Navik 3D

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Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 23, 2016 APN Health, LLC % Grace Bartoo Decus Biomedical Inc. 2342 Shattuck Ave, #333 Berkeley, California 94704 Re: K152160 Trade/Device Name: Navik 3D Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: January 27, 2016 Received: January 28, 2016 Dear Grace Bartoo: 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 yours, FDA for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152160 Device Name Navik 3D Indications for Use (Describe) Navik 3D is intended for catheter-based atrial and ventricular mapping using compatible catheters, and acquired data from compatible fluoroscopy systems and patient recording and monitoring systems. Navik 3D is intended to provide 3D location of these catheters from acquired 2D fluoroscopic images. The device allows real-time display of cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps and cardiac voltage maps. | 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 5.0 510(K) SUMMARY | Submitter | APN Health, LLC | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Grace Bartoo, PhD, RAC, CBA, FRAPS | | Title | Regulatory Consultant | | Phone | 650-488-7799 | | Fax | 650-227-2264 | | Email | grace@decusbiomedical.com | | Date Summary Was Prepared | January 26, 2016 | | Trade or Proprietary Name | Navik 3D™ | | Model Number | Navik 3D 1.0 | | Common or Usual Name | Cardiac mapping system | | Regulation Number | 21 CFR 870.1425 | | Product Code | DQK, Programmable Diagnostic Computer | | Device Class | Class II | | Predicate Device | Trade Device Name: CARTO® 3 System V3.0<br>Manufacturer: Biosense Webster, Inc.<br>Address: 333 Diamond Canyon Road, Diamond Bar, CA 91765<br>Regulation Number: 21 CFR 870.1425<br>Regulation Name: Programmable Diagnostic Computer<br>Regulatory Class: Class II<br>Product Code: DQK<br>510(k) Number: K120550<br>510(k) Clearance Date: May 7, 2012 | #### 5.1 Description of the Device Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed. Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care. #### 5.2 Indications for Use Navik 3D is intended for catheter-based atrial and ventricular mapping using compatible catheters, and acquired data from compatible fluoroscopy systems and patient recording and monitoring systems. Navik 3D is intended to provide 3D location of these catheters from acquired 2D fluoroscopic images. The device allows real-time display of cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps and cardiac voltage maps #### 5.3 Summary of Technological Characteristics Comparison Table 5-1 shows the similarities and differences of the technology between the two products. The key difference is that the predicate device uses a magnetic location pad, multiple patches around the {4}------------------------------------------------ patient's chest, a proprietary catheter with a built in magnetic sensor and a patient interface unit (PIU) to acquire 3D catheter location information, whereas Navik 3D uses an image processing approach to analyze 2D fluoroscopic images to identify the 3D catheter location and can use any compatible catheters. While these methods are different, the physical principles behind each technology are well-established and do not raise new questions of safety or effectiveness. | Technological Characteristics | | | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Predicate Device | Subject Device | | System Type | Electromagnetic and catheter-based<br>atrial and ventricular mapping system | Image and signal processing based<br>atrial and ventricular mapping system | | Primary<br>Feature | Displays anatomical and electrical<br>maps such as activation and voltage<br>maps of the human heart in real-time<br>using magnetic navigation techniques<br>and ECG-EGM analysis | Displays anatomical and electrical maps<br>such as activation and voltage maps of<br>the human heart in real-time using<br>fluoroscopic image processing<br>techniques and ECG-EGM analysis | | 3D Location<br>Technology | Electro anatomic location and ECG-<br>EGM signal processing | Fluoroscopic image and ECG-EGM<br>signal processing | | Compatible<br>Catheters | Proprietary catheter with in-built<br>magnetic sensor | Any compatible mapping and ablation<br>catheter. | | Display(s)<br>Control | Color monitor<br>Standard keyboard/mouse | Color monitor and Apple iPad®<br>iPad controller and/or standard<br>keyboard/mouse | | Inputs<br>Required | Proprietary and non-proprietary<br>catheters and patches, ECG and EGM<br>data from the patient | Fluoroscopic images, ECG and EGM<br>data from the patient recording and<br>monitoring system, ECG patches (for<br>motion tracking only) | | Map Types<br>Generated in<br>Real-Time | 3D cardiac maps including:<br>anatomical maps, cardiac electrical<br>activation maps, cardiac electrical<br>propagation maps, cardiac electrical<br>potential (voltage) maps, cardiac<br>chamber geometry maps and Complex<br>Fractionated Atrial Electrogram<br>(CFAE) maps | 3D cardiac maps including: anatomical<br>maps, cardiac electrical activation maps<br>and cardiac voltage maps | | Fluoroscopic<br>Image<br>Displayed | Not real-time | Real-time with 3D map projected on<br>fluoro image if desired | | Signal<br>Information<br>Displayed | Acquired patient signals, including<br>body surface ECG and intracardiac<br>EGMs | Imported signals, including body<br>surface ECG and intracardiac EGMs,<br>from the patient recording and<br>monitoring system | | 3D Viewing of<br>Maps | Standard 3D rendering, coloring and<br>user rotation and viewing methods | Standard 3D rendering, coloring and<br>user rotation and viewing methods | | Hardware<br>Design and<br>Materials | Off-the-shelf information technology<br>(IT) hardware: computer and monitor | Off-the-shelf IT hardware: computer,<br>router, graphics card and iPad | | | Proprietary catheters, patient interface<br>unit and accessories | Data Acquisition Module, based on<br>commercially available frame grabber | | Technological Characteristics | | | | Characteristic | Predicate Device | Subject Device | | | | and analog to digital (A/D) conversion<br>board | | CT/MRI/<br>Ultrasound<br>Registration | Includes optional modules for<br>integration of computed tomography<br>(CT), magnetic resonance imaging<br>(MRI) and ultrasound | None | | Track Multiple<br>Catheters | Visualization and tracking of multiple<br>catheters. No fluoroscopic images are<br>shown with the catheter tracking. | All catheters visualized on fluoro screen<br>with real-time fluoro data input.<br>Tracking of the mapping catheter only. | | Motion<br>compensation | Compensated (table) and<br>uncompensated (patient) motion | Using ECG patch detection algorithms,<br>compensates for patient and table<br>motion | | Non-Clinical<br>Performance<br>Testing | Underwent bench and animal testing<br>to verify the modified features and to<br>demonstrate with regression testing<br>that the new features did not<br>negatively affect existing features | Detailed performance testing conducted<br>to demonstrate performance<br>characteristics. Animal and bench<br>(phantom) study protocols executed to<br>enable performance comparison with<br>predicate device.<br><br>The device has been demonstrated to be<br>in compliance with IEC 62366-1<br>Edition 1.0 2015-02 and IEC 62304<br>First Edition 2006-05. | Table 5-1 Summary of Technological Characteristics Comparison {5}------------------------------------------------ #### 5.4 Performance Data APN Health conducted the following non-clinical performance tests: - Design verification and validation testing. - A phantom study to directly compare tip location accuracy performance by making measurement ● simultaneously on the predicate device CARTO and Navik 3D systems. - o An electrogram analysis and ECG gating study to directly compare cycle length (CL), local activation time (LAT) and EGM voltage measurements against reference signals. - . Extensive animal testing where navigation and mapping capabilities between Navik 3D and the predicate device were directly compared. Based upon the results of these studies, it was determined the Navik 3D performance was substantially equivalent to the predicate device. #### 5.5 Substantial Equivalence Conclusion The predicate device and Navik 3D have the same intended use, to provide 3D cardiac mapping. While CARTO has more indications for use than Navik 3D, the Navik 3D system's indications for use are a subset of those of CARTO. {6}------------------------------------------------ From a technological perspective. CARTO uses a magnetic localization method to obtain the 3D location of the catheter tip whereas Navik 3D utilizes image processing methods. Because of these differences in approach, CARTO includes more hardware elements, such as a magnetic location pad, patches around the chest of the patient, a PIU and other hardware. Additionally, CARTO requires use of a specific mapping catheter with magnetic sensors, whereas Navik 3D uses any compatible mapping and ablation catheters. CARTO also provides additional functionality, such as generating EGM signals, whereas Navik 3D takes output from the patient recording and monitoring system and the fluoroscopy system as inputs and performs digitization. While there are differences in the technology, the data acquisition technology is well-characterized. Additionally, the image processing approach of Navik 3D is founded on strong physics principles, and both the non-clinical and animal study performance data have shown substantially equivalent performance during simultaneous comparison studies Therefore, the differences in the technology characteristics does not raise new questions of safety or effectiveness and one can conclude that Navik 3D is substantially equivalent to the predicate device, CARTO.