The CARTO® 3 V2.0 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO® 3 V2.0 System is also intended to support EP procedures, maintaining CARTO® System capabilities, in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.0 System includes CARTOMERGE® Plus functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND™ image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

Device Description

The CARTO® 3 V2.0 EP Navigation System 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 realitime. The location information needed to create the cardiac maps and the local elector mans are acquired using a specialized mapping catheter and reference device. The system allows real-time display of electrograms and cardiac maps based on the received intra cardiac 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 V2.0 System uses two distinct your of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

AI/ML Overview

The provided text describes a 510(k) submission for the CARTO® 3 V2.0 EP Navigation System. It details the device's purpose, its substantial equivalence to predicate devices, and the non-clinical performance testing conducted. However, the document does not contain explicit acceptance criteria in a quantitative format, nor does it present detailed studies with specific performance metrics against those criteria.

Instead, the document states: "The CARTO® 3 V2.0 EP Navigation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness." and "The Bench and Animal Non-clinical Testing demonstrated that the CARTO® 3 V2.0 EP Navigation System is as safe, as effective, and performs as well as or better than the predicate devices."

Therefore, based on the provided text, I cannot complete the requested tables and information regarding specific acceptance criteria and detailed study results. The submission focuses on demonstrating substantial equivalence through general non-clinical testing rather than reporting on a specific study designed to meet predetermined acceptance metrics.

Here's an analysis of the questions where information can be extracted or where the document is silent:

1. A table of acceptance criteria and the reported device performance

Cannot be provided based on the input document. The document states that the device "passed all tests in accordance with appropriate test criteria and standards," but it does not specify what those criteria were (e.g., minimum accuracy, maximum error) or provide numerical performance data for the CARTO® 3 V2.0 EP Navigation System.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document mentions "extensive Bench and Animal Testing," but no details on the number of individual tests, animals, or test conditions are provided.
Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. The document describes "Bench and Animal Testing," which typically involves engineers, technicians, and potentially veterinary specialists, rather than human expert interpretation of data for ground truth in the way a medical imaging AI would. There is no mention of "experts" in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. Adjudication methods are typically used in studies involving human interpretation or subjective assessments. For bench and animal testing of a navigation system, validation usually involves direct measurement against known standards or physical benchmarks, rather than expert consensus on interpretive tasks.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical "Bench and Animal Testing" to verify and regression test the new features. It's not a study involving human readers or AI assistance in the way an MRMC study would typically evaluate. The CARTO® system itself is a navigation and mapping system, not an AI for image interpretation that would assist human readers in diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Partially applicable, but in a different context. The "Bench and Animal Testing" can be considered a form of standalone performance evaluation for the system's functionalities (e.g., accuracy of location, mapping capabilities). However, the document does not present specific "algorithm-only" performance metrics as one might expect from an AI diagnostic device. It focuses on the overall system's safety and effectiveness compared to predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Reference standards/known physical parameters. For "Bench Testing," ground truth would typically be established by highly accurate measurement devices or known physical properties of test phantoms. For "Animal Testing," ground truth would likely involve direct measurements, invasive procedures, or established physiological benchmarks within the animal model, rather than expert consensus or pathology in the context of clinical decision-making. The document does not specify these details.

8. The sample size for the training set

Not applicable. The CARTO® 3 V2.0 EP Navigation System is not described as an AI/ML device that requires a "training set" in the conventional sense. It's a real-time navigation and mapping system. The document does not mention any machine learning components that would have been trained on a dataset.

9. How the ground truth for the training set was established

Not applicable. As the device is not described as a machine learning system, the concept of a "training set" and its associated ground truth establishment does not apply here.

Summary

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K103746 ャリタ

15 510(K) SUMMARY

15.1 General Information

Applicant:

Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765 USA Phone: 909-839-8597 Fax: 909-839-8804

Date:

December 22, 2010.

Wayne R. Hohman

Contact Person:

Trade/Proprietary Device Name: Manufacturing Part Numbers:

Common Device Name:

Classification Name:

Predicate Devices:

Manufacturing Facilities:

Project Manager Regulatory Affairs

CARTO® 3 V2.0 EP Navigation System and Accessories FG-5400-00 (with standard location pad) FG-5600-00 (with RMT location pad)

Cardiac mapping system

Programmable diagnostic computer Class II, 21 CFR 870.1425 Product Code DQK

CARTO® 3 V1.05 EP Navigation System and Accessories (519(k) K093455) Ensite Velocity™ System (510(k) K101328)

Biosense Webster (Israel) Ltd. a Johnson & Johnson Company 4 Hatnufa Street, POB 275 Yokneam 20692 Israel

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15.2 Substantial Equivalence

The CARTO 3 EP Navigation System, Version 2.0, is substantially equivalent to the legally marketed CARTO 3 EP Navigation System, Version 1.05, and a second predicate device as shown in the Table below:

Predicate Devices for CARTO® 3 EP Navigation System, Version 2.0
Submission Name	510(k)Number	Equivalence Criteria
CARTO® 3 V1.05 EPNavigation System	K093455	FDA cleared version of CARTO®3EP Navigation System prior toVersion 2.0.
Ensite Velocity™ System	K101328	St. Jude Medical device

15.3 Description of Device

15.4 Indications for Use

The Indications for Use for the modified device are identical to the predicate device:

Biosense Webster, Inc. CARTO 3 v 2.0 Special 510(k)

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includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND™ image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

15.5 Summary of Non-clinical Performance Testing

The CARTO® 3 V2.0 EP Navigation System underwent extensive Bench and Animal Testing to verify the modified features and to demonstrate with regression testing that the new features did not negatively affect existing features. The CARTO® 3 V2.0 EP Navigation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.

15.6 Conclusions

The Bench and Animal Non-clinical Testing demonstrated that the CARTO® 3 V2.0 EP Navigation System is as safe, as effective, and performs as well as or better than the predicate devices. This testing program supports the determination of substantial equivalence to the predicate devices. . . . .

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Biosense Webster, Inc. c/o Mr. Wayne R. Hohman Project Manager Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765

JAN 2 1 201

Re: K103746

CARTO® 3 V2.0 EP Navigation System Regulatory Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: 74 DQK Dated: December 22, 2010 Received: December 23, 2010

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.

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.

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Page 2 - Mr. Wayne R. Hohman

Please be advised that I'DA'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 device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

W.R.M.

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 5

510(k) No (if known):

Device Name: CARTO® 3 V2.0 EP Navigation System

Indications for Use:

The CARTO® 3 V2.0 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO® 3 2.0 System is also intended to support IP procedures, maintaining CARTO® System capabilities, in the presence of a high metallic. environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe Catheter Navigation System. The CARTO® 3 V2.0 System includes CARTOMERGE® PLUS functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND™ image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

Prescription Use 2 (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

Page 1 of 1

510(k) Number k(08746

Biosense Webster, Inc. CARTO 3 v 2.0 Special 510(k)

Page 35 of 567

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).