iMap 3D Mapping & Navigation System (iMap System)

K201094 · Cardionxt, Inc. · DQK · Aug 16, 2021 · Cardiovascular

Device Facts

• Record ID: K201094
• Device Name: iMap 3D Mapping & Navigation System (iMap System)
• Applicant: Cardionxt, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Aug 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

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.

Device Story

iMap™ 3D Mapping & Navigation System tracks conventional electrophysiology catheters in 3D; utilizes electromagnetic and impedance tracking to generate patient-specific cardiac chamber geometries; measures and displays cardiac electrogram (EGM) information as waveform traces and electroanatomical maps. System includes iMap Controller, Field Generator (NDI Aurora), patient interface, ablation adapter, RF ground filter, and workstation. MultiLink CS Catheter serves as navigation reference using integrated electromagnetic sensors and electrodes. Used in clinical electrophysiology labs by physicians; provides real-time visualization of catheter position and electrical activity to assist in mapping cardiac arrhythmias; aids clinical decision-making during diagnostic procedures.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (electrical safety, EMC, biocompatibility, sterilization, diagnostic catheter performance per ISO 10555-1) and a GLP-compliant animal study to validate system performance and navigation accuracy.

Technological Characteristics

System utilizes impedance-based and electromagnetic (NDI Aurora) tracking. Components: iMap Controller, Field Generator, MultiLink CS Catheter (6 Fr, 10 electrodes, electromagnetic sensors). Biocompatibility per ISO 10993; electrical safety per ANSI/AAMI ES60601-1 and IEC 60601-2-2; EMC per IEC 60601-1-2. Software validated per IEC 62304.

Indications for Use

Indicated for patients undergoing conventional electrophysiological procedures requiring display of catheter position and cardiac electrical activity.

Regulatory Classification

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.

Predicate Devices

• EnSite Precision™ Cardiac Mapping System (K160210)
• EnSite™ Velocity Cardiac Mapping System with EnSite™ Velocity Surface Electrode Kit (K160186)
• IBI Inquiry Diagnostic Catheter (K961924)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K201094

Device Name

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

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 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: [phone] 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 or<br>Secondary<br>Predicate | Manufacturer | 510(k) No. |
|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------|------------|
| EnSite Precision™ Cardiac Mapping System | Primary | Abbott St. Jude | K160210 |
| EnSite™ Velocity Cardiac Mapping System with EnSite™<br>Velocity Surface Electrode Kit (Commonly known as<br>the NavX System) | Secondary | Abbott St. Jude | K160186 |
| IBI Inquiry Diagnostic Catheter (Secondary Predicate) | Secondary | Abbott St. Jude | K961924 |

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# 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

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.

## 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:<br>CardioNXT, Inc. | Primary Predicate:<br>Abbott / St. Jude | Secondary Predicate:<br>Abbott / St. Jude | Device<br>Comparison |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | iMapTM 3D Mapping<br>and Navigation<br>System | EnSiteTM Precision<br>Cardiac Mapping<br>System V2.0.1 | EnSiteTM Velocity<br>Cardiac Mapping<br>System v4.0.2 with<br>EnSiteTM Velocity<br>Surface Electrode Kit | |
| 510(k) Number | K201094 | K160210 | K160186 (with patches) | Not applicable |
| Product Code | DQK | DQK | DQK | Same |
| Regulation<br>Number | 21 CFR 870.1425 | 21 CFR 870.1425 | 21 CFR 870.1425 | Same |
| Regulation<br>Name | Programmable Diagnostic<br>Computer | Programmable<br>Diagnostic Computer | Programmable Diagnostic<br>Computer | Same |
| Indications for<br>Use | The CardioNXT iMap 3D<br>Mapping & Navigation | The EnSiteTM Precision<br>Cardiac Mapping | The EnSiteTM VelocityTM<br>Cardiac Mapping System | Similar with<br>minor variation. |
| Manufacturer | Subject Device:<br>CardioNXT, Inc. | Primary Predicate:<br>Abbott / St. Jude | Secondary Predicate:<br>Abbott / St. Jude | Device<br>Comparison |
| Trade Name | iMap™ 3D Mapping<br>and Navigation<br>System | EnSite™ Precision<br>Cardiac Mapping<br>System V2.0.1 | EnSite™ Velocity<br>Cardiac Mapping<br>System v4.0.2 with<br>EnSite™ Velocity<br>Surface Electrode Kit | |
| | System is intended for the<br>display of compatible<br>electrophysiology catheter<br>position and cardiac<br>electrical activity when<br>used with the MultiLink<br>CS Catheter during<br>conventional<br>electrophysiological<br>procedures.<br>The MultiLink CS<br>Catheter is used for<br>electrogram recording and<br>as a navigation reference<br>during conventional<br>electrophysiological<br>procedures. | System is a suggested<br>diagnostic tool in<br>patients for whom<br>electrophysiology<br>studies have been<br>indicated.<br>The EnSite™ Precision<br>System interfaces to<br>either the MediGuide™<br>Technology system or<br>the EnSite™ Precision<br>Module to combine and<br>display magnetic<br>processed patient<br>positioning and<br>navigation mapping<br>information.<br>When used with the<br>EnSite™ Array™<br>Catheter, the EnSite™<br>Precision™ Cardiac<br>Mapping System is<br>intended to be used in<br>the right atrium of<br>patients with complex<br>arrhythmias that may be<br>difficult to identify using<br>conventional mapping<br>systems alone.<br>OR<br>When used with an<br>EnSite™ Precision™<br>Surface Electrode Kit,<br>the EnSite™<br>Precision™ Cardiac<br>Mapping System is<br>intended to display the<br>position of conventional<br>electrophysiology (EP)<br>catheters in the heart. | is a suggested diagnostic<br>tool in patients for whom<br>electrophysiology studies<br>have been indicated.<br>When used with the<br>EnSite™ Array™<br>Catheter, the EnSite™<br>Velocity™ Cardiac<br>Mapping System is<br>intended to be used in the<br>right atrium of patients<br>with complex arrhythmias<br>that may be difficult to<br>identify using<br>conventional mapping<br>systems alone.<br>OR<br>When used with an<br>EnSite™ Velocity™<br>Surface Electrode Kit, the<br>EnSite™ Velocity™<br>Cardiac Mapping System<br>is intended to display the<br>position of conventional<br>electrophysiology (EP)<br>catheters in the heart. | While the exact<br>wording of the<br>indications for<br>use is not<br>identical, all<br>elements of the<br>indications for<br>the CardioNXT<br>iMap System are<br>contained within<br>the indications<br>for use for the<br>predicate devices. |
| Physical Characteristics | | | | |
| System<br>Components to | iMap Controller<br>iMap Field Generator<br>(NDI) | Ensite Precision™ Link<br>(NDI) | Ensite™ Amplifier<br>NavLink<br>GenConnect | Similar<br>components |
| Manufacturer | Subject Device:<br>CardioNXT, Inc. | Primary Predicate:<br>Abbott / St. Jude | Secondary Predicate:<br>Abbott / St. Jude | Device<br>Comparison |
| Trade Name | iMap™ 3D Mapping<br>and Navigation<br>System | EnSite™ Precision<br>Cardiac Mapping<br>System V2.0.1 | EnSite™ Velocity<br>Cardiac Mapping<br>System v4.0.2 with<br>EnSite™ Velocity<br>Surface Electrode Kit | |
| Achieve<br>Intended Use | iMap Patient Interface<br>iMap Ablation Adapter<br>iMap RF Ground Filter<br>iMap Power Unit<br>iMap Computer<br>workstation<br>Monitor, keyboard, and<br>mouse | Ensite™ Field Frame<br>(NDI)<br>Ensite™ Amplifier<br>NavLink<br>GenConnect<br>Computer workstation<br>Monitor, keyboard, and<br>mouse | Computer workstation<br>Monitor, keyboard, and<br>mouse | |
| Patient Patches | 6 external patches plus<br>electromagnetic<br>references. | 6 external patches with<br>one reference patch, plus<br>electromagnetic<br>references. | 6 external patches with<br>one reference patch | Similar |
| Catheters | Compatible EP catheters<br>and Multilink CS Catheter | Compatible EP catheters<br>and at least one<br>magnetic sensor-based<br>catheter; Advisor FL<br>Circular Mapping<br>Catheter | Compatible EP catheters | Similar |
| Technology | | | | |
| Principle of<br>Operation | Measure the impedance<br>position and<br>electromagnetic position<br>of catheters and display<br>position of both on a<br>computer screen.<br>Measure EGMs and<br>display that information<br>as tracings and as 3D<br>model information based<br>on a patient's cardiac<br>chamber. | Measure the impedance<br>position and<br>electromagnetic position<br>of catheters and display<br>position of both on a<br>computer screen.<br>Measure EGMs and<br>display that information<br>as tracings and as 3D<br>model information based<br>on a patient's cardiac<br>chamber. | Measure the impedance<br>position of catheters and<br>display position on a<br>computer screen.<br>Measure EGMs and<br>display that information<br>as tracings and as 3D<br>model information based<br>on patient's cardiac<br>chamber. | Technological<br>and performance<br>characteristics are<br>similar. |
| Localization<br>Technology | Proprietary<br>Patch to Electrode<br>Impedance measurement<br>Northern Digital (NDI) –<br>Aurora electromagnetic<br>Window Field Generator | Proprietary<br>Patch to Electrode<br>Impedance measurement<br>Northern Digital (NDI)<br>— Aurora<br>electromagnetic<br>Window Field Generator | Proprietary<br>Patch to Electrode<br>Impedance measurement | Similar<br>Impedance<br>Localization.<br>Same<br>Electromagnetic<br>localization. |
| 3D Geometry<br>of Endocardial<br>Surface | Chamber surface<br>(Geometry) gathered by<br>navigated catheter | Chamber surface<br>(Geometry) gathered by<br>navigated catheter | Chamber surface<br>(Geometry) gathered by<br>navigated catheter. | Same. |
| Manufacturer | Subject Device:<br>CardioNXT, Inc. | Primary Predicate:<br>Abbott / St. Jude | Secondary Predicate:<br>Abbott / St. Jude | Device<br>Comparison |
| Trade Name | iMap™ 3D Mapping<br>and Navigation<br>System | EnSite™ Precision<br>Cardiac Mapping<br>System V2.0.1 | EnSite™ Velocity<br>Cardiac Mapping<br>System v4.0.2 with<br>EnSite™ Velocity<br>Surface Electrode Kit | |
| Contact<br>Electro-<br>anatomical<br>Mapping | Activation and Voltage. | Activation and Voltage. | Activation and Voltage. | Same. |
| Simultaneous<br>Navigation of<br>multiple<br>catheters | Multiple catheters, with at<br>least Multilink CS<br>Catheter | Multiple catheters, with<br>at least one magnetic<br>sensor-based catheter. | Multiple catheters. | Similar. |

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| Manufacturer | Subject Device:<br>CardioNXT, Inc. | Primary Predicate:<br>Abbott / St. Jude / Irvine<br>Biomedical Inc. | Device<br>Comparison |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | MultiLink CS Catheter | IBI Inquiry Diagnostic<br>Electrophysiology 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 &<br>Navigation System is intended for the<br>display of compatible electrophysiology<br>catheter position and cardiac electrical<br>activity when used with the MultiLink<br>CS Catheter during conventional<br>electrophysiological procedures.<br>The MultiLink CS Catheter is used for<br>electrogram recording and as a<br>navigation reference during<br>conventional electrophysiological<br>procedures. | The InquiryTM fixed curve and<br>steerable electrophysiology catheters<br>are used for electrogram recording<br>and cardiac stimulation during<br>diagnostic electrophysiology studies.<br>The catheters are commonly placed at<br>the high right atrium, right<br>ventricular apex, and HIS bundle. | Similar. While<br>the exact<br>wording of the<br>indications for<br>use is not<br>identical, all<br>elements of the<br>indications for<br>the MultiLink<br>CS Catheter are<br>contained within<br>the indications<br>for use for the<br>predicate device. |
| Device Description | Steerable 6 Fr. decapolar (plus two<br>additional proximal electrodes and<br>electromagnetic sensors)<br>electrophysiology recording catheter. | Steerable 6 Fr. decapolar<br>electrophysiology recording catheter. | Similar |
| Physical Characteristics | | | |
| Shaft and<br>Electrodes | 110cm shaft, 6Fr, 10 electrodes with 2-<br>5-2 spacing and 2 electrodes along<br>proximal curve. | 110cm shaft, 6Fr, 10 electrodes with<br>2-5-2 spacing. | Same, Multilink<br>has 2 additional<br>electrodes |

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| Manufacturer | Subject Device:<br>CardioNXT, Inc. | Primary Predicate:<br>Abbott / St. Jude / Irvine<br>Biomedical Inc. | Device<br>Comparison |
|--------------|--------------------------------------------------------------|---------------------------------------------------------------------|----------------------|
| Trade Name | MultiLink CS Catheter | IBI Inquiry Diagnostic<br>Electrophysiology Catheter | |
| Handle | Push/Pull knob, uni-directional<br>deflection with connector…