K Number

Device Name

Navik 3D

Manufacturer

APN Health, LLC

Date Cleared

2016-02-23

(204 days)

Product Code

DQK

Regulation Number

870.1425

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K120550

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on image processing and signal analysis, with no mention of AI or ML techniques.

Therapeutic

No
The device is described as a multi-component computer system used for mapping and locating catheters, and displaying cardiac electrical activity. It is used for diagnostic purposes (mapping and visualizing cardiac electrical activity and catheter location) rather than directly treating a disease or condition.

Diagnostic

Yes

The device aids in diagnosis by "providing 3D location of these catheters" and displaying "cardiac electrical activation maps and cardiac voltage maps," which are used to assess the heart's electrical activity and diagnose conditions. It also states that it displays "body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals" and uses this information to "create and display 3D maps of the human heart" which are used for diagnostic purposes.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "multi-component computer system" and mentions utilizing data from "patient recording and monitoring systems that already exist in the electrophysiology (EP) lab," implying hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Navik 3D device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Navik 3D's Function: The description clearly states that Navik 3D is a computer system that uses image processing of fluoroscopic images to locate catheters within the human heart. It also processes and displays electrical signals (ECG and EGM) from the patient.
No Sample Analysis: The device does not analyze any biological samples taken from the patient. It works with real-time imaging and electrical signals from the patient's body.

Therefore, Navik 3D falls under the category of a medical device used for imaging, navigation, and mapping within the body, not for in vitro diagnostic testing of samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DQK

Device Description

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopic images

Anatomical Site

human heart (cardiac, atrial, ventricular)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

K120550

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

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

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

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)
-------------------------------------------------

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 V3.0
Manufacturer: Biosense Webster, Inc.
Address: 333 Diamond Canyon Road, Diamond Bar, CA 91765
Regulation Number: 21 CFR 870.1425
Regulation Name: Programmable Diagnostic Computer
Regulatory Class: Class II
Product Code: DQK
510(k) Number: K120550
510(k) Clearance Date: May 7, 2012

5.1 Description of the Device

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

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
atrial and ventricular mapping system	Image and signal processing based
atrial and ventricular mapping system
Primary
Feature	Displays anatomical and electrical
maps such as activation and voltage
maps of the human heart in real-time
using magnetic navigation techniques
and ECG-EGM analysis	Displays anatomical and electrical maps
such as activation and voltage maps of
the human heart in real-time using
fluoroscopic image processing
techniques and ECG-EGM analysis
3D Location
Technology	Electro anatomic location and ECG-
EGM signal processing	Fluoroscopic image and ECG-EGM
signal processing
Compatible
Catheters	Proprietary catheter with in-built
magnetic sensor	Any compatible mapping and ablation
catheter.
Display(s)
Control	Color monitor
Standard keyboard/mouse	Color monitor and Apple iPad®
iPad controller and/or standard
keyboard/mouse
Inputs
Required	Proprietary and non-proprietary
catheters and patches, ECG and EGM
data from the patient	Fluoroscopic images, ECG and EGM
data from the patient recording and
monitoring system, ECG patches (for
motion tracking only)
Map Types
Generated in
Real-Time	3D cardiac maps including:
anatomical maps, cardiac electrical
activation maps, cardiac electrical
propagation maps, cardiac electrical
potential (voltage) maps, cardiac
chamber geometry maps and Complex
Fractionated Atrial Electrogram
(CFAE) maps	3D cardiac maps including: anatomical
maps, cardiac electrical activation maps
and cardiac voltage maps
Fluoroscopic
Image
Displayed	Not real-time	Real-time with 3D map projected on
fluoro image if desired
Signal
Information
Displayed	Acquired patient signals, including
body surface ECG and intracardiac
EGMs	Imported signals, including body
surface ECG and intracardiac EGMs,
from the patient recording and
monitoring system
3D Viewing of
Maps	Standard 3D rendering, coloring and
user rotation and viewing methods	Standard 3D rendering, coloring and
user rotation and viewing methods
Hardware
Design and
Materials	Off-the-shelf information technology
(IT) hardware: computer and monitor	Off-the-shelf IT hardware: computer,
router, graphics card and iPad
	Proprietary catheters, patient interface
unit and accessories	Data Acquisition Module, based on
commercially available frame grabber
Technological Characteristics
Characteristic	Predicate Device	Subject Device
		and analog to digital (A/D) conversion
board
CT/MRI/
Ultrasound
Registration	Includes optional modules for
integration of computed tomography
(CT), magnetic resonance imaging
(MRI) and ultrasound	None
Track Multiple
Catheters	Visualization and tracking of multiple
catheters. No fluoroscopic images are
shown with the catheter tracking.	All catheters visualized on fluoro screen
with real-time fluoro data input.
Tracking of the mapping catheter only.
Motion
compensation	Compensated (table) and
uncompensated (patient) motion	Using ECG patch detection algorithms,
compensates for patient and table
motion
Non-Clinical
Performance
Testing	Underwent bench and animal testing
to verify the modified features and to
demonstrate with regression testing
that the new features did not
negatively affect existing features	Detailed performance testing conducted
to demonstrate performance
characteristics. Animal and bench
(phantom) study protocols executed to
enable performance comparison with
predicate device.

The device has been demonstrated to be
in compliance with IEC 62366-1
Edition 1.0 2015-02 and IEC 62304
First Edition 2006-05. |

Table 5-1 Summary of Technological Characteristics Comparison

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.

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.