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.

Device Description

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:

The vMap™ Software, which drives vMap™ and its core analysis functionalities;
The vMap™ Hardware, the computer workstation which facilitates the use of the vMap™ Software; and
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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Vektor Computational ECG Mapping System (vMap™), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Endpoint (Specific Arrhythmia - PVC and VT in Structurally Normal Hearts, <10% Scar)
Accuracy of correctly identifying chamber/region of clinical arrhythmia (CAT) location (ground truth)	98.7% (96.0 - 100%) in 75 episodes
Secondary Endpoints (All Supported Arrhythmia Types)
Accuracy of correctly identifying chamber/region of CAT location (ground truth)	96.9% (95.1% - 98.7%) across 255 total episodes and 9 arrhythmia subtypes
Accuracy of correctly identifying segment or neighboring segment of CAT location (ground truth)	97.3% (95.2% - 99.3%) across 255 total episodes and 9 arrhythmia subtypes

Note: The document states that the outcomes of this clinical study validated the performance of vMap™ by confirming that the Device... was able to provide information accurately across all nine supported arrhythmia and pacing types and in patients with and without structural heart disease. While it lists specific percentage ranges for the endpoints, it doesn't explicitly define what threshold was considered "acceptable clinical accuracy performance," but rather states the results demonstrated acceptable clinical accuracy performance because the endpoints were achieved. To interpret the acceptance criteria precisely, one would typically need a predefined numerical threshold (e.g., "accuracy > 90%"). Based on the phrasing, the achieved values themselves were implicitly considered acceptable.

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

Sample Size (Clinical Study/Test Set):
- Initially: 225 patients associated with 255 arrhythmia/pacing episodes.
- For Primary Endpoint analysis: 75 episodes (PVC and VT arrhythmias in cases with structurally normal hearts and less than 10% scar).
- For Secondary Endpoints analysis: 255 total episodes.
Data Provenance: Retrospective, multi-center clinical study conducted across four investigational sites within the United States.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. It mentions "clinical arrhythmia ('CAT') location as determined by ground truth," but does not detail how this ground truth was derived (e.g., if it was established by a panel of electrophysiologists).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth or evaluating the device's output against the ground truth.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on the standalone performance of the vMap™ system in identifying arrhythmia locations against a ground truth. There is no information provided about human readers improving with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was conducted. The clinical study details focus on the vMap™ system's ability to "correctly identify" the CAT location and segment based on ground truth, indicating an evaluation of the algorithm's performance without explicit mention of human interpretation of the device's output being a variable in the reported accuracy metrics. The system is "intended for the analysis, display, and storage... for analysis by a physician," but the performance metrics are attributed directly to the device's identification capabilities.

7. Type of Ground Truth Used

The ground truth used was the "clinical arrhythmia (CAT) location as determined by ground truth." While the exact methodology for establishing this "ground truth" is not detailed, it would typically be derived from invasive electrophysiology mapping procedures and expert interpretation, which is considered high-fidelity clinical data.

8. Sample Size for the Training Set

vMap™ (Proposed Device): The document states that the system leverages a "pre-computed cardiac voltage library which uses forward models and mathematical algorithms to derive cardiac signals from body surface signals." This library, called "RhythmMatrix," is described as "a collection of over one million precomputed cardiac voltage library solutions." Each solution includes a simulated cardiac activation source location and its corresponding vectorcardiogram. This over one million pre-computed simulations constitutes the "training" or foundational data for the vMap™'s core analytical parameters.
Volta Medical VX1 (Primary Predicate): For comparison, its training set is described as a "very large database of 1.5 second snippets of multipolar intra-cardiac atrial electrograms."

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

For vMap™'s "RhythmMatrix" (the pre-computed cardiac voltage library), the ground truth was established through simulated cardiac activation source locations that correspond to "pre-computed solutions" derived using "forward models and mathematical algorithms." This indicates a computational modeling approach rather than directly observed clinical data for the training of the underlying models; the clinical study then validates the system's performance on real-world patient data.

Summary

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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. 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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 (QS) 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 medical devices and radiation-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 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) 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)

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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

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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 vMap™ System consists of three key components:

1. The vMap™ Software, which drives vMap™ and its core analysis functionalities;
1. The vMap™ Hardware, the computer workstation which facilitates the use of the vMap™ Software; and
1. 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.

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™

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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.

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Table 1: Substantial Equivalence Table

Feature	Proposed DeviceVektor Medical, Inc. - VektorComputational ECG MappingSystem (vMap™) (K211546)	Primary Predicate DeviceVolta Medical – VX1(K201298)	Secondary Predicate DeviceMedtronic Inc. – CardioInsight®Cardiac Mapping System(K181918)
Classification	21 CFR§870.1425, ProgrammableDiagnostic Computer	21 CFR§870.1425, ProgrammableDiagnostic Computer	21 CFR§870.1425, ProgrammableDiagnostic Computer
Product Code	DQK, Computer, Diagnostic,Programmable	DQK, Computer, Diagnostic,Programmable	DQK, Computer, Diagnostic,Programmable
Intended Use/Indications for Use
Indications for Use	The Vektor Computational ECGMapping System (vMap™) isintended for the analysis, display, andstorage of cardiacelectrophysiological data and mapsfor analysis by a physician.	The VX1 assists operators in thereal-time manual annotation of 3Danatomical and electrical maps ofhuman atria for the presence ofmultipolar intra-cardiac atrialelectrograms exhibitingspatiotemporal dispersion duringatrial fibrillation or atrialtachycardia.The clinical significance of utilizingthe VX1 software to help identifyareas with intra-cardiac atrialelectrograms exhibitingspatiotemporal dispersion forcatheter ablation of atrialarrhythmias, such as atrialfibrillation, has not been establishedby clinical investigations.	The CardioInsight Cardiac MappingSystem is intended for acquisition,analysis, display and storage ofcardiac electrophysiological dataand maps for analysis by aphysician.
Intended Use Population	Individuals undergoing EPprocedures	Individuals undergoing EPprocedures	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 DeviceVektor Medical, Inc. - VektorComputational ECG MappingSystem (vMap™) (K211546)	Primary Predicate DeviceVolta Medical – VX1(K201298)	Secondary Predicate DeviceMedtronic Inc. – CardioInsight®Cardiac Mapping System(K181918)
MappingDisplay	Principal MappingApproach	Displays 3D anatomical maps afteranalyzing surface electrograms andpatient phenotype using signalprocessing and computationalmodeling techniques.	Displays adjudications as visual cuesafter analyzing intra-cardiac atrialelectrograms in real-time usingsignal processing, and deep andmachine learning techniques.	Displays 3D anatomical maps afteranalyzing surface electrograms andimaging information using signalprocessing techniques.
	Cardiac Model Used	Standard, idealized model	N/A; the locations are displayedrelative to the mapping catheterelectrodes.	Individualized, patient-specificmodel based on segmented CTimage
	Cardiac Maps Provided	3D Activation Heatmap:• Individual-beat• Composite beat• Beat-averaged summary• Custom Beat	Real-time Dispersed Electrogram(DE) subtype of multipolarelectrogram map- The operator isprovided with display of theelectrode locations where dispersedor non-dispersed electrograms havebeen recorded during atrialfibrillation or atrial tachycardia.	3D Electroanatomical Maps:• Phase Map• Potential Map• Voltage Map• Activation Maps (ActivationTime, Directional Activation,Slew Rate, Propagation)
	Software-DrivenAnalysis	Yes	Yes	Yes
PrinciplesofOperation	Display	• 2D electrogram signals display• Beat-by-beat comparison"mosaic" display• 3D beat and composite maps	• 2D electrogram signals display• Dispersion Location• Mapping Catheter• Estimated Reference CycleLength• Mapping Cycle Length	• 2D electrogram signals display• "Premature Beats" filter• 3D beat and composite maps
	Reports of DiagnosticResults	No	No	No
	ElectrophysiologicalInput	Patient-specific surface ECG (12-lead, acquired by compatible andcleared ECG devices)	Patient-specific intracardiacelectrogram information (acquiredby compatible catheter)	Patient-specific surface ECG(proprietary, acquired by devicevest)

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510(k) SUMMARY (K211546)

Table 1: Substantial Equivalence Table (cont.)

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510(k) SUMMARY (K211546)

			Table 1: Substantial Equivalence Table (cont.)
--	--	--	------------------------------------------------	--	--

Table 1. Substantial Equivalence Table (cont.)
	Feature	Proposed DeviceVektor Medical, Inc. - VektorComputational ECG MappingSystem (vMap™) (K211546)	Primary Predicate DeviceVolta Medical – VX1(K201298)	Secondary Predicate DeviceMedtronic Inc. – CardioInsight®Cardiac Mapping System(K181918)
	Considers DiseasePhenotype	Yes, through end user input and pre-computed cardiac voltage library.	Disease phenotype information isreflected within mapping catheterreadings.The deep learning model within thedevice was developed usingelectrograms recorded across arepresentative range of clinicaldisease phenotypes, such that thealgorithm can be generalizedaccordingly.	Yes, through CT scans.
	MathematicalMethodology	The system leverages a pre-computedcardiac voltage library which usesforward models and mathematicalalgorithms to derive cardiac signalsfrom body surface signals.	The device leverages a machinelearning/deep learning algorithm thatincludes analytical parameters thatpertain to previous similarprocedures to analyze electrogramsand identify the associated mappingoutputs (locations associated withdispersion/fractionation).	The system uses the inverse solutionand mathematical algorithms totransform the measured body surfacesignals into cardiac signals.
	Method forEstablishing AnalyticalParameters	RhythmMatrix – a collection of overone million precomputed cardiacvoltage library solutions. Each pre-computed solution includes asimulated cardiac activation sourcelocation and its correspondingvectorcardiogram.	The training set of the deep learningalgorithm consists of a "very largedatabase of 1.5 second snippets ofmultipolar intra-cardiac atrialelectrograms."	Mathematical-based inverse analysisis based on individual patientinformation only.
	System Components	Computer Workstation (monitor,main control unit, peripherals,and cords) Software/Firmware/Algorithm Off-the-shelf (OTS) ECG (notprovided) and ECG electrodes(12-Lead) (optional)	Computer Workstation Software/Firmware/Algorithm Off-the-shelf (OTS) mappingcatheters (not provided).	Computer Workstation(monitor, coreprocessor/isolation transformer,peripherals, and cabling) andCart Software/Firmware/Algorithm Vest with Sensor Array
Feature	Proposed DeviceVektor Medical, Inc. - VektorComputational ECG MappingSystem (vMap™) (K211546)	Primary Predicate DeviceVolta Medical – VX1(K201298)	Secondary Predicate DeviceMedtronic Inc. - CardioInsight®Cardiac Mapping System(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

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510(k) SUMMARY (K211546)

Table 1: Substantial Equivalence Table (cont.)

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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".

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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"".
1. 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).

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).