Who is the manufacturer of iMap 3D Mapping & Navigation System (iMap System)?

Cardionxt, Inc. filed the 510(k) submission for iMap 3D Mapping & Navigation System (iMap System) (K201094).

What is the FDA product code for iMap 3D Mapping & Navigation System (iMap System)?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for iMap 3D Mapping & Navigation System (iMap System)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for iMap 3D Mapping & Navigation System (iMap System)?

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

Who can help prepare an FDA 510(k) submission like iMap 3D Mapping & Navigation System (iMap System)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Indications for 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)

{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 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) | | |---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | 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 or Secondary Predicate | 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 as the 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 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: CardioNXT, Inc. | Primary Predicate: Abbott / St. Jude | Secondary Predicate: Abbott / St. Jude | Device Comparison | |--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | iMapTM 3D Mapping and Navigation System | EnSiteTM Precision Cardiac Mapping System V2.0.1 | EnSiteTM Velocity Cardiac Mapping System v4.0.2 with EnSiteTM Velocity Surface Electrode Kit | | | 510(k) Number | K201094 | K160210 | K160186 (with patches) | Not applicable | | Product Code | DQK | DQK | DQK | Same | | Regulation Number | 21 CFR 870.1425 | 21 CFR 870.1425 | 21 CFR 870.1425 | Same | | Regulation Name | Programmable Diagnostic Computer | Programmable Diagnostic Computer | Programmable Diagnostic Computer | Same | | Indications for Use | The CardioNXT iMap 3D Mapping & Navigation | The EnSiteTM Precision Cardiac Mapping | The EnSiteTM VelocityTM Cardiac Mapping System | Similar with minor variation. | | Manufacturer | Subject Device: CardioNXT, Inc. | Primary Predicate: Abbott / St. Jude | Secondary Predicate: Abbott / St. Jude | Device Comparison | | Trade Name | iMap™ 3D Mapping and Navigation System | EnSite™ Precision Cardiac Mapping System V2.0.1 | EnSite™ Velocity Cardiac Mapping System v4.0.2 with EnSite™ Velocity Surface Electrode Kit | | | | 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. | System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ Precision System interfaces to either the MediGuide™ Technology system or the EnSite™ Precision Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite™ Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with an EnSite™ Precision™ Surface Electrode Kit, the EnSite™ Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart. | is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. When used with the EnSite™ Array™ Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with an EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart. | While the exact wording of the indications for use is not identical, all elements of the indications for the CardioNXT iMap System are contained within the indications for use for the predicate devices. | | Physical Characteristics | | | | | | System Components to | iMap Controller iMap Field Generator (NDI) | Ensite Precision™ Link (NDI) | Ensite™ Amplifier NavLink GenConnect | Similar components | | Manufacturer | Subject Device: CardioNXT, Inc. | Primary Predicate: Abbott / St. Jude | Secondary Predicate: Abbott / St. Jude | Device Comparison | | Trade Name | iMap™ 3D Mapping and Navigation System | EnSite™ Precision Cardiac Mapping System V2.0.1 | EnSite™ Velocity Cardiac Mapping System v4.0.2 with EnSite™ Velocity Surface Electrode Kit | | | Achieve Intended Use | iMap Patient Interface iMap Ablation Adapter iMap RF Ground Filter iMap Power Unit iMap Computer workstation Monitor, keyboard, and mouse | Ensite™ Field Frame (NDI) Ensite™ Amplifier NavLink GenConnect Computer workstation Monitor, keyboard, and mouse | Computer workstation Monitor, keyboard, and mouse | | | Patient Patches | 6 external patches plus electromagnetic references. | 6 external patches with one reference patch, plus electromagnetic references. | 6 external patches with one reference patch | Similar | | Catheters | Compatible EP catheters and Multilink CS Catheter | Compatible EP catheters and at least one magnetic sensor-based catheter; Advisor FL Circular Mapping Catheter | Compatible EP catheters | Similar | | Technology | | | | | | Principle of Operation | Measure the impedance position and electromagnetic position of catheters and display position of both on a computer screen. Measure EGMs and display that information as tracings and as 3D model information based on a patient's cardiac chamber. | Measure the impedance position and electromagnetic position of catheters and display position of both on a computer screen. Measure EGMs and display that information as tracings and as 3D model information based on a patient's cardiac chamber. | Measure the impedance position of catheters and display position on a computer screen. Measure EGMs and display that information as tracings and as 3D model information based on patient's cardiac chamber. | Technological and performance characteristics are similar. | | Localization Technology | Proprietary Patch to Electrode Impedance measurement Northern Digital (NDI) – Aurora electromagnetic Window Field Generator | Proprietary Patch to Electrode Impedance measurement Northern Digital (NDI) — Aurora electromagnetic Window Field Generator | Proprietary Patch to Electrode Impedance measurement | Similar Impedance Localization. Same Electromagnetic localization. | | 3D Geometry of Endocardial Surface | Chamber surface (Geometry) gathered by navigated catheter | Chamber surface (Geometry) gathered by navigated catheter | Chamber surface (Geometry) gathered by navigated catheter. | Same. | | Manufacturer | Subject Device: CardioNXT, Inc. | Primary Predicate: Abbott / St. Jude | Secondary Predicate: Abbott / St. Jude | Device Comparison | | Trade Name | iMap™ 3D Mapping and Navigation System | EnSite™ Precision Cardiac Mapping System V2.0.1 | EnSite™ Velocity Cardiac Mapping System v4.0.2 with EnSite™ Velocity Surface Electrode Kit | | | Contact Electro- anatomical Mapping | Activation and Voltage. | Activation and Voltage. | Activation and Voltage. | Same. | | Simultaneous Navigation of multiple catheters | Multiple catheters, with at least Multilink CS Catheter | Multiple catheters, with at least one magnetic sensor-based catheter. | Multiple catheters. | Similar. | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ | Manufacturer | Subject Device: CardioNXT, Inc. | Primary Predicate: Abbott / St. Jude / Irvine Biomedical Inc. | Device Comparison | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | MultiLink CS Catheter | IBI Inquiry Diagnostic 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 & 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. | The InquiryTM fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle. | Similar. While the exact wording of the indications for use is not identical, all elements of the indications for the MultiLink CS Catheter are contained within the indications for use for the predicate device. | | Device Description | Steerable 6 Fr. decapolar (plus two additional proximal electrodes and electromagnetic sensors) electrophysiology recording catheter. | Steerable 6 Fr. decapolar electrophysiology recording catheter. | Similar | | Physical Characteristics | | | | | Shaft and Electrodes | 110cm shaft, 6Fr, 10 electrodes with 2- 5-2 spacing and 2 electrodes along proximal curve. | 110cm shaft, 6Fr, 10 electrodes with 2-5-2 spacing. | Same, Multilink has 2 additional electrodes | {8}------------------------------------------------ | Manufacturer | Subject Device: CardioNXT, Inc. | Primary Predicate: Abbott / St. Jude / Irvine Biomedical Inc. | Device Comparison | |--------------|--------------------------------------------------------------|---------------------------------------------------------------------|----------------------| | Trade Name | MultiLink CS Catheter | IBI Inquiry Diagnostic Electrophysiology Catheter | | | Handle | Push/Pull knob, uni-directional deflection with connector…

iMap 3D Mapping & Navigation System (iMap System)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

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iMap 3D Mapping & Navigation System (iMap System)

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Indications for Use

Device Story

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Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

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