(106 days)
No
The summary describes a navigation and mapping system that integrates electrophysiological data with structural images (CT/MRI). While it involves image processing and data integration, there is no mention of AI, ML, or any algorithms that learn from data to perform tasks like diagnosis, prediction, or automated interpretation beyond basic data display and merging. The focus is on real-time navigation and mapping based on acquired signals and pre-acquired images.
No
Explanation: The device is described as a "Navigation System" that acquires, analyzes, and displays electro-anatomical maps of the heart, and supports EP procedures. It does not perform a direct therapeutic action or deliver therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is for "catheter-based atrial and ventricular mapping" and allows "real-time display of cardiac maps" including "cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, and cardiac chamber geometry maps." It also states that acquired patient signals like "body surface ECG and intracardiac electrograms may also be displayed in real time." This mapping and display of physiological data are fundamental to diagnosing cardiac conditions.
No
The device description explicitly states that the system "enables cardiac mapping using CARTO™ RMT compatible catheters utilizing the magnetic navigation capabilities of the Stereotaxis Niobe Systems." This indicates the system relies on and integrates with specific hardware components (catheters and magnetic navigation systems) to function, making it more than just software.
Based on the provided text, the CARTO™ RMT EP Navigation System v8 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- CARTO RMT System's Function: The CARTO RMT System v8 is a navigation and mapping system used during a medical procedure (catheter-based atrial and ventricular mapping). It acquires and displays real-time data from within the patient's body (intracardiac electrograms, body surface ECG) and integrates it with pre-acquired imaging data (CT/MRI).
- No Specimen Examination: The system does not examine specimens derived from the human body in a laboratory setting. It is used to guide and visualize procedures performed on the patient.
Therefore, the CARTO™ RMT EP Navigation System v8 falls under the category of a medical device used for diagnosis and treatment in vivo, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CARTO" RMT EP Navigation System v8 is intended to acquire real time catheter based cardiac electrophysiological 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 RMT 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 0.1 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
DQK
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 potential 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.
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 pre-acquired 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 CARTO™ RMT EP Navigation System v8 is a programmable diagnostic computer.
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 who participate in a CARTO training course.
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)
Bench testing confirms that the Carto"" RMT EP Navigation System v8 can be used according to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CARTO™ RMT EP Navigation System v8 (K060047)
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).
0
pg. 1 of 2 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 5.
5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765 | OCT - 1 2009 |
|---------------------------|---------------------------------------------------------------------------------------------|--------------|
| OFFICIAL
CORRESPONDENT | Diana Thorson
Director, Regulatory Affairs
Tel: (800)-729-9010
Fax: (909) 839-8804 | |
| TRADE NAME | CARTO™ RMT EP Navigation System v8 | |
| COMMON NAME | Cardiac mapping system | |
| DEVICE
CLASSIFICATION | Class II, 21 CFR § 870.1425 Programmable diagnostic
computer | |
| PRODUCT CODES | DQK - Programmable diagnostic computer | |
| PREDICATE DEVICE | CARTO™ RMT EP Navigation System v8 | |
| MANUFACTURER | Biosense Webster (Israel), Ltd.
POB 2009
Tirat HaCarmel 39120
Israel | |
SUBSTANTIALLY EQUIVALENT TO:
The CARTO™ RMT EP Navigation System v8 is substantially equivalent in design and intended use to the CARTO™ RMT EP Navigation System v8 (K060047). The indications for use have been expanded to include operation in magnetic environments of up to 0.1 Tesla.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
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 potential maps, impedance maps and chamber geometry maps. The acquired patient signals,
1
K091789 pg. 2 of 2 SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
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 pre-acquired 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.
INDICATIONS FOR USE:
The CARTO" RMT EP Navigation System v8 is intended to acquire real time catheter based cardiac electrophysiological 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.
TECHNICAL CHARACTERISTICS:
The CARTO™ RMT EP Navigation System v8 is a programmable diagnostic computer.
PERFORMANCE DATA:
Bench testing confirms that the Carto"" RMT EP Navigation System v8 can be used according to its intended use.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
A technological comparison and bench testing demonstrates that the CARTO™ RMT EP NAVIGATION SYSTEM V8 is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Biosense Webster, Inc. c/o Ms. Diana Thorson Director, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
OCT -1 2009
Re: K091789
Trade/Device Name: Carto RMT EP Navigation System, v8 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated; September 3, 2009 Received: September 4, 2009
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 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.
3
Page 2 - Ms. Diana 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
Sincerely yours.
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4.
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K091789
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 RMT 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 0.1 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 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) | |
|---|---|
| (Division Sign-Off) Division of Cardiovascular Devices | |
| 510(k) Number | K091789 |
| Page | 1 of 1 |