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 System V4.2 is 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 in real-time. 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 realtime display of electrograms and cardiac maps based on the received intracardiac signals from the catheters in a number of different formats. The acquired patient, signals, including body surface ECG and intracardiac electrograms (IECG) may also be displayed on the display screen. The CARTO 3 System V4.2 uses two distinct types of location technology-magnetic sensor technology and Advanced Catheter Location (ACL) technology.

AI/ML Overview

The CARTO® 3 EP Navigation System, Version 4.2, is 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 in real-time. It provides information about the electrical activity of the heart and catheter location during electrophysiological procedures.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific quantitative acceptance criteria or objective performance metrics for the CARTO® 3 EP Navigation System, Version 4.2. Instead, it focuses on the device's substantial equivalence to a predicate device and its ability to perform as well as or better than the predicate for its intended use.

The reported performance is described qualitatively:

"The CARTO 3 EP Navigation System, Version 4.2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness."
"The Bench and Animal Non-Clinical Testing demonstrated that the CARTO® 3 EP Navigation System, Version 4.2 is as safe, as effective, and performs as well as or better than the predicate device and two reference devices."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Bench and Animal Non-Clinical Testing" for verification of new and modified features, but does not specify the sample size for these tests.
The data provenance is implied to be from internal company testing (Biosense Webster, Inc.) and is non-clinical (bench and animal), not human patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide information regarding the number of experts or their qualifications for establishing ground truth for the non-clinical test set.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method for the non-clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed or reported in this document. This submission primarily focuses on the device's technical updates and non-clinical performance for substantial equivalence.

6. Standalone (Algorithm Only) Performance:

The document describes "Bench and Animal Testing" which would likely evaluate the device's algorithms and hardware in a standalone manner. The conclusion states that the system "passed all tests" and "performs as well as or better than the predicate device." However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) were not provided.

7. Type of Ground Truth Used:

For the non-clinical testing, the ground truth would have been established through controlled experimental setups and measurements in bench and animal models, rather than expert consensus on patient data, pathology, or outcomes data.

8. Sample Size for the Training Set:

The document does not specify a sample size for any training set. Given the nature of the device (an EP navigation system with primarily software enhancements and hardware changes for existing functionalities), it's unlikely a machine learning-based training set in the conventional sense was used for this 510(k) submission. The "algorithms" mentioned are likely deterministic or rule-based, or if they involve machine learning, the details are not provided.

9. How the Ground Truth for the Training Set Was Established:

As no training set is described, this information is not available in the document.

Summary

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K133916

JUL 0 1 2014

510(K) SUMMARY 14

and the comments of the commend of the bearing the form and the

14.1 General Information
Applicant:	Biosense Webster, Inc.3333 Diamond Canyon RoadDiamond Bar, California 91765 USAPhone: 909-839-8597Fax: 909-839-8804
Date:	December 19, 2013
Contact Person:	Wayne R. HohmanProject Manager Regulatory Affairs
Authored By:	Moshe HochmitzQuality and Regulatory ManagerBiosense Webster (ISRAEL), Ltd.
Trade/Proprietary Device Name:	CARTO® 3 EP Navigation System, Version 4.2 andAccessories
Manufacturing Part Number:	FG-5400-00
Common Device Name:	Cardiac mapping system
Classification Name:	Programmable diagnostic computerClass II, 21 CFR 870.1425, Product Code DQK
Predicate Devices:	CARTO® 3 EP Navigation System, Version 3.0, clearedvia 510(k) K120550, May 7, 2012.Referenced Device 1Siemens MAGNETOM Skyra with Syngo MR D11,510(k) K111242 cleared November 23, 2011.Reference Device 2ST JUDE EnSite NavXTM CONTACT, 510(k)K130727 cleared August 29, 2013, included only forthe VeriSense System Software.
Manufacturing Facilities:	Biosense Webster (Israel), Ltd.a Johnson & Johnson Company4 Hatnufa Street, POB 275Yokneam 20692 ISRAEL

Biosense Webster, Inc. CARTO® 3.V4.2 EP Navigation

Traditional 510(k)
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Biosense Webster, Inc. a Johnson & Johnson Company 3333 Diamond Canyon Road Diamond Bar; California 91765 USA

14.2 Substantial Equivalence

The CARTO 3 EP Navigation System, Version 4:2 in substantially equivalent;to the legally marketed CARTO 3 EP Navigation System, Version 3.0 and two Reference Devices as shown in the following Table:

Predicate Devices for CARTO® 3 EP Navigation System, Version 4.2
Predicate/Reference Name	510(k)Number	Equivalence Criteria
CARTO® 3 EP NavigationSystem, Version 3.0	K120550	Main predicate for legacyfunctionality
Siemens MAGNETOMSkyra with Syngo MR D11	K111242	For segmentation functionality
ST JUDE EnSite NavXTMCONTACT, 510(k) clearedAugust 29, 2013, included	K130727	For segmentation functionality

143 Description of Device

14.4 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.

Biosense Wabstar, Inc. CARTO® 3 V4.2 EP Navigatio

Traditional 510(k)
Page 105 of 1491

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14.5 Technological Characteristics

The Proposed CARTO® 3 EP Navigation System, Version 4.2, has the same technological characteristics (i. e., design, material, chemical composition, energy isource) as the predicate CARTO® 3 EP Navigation System, Version 3.0. A summary of the technological characteristics of the new device compared to the predicate device is as follows:

· The hardware platform of the new Version 4.2 is identical to the predicate Version 3:0 except for replacement of a Printed Circuit Board.
· The differences between CARTO® 3 System, Version 3.0 and Version 4.2 a mainly three added software features, one of which required a hardware change, as follows:
- CARTOMERGE Plus Image Integration Software Module Improvement.
- Continuous ECG Visualization Module.
- · Tissue Proximity Indication (TPI) Module:
  - · Software Feature: Added Tissue Proximity Indication (TPI) algorithms.
  - · Hardware Feature: Modified ACL Tx card to add electrode voltage measurement.
- O SMARTTOUCHTM Module.
In addition, Biosense Webster improved (i. e., enhanced) the capabilities of four previously cleared software features as follows:
- Enhanced VisiTag II Module.
- Enhanced Continuous Acquisition of Electroanatomical Points.
- Enhanced Time-Sync Heart Rhythm for CARTOUNIVUTM Fluoro Background Cine Movies.
- o Enhanced Map Alignment Tool (MAT)
Finally, Biosense Webster updated FDA on features that were incorporated via 510(k) Letters to File since the last submission: Two new Map Displays New Signal Annotation Options, an additional Foot Pedal (ergonomic feature), support of New Catheters, and support of Dual Monitors.

14.6 Summary of Non-Clinical Performance Testing

The CARTO® 3 EP Navigation System, Version 4.2 underwent extensive Bench and Animal Testing to verify the new and modified features and to demonstrate with regression testing that the new/modified features did not negatively affect existing. features. The CARTO 3 EP Navigation System, Version 4.2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.

Biosense Webstar, Inc CARTO® 3 V4 2 EP Navi

Traditional 510(k)
Page 106 of 1491

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14.7 Conclusions

The Bench and Animal Non-Clinical Testing demonstrated that the CARTO® 3.EP
Navigation System, Version 4.2 is as safe, as effective, and performs as well as or better than the predicate device and two reference devices. This testing program
supports the determination of substantial equivalence to the predicate/reference devices.

Biosense Webster, Inc. CARTO® 3 V4.2 EP Navigation

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the seal is the department's symbol, which features a stylized human figure embracing a globe.

Public Health Service

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

July 1, 2014

Biosense Webster, Inc Wayne R. Hohman Product Manager Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re: K133916
Trade/Device Name: CARTO 3 EP Navigation System, Version 4.2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: May 29, 2014 Received: June 2, 2014

Dear Mr. Hohman,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. Wayne R. Hohman

the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Image /page/5/Picture/7 description: The image shows the closing of a letter with the phrase "Sincerely yours,". Below the phrase is a signature that is illegible. The signature is written over a logo that is also illegible. The logo appears to be a seal or emblem of some kind.

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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5 INDICATIONS FOR USE

Section of the states

510(k) No (if known):

Device Name: CARTO® 3 EP Navigation System, Version 4.2

Indications for Use:

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

K133916

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date:
2007.01
08.45.22 -04'00'

Blosense Webster, Inc. CARTO® 3 V4.2 EP Navigation

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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).