The CardioNXT iMap™ 3D Mapping and Navigation System (iMap™ System) is a catheter navigation and mapping system, capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as electroanatomical maps of the cardiac chamber. The contoured surfaces of these threedimensional maps are based on the anatomy of the patient's cardiac chamber. The iMap™ System utilizes electromagnetic tracking and impedance tracking to track conventional catheters and paint the surfaces of cardiac chambers in 3D to generate a patient-specific image of the heart, also called a geometry. The iMap System measures cardiac electrogram (EGM) information from navigated catheter electrodes throughout the heart and displays this information on the patient-specific geometry. The iMap System utilizes a Coronary Sinus(CS)catheter with both electromagnetic sensors and electrodes as a reference for its navigation coordinate system.

AI/ML Overview

The provided text describes the CardioNXT iMap™ 3D Mapping & Navigation System, but it does not contain acceptance criteria and specific study results in the format requested. Instead, it lists various types of testing performed and concludes that the device meets performance specifications and is substantially equivalent to predicate devices.

Here's a breakdown of what is and isn't present, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided. The document states that bench testing demonstrates the system meets performance specifications, but it does not list those specifications or the quantitative results against them.

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

Sample size for test set: Not explicitly stated. The document mentions a "GLP animal study" and "bench testing," but doesn't give specific numbers of animals or test items.
Data provenance: "GLP animal study" implies prospective animal data. "Bench testing" would be laboratory-based. No mention of human data, retrospective or prospective, for performance evaluation against acceptance criteria.

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

Not provided. The document mentions "usability testing demonstrating usability by licensed cardiac electrophysiologist physicians," but this is for usability, not for establishing ground truth for device performance metrics.

4. Adjudication Method:

Not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not performed/reported. The document does not mention an MRMC study or any effect sizes of human reader improvement with AI assistance.

6. Standalone Performance:

A standalone performance study was likely done as part of the "bench testing demonstrating substantially equivalent safety, performance, and accuracy to predicate" and the "GLP animal study." However, the specific metrics and results of this standalone performance are not detailed in the provided text. The overall conclusion is that it meets specifications, but the specifics are absent.

7. Type of Ground Truth Used:

For the "GLP animal study" and "bench testing," the ground truth would typically be established through direct measurements, established physiological parameters, or physical phantom models with known properties. However, the document does not explicitly specify the type of ground truth (e.g., direct measurement, histological analysis, etc.) for each performance metric evaluated.

8. Sample Size for the Training Set:

Not provided. The document does not mention any "training set." The iMap™ System is described as a "programmable diagnostic computer" and a "mapping and navigation system," implying it might use algorithms, but no details on machine learning model training or associated datasets are given.

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

Not applicable/Not provided. Since no training set is mentioned, the method for establishing its ground truth is also not mentioned.

In summary, the provided document focuses on regulatory clearance and substantial equivalence by listing various types of testing performed (bench, animal, electrical safety, biocompatibility, etc.) and concluding that the device meets requirements. However, it lacks the detailed quantitative acceptance criteria and specific study results that you requested to demonstrate how those criteria were met.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 16, 2021

CardioNXT, Inc. Jerome Edwards President 12011 Tejon Street, Suite 700 Westminster, Colorado 80234

Re: K201094

Trade/Device Name: iMap™ 3D Mapping & Navigation System (iMap™ System) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DRF Dated: August 13, 2021 Received: August 16, 2021

Dear Jerome Edwards:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Aneesh Deoras Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201094

Device Name

iMap™ 3D Mapping & Navigation System (iMap™ System)

Indications for Use (Describe)

The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.

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}------------------------------------------------

510(k) Summary

iMap™ 3D Mapping & Navigation System

K201094

1. Submission Sponsor

CardioNXT, Inc. 12011 Tejon Street, Suite 700 Westminster, Colorado 80234 USA Contact: Jerome Edwards Title: Chief Executive Officer Phone: 615.473.9012 Email: jerome.edwards(@cardionxt.com

2. Date Prepared

August 13, 2021

3. Device Identification

Trade/Proprietary Name:	iMapTM 3D Mapping & Navigation System (iMapTM System)
Common/Usual Name:	Programmable diagnostic computer
Classification Name:	Computer, Diagnostic, Programmable
Regulation Number:	21 CFR §870.1425
Product Code:	DQK; Computer, Diagnostic, Programmable
Device Class:	Class II
Classification Panel:	Cardiovascular

4. Predicate Device Information

Predicate Device	Primary orSecondaryPredicate	Manufacturer	510(k) No.
EnSite Precision™ Cardiac Mapping System	Primary	Abbott St. Jude	K160210
EnSite™ Velocity Cardiac Mapping System with EnSite™Velocity Surface Electrode Kit (Commonly known asthe NavX System)	Secondary	Abbott St. Jude	K160186
IBI Inquiry Diagnostic Catheter (Secondary Predicate)	Secondary	Abbott St. Jude	K961924

{4}------------------------------------------------

5. Indication for Use Statement

The CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures. The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.

6. Device Description

7. Substantial Equivalence Discussion

The following tables compares the iMap™ 3D Mapping & Navigation System and Multilink CS Catheter to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	Subject Device:CardioNXT, Inc.	Primary Predicate:Abbott / St. Jude	Secondary Predicate:Abbott / St. Jude	DeviceComparison
Trade Name	iMapTM 3D Mappingand NavigationSystem	EnSiteTM PrecisionCardiac MappingSystem V2.0.1	EnSiteTM VelocityCardiac MappingSystem v4.0.2 withEnSiteTM VelocitySurface Electrode Kit
510(k) Number	K201094	K160210	K160186 (with patches)	Not applicable
Product Code	DQK	DQK	DQK	Same
RegulationNumber	21 CFR 870.1425	21 CFR 870.1425	21 CFR 870.1425	Same
RegulationName	Programmable DiagnosticComputer	ProgrammableDiagnostic Computer	Programmable DiagnosticComputer	Same
Indications forUse	The CardioNXT iMap 3DMapping & Navigation	The EnSiteTM PrecisionCardiac Mapping	The EnSiteTM VelocityTMCardiac Mapping System	Similar withminor variation.
Manufacturer	Subject Device:CardioNXT, Inc.	Primary Predicate:Abbott / St. Jude	Secondary Predicate:Abbott / St. Jude	DeviceComparison
Trade Name	iMap™ 3D Mappingand NavigationSystem	EnSite™ PrecisionCardiac MappingSystem V2.0.1	EnSite™ VelocityCardiac MappingSystem v4.0.2 withEnSite™ VelocitySurface Electrode Kit
	System is intended for thedisplay of compatibleelectrophysiology catheterposition and cardiacelectrical activity whenused with the MultiLinkCS Catheter duringconventionalelectrophysiologicalprocedures.The MultiLink CSCatheter is used forelectrogram recording andas a navigation referenceduring conventionalelectrophysiologicalprocedures.	System is a suggesteddiagnostic tool inpatients for whomelectrophysiologystudies have beenindicated.The EnSite™ PrecisionSystem interfaces toeither the MediGuide™Technology system orthe EnSite™ PrecisionModule to combine anddisplay magneticprocessed patientpositioning andnavigation mappinginformation.When used with theEnSite™ Array™Catheter, the EnSite™Precision™ CardiacMapping System isintended to be used inthe right atrium ofpatients with complexarrhythmias that may bedifficult to identify usingconventional mappingsystems alone.ORWhen used with anEnSite™ Precision™Surface Electrode Kit,the EnSite™Precision™ CardiacMapping System isintended to display theposition of conventionalelectrophysiology (EP)catheters in the heart.	is a suggested diagnostictool in patients for whomelectrophysiology studieshave been indicated.When used with theEnSite™ Array™Catheter, the EnSite™Velocity™ CardiacMapping System isintended to be used in theright atrium of patientswith complex arrhythmiasthat may be difficult toidentify usingconventional mappingsystems alone.ORWhen used with anEnSite™ Velocity™Surface Electrode Kit, theEnSite™ Velocity™Cardiac Mapping Systemis intended to display theposition of conventionalelectrophysiology (EP)catheters in the heart.	While the exactwording of theindications foruse is notidentical, allelements of theindications forthe CardioNXTiMap System arecontained withinthe indicationsfor use for thepredicate devices.
Physical Characteristics
SystemComponents to	iMap ControlleriMap Field Generator(NDI)	Ensite Precision™ Link(NDI)	Ensite™ AmplifierNavLinkGenConnect	Similarcomponents
Manufacturer	Subject Device:CardioNXT, Inc.	Primary Predicate:Abbott / St. Jude	Secondary Predicate:Abbott / St. Jude	DeviceComparison
Trade Name	iMap™ 3D Mappingand NavigationSystem	EnSite™ PrecisionCardiac MappingSystem V2.0.1	EnSite™ VelocityCardiac MappingSystem v4.0.2 withEnSite™ VelocitySurface Electrode Kit
AchieveIntended Use	iMap Patient InterfaceiMap Ablation AdapteriMap RF Ground FilteriMap Power UnitiMap ComputerworkstationMonitor, keyboard, andmouse	Ensite™ Field Frame(NDI)Ensite™ AmplifierNavLinkGenConnectComputer workstationMonitor, keyboard, andmouse	Computer workstationMonitor, keyboard, andmouse
Patient Patches	6 external patches pluselectromagneticreferences.	6 external patches withone reference patch, pluselectromagneticreferences.	6 external patches withone reference patch	Similar
Catheters	Compatible EP cathetersand Multilink CS Catheter	Compatible EP cathetersand at least onemagnetic sensor-basedcatheter; Advisor FLCircular MappingCatheter	Compatible EP catheters	Similar
Technology
Principle ofOperation	Measure the impedanceposition andelectromagnetic positionof catheters and displayposition of both on acomputer screen.Measure EGMs anddisplay that informationas tracings and as 3Dmodel information basedon a patient's cardiacchamber.	Measure the impedanceposition andelectromagnetic positionof catheters and displayposition of both on acomputer screen.Measure EGMs anddisplay that informationas tracings and as 3Dmodel information basedon a patient's cardiacchamber.	Measure the impedanceposition of catheters anddisplay position on acomputer screen.Measure EGMs anddisplay that informationas tracings and as 3Dmodel information basedon patient's cardiacchamber.	Technologicaland performancecharacteristics aresimilar.
LocalizationTechnology	ProprietaryPatch to ElectrodeImpedance measurementNorthern Digital (NDI) –Aurora electromagneticWindow Field Generator	ProprietaryPatch to ElectrodeImpedance measurementNorthern Digital (NDI)— AuroraelectromagneticWindow Field Generator	ProprietaryPatch to ElectrodeImpedance measurement	SimilarImpedanceLocalization.SameElectromagneticlocalization.
3D Geometryof EndocardialSurface	Chamber surface(Geometry) gathered bynavigated catheter	Chamber surface(Geometry) gathered bynavigated catheter	Chamber surface(Geometry) gathered bynavigated catheter.	Same.
Manufacturer	Subject Device:CardioNXT, Inc.	Primary Predicate:Abbott / St. Jude	Secondary Predicate:Abbott / St. Jude	DeviceComparison
Trade Name	iMap™ 3D Mappingand NavigationSystem	EnSite™ PrecisionCardiac MappingSystem V2.0.1	EnSite™ VelocityCardiac MappingSystem v4.0.2 withEnSite™ VelocitySurface Electrode Kit
ContactElectro-anatomicalMapping	Activation and Voltage.	Activation and Voltage.	Activation and Voltage.	Same.
SimultaneousNavigation ofmultiplecatheters	Multiple catheters, with atleast Multilink CSCatheter	Multiple catheters, withat least one magneticsensor-based catheter.	Multiple catheters.	Similar.

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

Manufacturer	Subject Device:CardioNXT, Inc.	Primary Predicate:Abbott / St. Jude / IrvineBiomedical Inc.	DeviceComparison
Trade Name	MultiLink CS Catheter	IBI Inquiry DiagnosticElectrophysiology Catheter
510(k) Number	K201094	K961924	Not applicable
Product Code	DRF	DRF	Same
Regulation Number	21 CFR 870.1220	21 CFR 870.1220	Same
Indications for Use	The CardioNXT iMap 3D Mapping &Navigation System is intended for thedisplay of compatible electrophysiologycatheter position and cardiac electricalactivity when used with the MultiLinkCS Catheter during conventionalelectrophysiological procedures.The MultiLink CS Catheter is used forelectrogram recording and as anavigation reference duringconventional electrophysiologicalprocedures.	The InquiryTM fixed curve andsteerable electrophysiology cathetersare used for electrogram recordingand cardiac stimulation duringdiagnostic electrophysiology studies.The catheters are commonly placed atthe high right atrium, rightventricular apex, and HIS bundle.	Similar. Whilethe exactwording of theindications foruse is notidentical, allelements of theindications forthe MultiLinkCS Catheter arecontained withinthe indicationsfor use for thepredicate device.
Device Description	Steerable 6 Fr. decapolar (plus twoadditional proximal electrodes andelectromagnetic sensors)electrophysiology recording catheter.	Steerable 6 Fr. decapolarelectrophysiology recording catheter.	Similar
Physical Characteristics
Shaft andElectrodes	110cm shaft, 6Fr, 10 electrodes with 2-5-2 spacing and 2 electrodes alongproximal curve.	110cm shaft, 6Fr, 10 electrodes with2-5-2 spacing.	Same, Multilinkhas 2 additionalelectrodes

{8}------------------------------------------------

Manufacturer	Subject Device:CardioNXT, Inc.	Primary Predicate:Abbott / St. Jude / IrvineBiomedical Inc.	DeviceComparison
Trade Name	MultiLink CS Catheter	IBI Inquiry DiagnosticElectrophysiology Catheter
Handle	Push/Pull knob, uni-directionaldeflection with connector	Push/Pull knob, uni-directionaldeflection with connector	Similar

8. Performance Data

As part of demonstrating safety, effectiveness, and substantial equivalence of the iMap™ 3D Mapping & Navigation System, CardioNXT, Inc. completed bench and animal testing. The iMap™ 3D Mapping & Navigation System meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device as evidenced by the following testing:

CardioNXT iMap System verification testing
. GLP animal study
Bench Testing demonstrating substantially equivalent safety, performance, and accuracy to predicate
Electrical Safety Testing (ANSI/AAMI ES60601-1:2005/A1:2012) ●
. Electrical Safety Testing (IEC 60601-2-2:2017)
Electromagnetic Compatibility Testing (IEC 60601-1-2:2014, EN 55011:2009) .
. Biocompatibility Testing (ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017)
. Cleaning and Sterilization Testing per Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling
Storage and Transport Testing (ISTA 2A)
. Diagnostic Intravascular Catheter Testing (ISO 10555-1:2013)
Software verification and validation testing per IEC 62304/FDA Guidance
. Compatibility testing in a cardiac electrophysiology lab environment
Usability testing demonstrating usability by licensed cardiac electrophysiologist physicians

9. Conclusions

Bench testing demonstrates the iMap™ 3D Mapping & Navigation System meets performance specifications. Validation testing through a GLP controlled animal study further demonstrated performance of the iMap™ 3D Mapping & Navigation System and substantial equivalence to the predicate. As such, this collection of testing demonstrates the substantial equivalence of the iMap System to the predicate device.

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).