Not Cleared Direct

DEN180057 - IB-Stim (FDA 510(k) Clearance)

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

DEN180057 · Innovative Health Solutions (Ihs), Inc. · Neurology device
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Jun 2019
Decision
225d
Days
Class 2
Risk

DEN180057 is an FDA 510(k) submission (not cleared) for the IB-Stim. Classified as Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs) (product code QHH), Class II - Special Controls.

Submitted by Innovative Health Solutions (Ihs), Inc. (Versailles, US). The FDA issued a Not Cleared (DENG) decision on June 7, 2019 after a review of 225 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 876.5340 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Innovative Health Solutions (Ihs), Inc. devices

Submission Details

510(k) Number DEN180057 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 25, 2018
Decision Date June 07, 2019
Days to Decision 225 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 148d · This submission: 225d
Pathway characteristics

Device Classification

Product Code QHH Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5340
Definition A Non-implanted Nerve Stimulator For Functional Abdominal Pain Relief Is A Device That Stimulates Nerves Remotely From The Source Of Pain With The Intent To Relieve Functional Abdominal Pain. This Generic Type Of Device Does Not Include Devices Designed To Relieve Pelvic Pain.
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.