(365 days)
CARTO™ XP QWIKMAP EP Navigation System
Not Found
No
The summary describes a system for acquiring, analyzing, and displaying electro-anatomical maps of the heart based on integrated electrogram and location data. It focuses on real-time display and navigation capabilities, but there is no mention of AI, ML, or related concepts like deep learning, image processing (in the context of AI/ML analysis), or training/test sets for algorithmic development. The analysis and display functions appear to be based on conventional signal processing and visualization techniques.
No.
The device is used to acquire, analyze, and display electro-anatomical maps of the human heart for diagnostic and navigation purposes during electrophysiological procedures but does not provide direct therapeutic treatment.
Yes
The device is intended to acquire and display electrophysiological maps (electrical activation, propagation, potential, and geometry maps) and patient signals (ECG and intracardiac electrograms) to assist in diagnosing cardiac conditions related to electrical activity.
No
The device description explicitly states it acquires, analyzes, and displays electro-anatomical maps using information gathered from the integration of intracardiac electrograms with their respective locations. This implies the use of hardware components (catheters, sensors, etc.) to gather this information, making it more than just software. It also mentions integration with the Stereotaxis Magnetic Navigation System, which is a hardware system.
Based on the provided text, the CARTO™ RMT EP Navigation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, in order to provide information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- CARTO™ RMT EP Navigation System Function: The description clearly states that the system is used to "acquire real time catheter based cardiac electrophysiological maps in patients." This involves direct interaction with the patient's heart using catheters, not the examination of specimens outside the body.
- Intended Use: The intended use is "catheter-based atrial and ventricular mapping," which is an in vivo procedure.
Therefore, the CARTO™ RMT EP Navigation System falls under the category of an in vivo medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CARTO™ RMT 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™ RMT 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™ RMT EP Navigation System.
The intended use of the CARTO™ RMT mapping system is catheter-based atrial and ventricular mapping.
The CARTO XP RMT mapping 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, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the Stereotaxis Magnetic Navigation System in real time on the display screen.
The CARTO™ RMT System is intended to support EP procedures in the presence of the high metallic environment created by the Stereotaxis Magnetic Navigation System, as well as in a regular EP lab.
Product codes
DOK
Device Description
The CARTO " RMT 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 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.
In the conventional procedure both the patient and the physician are exposed to ionizing radiation during the course of the procedure. The CARTO™ RMT mapping system enables cardiac mapping using CARTO™ RMT compatible catheters utilizing the enhanced magnetic navigation capabilities of the Stereotaxis Magnetic Navigation System (remote catheter navigation). In this way the system seamlessly combines the benefits of cardiac 3D mapping with remote catheter navigation and may further reduce the exposure to dangerous ionizing radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CARTO™ XP QWIKMAP EP Navigation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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C. 510(K) SUMMARY
The 510(k) summary for the CARTO RMT Mapping System is provided below.
510(k) Summary for the CARTO™ RMT EP Navigation System
510(k) Notification Submitted by:
Biosense Webster, Inc. 3333 Diamond Canyon Rd. Diamond Bar, CA 91765 USA Phone: +1-800-729-9010 Fax: +1-909-839-8804
Contact Person:
Proprietary Device Name:
Classification Name:
Common Device Name:
Predicate Device:
Manufacturer:
Diana M. Thorson Project Manager, Regulatory Affairs
CARTO™ RMT EP Navigation System
Programmable diagnostic computer (per 21 CFR 870.1425)
Cardiac mapping system
CARTO™ XP QWIKMAP EP Navigation System
Biosense Webster (Israel) Ltd. POB 2009 Tirat HaCarmel, 39120 Israel
Indications For Use
The CARTO™ RMT 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™ RMT 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™ RMT EP Navigation System.
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General Device Description
The CARTO " RMT 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 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.
In the conventional procedure both the patient and the physician are exposed to ionizing radiation during the course of the procedure. The CARTO™ RMT mapping system enables cardiac mapping using CARTO™ RMT compatible catheters utilizing the enhanced magnetic navigation capabilities of the Stereotaxis Magnetic Navigation System (remote catheter navigation). In this way the system seamlessly combines the benefits of cardiac 3D mapping with remote catheter navigation and may further reduce the exposure to dangerous ionizing radiation.
The CARTO™ RMT 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 device to which it is being compared and does not raise any new questions of safety or effectiveness.
Biosense Webster, Inc CONFIDENTIAL
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
SEP 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biosense Webster, Inc. c/o Ms. Diana M. Thorson Project Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K042681 Trade Name: CARTOTM RMT EP Navigation System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated: September 1, 2005 Received: September 2, 2005
Dear Ms. Thorson:
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 cither 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, I DA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Diana M. Thorson
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) 276-0295. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bremmerfor
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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CARTO RMT Original 510(k)
D. INDICATIONS FOR USE STATEMENT
510(k) No (if known): K04268
Device Name: CARTO™ RMT EP Navigation System
Indication for Use:
The intended use of the CARTO™ RMT mapping system is catheter-based atrial and ventricular mapping.
The CARTO XP RMT mapping 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, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the Stereotaxis Magnetic Navigation System in real time on the display screen.
The CARTO™ RMT System is intended to support EP procedures in the presence of the high metallic environment created by the Stereotaxis Magnetic Navigation System, as well as in a regular EP lab.
· Prescription Use X (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)
Bhummar
(Division Sign Off)
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Kno
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Biosense Webster, Inc CONFIDENTIAL
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