(123 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 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 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 V6.0with the VISITAG SURPOINT™ Module are identical to those described for the predicate device.
This FDA 510(k) summary (K180238) for the CARTO 3 EP Navigation System Version 6.0 and Accessories with the VISITAG SURPOINT™ Module focuses on demonstrating substantial equivalence to a predicate device (K170600), rather than establishing new acceptance criteria or proving performance of the fundamental technology. Therefore, much of the requested information regarding specific acceptance criteria, detailed study results, sample sizes for test/training sets, and expert involvement is not explicitly provided in this document.
However, based on the information available, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the performance data in general terms, stating that "All testing passed in accordance with appropriate test criteria and standards." It does not provide specific quantitative acceptance criteria or detailed performance metrics. The focus is on demonstrating that modifications did not negatively affect existing features.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| New and modified features verified (functional testing) | All testing passed in accordance with appropriate test criteria and standards. |
| Existing features not negatively affected (regression testing) | All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness. |
| Magnetic location sensor accuracy (stated to be identical to predicate) | (Implied to be same as predicate due to "identical magnetic location sensor accuracy" statement, but no specific values provided) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "The CARTO® 3 EP Navigation System, Version 6.0 with the VISITAG SURPOINT™ Module underwent extensive bench testing..." This indicates the testing was conducted on the device itself (likely multiple units or configurations) rather than on patient data. No sample size for a "test set" in terms of patient data or data provenance (country of origin, retrospective/prospective) is provided, as the study appears to be bench-based and not a clinical study involving patient data with ground truth.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided as the testing described is bench testing, not a clinical study involving expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not provided as the testing described is bench testing, not a clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The document focuses on device modifications and bench testing, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
The document describes "extensive bench testing" to verify new and modified features. While this is likely focused on the algorithm's performance within the system, it's not explicitly labeled as an "algorithm-only standalone performance study" in the context of comparative clinical evaluations. The device itself is a "Programmable Diagnostic Computer," so its functionality is inherently algorithmic.
7. Type of Ground Truth Used:
For the bench testing, the "ground truth" would likely be derived from:
- Engineering specifications and design documents: To verify that the new features function as intended.
- Reference measurements/simulations: For aspects like magnetic location sensor accuracy, comparing device output to known physical parameters.
- Predicate device behavior: For regression testing, verifying that existing features still perform identically or within expected tolerances compared to the predicate.
No "expert consensus, pathology, or outcomes data" ground truth is relevant or mentioned for this type of testing.
8. Sample Size for the Training Set:
This information is not provided. The document describes enhancements to an existing system, implying refinement of existing algorithms rather than the development of entirely new ones requiring large-scale training sets for machine learning. If machine learning was used in the development of the "VISITAG SURPOINT™ Module" or "HD Coloring" feature, the details of its training are not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided as there is no mention of a dedicated training set or machine learning model development in detail.
In summary, this 510(k) pertains to modifications of an existing device and relies on bench testing to demonstrate substantial equivalence, rather than new clinical effectiveness studies with explicit acceptance criteria, patient data, and expert interpretation.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 1, 2018
Biosense Webster, Inc. Phuong Chau Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, CA 92618
Re: K180238
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: May 24, 2018 Received: May 25, 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);
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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.
M.A. Hilleheme
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) K180238
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
| Applicant: | Biosense Webster, Inc.33 Technology DriveIrvine, CA 92618, USATel.: (800) 729-9010Fax: (909) 839-8500 |
|---|---|
| Contact Person: | Phuong ChauSenior Regulatory Affairs Program LeadPhone: 949-923-4238Fax: 949-450-6886 |
| Authored by: | Anna GantmanQuality and Regulatory Program ManagerBiosense Webster (Israel), Ltd.AndPhuong ChauSenior Regulatory Affairs Program LeadBiosense Webster, Inc. |
| Date: | April 10, 2018 |
| 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 computerClass II, 21 CFR 870.1425 |
| Product Code | DQK |
| Predicate Device: | CARTO® 3 EP Navigation System Version 6.0 and Accessories510(k)#: K170600 |
| Manufacturing Facilities: | Biosense Webster (Israel), Ltd.a Johnson & Johnson Company4 Hatnufa StreetYokneam, ISRAEL 2066717Biosense Webster, Inc.15715 Arrow HwyIrwindale, CA 91706 |
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| Device Description: | The CARTO® 3 EP Navigation System, Version 6.0 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 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 V6.0with the VISITAG SURPOINT™ Module are identical to those described for the predicate device. | |
| 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. |
| Technological Characteristics: | The modified CARTO® 3 EP Navigation System, Version 6.0 with VISITAG SURPOINT™ Module, has the same technological characteristics (i. e., design, material, chemical composition, energy source) as the predicate CARTO® 3 EP Navigation System, Version 6.0. A summary of the technological characteristics of the new device compared to the predicate device is as follows: Have identical intended use. |
| Have the same hardware platform. Have identical magnetic location mapping technology. Have identical magnetic location sensor accuracy. | |
| The main difference between the predicate device and themodified device is the enhancement of the VISITAG Module toadd the VISITAG SURPOINT™ Module. The module is used todisplay Tag Index calculations performed by the VISITAGSURPOINT™ EPU device. Additionally, an HD Coloringfeature was implemented to provide high definition coloring ofelectroanatomical maps. The HD coloring feature includes thefollowing GUI enhancements: Cleaner map visualization,Enhanced wave propagation display, Enhanced visualization ofprojected points and Enhancements for the Early Meets Latemechanism. | |
| Performance Data: | The CARTO® 3 EP Navigation System, Version 6.0 with theVISITAG SURPOINT™ Module underwent extensive benchtesting to verify the new and modified features and todemonstrate with regression testing that these modifications didnot negatively affect existing features. All testing passed inaccordance with appropriate test criteria and standards, and themodified device did not raise new questions of safety oreffectiveness. |
| Conclusions: | The CARTO® 3 EP Navigation System, Version 6.0 andAccessories with the VISITAG SURPOINT™ Module issubstantially equivalent to the currently cleared CARTO® 3 EPNavigation System, Version 6.0 based on the completion of non-clinical bench testing and pre-clinical testing as well as similarprinciples of design, operation and indications for use. |
- Use the same fundamental scientific technology. ●
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§ 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).