(164 days)
CARTO™ XP EP Navigation System v8, CARTO™ RMT EP Navigation System v7
Not Found
No
The summary describes image processing and mapping capabilities but does not mention AI, ML, or related terms like neural networks or deep learning.
No
The device is described as a navigation and mapping system that acquires, analyzes, and displays electro-anatomical maps of the heart, supporting EP procedures, but it does not directly treat or provide therapy to the patient. It is a diagnostic and guidance tool.
Yes
The device is intended for "catheter-based atrial and ventricular mapping" and allows real-time display of various cardiac maps and signals, including "cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, and cardiac chamber geometry maps," as well as "body surface ECG and intracardiac electrograms." This information is used to "acquire, analyze, and display electro-anatomical maps of the human heart" to support EP procedures, which are diagnostic in nature.
No
The device description explicitly mentions the use of catheters (NAVISTAR RMT, NAVISTAR, QWIKSTAR) and integration with magnetic navigation systems (Stereotaxis Niobe MNS), which are hardware components. While it includes software for mapping and image processing, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "catheter-based atrial and ventricular mapping" and "to support EP procedures". This describes a system used during a medical procedure to guide a catheter and visualize the heart's electrical activity and anatomy.
- Device Description: The description focuses on acquiring, analyzing, and displaying electro-anatomical maps and patient signals (ECG, electrograms). It also mentions integrating with magnetic navigation systems and importing pre-acquired images (CT/MRI).
- Lack of In Vitro Activity: An IVD is a device intended for use in the examination of specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. This device does not perform tests on bodily fluids or tissues in vitro. It is used in vivo (within the body) during a procedure.
The device is a medical device used for navigation and mapping during electrophysiology procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The CARTO™ RMT EP Navigation System v8 is intended to acquire real time catheter based cardiac electrophysialogical maps in patients who are eligible for a conventional electrophysiological study. The CARTO " RMT EP Navigation System v8 is restricted for use by licensed medical practitioners who participate in a CARTO™ training course. There are no special contraindications when using the CARTO™ RMT EP Navigation System v8.
The intended use of the CARTO™ RMT EP Navigation System v8 is catheter-based atrial and ventricular mapping.
The CARTO RMT System v8 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.
The CARTO R.MT System v8 is intended to support EP procedures in the presence of the high metallic environment presented by the NIOBE 1 (PM3.0) and Niobe 2 (PM3.1 and PM3.2) Stereotaxis Magnetic Navigation Systems (MNS) in magnetic environments of up to 0.08 Tesla.
Although the CARTO™ RMT system requires the use of a magnetic steerable catheter, i.e. the NAVISTAR RMT, when used in conjunction with the Stereotaxis Niobe MNS, it also enables the use of the standard NAVISTAR and QWIKSTAR catheters when the Stereotaxis magnets are stowed away or when used in a conventional EP lab, maintaining full CARTOTM XP capabilities.
CARTO RMT System v8 includes the CARTOMERGE™ capability to import, register and merge CT or MRI structural images with CARTO maps physiological information and real time catheter navigation.
Product codes
DRF
Device Description
The CARTO™ RMT EP Navigation System v8 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 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.
In the conventional procedure both the patient and the physician are exposed to X-Ray radiation during the course of the procedure. The CARTO™ RMT System v8 enables cardiac mapping using CARTO™ RMT compatible catheters utilizing the magnetic navigation capabilities of the Stereotaxis Niobe Systems. In this way the system seamlessly combines the benefits of cardiac 3D mapping with remote catheter navigation and may further reduce the hospital staff exposure to dangerous ionizing radiation.
The CARTO" RMT EP Navigation System v8 includes the CARTOMERGE module. The CARTOMERGE module provides for the import, visualization and processing of preacquired cardiac images. These images are then registered and superimposed to the CARTO RMT EP maps. CARTOMERGE supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance (MRI)
Anatomical Site
human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical practitioners
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 tests and the location accuracy tests performed under the Niobe environment 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CARTO™ XP EP Navigation System v8, CARTO™ RMT EP Navigation System v7
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
CARTO RMT V8 Traditional 510(k)
JUN 19 2006
A 1/2
5. 510(K) SUMMARY
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: Manager, Regulatory Affairs CARTO™ RMT EP Navigation System v8 Proprietary Device Name: Classification Name: Programmable diagnostic computer (per 21 CFR 870.1425) Common Device Name: Cardiac mapping system 1. CARTOTM XP EP Navigation System v8 Predicate Devices: 2. CARTO™ RMT EP Navigation System v7
510(k) Summary for the CARTO™ RMT EP Navigation System v8
Manufacturer:
Biosense Webster (Israel) Ltd. POB 2009 Tirat HaCarmel, 39120 Israel
Biosense Webster, Inc. CONFIDENTIAL
1
CARTO RMT V8 Traditional 510(k)
Intended Use
The CARTO™ RMT EP Navigation System v8 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 v8 is restricted for use by licensed medical practitioners who participate in a CARTO™ training course. There are no special contraindications when using the CARTO™ RMT EP Navigation System v8.
General Device Description
The CARTO™ RMT EP Navigation System v8 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 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.
In the conventional procedure both the patient and the physician are exposed to X-Ray radiation during the course of the procedure. The CARTO™ RMT System v8 enables cardiac mapping using CARTO™ RMT compatible catheters utilizing the magnetic navigation capabilities of the Stereotaxis Niobe Systems. In this way the system seamlessly combines the benefits of cardiac 3D mapping with remote catheter navigation and may further reduce the hospital staff exposure to dangerous ionizing radiation.
The CARTO" RMT EP Navigation System v8 includes the CARTOMERGE module. The CARTOMERGE module provides for the import, visualization and processing of preacquired cardiac images. These images are then registered and superimposed to the CARTO RMT EP maps. CARTOMERGE supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format.
The non-clinical bench tests and the location accuracy tests performed under the Niobe environment 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.
2
Image /page/2/Picture/1 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 or bird-like figure with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diana M. Thorson Acting Director, Regulatory Affairs Biosense Webster, Inc. 3333 Diamond Canyon Rd Diamond Bar, CA 91765
Re: K060047
Trade/Device Name: CARTOTM RMT EP Navigation System v8 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: II (two) Product Code: DRF Dated: May 18, 2006 Received: June 2, 2006
JUN 19 2006
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 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.
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
3
Page 2 – Ms. Diane Thorson
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 (see bottom for #s). 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,
Blymmerman for
Bram B. Zuckerman, M. D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications For Use Statement
510(k) No (if known): K060047
Device Name: CARTO™ RMT EP Navigation System v8 Indications for Use:
The intended use of the CARTO™ RMT EP Navigation System v8 is catheter-based atrial and ventricular mapping.
The CARTO RMT System v8 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.
The CARTO R.MT System v8 is intended to support EP procedures in the presence of the high metallic environment presented by the NIOBE 1 (PM3.0) and Niobe 2 (PM3.1 and PM3.2) Stereotaxis Magnetic Navigation Systems (MNS) in magnetic environments of up to 0.08 Tesla.
Although the CARTO™ RMT system requires the use of a magnetic steerable catheter, i.e. the NAVISTAR RMT, when used in conjunction with the Stereotaxis Niobe MNS, it also enables the use of the standard NAVISTAR and QWIKSTAR catheters when the Stereotaxis magnets are stowed away or when used in a conventional EP lab, maintaining full CARTOTM XP capabilities.
CARTO RMT System v8 includes the CARTOMERGE™ capability to import, register and merge CT or MRI structural images with CARTO maps physiological information and real time catheter navigation.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Biosense Webster, Inc. CONFIDENTIAL