(29 days)
Not Found
No
The summary describes a system for acquiring, analyzing, and displaying electroanatomical maps based on integrated electrograms and location information. There is no mention of AI, ML, or related concepts like deep learning, image processing (in a way that suggests AI analysis), or training/test sets for algorithmic development. The performance studies compare it to a predicate device and focus on safety and effectiveness, not algorithmic performance metrics typically associated with AI/ML.
No.
The device is used for catheter-based cardiac mapping, acquiring, analyzing, and displaying electroanatomical maps of the human heart, and does not claim to treat any condition.
Yes
The device's intended use explicitly states "catheter-based cardiac mapping" to display various cardiac maps (electrical activation, propagation, potential, geometry, impedance) and acquired patient signals (ECG, electrograms). This information is used to diagnose cardiac conditions by visualizing and analyzing the heart's electrical and anatomical properties.
No
The device description explicitly states it uses "locatable-tip catheters equipped with a magnetic location sensor" to acquire location information, indicating the system includes hardware components beyond just software.
Based on the provided information, the CARTO EP Navigation System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "catheter-based cardiac mapping" and "real-time display of cardiac maps." This involves directly interacting with the patient's heart and displaying information about its electrical activity and geometry.
- Device Description: The device "acquire[s], analyze[s], and display[s] electroanatomical maps of the human heart" using information gathered from "intracardiac electrograms with their respective endocardial locations." This is a direct measurement of physiological signals within the body.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status. The CARTO system is used inside the body to gather real-time data.
The CARTO EP Navigation System is a medical device used for diagnostic and procedural guidance purposes within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the CARTO EP Navigation System is catheter-based cardiac mapping.
The CARTO EP Navigation 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)
DOK
Device Description
The CARTO EP Navigation 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 EP Navigation 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 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.)
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
DEC - 3 1999
Image /page/0/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized heart shape on the left, followed by the text "Biosense Webster" in a serif font. Below the company name, in a smaller, cursive font, is the text "a Johnson & Johnson company."
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters and numbers. The sequence is K993729. The characters are written in a cursive style, with varying stroke thicknesses. The image is in black and white.
Einstein Building, Etgar St., New Industrial Zone POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: sstolars@bwiil.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: | CARTO™ EP Navigation 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. K992968 |
The CARTO EP Navigation 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 EP Navigation 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 EP Navigation 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 60601-1/1990 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 heart shape on the left, followed by the words "Biosense Webster" in a serif font. Below the company name, in a smaller, italicized font, is the text "a Johnson-Johnson company."
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: sstolars@bwiil.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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 1999
Ms. Sandra Williamson Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re : K993729 CARTO™ EP Navigation System Requlatory Class: II (two) Product Code: DOK November 1, 1999 Dated: Received: November 4, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 regulatory 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 requlation (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 (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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,
Celia M. Witten, Ph.D., M.D. Acting 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: 16993729
Device Name: CARTO™ EP Navigation System
Indications For Use:
The intended use of the CARTO EP Navigation System is catheter-based cardiac mapping.
The CARTO EP Navigation 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.
N. Deuk Tith