CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

K173977 · Biosense Webster, Inc. · DQK · Jun 14, 2018 · Cardiovascular

Device Facts

• Record ID: K173977
• Device Name: CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jun 14, 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 V4.35 is a catheter-based mapping system for atrial and ventricular procedures. It acquires intracardiac electrical signals and catheter location data using magnetic sensor technology and Advanced Catheter Location (ACL) technology. The system processes these inputs to generate 3D anatomical and electro-anatomical maps of the heart. The COHERENT MAPPING module adds visualization of electric wave propagation, including coloring and electric wave direction vectors, to assist physicians in identifying paths of cyclic arrhythmia propagation. Used in clinical EP labs by physicians; the system displays maps on wide-screen monitors via a GUI. The output aids clinical decision-making by providing improved representation of conduction velocity vectors, potentially facilitating more focused arrhythmia treatment. Hardware components are identical to the predicate V4.2 system.

Clinical Evidence

No clinical trials were conducted. Evidence consists of extensive bench testing, pre-clinical testing under simulated clinical conditions, and retrospective validation to verify the COHERENT MAPPING feature and perform regression testing on existing features. The device passed all tests in accordance with established criteria.

Technological Characteristics

Programmable diagnostic computer (Class II). Hardware platform identical to predicate (PIU, 3D workstation, monitors, keyboard, mouse, intracardiac ports, power supply, patches connection box, pedals, location pad). Uses magnetic sensor technology and Advanced Catheter Location (ACL) technology. Software-based mapping system.

Indications for Use

Indicated for patients eligible for conventional catheter-based cardiac electrophysiological (EP) procedures. No specific age, gender, or disease state 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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

June 14, 2018

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

Re: K173977

Trade/Device Name: CARTO 3 EP Navigation System, Version 4.35 and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: May 10, 2018 Received: May 11, 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 medical devices and radiation-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.

cry,

for

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K173977

Device Name

CARTO® 3 EP Navigation System Version 4.35 and Accessories

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> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">  </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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>Quality and Regulatory Manager<br>Biosense Webster (Israel), Ltd.<br>And<br>Phuong Chau<br>Senior Regulatory Affairs Program Lead |
| Date: | December 27, 2017 |
| Device Trade Name: | CARTO® 3 EP Navigation System Version 4.35 and Accessories |
| 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 4.2 and Accessories<br>510(k)#: K133916 |
| Manufacturing Facilities: | Biosense Webster (Israel), Ltd.<br>a Johnson & Johnson Company<br>4 Hatnufa Street<br>Yokneam, ISRAEL 2066717 |

15715 Arrow Hwy Irwindale, CA 91706

{4}------------------------------------------------

### Device Description: The CARTO® 3 EP Navigation System Version 4.35 and Accessories with COHERENT MAPPING module is a catheterbased atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and electro-anatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using a set of 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 V4.35 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

CARTO® 3 EP Navigation System Version 4.35 and Accessories with COHERENT MAPPING module 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

All hardware components of the CARTO® 3 System V4.35 are identical to those described for the predicate CARTO® 3 System V4.2.

This File covers the functionality, introduced by the changes made in the CARTO®3 Navigation System 4.35 and Accessories with COHERENT MAPPING module

Because CARTO® 3 System V4.35 with COHERENT MAPPING module is only available on this version, the CARTO® 3 System V4.35 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

{5}------------------------------------------------

| | heart and about catheter location during the procedure. The<br>system can be used on patients who are eligible for a<br>conventional electrophysiological procedure. The system has no<br>special contraindications. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The proposed CARTO® 3 EP Navigation System, Version 4.35,<br>has the same technological characteristics (i. e., design, material,<br>chemical composition, energy source) as the predicate CARTO®<br>3 EP Navigation System, Version 4.2. A summary of the<br>technological characteristics of the new device compared to the<br>predicate device is as follows:<br><br>Have identical intended use. Use the same fundamental scientific technology. Have the same hardware platform. Have identical magnetic location mapping technology. Have identical magnetic location sensor accuracy. |
| | The main difference between the CARTO® 3 System V4.2 and<br>CARTO® 3 System V4.35 with COHERENT MAPPING<br>Module is to improve the representation of the electric wave<br>propagation over the atria by adding new coloring and electric<br>wave direction vector. This new coloring is an additional option<br>on top of the basic coloring of CARTO3® V4.2 cleared By FDA<br>(K133916). This improved representation of conduction velocity<br>vectors may help the physician to focus his/her attention on the<br>displayed path of cyclic arrhythmia propagation. |
| Performance Data: | The CARTO® 3 EP Navigation System, Version 4.35 underwent<br>extensive bench, pre-clinical testing under simulated clinical<br>conditions and retrospective validation to verify the new<br>COHERENT MAPPING feature to demonstrate with regression<br>testing that these modifications did not negatively affect existing<br>features. The CARTO® 3 EP Navigation System, Version 4.35<br>passed all tests in accordance with appropriate test criteria and<br>standards, and the modified device did not raise new questions of<br>safety or effectiveness. |
| Conclusions: | The CARTO® 3 EP Navigation System, Version 4.35 is<br>substantially equivalent to the currently cleared CARTO® 3 EP<br>Navigation System, Version 4.2 based on the completion of non-<br>clinical bench testing and pre-clinical testing as well as similar<br>principles of design, operation and indications for use. |