The CARTO® 3 EP Navigation System and accessories are intended for catheterbased atrial and ventricular mapping. The mapping system allows real-time visualization of the catheter as well as display of cardiac maps in a number of different formats. For example, maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the System's display screen.

Device Description

The CARTO® 3 System is a new platform for the CARTO® Navigation System that incorporates new hardware and software updates.

The CARTO® 3 System is a catheter-based atrial and ventricular mapping system designed to acquire and analyze individual data points, and use this information to display 3D 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 real-time display of cardiac maps based on the received intra cardiac signals from the catheters in a number of different formats. For example, maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electro grams may also be displayed on the display screen.

Unlike conventional mapping systems that utilize fluoroscopy to visualize the catheter, the CARTO® 3 System uses two distinct types of location technology. In order to locate the tip of the catheter, the System uses "Sensor Technology". In order to locate the electrodes on the catheter shaft, the System uses Active Current Localization (ACL) Technology. Six external reference patches (which are accessories to the system and needed for both tip and electrode localization) are placed externally on the patient's chest and back (three are placed on the chest and three are placed on the patient's back). Sensors at the distal end of each of the six "Patch Sensor Cables" attach to the external reference patches via a stud/snap connector.

When used with the CARTO® 3 System, the intracardiac location of the tip of the navigation catheter (such as the NaviStar Catheter) and the electrodes on the catheter shaft are referenced to the mean calculation obtained from the three sensors located in the Patch Sensor Cables (which are attached to the patient's back) and enable the CARTO® 3 System to construct 3D electrophysiological and electroanatomical maps of the human heart in real-time.

AI/ML Overview

This submission describes the CARTO® 3 EP Navigation System and Accessories. The information provided indicates that the CARTO® 3 System is a new platform with updated hardware and software for a cardiac mapping system. However, the documentation does not contain a table of acceptance criteria or details of a study that directly proves the device meets specific performance metrics against such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a combination of:

Description of the device and its new features (catheter shaft and electrode visualization, simultaneous multi-catheter connection).
Indications for Use statement.
Confirmation that the device underwent bench, animal, and electrical safety testing and "passed all intended criteria in accordance with appropriate test criteria and standards."

Without a specific performance study with clearly defined acceptance criteria, it is not possible to fill out all requested sections. However, based on the provided text, here's what can be inferred and stated:

Acceptance Criteria and Device Performance Study (as inferred from the provided text)

The provided text focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study against specific, quantified acceptance criteria. Therefore, a direct table of acceptance criteria and reported device performance cannot be created from this document.

The overall performance conclusion states: "Based on the results of the Risk Analysis, the bench, animal and electrical safety studies performed and the comprehensive safety analysis, we concluded that the risk to benefit ratio for the use of the CARTO® 3 System for catheter-based atrial and ventricular mapping has not been negatively affected by the proposed design changes." This implies that the device met safety and fundamental functional requirements during internal validation.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantified metrics in the provided document. The document implies meeting "appropriate test criteria and standards" for bench, animal, and electrical safety testing.
Reported Device Performance: The document states the CARTO® 3 System and accessories "passed all intended criteria." No specific quantitative performance metrics (e.g., accuracy, precision, error rates) are provided.

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

Sample Size: Not specified in the provided text. The terms "bench, animal and electrical safety testing" are used, but no details on the number of cases, animals, or specific test scenarios are given.
Data Provenance: Not specified beyond the general categories of "bench, animal and electrical safety testing." No information on country of origin or whether data was retrospective or prospective is present.

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

Not applicable/Not mentioned. The submission does not describe a study involving expert-based ground truth for performance evaluation in the context of clinical accuracy or diagnostic efficacy. The testing mentioned appears to be related to safety and basic functionality.

4. Adjudication method for the test set:

Not applicable/Not mentioned. No adjudication method is described as there isn't a performance study evaluating diagnostic or clinical accuracy with expert review.

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:

Not applicable. The CARTO® 3 System is a cardiac mapping system, not an AI-based diagnostic tool for human readers. No MRMC study is mentioned.

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

The CARTO® 3 System is described as a system that assists clinicians by providing real-time visualization and mapping. Its function inherently involves human interaction, and the provided text does not describe a standalone algorithm performance evaluation in the sense of a fully automated diagnostic or interpretive system.

7. The type of ground truth used:

Based on "bench, animal and electrical safety testing," the ground truth would likely be established through engineering specifications, validated measurement equipment, and physiological responses observed in animal models for safety. No specific "ground truth" for clinical accuracy based on pathology or outcomes data is described in this submission.

8. The sample size for the training set:

Not applicable/Not mentioned. The document does not describe a machine learning algorithm that requires a training set. The system's functionality is based on established electrophysiological principles and location technology.

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

Not applicable/Not mentioned, as there is no described training set.

Summary of Conclusions from the Document:

The provided 510(k) summary for the CARTO® 3 EP Navigation System primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (CARTO® XP V7, CARTO® RMT V8, RefStar External Reference Patch, and EnSite System). The performance data section broadly states that the device underwent "bench, animal and electrical safety testing" and "passed all intended criteria." This type of submission relies on the established safety and effectiveness of the predicate devices, combined with testing to ensure new features or updates do not negatively impact the risk-benefit profile. Specific, quantitative performance metrics and acceptance criteria for a general clinical accuracy study are not provided in this document.

Summary

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5. 510(K) SUMMARY

Applicant:	Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765USAPhone: 800-729-9010Fax: 909-839-8804
Date:	November 5, 2007
Contact Person:	Natalie BenningtonManager, Regulatory Affairs
Proprietary Device Name:	CARTO® 3 EP Navigation System and Accessories
Common Device Name:	Cardiac mapping system and surface reference device
Classification Name:	Programmable diagnostic computer(per 21 CFR 870.1245, Product Code DQK)
Predicate Device:	CARTO® XP V7 EP Navigation System (K013083)CARTO® RMT V8 EP Navigation System (K060047)RefStar External Reference Patch (K982415, K061468)EnSite System (K060954)
Manufacturing Facilities:	System & System CablesBiosense Webster (Israel) Ltd.POB 2009Tirat HaCarmel, 39120IsraelAccessories (Accessory Cables)Biosense Webster

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Substantially Equivalent To: 5.1

The Carto® 3 EP Navigation System is substantially equivalent to the CARTO® XP V7 EP Navigation System (K013083, cleared 11/21/01), the CARTO® RMT V8 EP Navigation System (K060047, cleared 6/19/06) and the RefStar External Reference Patch (K982415, cleared 8/10/98 and K061468, cleared 8/14/06), which are all manufactured by Biosense Webster. In addition, the CARTO® 3 System is also substantially equivalent to the EnSite System manufactured by Endocardial Solutions (K060954, cleared 4/21/06).

Description of the Device Subject to Premarket Notification: 5.2

The CARTO® 3 System is a new platform for the CARTO® Navigation System that incorporates new hardware and software updates.

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The new features offered with the CARTO® 3 System which differ from the current CARTO® XP V7 EP System include the following:

· Catheter shaft and electrode visualization.
· Ability to connect and visualize more than one catheter simultaneously.
· The CARTO® XP V7 System utilizes an external reference device that incorporates the reference sensor into the adhesive patches. This patch/sensor/cable device is a completely separate device and is sold separately from the CARTO® XP V7 System. The external reference for the CARTO® 3 System, on the other hand, is an integral component of the "Patch Unit" of the system. Only the adhesive patches are sold separately as accessories.

5.3 Indications for Use:

The CARTO® 3 EP Navigation System and accessories are intended for catheterbased atrial and ventricular mapping. The mapping system allows real-time visualization of the catheter as well as display of cardiac maps in a number of different formats. For example, maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the System's display screen.

Performance Data: 5.4

The CARTO® 3 System and accessories underwent bench, animal and electrical safety testing. The CARTO® 3 System and accessories passed all intended criteria in accordance with appropriate test criteria and standards.

5.5 Overall Performance Conclusions:

Based on the results of the Risk Analysis, the bench, animal and electrical safety studies performed and the comprehensive safety analysis, we concluded that the risk to benefit ratio for the use of the CARTO® 3 System for catheter-based atrial and ventricular mapping has not been negatively affected by the proposed design changes. In summary, the CARTO® 3 System (which incorporates the external reference device within the system) described in this submission is substantially equivalent to Biosense Webster's CARTO® XP V7 EP System, the CARTO® RMT V8 EP System, the RefStar External Reference Patch and to Endocardial Solution's EnSite System and are as safe and effective as the predicate devices for catheter-based atrial and ventricular mapping.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2007

Biosense Webster, Inc. c/o Ms. Natalie Bennington Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

Re: K072202

Trade/Device Name: CARTO 3 EP Navigation System (Model FG-5400-00) and CARTO 3 External Reference Patches (Model: D-1283-01) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: November 5, 2007 Received: November 6, 2007

Dear Ms. Bennington:

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 - Ms. Natalie Bennington

proceed to the market.

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 (OS) 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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

M. Y. Hillebenre

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 STATEMENT 4.

510(k) No (if known):

Device Name: CARTO® 3 EP Navigation System and Accessories

Indications for Use:

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)

M. A. Willebrenner

Page 1 of 1

Division Sian-C Division of Cardiovascular Devices

510(k) Number

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).