The intended use of the CARTO EP Navigation System is catheter-based cardiac mapping. The CARTO EP Navigation System 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, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

Device Description

The CARTO EP Navigation System is designed to acquire, analyze, and display electroanatomical 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. In the CARTO EP Navigation System the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a magnetic location sensor.

AI/ML Overview

The provided text is a 510(k) summary for the CARTO™ EP Navigation System. It describes the device, its intended use, and states that non-clinical bench and animal testing show it is as safe and effective as the previously marketed device (CARTO mapping system, 510(k) No. K992968).

However, the document is a regulatory submission summary and does not contain the detailed study information required to fully answer your request. Specifically, it lacks:

Explicit acceptance criteria, reported performance values, sample sizes for test sets (human or animal), details on ground truth establishment for test and training sets, expert qualifications, adjudication methods, or results of MRMC or standalone studies.

The key takeaway is that the device's substantial equivalence and performance are based on non-clinical bench and animal testing, comparing it to a predicate device, rather than human clinical studies with specific performance metrics against defined acceptance criteria.

Therefore, most of the information requested in your prompt cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

Aspect	Information from Document
1. Acceptance Criteria & Reported Device Performance	Not explicitly stated. The document states: "The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness." This implies the acceptance criterion was "equivalent safety and effectiveness to the predicate device" based on non-clinical data, but no specific performance metrics or thresholds are provided.
2. Sample Size (Test Set) & Data Provenance	Not specified. "Non-clinical bench and animal testing." No information on the number of animals or specific bench tests.
3. Number & Qualifications of Experts (Ground Truth - Test)	Not applicable/Not specified. As the testing was non-clinical (bench and animal), human experts establishing ground truth for a test set in the conventional sense is not described.
4. Adjudication Method (Test Set)	Not applicable.
5. MRMC Comparative Effectiveness Study	No. The document describes non-clinical testing.
6. Standalone (Algorithm Only) Performance Study	Implied by non-clinical testing, but no specific study details are provided. The device's performance was assessed without human-in-the-loop given it's bench and animal testing for equivalence to a predicate.
7. Type of Ground Truth Used	Not explicitly stated. For bench testing, "truth" would likely be engineering specifications or known electrical/spatial properties. For animal testing, it would involve direct anatomical/physiological measurements.
8. Sample Size (Training Set)	Not applicable/Not specified. The document does not describe an AI/ML algorithm that would undergo a training phase. It describes a system for acquiring, analyzing, and displaying electroanatomical maps using magnetic location technology.
9. Ground Truth Establishment (Training Set)	Not applicable/Not specified.

Summary

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DEC - 3 1999

Image /page/0/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized heart shape on the left, followed by the text "Biosense Webster" in a serif font. Below the company name, in a smaller, cursive font, is the text "a Johnson & Johnson company."

Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters and numbers. The sequence is K993729. The characters are written in a cursive style, with varying stroke thicknesses. The image is in black and white.

Einstein Building, Etgar St., New Industrial Zone POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: sstolars@bwiil.jnj.il

510(k) summary for the CARTO Mapping System

510(k) Notification submitted by:	Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765USAPhone: +1-800-729-9010Fax: +1-909-468-3781
Contact person:	Sandra WilliamsonSenior Regulatory Affairs Associate
Proprietary device name:	CARTO™ EP Navigation System
Classification name:	Programmable diagnostic computer(per 21 CFR 870.1425)
Common device name:	Cardiac mapping system
Cleared unmodified device	CARTO mapping system510(k) No. K992968

Currently, cardiac mapping is performed using a roving mapping catheter, a computerized mapping system, and fluoroscopy to determine the location of the tip of the mapping catheter. In the conventional procedure both the patient and the physician are exposed to harmful ionizing radiation during the course of the lengthy procedure. The CARTO EP Navigation System enables cardiac mapping using a magnetic location technology, and may reduce exposure to dangerous ionizing radiation.

The CARTO mapping system complies with the following safety standards:

EN 60601-1/1990 EN 60601-1 A1/1993 EN 60601-1 A2/1995 EN 60601-2-27/1994

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Image /page/1/Picture/0 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized heart shape on the left, followed by the words "Biosense Webster" in a serif font. Below the company name, in a smaller, italicized font, is the text "a Johnson-Johnson company."

Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: sstolars@bwiil.jnj.il

The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1999

Ms. Sandra Williamson Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re : K993729 CARTO™ EP Navigation System Requlatory Class: II (two) Product Code: DOK November 1, 1999 Dated: Received: November 4, 1999

Dear Ms. Williamson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sandra Williamson

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use statement

510(k) No: 16993729

Device Name: CARTO™ EP Navigation System

Indications For Use:

The intended use of the CARTO EP Navigation System is catheter-based cardiac mapping.

The CARTO EP Navigation System 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, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

N. Deuk Tith

000916

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).