K211546 is an FDA 510(k) clearance for the Vektor Computational ECG Mapping System (vMap). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.
Submitted by Vektor Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 9, 2021 after a review of 174 days - an extended review cycle.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Vektor Medical, Inc. devices
NCT04559061
Completed
Observational
Industry-sponsored
Vektor vMap™ Clinical Validation Study
Clinical Validation of the Vektor Computational ECG Mapping System (vMap™) for Atrial and Ventricular Arrhythmias/Pacing
| Condition studied |
Cardiac Arrhythmia; Atrial Fibrillation; Ventricular Arrythmia; Premature Ventricular Complexes Multiple; Ventricular Tachycardia; Ventricular Fibrillation; Premature Atrial Complex; Atrioventricular Reentrant Tachycardia |
| Eligibility |
All sexes
· 22 Years+
|
| Principal investigator |
Chris Villongco, PhD |
| Sponsor |
Vektor Medical
(industry)
|
Started 2020-12-01
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Primary completion 2021-04-06
Primary outcome
Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT.
Secondary outcome
Rate of accuracy/agreement of vMap™ in correctly identifying the chamber/region of the arrhythmia location for all arrhythmia types.
Study completed - no results published.
This trial concluded in 2021 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov