The CARTO® XP EP Navigation System, Version 9, allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen.

CARTO® XP EP Navigation System, Version 9, includes the CARTO CAR Capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real-time catheter navigation. CARTO® XP EP Navigation System, Version 9 also allows the integration of intracardiac echo (ICE) visualization to provide 3D combined maps.

Device Description

The CARTO® XP EP Navigation System, Version 9, is designed to acquire, analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, impedance maps and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen.

The CARTO® XP EP Navigation System, Version 9, includes the following capabilities:

The CARTOMERGE Module, released with the CARTO® XP EP . Navigation System, Version 8 under 510(k) K042999. This module enables the integration of pre-acquired Computed Tomography (CT) and Magnetic Resonance (MR) images.
The now CARTOSOUND" Image Integration Module. This module, when used on the CARTO® XP EP Navigation System, Version 9, with a SOUNDSTAR 3D Ultrasound Catheter (510(k) bundled with the CARTO XP Version 9 FP Navigation System Traditional 510(k) CARTO" XP EP Navigation System Version 9 System submission) enables interfacing with intracardiac ultrasound devices, providing for real-time integration of ultrasound (U/S) images with CARTO electromagnetic acquired maps.

The Biosense Webster SOUNDSTAR 3DTM Ultrasound Catherer is a 90 cm 10F IntraCardiac Echo (ICE) catheter with an acoustic array embedded in the catherer tip that allows the acquisition of real time ultrasound images. The catherer also contains a location sensor that enables the accurate location of the U/S-observed intrucardiac analomics in the CARTO® XP EP Navigation System Version 9 spatial coordinates.

AI/ML Overview

The CARTO® XP EP Navigation System, Version 9, underwent bench and electrical testing and was also tested under simulated use conditions in animals. The System passed all intended criteria in accordance with appropriate test criteria and standards and did not raise any new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria	Reported Device Performance
Bench Testing	Passed all criteria	Passed all intended criteria in accordance with appropriate test criteria and standards.
Electrical Testing	Passed all criteria	Passed all intended criteria in accordance with appropriate test criteria and standards.
Simulated Use (Animal Testing)	Passed all criteria	Passed all intended criteria in accordance with appropriate test criteria and standards.

2. Sample size used for the test set and data provenance:

The document mentions "simulated use conditions in animals" for testing. However, it does not specify the exact sample size (number of animals) used, nor does it provide information on the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This information is not provided in the document.

4. Adjudication method for the test set:

This information is not provided in the document.

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

No MRMC comparative effectiveness study is mentioned. This device is an EP navigation system, not an AI diagnostic tool designed to assist human readers in image interpretation or diagnosis.

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

The device is a system that acquires and displays electro-anatomical maps for catheter-based cardiac procedures. It functions as a tool for clinicians, with a human-in-the-loop by design. The performance described (bench, electrical, simulated use) would inherently assess the system's ability to function as intended in this context, rather than as a standalone algorithm in the absence of human interaction.

7. The type of ground truth used:

For the simulated use in animals, the ground truth would inherently be the physiological data and anatomical structures within the animal's heart that the CARTO system is designed to map and display. This would involve direct observation and measurement of cardiac electrical activity and anatomy.

8. The sample size for the training set:

The document does not mention a separate training set. The descriptions of testing (bench, electrical, simulated use) relate to validation and verification of the system's performance, rather than a machine learning training phase.

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

As no separate training set is explicitly mentioned in the context of machine learning, this information is not applicable. The system's functionality appears to be based on established engineering principles and medical understanding of cardiac electrophysiology and anatomy, rather than being "trained" on a dataset in the modern AI sense.

Summary

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K070240
Pg 1 of 3

5 510(K) SUMMARY

Applicant:

Date:

Contact Person:

Biosense Webster, Inc. 3333 Diamond Canyon Rd, Diamond Bar, CA 91765 USA Phone: +1-800-729-9010 Fax: +1-909-839-8804

January 24, 2007

Neelu Medhekar Manager, Regulatory Affairs

Proprictary Device Name:

Common Device Name: Classitication Name:

Predicate Devices:

Manufacturer:

CARTO" XP EP Navigation System, Version 9

Cardiac mapping system Programmable diagnostic computer (per 21 CFR 870.1425, Product Code DQK) Class II Device

CARTO® XP EP Navigation System, Version 8 510(k) K042999

Biosense Webster (Israel) Ltd. POB 2009 Tiral HaCarmel 39120 Isracl

MAY - 4 2007

Page 18 of 3080

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K070240
Pg 2 of 3

ર્સ I SUBSTANTIALLY EQUIVALENT TO

The Biosense Webster, Inc., CARTO® XP EP Navigation System, Version 9, is substantially cquivalent to the CARTO® XP EP Navigation System. Version 8, cleared under 510(k) K042999 on March 21, 2005.

5.2 INTENDED USE

The intended use of the CARTO® XP EP Navigation System, Version 9, is catherer-based atrial and ventricular mapping,

The CARTO® XP EP Navigation System, Version 9, allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac clectrical activation maps, cardiae clectrical propagation maps, cardiac electrical potential maps, impedance maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac clectrograms may also be displayed in real-time on the display screen.

Carto" XP EP Navigation System, Version 9, includes the CARTO CAR Capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and realtime catheter navigation. CARTO® XP EP Navigation System, Version 9 also allows the integration of intracardiac ccho (ICE) visualization to provide 3D combined maps.

5.3 GENERAL DEVICE DESCRIPTION

The CARTO® XP EP Navigation System, Version 9, is designed to acquire, analyze, and display clectro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac clectrograms with their respective cndocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, impedance maps and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen.

The CARTO® XP EP Navigation System, Version 9, includes the following capabilities:

The CARTOMERGE Module, released with the CARTO® XP EP . Navigation System, Version 8 under 510(k) K042999. This module enables the integration of pre-acquired Computed Tomography (CT) and Magnetic Resonance (MR) images.
The now CARTOSOUND" Image Integration Module. This module, when used on the CARTO® XP EP Navigation System, Version 9, with a SOUNDSTAR 3D Ultrasound Catheter (510(k) bundled with the

{2}------------------------------------------------

CARTO XP Version 9 FP Navigation System Traditional 510(k)

CARTO" XP EP Navigation System Version 9 System submission) enables interfacing with intracardiac ultrasound devices, providing for real-time integration of ultrasound (U/S) images with CARTO clectromagnetic acquired maps.

The Biosense Webster SOUNDSTAR 3DTM Ultrasound Catherer is a 90 cm 10F IntraCardiac Echo (ICE) catheter with an acoustic array cmbedded in the catherer tip that allows the acquisition of real time ultrasound images. The catherer also contains a location sensor that enables the accurate location of the U/S-observed intrucardiac analomics in the CARTO® XP EP Navigation System Version 9 spatial coordinates.

ર્ડ.4 PERFORMANCE DATA AND CONCLUSION

The CARTO XP EP Navigation System, Version 9, underwent bench and clectrical testing and was also tested under simulated use conditions in animals. The System passed all intended criteria in accordance with appropriate test criteria and standards and did not raise any new questions of safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2007

Biosense Webster c/o Neelu Medhekar Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

Re: K070240

Trade/Device Name: Carto XP EP Navigation System, Version 9 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: April 6, 2007 Received: April 9, 2007

Dear Mr. Medhekar:

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 such 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. Medhekar

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); 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, This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Donna R. Lo Lane

Sram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CARTO XP Version 9 EP Navigation System Traditional 510(k)

INDICATIONS FOR USE STATEMENT

510(k) No (if known): KO 70240

Device Name: Carrow XP EP Navigation System, Version 9

Indications for Use:

The intended use of the CARTO" XP EP Navigation System, Version 9 is catheter-based atrial and ventricular mapping.

The CARTO® XP EP Navigation System, Version 9 allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, and cardiac chamber geomery maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in realtime on the display screen.

CARTO® XP EP Navigation System, Version 9 includes the CARTOMERGE capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real-time cather navigation. CARTO® XP EP Navigation System, Version 9 also allows the integration of intracardiae ccho (ICE) visualization to provide 3D combined maps.

Over-The-Counter Use Prescription Use X - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1_ of _ 1_

Duma R. Vachner

(Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices

510(k) Number_Ko70240

Page 17 of 3080

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).