(83 days)
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures, maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE® PLUS functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.
The CARTO® 3 V2.2 EP Navigation System 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 in real-time. 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 real-time display of electrograms and cardiac maps based on the received intra cardiac signals in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the display screen. The CARTO® 3 V2.2 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
Here's an analysis of the provided text regarding the CARTO® 3 V2.2 EP Navigation System, structured to address your specific points:
Acceptance Criteria and Device Performance Study
The provided text describes a special 510(k) for software additions and hardware modifications to an existing device, the CARTO® 3 V2.0 EP Navigation System. As such, the study primarily focuses on demonstrating that the new features do not negatively impact existing features and that the modified device remains safe and effective. It does not present a typical "acceptance criteria vs. reported performance" table for a novel device, nor a comparative effectiveness study in the usual sense (e.g., human readers with vs. without AI).
Summary of Study Information:
| Section/Element | Details from Text | Inference/Explanation |
|---|---|---|
| 1. Acceptance Criteria and Reported Device Performance | "The CARTO® 3 V2.2 EP Navigation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness." | The text states that the device passed all tests according to appropriate test criteria and standards. However, the specific quantitative acceptance criteria (e.g., accuracy thresholds, latency limits) and the detailed results showing how well it performed against these criteria are not explicitly provided in the summary. The core acceptance criterion for this 510(k) appears to be demonstrating non-inferiority or equivalence to the predicate device regarding safety and effectiveness, and that the new features function as intended without adverse effects. |
| 2. Sample size and Data Provenance (test set) | "The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing..." | The specific sample sizes for the bench and animal tests are not provided. The data provenance is described as "bench and animal testing," implying controlled laboratory and in-vivo environments, rather than human clinical data. No country of origin is specified for these tests, but the manufacturer is Biosense Webster (Israel) Ltd. |
| 3. Number of experts and qualifications (ground truth for test set) | This information is not provided. | Given the nature of a 510(k) for modifications to an established device, and the use of "bench and animal testing," the ground truth would likely be established through engineering specifications, known physiological parameters, direct measurement, or potentially expert veterinary assessment for animal studies. |
| 4. Adjudication method (test set) | This information is not provided. | Adjudication methods like '2+1' are typically relevant for human-read evaluations (e.g., radiologists reviewing images). Since the evaluation involves "bench and animal testing," such adjudication methods are unlikely to apply in the same way. Performance would be assessed against defined metrics and expected behavior. |
| 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | "The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing to verify the new and enhanced features and to demonstrate with regression testing that the new features did not negatively affect existing features." | No MRMC comparative effectiveness study involving human readers with and without AI assistance was described. This type of study (human readers improve with AI) is not relevant for this device, which is an EP Navigation System providing real-time 3D anatomical and electroanatomical maps, not an AI diagnostic aid that assists human readers in interpreting images. The "AI" here refers to algorithms within the system (e.g., for mapping, signal analysis, Fluoro Effect Reduction), integrating into the EP procedure, not directly enhancing human interpretation of data in a comparative fashion. The study focused on functional verification and safety/effectiveness equivalence to the predicate. |
| 6. Standalone (algorithm only without human-in-the-loop) performance | "The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing to verify the new and enhanced features..." The system is designed for real-time display and analysis. | The functionality of the core algorithms (e.g., for 3D mapping, electrical activation, impedance, FAM, Fluoro Effect Reduction) would inherently be tested in a standalone manner during bench testing to verify their performance against specifications, even though the system is intended for use with a human operator. The "no human in the loop" aspect is a bit ambiguous for an interactive navigation system, but the algorithms themselves are evaluated for their independent accuracy and function. |
| 7. Type of ground truth used (test set) | "bench and animal testing" | For bench testing, ground truth would likely be established through engineering specifications, simulations, or phantom models with known properties. For animal testing, it would involve direct physiological measurements, established anatomical landmarks, and possibly expert veterinary assessment during the procedures. It would not be expert consensus on image interpretation or pathology in the typical sense. |
| 8. Sample size for the training set | This information is not provided. | The text describes a system that acquires and analyzes data, implying algorithms are involved. However, the specific training data for any machine learning components (if present and central to the new features in this version) is not detailed. Given the focus on demonstrating equivalence for updates to an existing system, it's possible much of the core algorithm training was conducted for prior versions. |
| 9. How ground truth for the training set was established | This information is not provided. | Similar to the test set, if training was involved for new or refined algorithms, it would likely rely on similar methods – well-characterized physiological data from research, controlled simulations, or animal studies where ground truth could be directly observed or measured. |
Key Takeaways from the Provided Text:
- Focus on Equivalence: This 510(k) is a "Special 510(k)" which typically means minor changes to an already cleared device. The primary goal is to demonstrate "substantial equivalence" to the predicate device (CARTO® 3 V2.0) and that the new features (Fluoro Effect Reduction, support for specific catheters, hardware modification) do not negatively affect safety or effectiveness.
- Study Types: The study involved "extensive bench and animal testing."
- Lack of Quantitative Details: The summary intentionally lacks detailed quantitative acceptance criteria and specific performance metrics. This is often the case in 510(k) summaries where the full study report (not publicly provided) would contain such details. The summary indicates that the tests were passed according to "appropriate test criteria and standards."
- No Human Reader Study: There is no mention of a human reader study or a comparative effectiveness study involving human readers with/without AI assistance. The device is a navigation system, not a diagnostic imaging AI designed to assist human interpretation.
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16 510(k) SUMMARY
16.1
General Information
Image /page/0/Picture/2 description: The image shows the text 'K112007' in a handwritten style. The characters are connected, giving it a cursive appearance. The text is written in black ink on a white background, and the numbers are slightly smaller than the letters.
Applicant: Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765 USA Phone: 909-839-8597 Fax: 909-839-8804 July 8, 2011 Date: Wayne R. Hohman Contact Person: Project Manager Regulatory Affairs Trade/Proprietary Device CARTO® 3 V2.2 EP Navigation System and Accessories Name: Manufacturing Part FG-5400-00 (with standard location pad) Numbers: FG-5600-00 (with RMT location pad) Common Device Name: Cardiac mapping system Programmable diagnostic computer Classification Name: Device Classification: Class II, 21 CFR 870.1425 Product Code DQK CARTO® 3 V2.0 EP Navigation System and Accessories Predicate Device: 510(k) K103746, January 21, 2011 Manufacturing Facility: Biosense Webster (Israel) Ltd. 4 Hatnufa Street, POB 275 Yokneam 20692 Israel
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CONFIDENTIAL
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Description of Device 16.2
The CARTO® 3 V2.2 EP Navigation System 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 in real-time. 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 real-time display of electrograms and cardiac maps based on the received intra cardiac signals in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the display screen. The CARTO® 3 V2.2 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
16.3 New Features
The new features in this Special 510(k) Notification were software additions of Fluoro Effect Reduction (FER), support of Biosense Webster PENTARAY® Catheter, and support of SOUNDSTAR® eco Catheters with Split Handle, and hardware modification of an ECG board and addition of an Extension Cable. In addition, all modifications cleared via documentation since the prior predicate version were described.
16.4 Indications for Use
The Indications for Use for the modified device are identical to the predicate device:
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE® Plus functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of
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Biosense Webster, Inc. CARTO® 3 x 7 2 Snecial 510/k) CONFIDENTIAL
Page 80 of 631
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intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, nonnavigational, electrophysiology catheters without magnetic location sensors.
Summary of Non-Clinical Performance Testing 16.5
The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing to verify the new and enhanced features and to demonstrate with regression testing that the new features did not negatively affect existing features. The CARTO® 3 V2.2 EP Navigation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.
Substantial Equivalence 16.6
The Carto® 3 EP Navigation System, Version 2.2, is substantially equivalent to the legally marketed Carto® 3 EP Navigation System, Version 2.0, 510(k) K103746, cleared on January 21, 2011.
16.7 Conclusions
The bench and animal pre-clinical testing demonstrated that the CARTO® 3 V2.2 EP Navigation System is safe, effective, and performs as well as or better than the predicate device. This testing program supports the determination of substantial equivalence to the predicate device.
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Biosense Webster, Inc. CARTO® 3 v 7 7 Snerial SIN/k) CONFIDENTIAL
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Image /page/3/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic. The text is small and difficult to read, but it appears to be part of an organization's name. The graphic consists of three curved lines that resemble a stylized human figure or a flowing design, with wavy lines at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20903-0002
Biosense Webster, Inc. c/o Mr. Wayne R. Hohmann Project Manager Regulatory Affairs 3333 Diamond Canyon Road. Diamond Bar, CA 91765
2.11
Re: [510(k)] K112007 [210(W)] Trade/Device Name: CARTO 3 V2.2 EP Navigation System (Version 2.2) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: September 8, 2011 Received: September 9, 2011
Dear Mr. Hohmann:
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
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Page 2 - Mr. Wayne R. Hohmann
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/About/DA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Bram D. Zuckerman, M.D.
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) No (if known): K112007
Device Name: CARTO® 3 V2.2 EP Navigation System
Indications for Use:
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures, maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE® PLUS functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of (Division Sign-Off) Device Evaluation (ODE)
Division of Cardiovascular Devices
| 510(k) Number | 1/1/2007 |
|---|---|
| --------------- | ---------- |
Page 1 of 1Biosense Webster, Inc. CARTOR 3 x 7 7 Snecial 510/k) CONFIDENTIAL
§ 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).