(238 days)
Not Found
No
The summary describes a system for creating 3D anatomical and electroanatomical maps using location technology and signal processing. While it analyzes data points and generates visual maps, there is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML models (AUC, sensitivity, specificity), or image processing which is often a domain for AI/ML in medical devices. The description focuses on signal processing, location technology, and map generation based on received signals.
No.
The device is used for diagnostic purposes (displaying 3D anatomical and electroanatomical maps of the heart; providing information about electrical activity and catheter location), and the text explicitly states, "The information provided by these maps are for diagnostic purposes only. Therapeutic treatment should rely on all available information in the EP lab."
Yes
Explanation: The "Intended Use" section states that the system "provides information about the electrical activity of the heart," and the "Device Description" explains that it "display[s] 3D anatomical and electroanatomical maps of the human heart" based on acquired and analyzed data points. Furthermore, the "Summary of Performance Studies" states, "The information provided by these maps are for diagnostic purposes only." These aspects clearly indicate its role in diagnosing cardiac conditions.
No
The device description explicitly mentions "specialized mapping catheters and reference devices" and "magnetic sensor technology and Advanced Catheter Location (ACL) technology," indicating the system includes hardware components beyond just software. The testing also includes verification of "hardware configurations."
Based on the provided information, the CARTO® 3 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "catheter-based cardiac electrophysiological (EP) procedures." This describes a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device acquires and analyzes data points from within the human heart using catheters and reference devices. It displays 3D anatomical and electroanatomical maps based on these in vivo signals.
- Nature of Data: The system processes electrical signals directly from the heart, not biological samples like blood, urine, or tissue.
- Clinical Data Section: While the clinical data section mentions that the information provided by the maps is for "diagnostic purposes only," this refers to diagnosing conditions within the living patient during the EP procedure, not diagnosing conditions based on in vitro analysis of samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or compatibility purposes. The CARTO® 3 System operates directly within the patient's body to gather information about the heart's electrical activity and catheter location during a procedure.
N/A
Intended Use / Indications for Use
The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
Product codes (comma separated list FDA assigned to the subject device)
DOK
Device Description
The CARTO® 3 EP Navigation System Version 5.2 and Accessories 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. 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 electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System V5.2 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 EP Navigation System Version 5.2 is a modification to the CARTO® 3 EP Navigation System Version 4.2 to add the CARTOFINDER™ Module and workstation as an accessory to the CARTO® 3 System. The CARTOFINDER™ Module sends recorded electrical signals collected from multi-connector electrode catheters to the CARTOFINDER™ workstation, which generates new visual format maps to be displayed in the CARTO® 3 EP Navigation System. The new visual format maps generated by the CARTOFINDER™ Workstation are divided into two categories:
-
- Dynamic mapping algorithms: Wherein the physiological scoring is changing over time after inspecting the input signals in a certain window of interest.
-
- Static mapping algorithms: These maps set a single physiological scoring per electrode, after analyzing the input signals during the full recording time.
The CARTOFINDER™ Workstation creates the following Dynamic and Static Maps:
-
- 4D LAT: Dynamic map of the Local Activation Time.
-
- Cycle Length (CL) Unipolar Signal: Static map showing the dominant cycle length measured on each recorded channel per recording/data acquisition set.
-
- Cycle Length (CL) Variation: Static map showing the standard deviation cycle length measured on each recorded channel.
-
- CARTOFINDER™ Region of Interest (ROI) Focal: This map will identify the area with OS morphology on the unipolar electrograms that are activated early compared to the surrounding multi-connector (MC) electrode catheter recorded channels.
-
- CARTOFINDER™ (ROI) Rotational: This map will identify rotational activation patterns that occupy at least 50% of the cycle length map (this condition requires sufficient spatial and temporal resolution).
CARTO® 3 EP Navigation System Version 5.2 and Accessories consists of the following components:
- Patient Interface Unit (PIU)
- 3D graphical Workstation that serves as the Graphic User Interface (GUI), Wide-Screen monitors, keyboard, and mouse
- Intracardiac In Port
- Intracardiac Out Port
- Power Supply
- Patches Connection Box and Cables
- Pedals
- Location Pad
- CARTOFINDER™ Workstation
- Non-Biosense Webster basket catheter interface cable (CA-5400-61)
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)
Performance Data: The CARTO® 3 EP Navigation System, Version 5.2 underwent extensive bench and pre-clinical testing under simulated clinical conditions to verify the new and modified features and to demonstrate with regression testing that these modifications did not negatively affect existing features. The CARTO® 3 EP Navigation System, Version 5.2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.
Bench Testing:
Non-clinical performance testing completed for the CARTO® 3 EP Navigation System, Version 5.2 included:
- CARTO® 3 System Version 5.2 verify the functional requirements and hardware configurations with the new CARTOFINDER™ Module and Workstation, regression testing of all CARTO® 3 System legacy features, verify system functionality for all supported catheters, and usability testing.
- CARTOFINDERTM Workstation testing - verify the signal preprocessing and annotation detection, maps and catheter generation and coloring, CARTOFINDER™ functionality (including MC catheter support), stimulation detection and blanking, coloring projection and interpolation, power reject algorithm performance, and usability testing.
- CARTOFINDER™ integration verify that the new module interface with the CARTOFINDER™ Workstation meets requirements and functions as intended when integrated with the CARTO® 3 system.
- Interface cable - verification testing was completed for the interface cable connected to a non-Biosense Webster basket catheter with the CARTO® 3 System.
Animal Testing:
Animal testing was performed to evaluate the CARTO® 3 System Version 5.2 and CARTOFINDER™ Workstation workflow under simulated clinical workflow.
Clinical Data:
Clinical data from Biosense Webster sponsored studies, published literature, and manuscripts were used to support the clinical performance of the new maps for their respective intended use. The data also supported the clinical performance of the compatible catheters with the new maps. The information provided by these maps are for diagnostic purposes only. Therapeutic treatment should rely on all available information in the EP lab.
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.
CARTO® 3 EP Navigation System Version 4.2 and Accessories 510(k)#: K133916
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2018
Biosense Webster, Inc. Phuong Chau Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618
Re: K173978
Trade/Device Name: CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK. Dated: July 31, 2018 Received: August 1, 2018
Dear Phuong Chau:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mude Jellm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
CARTO® 3 EP Navigation System Version 5.2 and Accessories with CARTOFINDER Module
Indications for Use (Describe)
The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
| Applicant: | Biosense Webster, Inc.
33 Technology Drive
Irvine, CA 92618, USA
Phone: 909-839-8500
Fax: 909-839-8804 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Phuong Chau
Senior Regulatory Affairs Program Lead
Phone: 949-923-4238
Fax: 949-450-6886 |
| Authored by: | Moshe Hochmitz
Associate Director, Quality and Regulatory
Biosense Webster (Israel), Ltd.
And
Phuong Chau
Senior Regulatory Affairs Program Lead |
| Date: | July 27, 2018 |
| Device Trade
Name: | CARTO® 3 EP Navigation System Version 5.2 and Accessories with
CARTOFINDER™ Module |
| Device Common
Name: | Cardiac Mapping System |
| Manufacturing
Number: | FG-5400-00 |
| Device
Classification: | Programmable diagnostic computer |
| Classification: | Class II, 21 CFR 870.1425 |
| Product Code | DQK |
| Predicate Device: | CARTO® 3 EP Navigation System Version 4.2 and Accessories
510(k)#: K133916 |
| Manufacturing
Facilities: | Biosense Webster (Israel), Ltd.
a Johnson & Johnson Company
4 Hatnufa Street
Yokneam ISRAEL 2066717 |
4
Biosense Webster, Inc. 15715 Arrow Hwy Irwindale, CA 91706
The CARTO® 3 EP Navigation System Version 5.2 and Accessories is Device Description: 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. 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 electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System V5.2 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 EP Navigation System Version 5.2 is a modification to the CARTO® 3 EP Navigation System Version 4.2 to add the CARTOFINDER™ Module and workstation as an accessory to the CARTO® 3 System. The CARTOFINDER™ Module sends recorded electrical signals collected from multi-connector electrode catheters to the CARTOFINDER™ workstation, which generates new visual format maps to be displayed in the CARTO® 3 EP Navigation System. The new visual format maps generated by the CARTOFINDER™ Workstation are divided into two categories:
-
- Dynamic mapping algorithms: Wherein the physiological scoring is changing over time after inspecting the input signals in a certain window of interest.
-
- Static mapping algorithms: These maps set a single physiological scoring per electrode, after analyzing the input signals during the full recording time.
The CARTOFINDER™ Workstation creates the following Dynamic and Static Maps:
-
- 4D LAT: Dynamic map of the Local Activation Time.
-
- Cycle Length (CL) Unipolar Signal: Static map showing the dominant cycle length measured on each recorded channel per recording/data acquisition set.
-
- Cycle Length (CL) Variation: Static map showing the standard deviation cycle length measured on each recorded channel.
-
- CARTOFINDER™ Region of Interest (ROI) Focal: This map will identify the area with OS morphology on the unipolar electrograms that are activated early compared to the
5
surrounding multi-connector (MC) electrode catheter recorded channels.
-
- CARTOFINDER™ (ROI) Rotational: This map will identify rotational activation patterns that occupy at least 50% of the cycle length map (this condition requires sufficient spatial and temporal resolution).
CARTO® 3 EP Navigation System Version 5.2 and Accessories consists of the following components:
- CARTOFINDER™ (ROI) Rotational: This map will identify rotational activation patterns that occupy at least 50% of the cycle length map (this condition requires sufficient spatial and temporal resolution).
-
Patient Interface Unit (PIU) ●
-
3D graphical Workstation that serves as the Graphic User Interface (GUI), Wide-Screen monitors, keyboard, and mouse
-
Intracardiac In Port
-
Intracardiac Out Port ●
-
Power Supply ●
-
. Patches Connection Box and Cables
-
Pedals
-
Location Pad ●
-
CARTOFINDER™ Workstation ●
-
Non-Biosense Webster basket catheter interface cable (CA-● 5400-61)
Because CARTOFINDER™ is only available on this version, the CARTO® 3 System V5.2 will be marketed in parallel with the CARTO® 3 System V6.0 software. Future software releases may incorporate this functionality pending company business decisions
- Indications for Use: The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
The proposed CARTO® 3 EP Navigation System, Version 5.2, has the Technological same technological characteristics as the predicate CARTO® 3 EP Characteristics: Navigation System, Version 4.2. A summary of the technological characteristics of the new device compared to the predicate device is provided in the following table.
| | CARTO 3 System V4.2
(K133916) | CARTO® 3 EP Navigation
System Version 5.2 with
CARTOFINDER™ Module
(K173978) |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The intended use of the
CARTO® 3 System is catheter-
based cardiac
electrophysiological (EP) | Same |
| | procedures. The CARTO® 3
System provides information
about the electrical activity of the
heart and about catheter location
during the procedure. The system
can be used on patients who are
eligible for a conventional
electrophysiological procedure.
The system has no special
contraindications. | |
| System | Patient Interface Unit (PIU)
Workstation Computer with
standard keyboard and
mouse
Single monitor display
Intracardiac Port
Intracardiac Out Port
Power Supply
Patch Connections Box and
Cables
Pedals
Location Pad | Addition of the
CARTOFINDER™ Workstation
(Workstation specifications are
same as CARTO 3 System
Workstation specifications) |
| Sensors catheters
support | Mapping and visualization based
on Basic triangulation of
Magnetic Location algorithm | Same |
| Non-Sensors
catheters support | Mapping and visualization based
on Current based location (ACL)
algorithm | Same |
| Interface for Data
transfer
CARTOFINDERTM
Module | Interfacing with compatible
devices (such as Ultrasound
systems, EP recording systems,
Fluoroscopic systems, RF
Generators) | Extended interface abilities to
support the CARTOFINDERTM
Workstation data. |
| Offers Display
Options for Review
of Processed
Signals | LAT (including propagation of
single beat)
Anatomical
Unipolar & Bipolar Voltage
maps
Impedance | 4D LAT
enhanced to review signal
propagation over the
complete periods of time of
signal recording
CL Stability
CL Variation
ROI - Focal
ROI - Rotational |
| Supports Multi
Electrode Catheter
Recordings | Yes | MEM capability was expanded
to high number of electrodes,
including interface cable (CA-
5400-61) to support basket
catheter |
6
The CARTO® 3 System V5.2 is substantially equivalent to the CARTO® 3 System V4.2, as the mechanism of the diagnostic maps of both devices remains the same. Both devices use IC annotated signal in a known location and present them in a sequence that determines the propagation direction of the signal in the tissue allowing the physician to diagnose the arrhythmia pattern. Except for the CARTOFINDER™ Workstation, the hardware components of the CARTO® 3 System V5.2
7
are identical to those described for the predicate CARTO® 3 System V4.2.
The CARTO® 3 EP Navigation System, Version 5.2 underwent Performance Data: extensive bench and pre-clinical testing under simulated clinical conditions to verify the new and modified features and to demonstrate with regression testing that these modifications did not negatively affect existing features. The CARTO® 3 EP Navigation System, Version 5.2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.
Bench Testing:
Non-clinical performance testing completed for the CARTO® 3 EP Navigation System, Version 5.2 included:
- CARTO® 3 System Version 5.2 verify the functional . requirements and hardware configurations with the new CARTOFINDER™ Module and Workstation, regression testing of all CARTO® 3 System legacy features, verify system functionality for all supported catheters, and usability testing.
- . CARTOFINDERTM Workstation testing - verify the signal preprocessing and annotation detection, maps and catheter generation and coloring, CARTOFINDER™ functionality (including MC catheter support), stimulation detection and blanking, coloring projection and interpolation, power reject algorithm performance, and usability testing.
- CARTOFINDER™ integration verify that the new module . interface with the CARTOFINDER™ Workstation meets requirements and functions as intended when integrated with the CARTO® 3 system.
- . Interface cable - verification testing was completed for the interface cable connected to a non-Biosense Webster basket catheter with the CARTO® 3 System.
Animal Testing:
Animal testing was performed to evaluate the CARTO® 3 System Version 5.2 and CARTOFINDER™ Workstation workflow under simulated clinical workflow.
Clinical Data:
Clinical data from Biosense Webster sponsored studies, published literature, and manuscripts were used to support the clinical performance of the new maps for their respective intended use. The data also supported the clinical performance of the compatible catheters with the new maps. The information provided by these maps
8
are for diagnostic purposes only. Therapeutic treatment should rely on all available information in the EP lab.
The CARTO® 3 EP Navigation System, Version 5.2 is substantially Conclusions: equivalent to the currently cleared CARTO® 3 EP Navigation System, Version 4.2 based on the completion of non-clinical bench testing, preclinical testing, and clinical data as well as similar principles of design, operation and indications for use.