(140 days)
Not Found
No
The document describes image processing and merging capabilities but does not mention AI, ML, or related terms like deep learning or neural networks.
No
Explanation: The device is described as an "EP Navigation System" and "mapping system" used to acquire, analyze, and display electro-anatomical maps of the heart. Its purpose is diagnostic, providing information for conventional electrophysiological studies and guiding catheter-based mapping, rather than directly providing therapy.
Yes
The device is intended to acquire real-time catheter-based cardiac electrophysiological maps for patients eligible for a conventional electrophysiological study and provides various types of maps (electrical activation, propagation, potential, and chamber geometry) based on collected data, all of which are diagnostic functions.
No
The device description explicitly states it is a "system" designed to acquire, analyze, and display electro-anatomical maps using information gathered from the integration of intracardiac electrograms with their respective endocardial locations. This implies the use of hardware components (catheters, sensors, etc.) to acquire the data, in addition to the software for processing and display. The CARTOMERGE module, while software-based for image processing, is an addition to this core system.
Based on the provided text, the CARTO™ XP EP Navigation 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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CARTO™ XP Function: The CARTO™ XP system is described as a navigation system that acquires real-time catheter-based cardiac electrophysiological maps. It uses information gathered from intracardiac electrograms and their locations, and can also incorporate pre-acquired CT or MRI images.
- Focus on In Vivo Data: The system primarily works with data acquired within the patient's body (intracardiac electrograms and catheter location) and structural images of the heart. It does not analyze specimens taken from the body.
Therefore, the CARTO™ XP EP Navigation System falls under the category of a medical device used for diagnosis and navigation in vivo, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CARTO™ XP 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™ XP 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™ XP EP Navigation System.
The intended use of the CARTO™ XP mapping system is catheter-based atrial and ventricular mapping.
The CARTO™ XP mapping system allows real-time display of cardias maps in a uumber The CARTO'" XF inapping System anows of cardiac electrical activation maps, cardiac of different formals. Maps may of expression maps, and cardiac electrical propagation naps, carenas t signals, including body surface ECG and geomeny maps. The acquired panelle organia, and time on the display screen.
The intended use of the modified device is the same as for Predicate Device A cleared under 510(k) Number K020863. The indications for use have been expanded to include 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 (comma separated list FDA assigned to the subject device)
DQK
Device Description
The CARTO™ XP 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 endocardial 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.
The CARTOMERGE module provides for the import, processing, visualization and analysis of pre-acquired cardiac images, superimposed to the CARTO XP EP maps. The 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) and Magnetic Resonance (MRI)
Anatomical Site
Human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed medical practitioner who participated 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)
The non-clinical bench and animal testing 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.
A. CARTOTM XP QwikMap EP Navigation System, K020863
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.
B. Siemens Medical System singo Multimodality Workstation
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
MAR 2 1 2005
CARTO XP Version 8 EP Navigation System Special 510(k)
C. 510(K) Summary
The 510(k) summary for the CARTO XP V8 Mapping System is provided below.
510(k) Summary for the CARTO™ XP V8 EP Navigation System 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: Project Manager, Regulatory Affairs CARTO™ XP EP Navigation System Proprietary Device Name: Programmable diagnostic computer Classification Name: (per 21 CFR 870.1425) Cardiac mapping system Common Devicc Name: A. CARTOTM XP QwikMap EP Navigation Predicate Devices: System B. Siemens Medical System singo Multimodality Workstation Biosense Webster (Israel) Ltd. Manufacturer: POB 2009 Tirat HaCarmel, 39120 Israel
1
K042999/52
P2/2
CARTO XP Version 8 EP Navigation System Special 510(k)
Indications For Use
The CARTO™ XP 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™ XP 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™ XP EP Navigation System.
General Device Description
The CARTO™ XP 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 endocardial 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.
The CARTOMERGE module provides for the import, processing, visualization and analysis of pre-acquired cardiac images, superimposed to the CARTO XP EP maps. The CARTOMERGE supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format.
The CARTO™ XP 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 devices to which it is being compared and does not raise any new questions of safety or effectiveness.
2
Image /page/2/Picture/2 description: The image is a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center is a stylized eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2005
Biosense Webster, Inc. c/o Ms. Diana Thorson Project Manager, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re: K042999
Trade Name: CARTO™ EP Navigation System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DQK Dated: January 31, 2005 Received: February 03, 2005
Dear Ms. Thorson:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section 910(x) promotion is substantially equivalent (for the indications for use stated in the enclosure) the acted predicate devices marketed in interstate for use stated in the encrosule) to regard manative posice Amendments, or to commerce provided to May 20, 1978, the exactions of the Federal Food, Drug, devices that have occh recaisoned in assess approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment ACT (Act) that do not require apper o the general controls provisions of the Act. The You may, therefore, market the devices, books of the more of the manual registration, listing of general controls provisions of the rise, 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 If your device is classified (see above) me etails in the regulations affecting your device can be may be subject to such additional econtroller interest and to 898. In addition, FDA may oc found in the Code of Pederal Regarations, 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 r lease oc devisou and I Drimination that your device complies with other requirements of the Act that I Drimas Intacted and regulations administered by other Federal agencies. You must or any I edetar statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF IT rate 677, idoomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product indiation control to begin marketing your device as described in your Section 510(k) I mis letter will and will yourse finding of substantial equivalence of your device to a legally prematics notication "The 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 If you t the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Whoordinating of responsibilities under the Act may be obtained from the Oiner general informational 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/dsma/dsmamain.html
Sincerely yours,
B. Zimmerman for
R. Z. Zimmerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1042999
CARTO XP Version 8 EP Navigation System Special 510(k)
D. Indications For Use Statement
510(k) No (if known): K042999
Device Name: CARTO™ EP Navigation System
Indication for Use:
The intended use of the CARTO™ XP mapping system is catheter-based atrial and ventricular mapping.
The CARTO™ XP mapping system allows real-time display of cardias maps in a uumber The CARTO'" XF inapping System anows of cardiac electrical activation maps, cardiac of different formals. Maps may of expression maps, and cardiac chamber electrical propagation naps, carenas t signals, including body surface ECG and geomeny maps. The acquired panelle organia, and time on the display screen.
The intended use of the modified device is the same as for Predicate Device A cleared I he intended use of the modified dovied to also for use have been expanded to include
under 510 (k) Number K020863. The indications for use have been expanded to include the CARTOMERGE™ capability to import, register and merge CT or MRI structural the CARTOMERGE™ Capability to import, rogister and the catheter navigation.
images with CARTO maps physiological information and real time catheter navigation.
Prescription Use × (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)
Blumamoto
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K043999
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Brosense Webster, Inc
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