(26 days)
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No
The document describes a system for electroanatomical mapping based on integrating electrograms with location information from magnetic sensors. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
No
The device is described as a mapping system that acquires, analyzes, and displays electroanatomical maps of the human heart. It is used for diagnosis and monitoring, not for treating a condition.
Yes
The device is intended for "catheter-based cardiac mapping" to create various "cardiac maps" (electrical activation, propagation, potential, geometry, impedance) and display "patient signals, including body surface ECG and intracardiac electrograms". This process of acquiring and analyzing data from the heart to identify its electrical and structural characteristics falls under diagnostic imaging.
No
The device description explicitly states it uses "locatable-tip catheters equipped with a magnetic location sensor" to acquire location information, indicating the inclusion of hardware components beyond just software.
Based on the provided information, the CARTO mapping system is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "catheter-based cardiac mapping." This involves analyzing electrical signals and creating maps within the patient's body (in vivo), not analyzing samples taken from the body (in vitro).
- Device Description: The system acquires and analyzes "intracardiac electrograms" and "endocardial locations" using catheters inside the heart. This is a direct interaction with the patient's internal anatomy.
- Lack of IVD Characteristics: The description does not mention analyzing blood, tissue, urine, or any other biological samples typically associated with IVD devices.
Therefore, the CARTO mapping system is a medical device used for in-vivo diagnostic and procedural guidance, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the CARTO mapping system is catheter-based cardiac mapping.
The CARTO 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, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The CARTO mapping system is designed to acquire, analyze, and display electroanatomical 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. In the CARTO mapping system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a magnetic location sensor.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human heart
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.)
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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.
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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).
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§ 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
Kg92968
Image /page/0/Picture/2 description: The image shows the Biosense Webster logo. The logo consists of a stylized letter "B" made up of four squares, followed by the word "Biosense" in a bold, sans-serif font. Below the word "Biosense" is a horizontal line, and below that is the text "a Johnson & Johnson company" in a smaller, italicized font.
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: sstolars@bioil.jnj.il
510(k) summary for the CARTO Mapping System
| 510(k) Notification submitted
by: | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765
USA
Phone: +1-800-729-9010
Fax: +1-909-468-3781 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Sandra Williamson
Senior Regulatory Affairs Associate |
| Proprietary device name: | CARTOTM Mapping System |
| Classification name: | Programmable diagnostic computer
(per 21 CFR 870.1425) |
| Common device name: | Cardiac mapping system |
| Cleared unmodified device | CARTO mapping system
510(k) No.K954395 |
The CARTO mapping system is designed to acquire, analyze, and display electroanatomical 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. In the CARTO mapping system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a magnetic location sensor.
Currently, cardiac mapping is performed using a roving mapping catheter, a computerized mapping system, and fluoroscopy to determine the location of the tip of the mapping catheter. In the conventional procedure both the patient and the physician are exposed to harmful ionizing radiation during the course of the lengthy procedure. The CARTO mapping system enables cardiac mapping using a magnetic location technology, and may reduce exposure to dangerous ionizing radiation.
The CARTO mapping system complies with the following safety standards:
EN 60601-111990 EN 60601-1 A1/1993 EN 60601-1 A2/1995 EN 60601-2-27/1994
1
Image /page/1/Picture/0 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized letter "B" made up of black squares, followed by the word "Biosense" in a bold, sans-serif font. Below the word "Biosense" is the phrase "a Johnson & Johnson company" in a smaller, serif font. A horizontal line is placed under the word "Biosense".
. .
. .
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: sstolars@bioil.jnj.il
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.
000786
2
Image /page/2/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1999
Ms. Sandra Williamson Senior Regulatory Affairs Associate Cordis Webster, Inc. 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
K992968 Re : Carto™ EP Navigation System Requlatory Class: II (two) Product Code: DQK Dated: Auqust 30, 1999 Received: September 3, 1999
Dear Ms. Williamson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Sandra Williamson
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for use statement
510(k) No:
Device Name: CARTO mapping system
Indications For Use:
The intended use of the CARTO mapping system is catheter-based cardiac mapping.
The CARTO 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, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
Dan Va Hill
(Division Signand Neur 510k) N
Prescription Use
(Per 21 CFR 801.109)