Cleared Special

K192834 - MECTA Sigma (FDA 510(k) Clearance)

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

K192834 · Mecta Corporation · Neurology device
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Apr 2020
Decision
207d
Days
Class 2
Risk

K192834 is an FDA 510(k) clearance for the MECTA Sigma. Classified as Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder (product code QGH), Class II - Special Controls.

Submitted by Mecta Corporation (Suite B, US). The FDA issued a Cleared decision on April 26, 2020 after a review of 207 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5940 - the FDA neurology device 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K192834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2019
Decision Date April 26, 2020
Days to Decision 207 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 148d · This submission: 207d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5940
Definition Catatonia Or A Severe Major Depressive Episode (mde) Associated With Major Depressive Disorder (mdd) Or Bipolar Disorder (bpd) In Patients Age 13 Years And Older Who Are Treatment-resistant Or Who Require A Rapid Response Due To The Severity Of Their Psychiatric Or Medical Condition.
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 Neurology devices follow this clearance model.