CARTO 3 EP Navigation System, Version 6.0 and Accessories

K170600 · Biosense Webster, Inc. · DQK · Jul 25, 2017 · Cardiovascular

Device Facts

• Record ID: K170600
• Device Name: CARTO 3 EP Navigation System, Version 6.0 and Accessories
• Applicant: Biosense Webster, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jul 25, 2017
• 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

System acquires/analyzes intracardiac signals and catheter location data to generate 3D anatomical and electroanatomical maps of heart; utilizes magnetic sensor technology and Advanced Catheter Location (ACL) technology. Used in clinical EP labs by physicians; hardware includes Patient Interface Unit, GUI, monitors, and location pad. Enhancements in V6.0 include ConfiDENSE module for point annotation (body surface morphology, complex point identification), CARTO VIZIGO software for sheath visualization, and expanded X-ray/imaging library compatibility. Output provides real-time visualization of catheter position and electrical activity to guide cardiac procedures; assists in diagnosis and treatment of arrhythmias.

Clinical Evidence

Bench testing and pre-clinical testing under simulated clinical conditions only. No human clinical trial data presented. Testing verified new/modified features and confirmed no negative impact on existing system functionality via regression testing.

Technological Characteristics

Cardiac mapping system; magnetic sensor and ACL technology. Hardware includes PIU, GUI, monitors, and location pad. Software-based analysis of intracardiac signals. Connectivity via standard peripheral ports. Identical hardware platform to predicate. No specific materials or sterilization standards cited.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 25, 2017

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

Re: K170600

Trade/Device Name: CARTO 3 EP Navigation System. Version 6.0 and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: June 16, 2017 Received: June 19, 2017

Dear Phoung 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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Wilhelm

for

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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## Indications for Use

510(k) Number (if known) K170600

Device Name

CARTO® 3 EP Navigation System, Version 6.0 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> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) Summary – K170600

| 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<br>Phone: [phone]<br>Fax: [phone] |
| Date: | February 28, 2017 |
| Device Trade<br>Name: | CARTO® 3 EP Navigation System Version 6.0 and Accessories |
| Device Common<br>Name: | Cardiac Mapping System |
| Manufacturing<br>Number: | FG-5400-00 |
| Device<br>Classification: | Programmable diagnostic computer<br>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

Device Description: The CARTO® 3 EP Navigation System, Version 6.0 is a catheterbased 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 V6.0 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

> The CARTO® 3 System V6.0 consists of the following components:

- . Patient Interface Unit (PIU)
- 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 V6.0 are identical to those described for the predicate CARTO® 3 System V4.2.

- 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.

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Technological The proposed CARTO® 3 EP Navigation System, Version 6.0, has the same technological characteristics (i. e., design, material, Characteristics: chemical composition, energy source) as the predicate CARTO® 3 EP Navigation System, Version 4.2. 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 location mapping technology. ●
- Have identical magnetic location sensor accuracy.

The main difference between the CARTO® 3 System V4.2 and CARTO® 3 System V6.0 is to enhance the following areas:

| Enhancements | CARTO® 3 System V6.0 | Rationale for<br>Difference |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Annotations | ConfiDENSE Module has two<br>new types of point annotations<br>Body Surface Morphology<br>Matching Complex Point<br>Identification | Addition of two<br>new filters to<br>assist physicians<br>with points<br>acquisition. |
| Visualization | CARTO VIZIGO™ Software | Addition of<br>CARTO VIZIGO<br>Software to<br>support<br>visualization of<br>the VIZIGO™<br>Bi-Directional<br>Guiding Sheath. |
| Fluoro<br>Integration | Addition of TOSHIBA to the<br>CARTOUNIVU module<br>supported X-ray systems<br>library. | Compatibility<br>with TOSHIBA<br>X-ray Systems<br>has been<br>established. |
| Imaging | CARTOSEG CT and<br>CARTOSEG MR library<br>update. | Update to add<br>Siemens to the<br>library has no<br>impact on system<br>functionality or<br>workflow. |

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| | Usability | | Software Graphical User<br>Interface (GUI)<br>modifications to allow<br>Intuitive use of most used<br>features<br>• Usability features for<br>Maps | Usability changes<br>for improved<br>CARTO® 3<br>System look and<br>feel. No impact<br>on system<br>functionality or<br>workflow. |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | The CARTO® 3 EP Navigation System, Version 6.0 underwent<br>extensive bench and pre-clinical testing under simulated clinical<br>conditions to verify the new and modified features and to<br>demonstrate with regression testing that these modifications did<br>not negatively affect existing features. The CARTO® 3 EP<br>Navigation System, Version 6.0 passed all tests in accordance<br>with appropriate test criteria and standards, and the modified<br>device did not raise new questions of safety or effectiveness. | | | |
| Conclusions: | The CARTO® 3 EP Navigation System, Version 6.0 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. | | | |