Cleared Traditional

Vektor Computational ECG Mapping System (vMap) (K211546) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K211546 · Vektor Medical, Inc. · Cardiovascular device
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Nov 2021
Decision
174d
Days
Class 2
Risk

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

Submission Details

510(k) Number K211546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2021
Decision Date November 09, 2021
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Experien Group, LLC
Michael J Billig

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
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

225
Patients (actual)
4
Sites
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 → 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

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 183
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