(167 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on established mapping and location technologies.
No.
The device is a diagnostic and navigation system used in cardiac electrophysiological procedures to map the heart's electrical activity and catheter location. This information aids in diagnosis and guiding the procedure, but the device itself does not directly provide therapy.
Yes
The device "provides information about the electrical activity of the heart and about catheter location during the procedure" and is "designed to acquire and analyze data points, and use this information to display 3D anatomical and electro-anatomical maps of the human heart" based on "intracardiac signals from the catheters." This aligns with the definition of a diagnostic device, as it gathers and analyzes data to provide information about the patient's condition (electrical activity, anatomical maps) for diagnostic purposes during EP procedures.
No
The device description explicitly lists multiple hardware components (Patient Interface Unit, Workstation, monitors, keyboard, mouse, ports, power supply, connection box, pedals, location pad) that are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The CARTO® 3 System is described as a catheter-based cardiac electrophysiological (EP) navigation system. It acquires and analyzes data points directly from within the human heart during a procedure to create 3D anatomical and electro-anatomical maps. It provides information about the electrical activity and catheter location during the procedure.
- Lack of Specimen Examination: The system does not examine specimens (like blood or tissue) in vitro (outside the body). It interacts directly with the patient's heart in vivo (within the body).
Therefore, the CARTO® 3 System falls under the category of a medical device used for diagnosis and treatment in vivo, not an In Vitro Diagnostic.
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 4.35 and Accessories with COHERENT MAPPING module is a catheterbased atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and electro-anatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using a set of 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 V4.35 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
CARTO® 3 EP Navigation System Version 4.35 and Accessories with COHERENT MAPPING module 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
All hardware components of the CARTO® 3 System V4.35 are identical to those described for the predicate CARTO® 3 System V4.2.
This File covers the functionality, introduced by the changes made in the CARTO®3 Navigation System 4.35 and Accessories with COHERENT MAPPING module
Because CARTO® 3 System V4.35 with COHERENT MAPPING module is only available on this version, the CARTO® 3 System V4.35 will be marketed in parallel with the CARTO® 3 System V6.0 software. Future software releases, may incorporate this functionality pending company business decisions.
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 4.35 underwent extensive bench, pre-clinical testing under simulated clinical conditions and retrospective validation to verify the new COHERENT MAPPING feature to demonstrate with regression testing that these modifications did not negatively affect existing features. The CARTO® 3 EP Navigation System, Version 4.35 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.
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).
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
June 14, 2018
Biosense Webster, Inc. Phuong Chau Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618
Re: K173977
Trade/Device Name: CARTO 3 EP Navigation System, Version 4.35 and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: May 10, 2018 Received: May 11, 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. 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 medical devices and radiation-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.
cry,
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173977
Device Name
CARTO® 3 EP Navigation System Version 4.35 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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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
Quality and Regulatory Manager
Biosense Webster (Israel), Ltd.
And
Phuong Chau
Senior Regulatory Affairs Program Lead |
| Date: | December 27, 2017 |
| Device Trade Name: | CARTO® 3 EP Navigation System Version 4.35 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 |
15715 Arrow Hwy Irwindale, CA 91706
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Device Description: The CARTO® 3 EP Navigation System Version 4.35 and Accessories with COHERENT MAPPING module is a catheterbased atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and electro-anatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using a set of 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 V4.35 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
CARTO® 3 EP Navigation System Version 4.35 and Accessories with COHERENT MAPPING module 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
All hardware components of the CARTO® 3 System V4.35 are identical to those described for the predicate CARTO® 3 System V4.2.
This File covers the functionality, introduced by the changes made in the CARTO®3 Navigation System 4.35 and Accessories with COHERENT MAPPING module
Because CARTO® 3 System V4.35 with COHERENT MAPPING module is only available on this version, the CARTO® 3 System V4.35 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
5
| | 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. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The proposed CARTO® 3 EP Navigation System, Version 4.35,
has the same technological characteristics (i. e., design, material,
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 V4.35 with COHERENT MAPPING
Module is to improve the representation of the electric wave
propagation over the atria by adding new coloring and electric
wave direction vector. This new coloring is an additional option
on top of the basic coloring of CARTO3® V4.2 cleared By FDA
(K133916). This improved representation of conduction velocity
vectors may help the physician to focus his/her attention on the
displayed path of cyclic arrhythmia propagation. |
| Performance Data: | The CARTO® 3 EP Navigation System, Version 4.35 underwent
extensive bench, pre-clinical testing under simulated clinical
conditions and retrospective validation to verify the new
COHERENT MAPPING feature to demonstrate with regression
testing that these modifications did not negatively affect existing
features. The CARTO® 3 EP Navigation System, Version 4.35
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 4.35 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. |