(146 days)
Not Found
No
The summary describes a system for cardiac mapping based on acquiring and analyzing data points and displaying 3D maps. It mentions location technologies (magnetic sensor and ACL) and signal processing but does not mention any AI or ML algorithms, training, or testing related to such technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a mapping and navigation system that provides information and displays 3D anatomical and electroanatomical maps of the heart; it does not directly treat a condition.
Yes
This device provides "information about the electrical activity of the heart" and "displays 3D anatomical and electroanatomical maps of the human heart" based on acquired data points and electrograms, which are used to understand the heart's condition during EP procedures. This aligns with the definition of a diagnostic device as it helps identify and understand a medical condition.
No
The device description explicitly lists multiple hardware components (Patient Interface Unit, Graphic User Interface, monitors, keyboard, mouse, ports, power supply, connection box, pedals, location pad) that are part of the system. While software is a key component for data analysis and display, the system is not solely software.
Based on the provided information, the CARTO® 3 System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states "catheter-based cardiac electrophysiological (EP) procedures." This involves direct interaction with the patient's heart in vivo to gather electrical activity and catheter location information.
- Device Description: The description details a system that acquires and analyzes data points from within the human heart using specialized catheters and reference devices. It displays 3D anatomical and electroanatomical maps based on these intracardiac signals.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. The CARTO® 3 System does not perform this function. It is a navigation and mapping system used during a medical procedure on a living patient.
Therefore, the CARTO® 3 System is a medical device used for in vivo procedures, not an IVD.
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 6.0 is a catheterbased 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 V6.0 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 System V6.0 consists of the following components:
- Patient Interface Unit (PIU)
- 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
All hardware components of the CARTO® 3 System V6.0 are identical to those described for the predicate CARTO® 3 System V4.2.
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 CARTO® 3 EP Navigation System, Version 6.0 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 6.0 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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2017
Biosense Webster, Inc. Phoung Chau Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618
Re: K170600
Trade/Device Name: CARTO 3 EP Navigation System. Version 6.0 and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: June 16, 2017 Received: June 19, 2017
Dear Phoung 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. 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 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
1
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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.
M.A. Wilhelm
for
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170600
Device Name
CARTO® 3 EP Navigation System, Version 6.0 And Accessories
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) |
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3
510(k) Summary – K170600
| 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: 909-839-7249
Fax: 909-839-8804 |
| Authored by: | Moshe Hochmitz
Quality and Regulatory Manager
Biosense Webster (Israel), Ltd.
And
Phuong Chau
Senior Regulatory Affairs Program Lead
Phone: 909-839-7249
Fax: 909-839-8804 |
| Date: | February 28, 2017 |
| Device Trade
Name: | CARTO® 3 EP Navigation System Version 6.0 and Accessories |
| Device Common
Name: | Cardiac Mapping System |
| Manufacturing
Number: | FG-5400-00 |
| Device
Classification: | Programmable diagnostic computer
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
Device Description: The CARTO® 3 EP Navigation System, Version 6.0 is a catheterbased 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 V6.0 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 System V6.0 consists of the following components:
- . Patient Interface Unit (PIU)
- 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 ●
All hardware components of the CARTO® 3 System V6.0 are identical to those described for the predicate CARTO® 3 System V4.2.
- 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.
5
Technological The proposed CARTO® 3 EP Navigation System, Version 6.0, has the same technological characteristics (i. e., design, material, Characteristics: chemical composition, energy source) as the predicate CARTO® 3 EP Navigation System, Version 4.2. A summary of the technological characteristics of the new device compared to the predicate device is as follows:
- Have identical intended use. ●
- Use the same fundamental scientific technology. ●
- Have the same hardware platform. ●
- Have identical magnetic location mapping technology. ●
- Have identical magnetic location sensor accuracy.
The main difference between the CARTO® 3 System V4.2 and CARTO® 3 System V6.0 is to enhance the following areas:
| Enhancements | CARTO® 3 System V6.0 | Rationale for
Difference |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Annotations | ConfiDENSE Module has two
new types of point annotations
Body Surface Morphology
Matching Complex Point
Identification | Addition of two
new filters to
assist physicians
with points
acquisition. |
| Visualization | CARTO VIZIGO™ Software | Addition of
CARTO VIZIGO
Software to
support
visualization of
the VIZIGO™
Bi-Directional
Guiding Sheath. |
| Fluoro
Integration | Addition of TOSHIBA to the
CARTOUNIVU module
supported X-ray systems
library. | Compatibility
with TOSHIBA
X-ray Systems
has been
established. |
| Imaging | CARTOSEG CT and
CARTOSEG MR library
update. | Update to add
Siemens to the
library has no
impact on system
functionality or
workflow. |
6
| | Usability | | Software Graphical User
Interface (GUI)
modifications to allow
Intuitive use of most used
features
• Usability features for
Maps | Usability changes
for improved
CARTO® 3
System look and
feel. No impact
on system
functionality or
workflow. |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | The CARTO® 3 EP Navigation System, Version 6.0 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 6.0 passed all tests in accordance
with appropriate test criteria and standards, and the modified
device did not raise new questions of safety or effectiveness. | | | |
| Conclusions: | The CARTO® 3 EP Navigation System, Version 6.0 is
substantially equivalent to the currently cleared CARTO® 3 EP
Navigation System, Version 4.2 based on the completion of non-
clinical bench testing and pre-clinical testing as well as similar
principles of design, operation and indications for use. | | | |