The CARTO™ XP EP Navigation System is intended to acquire real time catheter based cardiac electrophysiolgical maps in patients who are eligible for a conventional electrophysiological study. The CARTO™ XP EP Navigation System is restricted for use by licensed medical practitioner who participated in a CARTO™ training course. There are no special contraindications when using the CARTO™ XP EP Navigation System.

The intended use of the CARTO™ XP mapping system is catheter-based atrial and ventricular mapping.

The intended use of the modified device is the same as for Predicate Device A cleared under 510(k) Number K020863. The indications for use have been expanded to include the CARTOMERGE™ capability to import, register and merge CT or MRI structural images with CARTO maps physiological information and real time catheter navigation.

Device Description

The CARTO™ XP EP Navigation system 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, 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 CARTOMERGE module provides for the import, processing, visualization and analysis of pre-acquired cardiac images, superimposed to the CARTO XP EP maps. The CARTOMERGE supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria for device performance or a specific study proving the device meets those criteria. The 510(k) summary focuses on the device description, indications for use, and a statement of substantial equivalence to predicate devices, rather than detailed performance metrics and study results.

However, based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy of electro-anatomical maps	Not explicitly stated in terms of quantitative metrics. The device is designed to "acquire, analyze, and display electro-anatomical maps of the human heart" and "reconstruct maps using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations." Implies accuracy for its intended purpose.
Real-time display of cardiac maps	The device "allows real-time display of cardiac maps in a number of different formats" and "acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen."
Ability to import, process, visualize, and analyze pre-acquired cardiac images (CT/MRI) and superimpose them with CARTO XP maps.	The CARTOMERGE module "provides for the import, processing, visualization and analysis of pre-acquired cardiac images, superimposed to the CARTO XP EP maps." It "supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format."
Safety and Effectiveness	"The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed devices to which it is being compared and does not raise any new questions of safety or effectiveness." (This is a general statement, not specific quantitative criteria or performance).
Compliance with Safety Standards	UL 2601-1:97/CSA C22.2 NO.601.1; IEC 60601-2-25:93 and A1(99); IEC 60601-2-27:94

Missing Information for this Section:

Specific quantitative acceptance criteria (e.g., "mapping accuracy must be within X mm," "image registration error must be less than Y mm").
Detailed reported device performance metrics against these criteria.

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

Sample Size: Not specified. The document mentions "non-clinical bench and animal testing" but does not give sample sizes for these tests or for any human clinical test sets.
Data Provenance: Not specified. It's likely the "non-clinical bench and animal testing" were conducted internally by the manufacturer (Biosense Webster, Inc., with manufacturing in Israel), but no country of origin for specific data is provided. The tests are described as "non-clinical bench and animal testing," which implies prospective studies in controlled environments, but this is not explicitly stated for a "test set" in the context of human data.

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

This information is not provided in the given text.

4. Adjudication method for the test set

This information is not provided in the given text.

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

This information is not provided in the given text. The device is a "EP Navigation System" that aids in mapping, and while it processes information, it's not described as an AI system that improves human readers in a diagnostic sense that would typically involve an MRMC study comparing AI-assisted vs. unassisted performance.

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

While the system "acquires, analyzes, and displays" information, its intended use is to assist a "licensed medical practitioner." The text does not describe a standalone algorithm-only performance evaluation, but rather emphasizes its role in conjunction with human expertise in electrophysiological studies.

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

This information is not provided in the given text. For electro-anatomical mapping, ground truth would typically be established by highly experienced electrophysiologists based on combined electrical and anatomical data, but the document does not detail this.

8. The sample size for the training set

This information is not provided in the given text. Given the device's nature as an EP navigation system for mapping rather than a machine learning model trained on large datasets for diagnosis, the concept of a "training set" in the modern AI sense might not be directly applicable or detailed. The functionality is described more as signal processing and display.

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

This information is not provided in the given text, and for the reasons mentioned above, a "training set" as commonly understood in AI/ML might not be central to the device's development as described.

In summary: The provided 510(k) summary is a high-level regulatory document focused on demonstrating substantial equivalence to predicate devices and outlining the device's intended use and technical specifications. It lacks the detailed performance study information, including specific acceptance criteria, sample sizes, ground truth methodology, and expert involvement, that would be found in a comprehensive clinical or technical validation study report.

Summary

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MAR 2 1 2005

CARTO XP Version 8 EP Navigation System Special 510(k)

C. 510(K) Summary

The 510(k) summary for the CARTO XP V8 Mapping System is provided below.

510(k) Summary for the CARTO™ XP V8 EP Navigation System Biosense Webster, Inc. 510(k) Notification Submitted by: 3333 Diamond Canyon Rd. Diamond Bar, CA 91765 USA Phone: +1-800-729-9010 Fax: +1-909-839-8804 Diana Thorson Contact Person: Project Manager, Regulatory Affairs CARTO™ XP EP Navigation System Proprietary Device Name: Programmable diagnostic computer Classification Name: (per 21 CFR 870.1425) Cardiac mapping system Common Devicc Name: A. CARTOTM XP QwikMap EP Navigation Predicate Devices: System B. Siemens Medical System singo Multimodality Workstation Biosense Webster (Israel) Ltd. Manufacturer: POB 2009 Tirat HaCarmel, 39120 Israel

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K042999/52
P2/2

CARTO XP Version 8 EP Navigation System Special 510(k)

Indications For Use

The CARTO™ XP EP Navigation System is intended to acquire real time catheter based cardiac electrophysiogical maps in patients who are eligible for a conventional electrophysiological study. The CARTO™ XP EP Navigation System is restricted for use by licensed medical practitioner who participated in a CARTO™ training course. There are no special contraindications when using the CARTO™ XP EP Navigation System.

General Device Description

The CARTO™ XP EP Navigation System complies with the following safety standards: UL 2601-1:97/CSA C22.2 NO.601.1 IEC 60601-2-25:93 and Al(99) IEC 60601-2-27:94

The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed devices to which it is being compared and does not raise any new questions of safety or effectiveness.

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Image /page/2/Picture/2 description: The image is a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center is a stylized eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2005

Biosense Webster, Inc. c/o Ms. Diana Thorson Project Manager, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re: K042999

Trade Name: CARTO™ EP Navigation System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DQK Dated: January 31, 2005 Received: February 03, 2005

Dear Ms. Thorson:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section 910(x) promotion is substantially equivalent (for the indications for use stated in the enclosure) the acted predicate devices marketed in interstate for use stated in the encrosule) to regard manative posice Amendments, or to commerce provided to May 20, 1978, the exactions of the Federal Food, Drug, devices that have occh recaisoned in assess approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment ACT (Act) that do not require apper o the general controls provisions of the Act. The You may, therefore, market the devices, books of the more of the manual registration, listing of general controls provisions of the rise, 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 If your device is classified (see above) me etails in the regulations affecting your device can be may be subject to such additional econtroller interest and to 898. In addition, FDA may oc found in the Code of Pederal Regarations, your device in the Federal Register.

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Page 2 – Ms. Diana Thorson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc devisou and I Drimination that your device complies with other requirements of the Act that I Drimas Intacted and regulations administered by other Federal agencies. You must or any I edetar statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF IT rate 677, idoomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product indiation control to begin marketing your device as described in your Section 510(k) I mis letter will and will yourse finding of substantial equivalence of your device to a legally prematics notication "The 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 If you t 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. Whoordinating of responsibilities under the Act may be obtained from the Oiner general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B. Zimmerman for
R. Z. Zimmerman, M.D.

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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1042999

CARTO XP Version 8 EP Navigation System Special 510(k)

D. Indications For Use Statement

510(k) No (if known): K042999

Device Name: CARTO™ EP Navigation System

Indication for Use:

The intended use of the CARTO™ XP mapping system is catheter-based atrial and ventricular mapping.

The CARTO™ XP mapping system allows real-time display of cardias maps in a uumber The CARTO'" XF inapping System anows of cardiac electrical activation maps, cardiac of different formals. Maps may of expression maps, and cardiac chamber electrical propagation naps, carenas t signals, including body surface ECG and geomeny maps. The acquired panelle organia, and time on the display screen.

The intended use of the modified device is the same as for Predicate Device A cleared I he intended use of the modified dovied to also for use have been expanded to include
under 510 (k) Number K020863. The indications for use have been expanded to include the CARTOMERGE™ capability to import, register and merge CT or MRI structural the CARTOMERGE™ Capability to import, rogister and the catheter navigation.
images with CARTO maps physiological information and real time catheter navigation.

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 (ODE)

Blumamoto

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K043999

Page 1 of 1

Brosense Webster, Inc

Page 15 of 111

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).