(83 days)
Not Found
No
The document describes a navigation and mapping system based on magnetic sensor and ACL technology, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The system is for mapping and display of cardiac information, not for treatment.
Yes
The device is explicitly described as a "catheter-based atrial and ventricular mapping system" that "acquire[s] and analyze[s] data points" to "display 3D anatomical and electroanatomical maps of the human heart in real-time." This process of acquiring and analyzing data to create maps of the heart's electrical activity and anatomy is a diagnostic function, as it helps in identifying and understanding cardiac conditions.
No
The device description explicitly states it is a "catheter-based atrial and ventricular mapping system" that acquires data using "specialized mapping catheters and reference devices." This indicates the system includes hardware components beyond just software.
Based on the provided information, the CARTO® 3 V2.2 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CARTO® 3 V2.2 System Function: The description clearly states that the CARTO® 3 V2.2 System is a catheter-based system used for mapping the electrical activity and anatomy of the heart in real-time within the body. It uses catheters inserted into the patient to acquire signals and create maps.
- Lack of Specimen Analysis: The system does not involve the analysis of specimens taken from the body. It directly interacts with and measures physiological signals within the body.
Therefore, the CARTO® 3 V2.2 System falls under the category of a medical device used for diagnosis and guidance during procedures, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE® Plus functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The CARTO® 3 V2.2 EP Navigation System is a catheter-based atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and 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 catheters and reference devices. The system allows real-time display of electrograms and cardiac maps based on the received intra cardiac signals in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the display screen. The CARTO® 3 V2.2 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MRI structural images, intracardiac echo (ICE)
Anatomical Site
Human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing to verify the new and enhanced features and to demonstrate with regression testing that the new features did not negatively affect existing features. The CARTO® 3 V2.2 EP Navigation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise 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.
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
§ 870.1425 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
16 510(k) SUMMARY
16.1
General Information
Image /page/0/Picture/2 description: The image shows the text 'K112007' in a handwritten style. The characters are connected, giving it a cursive appearance. The text is written in black ink on a white background, and the numbers are slightly smaller than the letters.
Applicant: Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765 USA Phone: 909-839-8597 Fax: 909-839-8804 July 8, 2011 Date: Wayne R. Hohman Contact Person: Project Manager Regulatory Affairs Trade/Proprietary Device CARTO® 3 V2.2 EP Navigation System and Accessories Name: Manufacturing Part FG-5400-00 (with standard location pad) Numbers: FG-5600-00 (with RMT location pad) Common Device Name: Cardiac mapping system Programmable diagnostic computer Classification Name: Device Classification: Class II, 21 CFR 870.1425 Product Code DQK CARTO® 3 V2.0 EP Navigation System and Accessories Predicate Device: 510(k) K103746, January 21, 2011 Manufacturing Facility: Biosense Webster (Israel) Ltd. 4 Hatnufa Street, POB 275 Yokneam 20692 Israel
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CONFIDENTIAL
1
Description of Device 16.2
The CARTO® 3 V2.2 EP Navigation System is a catheter-based atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and 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 catheters and reference devices. The system allows real-time display of electrograms and cardiac maps based on the received intra cardiac signals in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the display screen. The CARTO® 3 V2.2 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
16.3 New Features
The new features in this Special 510(k) Notification were software additions of Fluoro Effect Reduction (FER), support of Biosense Webster PENTARAY® Catheter, and support of SOUNDSTAR® eco Catheters with Split Handle, and hardware modification of an ECG board and addition of an Extension Cable. In addition, all modifications cleared via documentation since the prior predicate version were described.
16.4 Indications for Use
The Indications for Use for the modified device are identical to the predicate device:
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE® Plus functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of
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Biosense Webster, Inc. CARTO® 3 x 7 2 Snecial 510/k) CONFIDENTIAL
Page 80 of 631
2
intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, nonnavigational, electrophysiology catheters without magnetic location sensors.
Summary of Non-Clinical Performance Testing 16.5
The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing to verify the new and enhanced features and to demonstrate with regression testing that the new features did not negatively affect existing features. The CARTO® 3 V2.2 EP Navigation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.
Substantial Equivalence 16.6
The Carto® 3 EP Navigation System, Version 2.2, is substantially equivalent to the legally marketed Carto® 3 EP Navigation System, Version 2.0, 510(k) K103746, cleared on January 21, 2011.
16.7 Conclusions
The bench and animal pre-clinical testing demonstrated that the CARTO® 3 V2.2 EP Navigation System is safe, effective, and performs as well as or better than the predicate device. This testing program supports the determination of substantial equivalence to the predicate device.
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Biosense Webster, Inc. CARTO® 3 v 7 7 Snerial SIN/k) CONFIDENTIAL
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Image /page/3/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic. The text is small and difficult to read, but it appears to be part of an organization's name. The graphic consists of three curved lines that resemble a stylized human figure or a flowing design, with wavy lines at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20903-0002
Biosense Webster, Inc. c/o Mr. Wayne R. Hohmann Project Manager Regulatory Affairs 3333 Diamond Canyon Road. Diamond Bar, CA 91765
2.11
Re: [510(k)] K112007 [210(W)] Trade/Device Name: CARTO 3 V2.2 EP Navigation System (Version 2.2) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: September 8, 2011 Received: September 9, 2011
Dear Mr. Hohmann:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Mr. Wayne R. Hohmann
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 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/About/DA/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 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
· INDICATIONS FOR USE
510(k) No (if known): K112007
Device Name: CARTO® 3 V2.2 EP Navigation System
Indications for Use:
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures, maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE® PLUS functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.
Prescription Use V (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 (Division Sign-Off) Device Evaluation (ODE)
Division of Cardiovascular Devices
| 510(k) Number | 1/1/2007 |
|---|---|
| --------------- | ---------- |
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