(146 days)
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 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.
This document is a 510(k) Summary for the CARTO® 3 EP Navigation System, Version 6.0 and Accessories. It focuses on demonstrating substantial equivalence to a predicate device (CARTO® 3 EP Navigation System Version 4.2) rather than presenting a study demonstrating acceptance criteria met for a novel device performance.
Therefore, much of the requested information (acceptance criteria, specific study design details like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for a training set) is not explicitly provided in this document in the format typically seen for a new device's performance evaluation.
However, based on the provided text, we can infer some information relevant to the performance evaluation that was conducted to support the updated device's safety and effectiveness.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with corresponding performance metrics. Instead, it states that the device "passed all tests in accordance with appropriate test criteria and standards." The performance data section describes the type of testing conducted.
Implied Acceptance Criteria (based on predicate equivalence and enhancements):
- Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to the predicate device.
- Functionality of New Features: The new and modified features (ConfiDENSE Module annotations, CARTO VIZIGO™ Software, TOSHIBA X-ray system compatibility, CARTOSEG updates, GUI modifications) perform as intended.
- Preservation of Existing Functionality: Existing features are not negatively affected by modifications. This implies that the performance of core features (like magnetic location mapping technology and sensor accuracy) is maintained at the level of the predicate device (Version 4.2).
Reported Device Performance:
- "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."
- Specifically noted is that the device "Have identical magnetic location sensor accuracy" as the predicate.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document mentions "extensive bench and pre-clinical testing under simulated clinical conditions." This suggests that a test set was used, but the size is not quantified.
- Data Provenance: "simulated clinical conditions." This implies a retrospective or de-identified prospective approach if clinical data was used in simulation, or purely simulated data for bench testing. The country of origin for the data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. The evaluation was primarily engineering and functional testing rather than a clinical study requiring expert ground truth in the traditional sense. The "acceptance criteria and standards" would likely refer to engineering specifications and regulatory standards.
4. Adjudication method for the test set
Not explicitly stated. Given the nature of bench and pre-clinical testing, it's unlikely a formal clinical adjudication method (like 2+1 or 3+1) was used. Testing would involve verifying output against known inputs or engineering specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a navigation system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The enhancements are primarily software features and compatibility updates.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Yes, the described "extensive bench and pre-clinical testing" would represent a form of standalone performance evaluation for the system's functionalities, particularly the new modules and integrability, without direct human-in-the-loop performance being a primary assessment as a "diagnostic" device. For instance, the "magnetic location sensor accuracy" being identical to the predicate would be a standalone technical measurement.
7. The type of ground truth used
- Type of Ground Truth: For the "bench and pre-clinical testing," the ground truth would be based on:
- Engineering specifications: For quantitative measurements like magnetic location sensor accuracy.
- Predicate device's established performance: For verifying that existing features were not negatively impacted.
- Expected functionality: For new features, verifying they operate as designed (e.g., specific annotations are produced, software integrates correctly).
8. The sample size for the training set
Not applicable in the context of this 510(k) summary. This document describes an update to an existing medical device, primarily involving software enhancements and hardware compatibility, not a de novo AI/ML algorithm development that would typically require a training set in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable for the reasons stated above (no training set mentioned for an AI/ML algorithm in this context).
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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
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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
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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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510(k) Summary – K170600
| Applicant: | Biosense Webster, Inc.33 Technology DriveIrvine, CA 92618, USAPhone: 909-839-8500Fax: 909-839-8804 |
|---|---|
| Contact Person: | Phuong ChauSenior Regulatory Affairs Program LeadPhone: 909-839-7249Fax: 909-839-8804 |
| Authored by: | Moshe HochmitzQuality and Regulatory ManagerBiosense Webster (Israel), Ltd.AndPhuong ChauSenior Regulatory Affairs Program LeadPhone: 909-839-7249Fax: 909-839-8804 |
| Date: | February 28, 2017 |
| Device TradeName: | CARTO® 3 EP Navigation System Version 6.0 and Accessories |
| Device CommonName: | Cardiac Mapping System |
| ManufacturingNumber: | FG-5400-00 |
| DeviceClassification: | Programmable diagnostic computerClass II, 21 CFR 870.1425 |
| Product Code | DQK |
| Predicate Device: | CARTO® 3 EP Navigation System Version 4.2 and Accessories510(k)#: K133916 |
| ManufacturingFacilities: | Biosense Webster (Israel), Ltd.a Johnson & Johnson Company4 Hatnufa StreetYokneam ISRAEL 2066717 |
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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.
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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 forDifference |
|---|---|---|
| Annotations | ConfiDENSE Module has twonew types of point annotationsBody Surface MorphologyMatching Complex PointIdentification | Addition of twonew filters toassist physicianswith pointsacquisition. |
| Visualization | CARTO VIZIGO™ Software | Addition ofCARTO VIZIGOSoftware tosupportvisualization ofthe VIZIGO™Bi-DirectionalGuiding Sheath. |
| FluoroIntegration | Addition of TOSHIBA to theCARTOUNIVU modulesupported X-ray systemslibrary. | Compatibilitywith TOSHIBAX-ray Systemshas beenestablished. |
| Imaging | CARTOSEG CT andCARTOSEG MR libraryupdate. | Update to addSiemens to thelibrary has noimpact on systemfunctionality orworkflow. |
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| Usability | Software Graphical UserInterface (GUI)modifications to allowIntuitive use of most usedfeatures• Usability features forMaps | Usability changesfor improvedCARTO® 3System look andfeel. No impacton systemfunctionality orworkflow. | ||
|---|---|---|---|---|
| Performance Data: | The CARTO® 3 EP Navigation System, Version 6.0 underwentextensive bench and pre-clinical testing under simulated clinicalconditions to verify the new and modified features and todemonstrate with regression testing that these modifications didnot negatively affect existing features. The CARTO® 3 EPNavigation System, Version 6.0 passed all tests in accordancewith appropriate test criteria and standards, and the modifieddevice did not raise new questions of safety or effectiveness. | |||
| Conclusions: | The CARTO® 3 EP Navigation System, Version 6.0 issubstantially equivalent to the currently cleared CARTO® 3 EPNavigation System, Version 4.2 based on the completion of non-clinical bench testing and pre-clinical testing as well as similarprinciples of design, operation and indications for use. |
§ 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).