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.

Device Description

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.

AI/ML Overview

The provided text describes the Navik 3D device's performance data and its comparison to a predicate device, the CARTO 3 System V3.0. However, the document does not provide specific acceptance criteria or detailed results of a study demonstrating the device meets quantified acceptance criteria. Instead, it outlines a series of non-clinical performance tests and concludes that the Navik 3D's performance was "substantially equivalent" to the predicate device.

Given the information in the provided document, the following answers are based on what is available. Many fields will be marked as "Not provided" or "Not applicable" as the source text does not contain that level of detail.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not list specific quantitative acceptance criteria. Instead, it reports that the device's performance was "substantially equivalent" to a predicate device (CARTO 3 System V3.0) through comparative studies, particularly focusing on tip location accuracy. Without explicit numerical acceptance thresholds, a table with specific criteria and results cannot be fully constructed.

Acceptance Criteria (Not explicitly stated in document - assumed based on "Substantial Equivalence")	Reported Device Performance (as per "Substantial Equivalence Conclusion")
Catheter Tip Location Accuracy (comparable to predicate device)	Demonstrated "substantially equivalent" accuracy to CARTO in a phantom study.
Cycle Length (CL) Measurement Accuracy (comparable to reference signals)	Demonstrated "substantially equivalent" accuracy in an electrogram analysis and ECG gating study.
Local Activation Time (LAT) Measurement Accuracy (comparable to reference signals)	Demonstrated "substantially equivalent" accuracy in an electrogram analysis and ECG gating study.
EGM Voltage Measurement Accuracy (comparable to reference signals)	Demonstrated "substantially equivalent" accuracy in an electrogram analysis and ECG gating study.
Navigation and Mapping Capabilities (comparable to predicate device)	Demonstrated "substantially equivalent" performance to CARTO in extensive animal testing.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "a phantom study" and "extensive animal testing" without providing specific sample sizes for these tests.

Sample Size (Test Set): Not provided (for phantom study or animal testing).
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are described as "non-clinical performance tests," implying they were specifically conducted for the device's evaluation, likely prospectively.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the tests mentioned. The comparison was primarily against the predicate device's performance or "reference signals," rather than a panel of human experts.

4. Adjudication Method for the Test Set

Not applicable. The reported studies were technical performance comparisons (e.g., accuracy against a predicate device or reference signals), not expert-adjudicated clinical case reviews.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes non-clinical performance tests (phantom and animal studies) and electrogram analysis, not a multi-reader, multi-case clinical study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, the studies described are standalone performance evaluations of the device, comparing its output directly to a predicate device or reference signals. The "phantom study," "electrogram analysis and ECG gating study," and "extensive animal testing" appear to assess the algorithm's performance and the device's capabilities in a controlled environment without human-in-the-loop clinical interpretation as the primary endpoint.

7. The Type of Ground Truth Used

For Catheter Tip Location Accuracy: The "ground truth" was established by simultaneously comparing measurements from the Navik 3D system against the predicate device (CARTO) in a phantom study. This implies the CARTO system's output served as the comparative reference.
For Electrogam Analysis (CL, LAT, EGM voltage): "Reference signals" were used for comparison. The nature of these reference signals (e.g., gold standard recordings, manually generated data) is not further specified.
For Navigation and Mapping Capabilities: The "ground truth" was established through direct comparison of capabilities between Navik 3D and the predicate device during animal testing.

8. The Sample Size for the Training Set

Not provided. The document outlines performance testing (validation) but does not detail the development or training of the device's algorithms.

9. How the Ground Truth for the Training Set Was Established

Not provided. Information regarding the training set's ground truth establishment is not included in the document.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K152160

Device Name Navik 3D

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 V3.0Manufacturer: Biosense Webster, Inc.Address: 333 Diamond Canyon Road, Diamond Bar, CA 91765Regulation Number: 21 CFR 870.1425Regulation Name: Programmable Diagnostic ComputerRegulatory Class: Class IIProduct Code: DQK510(k) Number: K120550510(k) Clearance Date: May 7, 2012

5.1 Description of the Device

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

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

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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-basedatrial and ventricular mapping system	Image and signal processing basedatrial and ventricular mapping system
PrimaryFeature	Displays anatomical and electricalmaps such as activation and voltagemaps of the human heart in real-timeusing magnetic navigation techniquesand ECG-EGM analysis	Displays anatomical and electrical mapssuch as activation and voltage maps ofthe human heart in real-time usingfluoroscopic image processingtechniques and ECG-EGM analysis
3D LocationTechnology	Electro anatomic location and ECG-EGM signal processing	Fluoroscopic image and ECG-EGMsignal processing
CompatibleCatheters	Proprietary catheter with in-builtmagnetic sensor	Any compatible mapping and ablationcatheter.
Display(s)Control	Color monitorStandard keyboard/mouse	Color monitor and Apple iPad®iPad controller and/or standardkeyboard/mouse
InputsRequired	Proprietary and non-proprietarycatheters and patches, ECG and EGMdata from the patient	Fluoroscopic images, ECG and EGMdata from the patient recording andmonitoring system, ECG patches (formotion tracking only)
Map TypesGenerated inReal-Time	3D cardiac maps including:anatomical maps, cardiac electricalactivation maps, cardiac electricalpropagation maps, cardiac electricalpotential (voltage) maps, cardiacchamber geometry maps and ComplexFractionated Atrial Electrogram(CFAE) maps	3D cardiac maps including: anatomicalmaps, cardiac electrical activation mapsand cardiac voltage maps
FluoroscopicImageDisplayed	Not real-time	Real-time with 3D map projected onfluoro image if desired
SignalInformationDisplayed	Acquired patient signals, includingbody surface ECG and intracardiacEGMs	Imported signals, including bodysurface ECG and intracardiac EGMs,from the patient recording andmonitoring system
3D Viewing ofMaps	Standard 3D rendering, coloring anduser rotation and viewing methods	Standard 3D rendering, coloring anduser rotation and viewing methods
HardwareDesign andMaterials	Off-the-shelf information technology(IT) hardware: computer and monitor	Off-the-shelf IT hardware: computer,router, graphics card and iPad
	Proprietary catheters, patient interfaceunit and accessories	Data Acquisition Module, based oncommercially available frame grabber
Technological Characteristics
Characteristic	Predicate Device	Subject Device
		and analog to digital (A/D) conversionboard
CT/MRI/UltrasoundRegistration	Includes optional modules forintegration of computed tomography(CT), magnetic resonance imaging(MRI) and ultrasound	None
Track MultipleCatheters	Visualization and tracking of multiplecatheters. No fluoroscopic images areshown with the catheter tracking.	All catheters visualized on fluoro screenwith real-time fluoro data input.Tracking of the mapping catheter only.
Motioncompensation	Compensated (table) anduncompensated (patient) motion	Using ECG patch detection algorithms,compensates for patient and tablemotion
Non-ClinicalPerformanceTesting	Underwent bench and animal testingto verify the modified features and todemonstrate with regression testingthat the new features did notnegatively affect existing features	Detailed performance testing conductedto demonstrate performancecharacteristics. Animal and bench(phantom) study protocols executed toenable performance comparison withpredicate device.The device has been demonstrated to bein compliance with IEC 62366-1Edition 1.0 2015-02 and IEC 62304First Edition 2006-05.

Table 5-1 Summary of Technological Characteristics Comparison

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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.

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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.

Regulation Number and Section

§ 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).