(29 days)
No
The summary describes a system for cardiac mapping and navigation based on established location technologies and signal processing, with no mention of AI or ML.
No.
The descriptions consistently refer to the CARTO® 3 System as a "mapping diagnostic system" and indicate its primary purpose is to "acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical diagnostic maps of the human heart" and to provide "information about the electrical activity of the heart." There is no mention of treating or alleviating a disease or condition.
Yes
Explanation: The "Device Description" explicitly states that the CARTO® 3 EP Navigation System is a "catheter-based atrial and ventricular mapping diagnostic system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical diagnostic maps of the human heart." The term "diagnostic system" directly indicates its function as a diagnostic device.
No
The device description explicitly lists multiple hardware components that are part of the system, indicating it is not software-only.
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 and displays maps based on "intracardiac signals from the catheters." This data is collected directly from within the patient's heart.
- Lack of Mention of Samples: There is no mention of the device analyzing biological samples (like blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CARTO® 3 System is a navigation and mapping system used during a medical procedure on the patient.
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)
DQK
# Device Description
The CARTO® 3 EP Navigation System, Version 7.1 is a catheter-based atrial and ventricular mapping diagnostic system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical diagnostic maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using 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 V7.1 uses the same two distinct types of location technology as the predicate device - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 System V7.1 consists of the following hardware components:
- Patient Interface Unit (PIU) and Cables
- 3D Graphics Workstation
- 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 V7.1 are identical to those described for the predicate device.
# 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 7.1 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 in the predicate and reference devices. All testing passed 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 6.0 and Accessories with VISITAG SURPOINT 510(k)#: [K180238](https://510k.innolitics.com/search/K180238)
# 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.
CARTOFINDER [K173978](https://510k.innolitics.com/search/K173978), Coherent Mapping module [K173977](https://510k.innolitics.com/search/K173977)
# 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
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July 20, 2019
Biosense Webster, Inc. Phuong Chau Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618
Re: K191660
Trade/Device Name: CARTO 3 EP Navigation System, Version 7.1 and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 19, 2019 Received: June 21, 2019
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 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191660
Device Name
CARTO® 3 EP Navigation System Version 7.1 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
K191660 510(k) Summary
| Applicant: | Biosense Webster, Inc.
33 Technology Drive
Irvine, CA 92618, USA
Tel.: (800) 729-9010
Fax: (909) 839-8500 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Phuong Chau
Senior Regulatory Affairs Program Lead
Phone: 949-923-4238
Fax: 949-450-6886 |
| Authored by: | Elena Goldin
Quality and Regulatory Senior Specialist
Biosense Webster (Israel), Ltd.
And
Phuong Chau
Senior Regulatory Affairs Program Lead
Biosense Webster, Inc. |
| Date: | June 19, 2019 |
| Device Trade Name: | CARTO® 3 EP Navigation System Version 7.1 and
Accessories |
| Device Common
Name: | Cardiac Mapping System |
| Manufacturing
Number: | FG-5400-00/FG-5400-00U |
| Device
Classification: | Programmable diagnostic computer
Class II, 21 CFR 870.1425 |
| Product Code | DQK |
| Predicate Device: | CARTO® 3 EP Navigation System Version 6.0 and
Accessories with VISITAG SURPOINT
510(k)#: K180238 |
| 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 7.1 is a catheter-based atrial and ventricular mapping diagnostic system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical diagnostic maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using 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 V7.1 uses the same two distinct types of location technology as the predicate device - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 System V7.1 consists of the following hardware components:
- Patient Interface Unit (PIU) and Cables ●
- 3D Graphics Workstation
- Wide-Screen monitors, keyboard, and mouse ●
- Intracardiac In Port ●
- Intracardiac Out Port ●
- Power Supply
- Patches Connection Box and Cables 0
- Pedals ●
- Location Pad o
All hardware components of the CARTO® 3 System V7.1 are identical to those described for the predicate device.
The intended use of the CARTO® 3 System is catheter-based Indications for Use: 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 modified CARTO® 3 EP Navigation System, Version 7.1 Technological has the same technological characteristics (i. e., design, Characteristics: material, chemical composition, energy source) as the predicate CARTO® 3 EP Navigation System device. A
5
Page 3 of 4
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 0
- o Have identical magnetic location mapping technology
The main difference between the predicate device and the modified device are the merging of previously cleared functions (CARTOFINDER K173978 and Coherent Mapping module K173977 reference devices) in a CARTO3 software version, new modifications, and the addition of Letter to File changes as described below:
Summary of Modifications
Mapping and Annotations:
- LAT Histogram a graphical representation of the ● Local Activation Time (LAT) values of all points that contribute to the Active Map's LAT coloring, over a time interval (range) from the lowest to highest LAT value.
Letter To File Changes:
- LAT Hybrid Maps
- Improvements for displays (Map Consistency Display) ●
- o Map filtering (Parallel Mapping)
- Signals displays (previous beat overlay)
- Signals annotations (Advanced Reference Annotation (ARA))
- Signals filtering (Power line noise rejection) ●
- GUI improvement to improve user experience ● (usability) such as high definition (HD) propagation style
- Updated Visualization Setup window display
- Increased limit of points in map
- Backup time reduction
- The CARTO® 3 EP Navigation System, Version 7.1 underwent Performance Data: extensive bench and pre-clinical testing under simulated
6
K191660
Page 4 of 4
clinical conditions to verify the new and modified features and to demonstrate with regression testing that these modifications did not negatively affect existing features in the predicate and reference devices. All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness. The CARTO® 3 EP Navigation System, Version 7.1 and Conclusions: Accessories is substantially equivalent to the cleared CARTO® 3 EP Navigation System V6 based on the completion of nonclinical bench testing and pre-clinical testing as well as similar
principles of design, operation and indications for use.