Vektor Computational ECG Mapping System (vMap)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other. November 9, 2021 Vektor Medical, Inc. % Michael Billig Co-Founder and Chief Executive Officer Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose. California 95110 Re: K211546 Trade/Device Name: Vektor Computational ECG Mapping System (vMap™) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: May 18, 2021 Received: May 19, 2021 Dear Michael Billig: 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. 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Sincerely, Aneesh Deoras Assistant Director 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) K211546 Device Name Vektor Computational ECG Mapping System (vMap™) Indications for Use (Describe) The Vektor Computational ECG Mapping System (vMap™) is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician. > 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) Notification K211546 ## GENERAL INFORMATION [807.92(a)(1)] #### Applicant: Vektor Medical, Inc. 7875 Sitio Abeto Carlsbad, CA, 92009 Phone: 800-610-8587 ### Sponsor Contact Person: Mike Monko Chief Executive Officer, Vektor Medical, Inc. Vektor Medical, Inc. 7875 Sitio Abeto Carlsbad, CA, 92009 ### Application Correspondent: Michael J. Billig Regulatory Consultant to Vektor Medical, Inc. Co-Founder and Chief Executive Officer, Experien Group, LLC Now a Part of Veranex 224 Airport Parkway, Suite 250 San Jose, CA, 95110 ### Date Prepared: November 8, 2021 ### DEVICE INFORMATION [807.92(a)(2)] #### Trade Name: Vektor Computational ECG Mapping System (vMap") ### Generic/Common Name: Electrophysiological cardiac mapping system ### Classification: 21 CFR§870.1425. Programmable Diagnostic Computer, Class II ### Product Code: DOK, Computer, Diagnostic, Programmable {4}------------------------------------------------ ## PREDICATE DEVICE(S) [807.92(a)(3)] Primary Predicate Device: Volta Medical VX1 (K201298) Secondary Predicate Device: Medtronic. Inc. CardioInsight® Cardiac Mapping System (K181918) ### DEVICE DESCRIPTION [807.92(a)(4)] The Vektor Computational ECG Mapping System (vMap™) is a non-invasive software-driven tool for beat-by-beat, multi-chamber, two-dimensional ("2D") and three-dimensional ("3D") analysis and mapping of the heart. vMap" analyzes standard, 12-lead electrocardiographic signals acquired non-invasively from the body surface. vMap™ uses this data to provide various 2D cardiac information and interactive 3D color maps, including cardiac electrical features for analysis by a physician. vMap™ can be used in the clinical environment, such as the electrophysiology ("EP") lab, and in a hospital environment. The vMap™ System consists of three key components: - 1. The vMap™ Software, which drives vMap™ and its core analysis functionalities; - 2. The vMap™ Hardware, the computer workstation which facilitates the use of the vMap™ Software; and - 3. The vMap™ Disposables, which includes a "Mapping Key" that serves as a license mechanism for the software. Commercial off-the-shelf components such as a USB flash drive and a set of FDA-cleared ECG leads are provided for the physician's convenience. The electrocardiogram (ECG) signals are displayed and used in proprietary algorithms to transform the measured body surface signals into cardiac signals. vMap™ provides information directly to the physician to help assess patients exhibiting abnormal heart rhythmias). vMap" provides this information by analyzing electrocardiographic information with reference to an arrhythmia-specific cardiac voltage library. ### INDICATIONS FOR USE [807.92(a)(5)] The Vektor Computational ECG Mapping System (vMap") is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)] The proposed device and the predicate devices have intended use and similar Indications for Use. All devices are non-invasive cardiac mapping systems for use by licensed physicians on patients undergoing electrophysiology ("EP") procedures. vMap™, VX1, and CardioInsight® all perform analysis, display, and storage of EP data and maps for analysis by a physician. The proposed and predicate devices share key technological similarities. In order to process the device signal input and provide output, all devices analyze cardiac electrogram data in order to generate electrical activity "maps" indicative of cardiac electrical activity within the heart anatomy for physician analysis. In consideration of the specific analysis methodology, vMap™ {5}------------------------------------------------ and CardioInsight utilize electrical activity information gathered from surface-lead inputs to estimate the origins of the measured electrical activity. In this analysis, both devices consider the patient's cardiac anatomy to arrive at the mapping result. Further, vMap™ and VX1 also leverage analytical parameters from externally developed models as part of the analysis to relate the input source signals to the final geometric output. There are a few differences between the proposed device and the predicate devices which relate primarily to input signals, mathematical approach, and output map formats, which do not raise different questions of safety or effectiveness, as was further confirmed through the results of bench, usability, and clinical performance testing. Table 1 presents a tabular comparison of technological characteristics between the proposed device and predicate devices. {6}------------------------------------------------ # Table 1: Substantial Equivalence Table | Feature | Proposed Device<br>Vektor Medical, Inc. - Vektor<br>Computational ECG Mapping<br>System (vMap™) (K211546) | Primary Predicate Device<br>Volta Medical – VX1<br>(K201298) | Secondary Predicate Device<br>Medtronic Inc. – CardioInsight®<br>Cardiac Mapping System<br>(K181918) | | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | 21 CFR§870.1425, Programmable<br>Diagnostic Computer | 21 CFR§870.1425, Programmable<br>Diagnostic Computer | 21 CFR§870.1425, Programmable<br>Diagnostic Computer | | | Product Code | DQK, Computer, Diagnostic,<br>Programmable | DQK, Computer, Diagnostic,<br>Programmable | DQK, Computer, Diagnostic,<br>Programmable | | | Intended Use/Indications for Use | | | | | | Indications for Use | The Vektor Computational ECG<br>Mapping System (vMap™) is<br>intended for the analysis, display, and<br>storage of cardiac<br>electrophysiological data and maps<br>for analysis by a physician. | The VX1 assists operators in the<br>real-time manual annotation of 3D<br>anatomical and electrical maps of<br>human atria for the presence of<br>multipolar intra-cardiac atrial<br>electrograms exhibiting<br>spatiotemporal dispersion during<br>atrial fibrillation or atrial<br>tachycardia.<br>The clinical significance of utilizing<br>the VX1 software to help identify<br>areas with intra-cardiac atrial<br>electrograms exhibiting<br>spatiotemporal dispersion for<br>catheter ablation of atrial<br>arrhythmias, such as atrial<br>fibrillation, has not been established<br>by clinical investigations. | The CardioInsight Cardiac Mapping<br>System is intended for acquisition,<br>analysis, display and storage of<br>cardiac electrophysiological data<br>and maps for analysis by a<br>physician. | | | Intended Use Population | Individuals undergoing EP<br>procedures | Individuals undergoing EP<br>procedures | Individual undergoing EP procedure | | | Intended Use Environment | Clinical and hospital environment | Clinical and hospital environments | Clinical and hospital environment | | | Prescription/Over-the-Counter | Rx | Rx | Rx | | | | Feature | Proposed Device<br>Vektor Medical, Inc. - Vektor<br>Computational ECG Mapping<br>System (vMap™) (K211546) | Primary Predicate Device<br>Volta Medical – VX1<br>(K201298) | Secondary Predicate Device<br>Medtronic Inc. – CardioInsight®<br>Cardiac Mapping System<br>(K181918) | | Mapping<br>Display | Principal Mapping<br>Approach | Displays 3D anatomical maps after<br>analyzing surface electrograms and<br>patient phenotype using signal<br>processing and computational<br>modeling techniques. | Displays adjudications as visual cues<br>after analyzing intra-cardiac atrial<br>electrograms in real-time using<br>signal processing, and deep and<br>machine learning techniques. | Displays 3D anatomical maps after<br>analyzing surface electrograms and<br>imaging information using signal<br>processing techniques. | | | Cardiac Model Used | Standard, idealized model | N/A; the locations are displayed<br>relative to the mapping catheter<br>electrodes. | Individualized, patient-specific<br>model based on segmented CT<br>image | | | Cardiac Maps Provided | 3D Activation Heatmap:<br>• Individual-beat<br>• Composite beat<br>• Beat-averaged summary<br>• Custom Beat | Real-time Dispersed Electrogram<br>(DE) subtype of multipolar<br>electrogram map- The operator is<br>provided with display of the<br>electrode locations where dispersed<br>or non-dispersed electrograms have<br>been recorded during atrial<br>fibrillation or atrial tachycardia. | 3D Electroanatomical Maps:<br>• Phase Map<br>• Potential Map<br>• Voltage Map<br>• Activation Maps (Activation<br>Time, Directional Activation,<br>Slew Rate, Propagation) | | | Software-Driven<br>Analysis | Yes | Yes | Yes | | Principles<br>of<br>Operation | Display | • 2D electrogram signals display<br>• Beat-by-beat comparison<br>"mosaic" display<br>• 3D beat and composite maps | • 2D electrogram signals display<br>• Dispersion Location<br>• Mapping Catheter<br>• Estimated Reference Cycle<br>Length<br>• Mapping Cycle Length | • 2D electrogram signals display<br>• "Premature Beats" filter<br>• 3D beat and composite maps | | | Reports of Diagnostic<br>Results | No | No | No | | | Electrophysiological<br>Input | Patient-specific surface ECG (12-<br>lead, acquired by compatible and<br>cleared ECG devices) | Patient-specific intracardiac<br>electrogram information (acquired<br>by compatible catheter) | Patient-specific surface ECG<br>(proprietary, acquired by device<br>vest) | {7}------------------------------------------------ ## 510(k) SUMMARY (K211546) # Table 1: Substantial Equivalence Table (cont.) {8}------------------------------------------------ # 510(k) SUMMARY (K211546) | | | | Table 1: Substantial Equivalence Table (cont.) | | | |--|--|--|------------------------------------------------|--|--| |--|--|--|------------------------------------------------|--|--| | Table 1. Substantial Equivalence Table (cont.) | | | | | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Feature | Proposed Device<br>Vektor Medical, Inc. - Vektor<br>Computational ECG Mapping<br>System (vMap™) (K211546) | Primary Predicate Device<br>Volta Medical – VX1<br>(K201298) | Secondary Predicate Device<br>Medtronic Inc. – CardioInsight®<br>Cardiac Mapping System<br>(K181918) | | | Considers Disease<br>Phenotype | Yes, through end user input and pre-<br>computed cardiac voltage library. | Disease phenotype information is<br>reflected within mapping catheter<br>readings.<br>The deep learning model within the<br>device was developed using<br>electrograms recorded across a<br>representative range of clinical<br>disease phenotypes, such that the<br>algorithm can be generalized<br>accordingly. | Yes, through CT scans. | | | Mathematical<br>Methodology | The system leverages a pre-computed<br>cardiac voltage library which uses<br>forward models and mathematical<br>algorithms to derive cardiac signals<br>from body surface signals. | The device leverages a machine<br>learning/deep learning algorithm that<br>includes analytical parameters that<br>pertain to previous similar<br>procedures to analyze electrograms<br>and identify the associated mapping<br>outputs (locations associated with<br>dispersion/fractionation). | The system uses the inverse solution<br>and mathematical algorithms to<br>transform the measured body surface<br>signals into cardiac signals. | | | Method for<br>Establishing Analytical<br>Parameters | RhythmMatrix – a collection of over<br>one million precomputed cardiac<br>voltage library solutions. Each pre-<br>computed solution includes a<br>simulated cardiac activation source<br>location and its corresponding<br>vectorcardiogram. | The training set of the deep learning<br>algorithm consists of a "very large<br>database of 1.5 second snippets of<br>multipolar intra-cardiac atrial<br>electrograms." | Mathematical-based inverse analysis<br>is based on individual patient<br>information only. | | | System Components | Computer Workstation (monitor,<br>main control unit, peripherals,<br>and cords) Software/Firmware/Algorithm Off-the-shelf (OTS) ECG (not<br>provided) and ECG electrodes<br>(12-Lead) (optional) | Computer Workstation Software/Firmware/Algorithm Off-the-shelf (OTS) mapping<br>catheters (not provided). | Computer Workstation<br>(monitor, core<br>processor/isolation transformer,<br>peripherals, and cabling) and<br>Cart Software/Firmware/Algorithm Vest with Sensor Array | | Feature | Proposed Device<br>Vektor Medical, Inc. - Vektor<br>Computational ECG Mapping<br>System (vMap™) (K211546) | Primary Predicate Device<br>Volta Medical – VX1<br>(K201298) | Secondary Predicate Device<br>Medtronic Inc. - CardioInsight®<br>Cardiac Mapping System<br>(K181918) | | | Operational Workflow | Creates patient records Acquires ECG input (from FDA-cleared ECG acquisition devices) Analyzes electrocardiographic signals Creates and reviews maps | Creates patient records Acquires electrogram input (from compatible FDA-cleared mapping catheters) Analyzes electrocardiographic signals and derives mapping outputs for real-time review | Creates patient records Segments heart and vest electrodes Analyzes electrocardiographic signals Creates and reviews maps | | {9}------------------------------------------------ ## 510(k) SUMMARY (K211546) Table 1: Substantial Equivalence Table (cont.) {10}------------------------------------------------ ## 510(k) SUMMARY (CONT.) ### PERFORMANCE DATA [807.92(b)] All necessary bench, usability, and clinical testing were conducted on vMap™ to support a determination of substantial equivalence to the predicate device. ### [807.92(b)(1)] Nonclinical Testing Summary: The nonclinical, bench testing included: - Shipping and packaging validation, in accordance with ISTA 3A:2018, Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less. - . Electrical safety and electromagnetic compatibility testing in accordance with the applicable IEC 60601 series consensus standards as well as the recommendations of FDA's Guidance Document entitled, "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, " issued July 11, 2016. - Software verification and validation completed in alignment with FDA Guidance ● Document entitled, "General Principles of Software Validation," issued January 11, 2002. - Documentation, verification, validation, and uncertainty quantification of the Device's . arrhythmia-specific cardiac voltage libraries in accordance with FDA's Guidance Document entitled, "Reporting of Computational Modeling Studies in Medical Device Submissions," issued September 21, 2016. - Human factors usability testing, conducted in accordance with FDA's Guidance . Document entitled, "Applying Human Factors and Usability Engineering to Medical Devices," issued February 03, 2016 and IEC 62366-1:2015, Medical devices - Part 1: Application of usability engineering to medical devices. The collective results of bench and usability testing, in conjunction with the multi-center clinical study of vMap", demonstrate that the proposed device meets all design specifications and performs as intended for its intended use. ### [807.92(b)(2)] Clinical Testing Summarv: A retrospective, blinded, and multi-center clinical study was conducted to validate performance of vMap". The outcomes of this clinical study validated the performance of vMap"" by confirming that the Device, when used by the intended user in the intended use patient population, was able to provide information accurately across all nine supported arrhythmia and pacing types and in patients with and without structural heart disease. The results support that the vMap" output substantiates vMap""s intended use/Indications for Use for "the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician." Four investigational sites within the United States were identified and selected based on qualifying criteria. Across these four sites, the study retrospectively enrolled 225 patients associated with 255 arrhythmia/pacing episodes. Of the 225 subjects, 61.3% of the subjects were male, with a representative range of ages. The study subjects were representative of the intended user patient population, and the ECG episodes collected included all arrhythmia/pacing subtypes supported by vMap". {11}------------------------------------------------ ### 510(k) SUMMARY (CONT.) The study results demonstrated acceptable clinical accuracy performance of vMap". The primary endpoint of the study was achieved. Of 75 episodes, which met the criteria for inclusion in this analysis, (premature ventricular complex (PVC) and ventricular tachycardia (VT) arrhythmias in cases with structurally normal hearts and less than 10% scar), vMap correctly identified chamber/region of the clinical arrhythmia ("CAT") location as determined by ground truth in 74 episodes, representing an accuracy of 98.7% (96.0 - 100%). In addition, both key secondary endpoints were achieved, as follows: - 1. Of 255 total episodes, vMap™ correctly identified the chamber/region of the CAT location as determined by ground truth (Atria: left atrial free wall, septum, or right atrial free wall; Ventricles: left ventricular free wall, septum, or right ventricular free wall) with an accuracy of 96.9% (95.1% - 98.7%) across all nine arrhythmia subtypes supported by vMap"". - 2. Of 255 total episodes, vMap" correctly identified the segment or neighboring segment of the CAT location as determined by ground truth with an accuracy of 97.3% (95.2% -99.3%) across all nine arrhythmia subtypes supported by vMap ### CONCLUSIONS [807.92(b)(3)] The proposed device and the predicate devices have intended use and similar Indications for Use. Furthermore, the proposed and predicate devices share key technological similarities. Demonstrated by the results of bench, usability, and clinical testing, the design of which were highly similar to that of the predicate devices, any technological differences presented with the proposed device do not raise different questions of safety or effectiveness, and the proposed device is as safe and as effective as the predicate devices for the same intended use. #### SUMMARY The predicate device's Indications for Use is substantially equivalent to the proposed Indications for Use for vMap". Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, the Vektor Computational ECG Mapping System (vMap") is substantially equivalent to the predicate devices, the Volta Medical VX1 (K201298) and the Medtronic, Inc. CardioInsight® Cardiac Mapping System (K181918).