<br>based cardiac<br>electrophysiological (EP) | Same |
| | procedures. The CARTO® 3<br>System provides information<br>about the electrical activity of the<br>heart and about catheter location<br>during the procedure. The system<br>can be used on patients who are<br>eligible for a conventional<br>electrophysiological procedure.<br>The system has no special<br>contraindications. | |
| System | Patient Interface Unit (PIU)<br>Workstation Computer with<br>standard keyboard and<br>mouse<br>Single monitor display<br>Intracardiac Port<br>Intracardiac Out Port<br>Power Supply<br>Patch Connections Box and<br>Cables<br>Pedals<br>Location Pad | Addition of the<br>CARTOFINDER™ Workstation<br>(Workstation specifications are<br>same as CARTO 3 System<br>Workstation specifications) |
| Sensors catheters<br>support | Mapping and visualization based<br>on Basic triangulation of<br>Magnetic Location algorithm | Same |
| Non-Sensors<br>catheters support | Mapping and visualization based<br>on Current based location (ACL)<br>algorithm | Same |
| Interface for Data<br>transfer<br>CARTOFINDERTM<br>Module | Interfacing with compatible<br>devices (such as Ultrasound<br>systems, EP recording systems,<br>Fluoroscopic systems, RF<br>Generators) | Extended interface abilities to<br>support the CARTOFINDERTM<br>Workstation data. |
| Offers Display<br>Options for Review<br>of Processed<br>Signals | LAT (including propagation of<br>single beat)<br>Anatomical<br>Unipolar & Bipolar Voltage<br>maps<br>Impedance | 4D LAT<br>enhanced to review signal<br>propagation over the<br>complete periods of time of<br>signal recording<br>CL Stability<br>CL Variation<br>ROI - Focal<br>ROI - Rotational |
| Supports Multi<br>Electrode Catheter<br>Recordings | Yes | MEM capability was expanded<br>to high number of electrodes,<br>including interface cable (CA-<br>5400-61) to support basket<br>catheter |

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The CARTO® 3 System V5.2 is substantially equivalent to the CARTO® 3 System V4.2, as the mechanism of the diagnostic maps of both devices remains the same. Both devices use IC annotated signal in a known location and present them in a sequence that determines the propagation direction of the signal in the tissue allowing the physician to diagnose the arrhythmia pattern. Except for the CARTOFINDER™ Workstation, the hardware components of the CARTO® 3 System V5.2

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are identical to those described for the predicate CARTO® 3 System V4.2.

The CARTO® 3 EP Navigation System, Version 5.2 underwent Performance Data: 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. The CARTO® 3 EP Navigation System, Version 5.2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.

### Bench Testing:

Non-clinical performance testing completed for the CARTO® 3 EP Navigation System, Version 5.2 included:

- CARTO® 3 System Version 5.2 verify the functional . requirements and hardware configurations with the new CARTOFINDER™ Module and Workstation, regression testing of all CARTO® 3 System legacy features, verify system functionality for all supported catheters, and usability testing.
- . CARTOFINDERTM Workstation testing - verify the signal preprocessing and annotation detection, maps and catheter generation and coloring, CARTOFINDER™ functionality (including MC catheter support), stimulation detection and blanking, coloring projection and interpolation, power reject algorithm performance, and usability testing.
- CARTOFINDER™ integration verify that the new module . interface with the CARTOFINDER™ Workstation meets requirements and functions as intended when integrated with the CARTO® 3 system.
- . Interface cable - verification testing was completed for the interface cable connected to a non-Biosense Webster basket catheter with the CARTO® 3 System.

### Animal Testing:

Animal testing was performed to evaluate the CARTO® 3 System Version 5.2 and CARTOFINDER™ Workstation workflow under simulated clinical workflow.

### Clinical Data:

Clinical data from Biosense Webster sponsored studies, published literature, and manuscripts were used to support the clinical performance of the new maps for their respective intended use. The data also supported the clinical performance of the compatible catheters with the new maps. The information provided by these maps

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are for diagnostic purposes only. Therapeutic treatment should rely on all available information in the EP lab.

The CARTO® 3 EP Navigation System, Version 5.2 is substantially Conclusions: equivalent to the currently cleared CARTO® 3 EP Navigation System, Version 4.2 based on the completion of non-clinical bench testing, preclinical testing, and clinical data as well as similar principles of design, operation and indications for use.