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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CARTO® 3 EP Navigation System, Version 4.35:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly define quantitative acceptance criteria for the new COHERENT MAPPING feature, nor does it provide specific numerical performance metrics for this feature. The document generally states that the device "passed all tests in accordance with appropriate test criteria and standards."

The main claim of the new version 4.35 is to "improve the representation of the electric wave propagation over the atria by adding new coloring and electric wave direction vector." The performance is described qualitatively as "This improved representation of conduction velocity vectors may help the physician to focus his/her attention on the displayed path of cyclic arrhythmia propagation."

Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported performance figures.

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

The document mentions "extensive bench, pre-clinical testing under simulated clinical conditions and retrospective validation." While it refers to a "test set," the specific sample size used for the test set is not provided.

The data provenance for this validation is also not explicitly detailed. The mention of "pre-clinical testing under simulated clinical conditions" suggests controlled experiments, but it doesn't specify if these were conducted in humans or animals, or the geographic origin of any data if human data was used. "Retrospective validation" implies the use of existing data, but again, the specifics are missing.

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

The document does not provide any information about the number of experts used to establish the ground truth for the test set or their qualifications. The nature of the "improved representation" suggests that expert review would be crucial, but there's no mention of it.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The focus is on the "improved representation" and how it may help physicians, rather than a quantifiable improvement in physician performance with and without the AI. Therefore, no effect size of how human readers improve with AI vs. without AI assistance is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The text describes the COHERENT MAPPING module as providing "new coloring and electric wave direction vector" and improving the "representation of the electric wave propagation." This is an enhancement of human visualization and interpretation, not a standalone diagnostic algorithm. The system provides information for "catheter-based cardiac electrophysiological (EP) procedures" and helps in understanding "electrical activity of the heart and about catheter location." Therefore, a standalone (algorithm only) performance study as typically understood for AI diagnostics would not be applicable or was not reported for this device's new feature. Its primary function is to assist human operators.

7. The Type of Ground Truth Used

Given the nature of the "improved representation of conduction velocity vectors," the ground truth would likely be expert consensus or accepted electrophysiological principles regarding the accurate depiction of cardiac electrical activity. However, the document does not explicitly state the type of ground truth used for the validation of the COHERENT MAPPING feature.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This suggests the COHERENT MAPPING module might be based on refining existing algorithms for data visualization rather than a new machine learning model trained on a specific dataset.

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

Since no training set is mentioned (or implied heavily for a new ML-based algorithm), there is no information on how ground truth for a training set was established.

Summary

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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);

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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)

Type of Use (Select one or both, as applicable)

✖ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Applicant:	Biosense Webster, Inc.33 Technology DriveIrvine, CA 92618, USAPhone: 909-839-8500Fax: 909-839-8804
Contact Person:	Phuong ChauSenior Regulatory Affairs Program LeadPhone: 949-923-4238Fax: 949-450-6886
Authored by:	Moshe HochmitzQuality and Regulatory ManagerBiosense Webster (Israel), Ltd.AndPhuong ChauSenior 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 Accessories510(k)#: K133916
Manufacturing Facilities:	Biosense Webster (Israel), Ltd.a Johnson & Johnson Company4 Hatnufa StreetYokneam, ISRAEL 2066717

15715 Arrow Hwy Irwindale, CA 91706

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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

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

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	heart and about catheter location during the procedure. Thesystem can be used on patients who are eligible for aconventional electrophysiological procedure. The system has nospecial contraindications.
TechnologicalCharacteristics:	The proposed CARTO® 3 EP Navigation System, Version 4.35,has the same technological characteristics (i. e., design, material,chemical composition, energy source) as the predicate CARTO®3 EP Navigation System, Version 4.2. A summary of thetechnological characteristics of the new device compared to thepredicate 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 andCARTO® 3 System V4.35 with COHERENT MAPPINGModule is to improve the representation of the electric wavepropagation over the atria by adding new coloring and electricwave direction vector. This new coloring is an additional optionon top of the basic coloring of CARTO3® V4.2 cleared By FDA(K133916). This improved representation of conduction velocityvectors may help the physician to focus his/her attention on thedisplayed path of cyclic arrhythmia propagation.
Performance Data:	The CARTO® 3 EP Navigation System, Version 4.35 underwentextensive bench, pre-clinical testing under simulated clinicalconditions and retrospective validation to verify the newCOHERENT MAPPING feature to demonstrate with regressiontesting that these modifications did not negatively affect existingfeatures. The CARTO® 3 EP Navigation System, Version 4.35passed all tests in accordance with appropriate test criteria andstandards, and the modified device did not raise new questions ofsafety or effectiveness.
Conclusions:	The CARTO® 3 EP Navigation System, Version 4.35 issubstantially equivalent to the currently cleared CARTO® 3 EPNavigation System, Version 4.2 based on the completion of non-clinical bench testing and pre-clinical testing as well as similarprinciples of design, operation and indications for use.

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).