Cleared Special

K192775 - Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192775 · Stereotaxis, Inc. · Cardiovascular device
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Oct 2019
Decision
30d
Days
Class 2
Risk

K192775 is an FDA 510(k) clearance for the Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and C.... Classified as Catheter Remote Control System (product code PJB), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 30, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5700 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stereotaxis, Inc. devices

Submission Details

510(k) Number K192775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date October 30, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PJB Catheter Remote Control System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5700
Definition A Steerable Cardiac Ablation Catheter Remote Control System Is A Device That Is External To The Body And Interacts With The Manual Handle Of A Steerable Cardiac Ablation Catheter To Remotely Control The Advancement, Retraction, Rotation, And Deflection Of A Steerable Ablation Catheter Used For The Treatment Of Cardiac Arrhythmias In The Right Side Of The Heart. The Device Allows Reversion To Manual Control Of The Steerable Cardiac Ablation Catheter Without Withdrawal Of The Catheter And Interruption Of The Procedure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.