Cleared Traditional

K170948 - AcQMap High Resolution Imaging and Mapp...

K170948 is an FDA 510(k) clearance for AcQMap High Resolution Imaging and Mapp..., manufactured by Acutus Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K170948 · Acutus Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Oct 2017
Decision
200d
Days
Class 2
Risk

K170948 is an FDA 510(k) clearance for the AcQMap High Resolution Imaging and Mapping System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 16, 2017 after a review of 200 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 Acutus Medical, Inc. devices

FDA 510(k) Submission Details - K170948

510(k) Number K170948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2017
Decision Date October 16, 2017
Days to Decision 200 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
75d slower than avg
Panel avg: 125d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

DQK Device Classification - Class 2, Special Controls

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.

Clinical Evidence

ClinicalTrials.gov
NCT01875614 Completed Interventional Industry-sponsored

Dipole Density Mapping in Supraventricular Tachycardia

Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia

85
Patients (actual)
8
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Supraventricular Tachycardia
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Petr Neuzil, MD
Sponsor Acutus Medical (industry)
Started 2014-09-06 → Primary completion 2017-05-22
Primary outcome
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
View full study on ClinicalTrials.gov

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 280
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K170948.
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
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CARTO 3 EP Navigation System, Version 6.0 and Accessories
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HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
K163381 · Edwards Lifesciences, LLC · Apr 2017
RHYTHMIA HDx Mapping System
K162793 · Boston Scientific Corporation · Mar 2017