Cleared Traditional

K122288 - BRAINSWAY DEEP TMS SYSTEM

K122288 is an FDA 510(k) clearance for BRAINSWAY DEEP TMS SYSTEM, manufactured by Brainsway , Ltd.. The device is a Class 2 Neurology device with product code OBP cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K122288 · Brainsway , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
161d
Days
Class 2
Risk

K122288 is an FDA 510(k) clearance for the BRAINSWAY DEEP TMS SYSTEM. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Brainsway , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on January 7, 2013 after a review of 161 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainsway , Ltd. devices

FDA 510(k) Submission Details - K122288

510(k) Number K122288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2012
Decision Date January 07, 2013
Days to Decision 161 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 149d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

OBP Device Classification - Class 2, Special Controls

Product Code OBP Transcranial Magnetic Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.
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 Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00927173 Completed Interventional Industry-sponsored

Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder

A Prospective Multicenter Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Major Depression Disorder (MDD)

233
Patients (actual)
22
Sites
Treatment
Purpose
Quadruple
Masking
Condition studied Major Depressive Disorder
Study design Parallel
Eligibility All sexes · 22 Years+
Principal investigator Yechiel Levkovitz, M.D
Sponsor Brainsway (industry)
Started 2009-09-01 → Primary completion 2012-03-01 → Completed 2012-06-01
Primary outcome
HDRS-21
Secondary outcome
Response rate
Study completed - no results published. This trial concluded in 2012 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 - OBP Transcranial Magnetic Stimulator

All 68
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K122288.
Rapid Therapy System
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K133408 · Neuronetics · Mar 2014
NEUROSTAR TMS THERAPY SYSTEM
K130233 · Neuronetics · Apr 2013
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
K083538 · Neuronetics · Dec 2008
NEUROSTAR TMS SYSTEM
DEN070003 · Neuronetics · Oct 2008