The CARTO® 3 System V3.0 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 System V3.0 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 System V3.0 includes CARTOMERGE® PLUS Module 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. A fluoro background capability enables visualization of X-ray images as reference to the CARTO® Maps images and catheters. 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 System V3.0 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 catheter and reference device. The system allows realtime 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 System V3.0 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device efficacy, structured according to your request:

It's important to note that the provided text is a 510(k) Summary for a medical device (CARTO® 3 System V3.0), which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving effectiveness in a clinical trial with specific performance metrics against a predefined acceptance criterion. As such, some of the requested information (like effect size of AI assistance, sample size for training sets, or detailed ground truth establishment for specific metrics) may not be explicitly present because the submission's goal is different.

Acceptance Criteria and Device Performance Study (CARTO® 3 System V3.0)

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) submission for the CARTO® 3 System V3.0 focuses on substantial equivalence to its predicate device (CARTO® 3 EP Navigation System, Version 2.2) and two reference devices. Instead of explicit quantitative "acceptance criteria" with specific performance metrics (e.g., sensitivity, specificity, accuracy against a numerical threshold), the criteria are framed around demonstrating that the new features work as intended and do not negatively impact existing features, making it "as safe, as effective, and performs as well as or better than" the predicate.

Therefore, the "acceptance criteria" are implied by the comprehensive non-clinical testing performed, and the "reported device performance" is a general statement of successful completion of these tests.

Acceptance Criterion (Implied)	Reported Device Performance
Functional Equivalence & Safety of New Features:	Passed all tests in accordance with appropriate test criteria and standards. The modified device did not raise new questions of safety or effectiveness.
- WiseTag functionality (legacy & new)	Successfully implemented and verified.
- Multi Electrode Mapping (legacy & new)	Functionality confirmed to be equivalent or improved.
- Fluoroscopic background view (legacy & new)	Functionality confirmed to be equivalent or improved.
- Magnetic sensor technology & Advanced Catheter Location (ACL)	Verified to acquire and analyze data points, display 3D anatomical and electroanatomical maps, and real-time electrograms.
- Support for EP procedures in high metallic environments / magnetic fields (up to 0.1 T)	Functionality verified.
- Data communication channel to Stereotaxis Niobe System	Functionality verified.
- CARTOMERGE® PLUS Module functionality (CT/MRI integration)	Functionality verified.
- Fast Anatomical Mapping (FAM) functionality	Functionality verified.
- CARTOSOUND® Image Integration functionality	Functionality verified.
- Compatibility with both specialized and conventional EP catheters	Verified.
Non-Inferiority to Predicate Device:	The CARTO® 3 System V3.0 is as safe, as effective, and performs as well as or better than the predicate device and two Reference Devices.
Compliance with Standards:	Passed all tests in accordance with appropriate test criteria and standards.

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

The document states: "The CARTO® 3 System V3.0 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."

Test Set Description: "Bench and Animal Testing."
Sample Size: Not specified in the provided text. The term "extensive" is used but no numerical count of tests performed, data points, or animals used is given.
Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. Animal testing is typically prospective, but bench testing methodology details are absent.

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

The 510(k) summary does not mention the use of human experts to establish ground truth for test sets. The testing described is primarily technical and functional ("Bench and Animal Testing") rather than clinical performance evaluated by human readers against a gold standard.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing performed was primarily technical/functional and animal testing, not human expert interpretation of device output.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not mentioned in the provided 510(k) summary. The submission focuses on substantial equivalence via non-clinical testing. Therefore, there's no reported effect size of how much human readers improve with AI vs. without AI assistance. The device is a "Cardiac mapping system" and "Programmable diagnostic computer," which primarily assists electrophysiologists by providing real-time maps and data, rather than an AI-driven diagnostic tool designed for human-in-the-loop diagnostic improvement in the sense of image interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The device itself is a "Cardiac mapping system" and "Programmable diagnostic computer." Its primary function is to acquire, analyze, and display data for a physician's use in real-time procedures. The "Non-Clinical Performance Testing" described (Bench and Animal Testing) can be considered a form of standalone testing in that the device's technical specifications and functionalities were verified independently. However, this is not "standalone performance" in the context of an AI diagnostic algorithm's ability to interpret medical data without human intervention. The device's output (cardiac maps, electrograms) requires interpretation and action by a clinician, so there isn't a "standalone" diagnostic output in the way one might consider an AI-driven image analysis tool.

7. The Type of Ground Truth Used

For the "Bench and Animal Testing," the ground truth would be established through a combination of:

Technical Specifications: Verification against predefined engineering and performance specifications.
Physical Measurements & Known Conditions: In bench testing, this involves using phantoms, known electrical signals, or controlled environments where the "true" values are known and the device's measurements are compared against them.
Physiological Observations (Animal Testing): In animal studies, ground truth would be based on direct physiological measurements, observations of physical effects, or pathological findings where applicable. The goal is to see if the device accurately reflects the physiological state of the animal heart.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. The CARTO® 3 System V3.0 is a hardware/software system for cardiac mapping, not an AI/ML device in the modern sense that typically relies on large "training sets" for model development. Its functionalities are based on established biophysical principles and algorithms for signal processing and 3D reconstruction, rather than machine learning from a specific training dataset in the same way a diagnostic AI algorithm would be.

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

Not applicable/Not mentioned for the reasons stated above (not an AI/ML device relying on "training sets").

Summary

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MAY - 7 2012

14 510(K) SUMMARY

General Information 14.1

Applicant:	Biosense Webster, Inc.3333 Diamond Canyon RoadDiamond Bar, CA 91765USAPhone: 909-839-8597Fax: 909-839-8804
Date:	January 15, 2012
Contact Person:	Wayne R. HohmanProject Manager Regulatory Affairs
Trade/Proprietary DeviceName:	CARTO® 3 System V3.0 and Accessories
Manufacturing PartNumbers:	FG-5400-00 (with standard location pad)FG-5600-00 (with RMT location pad)
Common Device Name:	Cardiac mapping system
Classification Name:	Programmable diagnostic computerClass II, 21 CFR 870.1425 Product Code DQK
Predicate Device:	CARTO® 3 SYSTEM V2.2 and Accessories510(k) K112007 (October 5, 2011)
Reference Devices:	Reference Device 1:CARTO® XP EP Navigation System 2007, Version 9,510(k) K070240 (May 4, 2007)
	Reference Device 2:Stereotaxis NIOBE® Magnetic Navigation System510(k) K060967 (October 19, 2006)
Manufacturing Facilities:	Biosense Webster (Israel), Ltd.a Johnson & Johnson Company4 Hatnufa Street, POB 275Yokneam 20692Israel

14.2 Substantial Equivalence

CONFIDENTIAL

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The CARTO® 3 EP Navigation System, Version 3.0, is substantially equivalent to the legally marketed CARTO® 3 EP Navigation System, Version 2.2and two Reference Devices as shown in the following Table:

Table 6. Reference Devices for CARTO® 3 System, Version 3.0
Predicate/Reference Name	510(k) Number	Equivalence Criteria
CARTO® 3 EP Navigation System, Version 2.2	K112007	Legacy Functionality and WiseTag
CARTO® XP EP Navigation System 2007, Version 9	K070240	Multi Electrode Mapping
Stereotaxis Niobe® Magnetic Navigation System	K060967	Fluoroscopic background view

14.3 Description of Device

14.4 Indications for Use

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

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catheters with magnetic location sensors. The system's CARTOSOUND® Image Integration Module 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.

14.5 Summary of Non-Clinical Performance Testing

The CARTO® 3 System V3.0 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 System V3.0 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.

14.6 Conclusions

The Bench and Animal Non-Clinical Testing demonstrated that the CARTO® 3 System V3.0 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 devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter, with the department's emblem in the center. The stylized symbol on the right resembles an abstract representation of a human figure or a bird in flight, composed of curved lines.

Public Health Service

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

MAY - 7 2012

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

Re: K120550

Trade/Device Name: CARTO® 3 EP Navigation System Version 3.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Codes: DQK Dated: February 20, 2012 Received: February 23, 2012

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.

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

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Page 2 - Mr. Wayne R. Hohman

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/CDRH0ffices/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,

R. D. Zimbawe, M.P.

(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) No (if known): K 120550

Device Name: CARTO® 3 EP Navigation System, Version 3.0

Indications for Use:

V-Prescription Use (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 (ADEA

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K100550

Biosense Webster, Inc. CARTO® 3 V3.0 EP NAVIGATION CONFIDENTIAL

Traditional 510(k) Page 44 of 1219

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).