Not Cleared Direct

NSS-2 System (DEN170018) - FDA 510(k) Clearance

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

DEN170018 · Innovative Health Solutions (Ihs), Inc. · Neurology device
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Nov 2017
Decision
243d
Days
Class 2
Risk

DEN170018 is an FDA 510(k) submission (not cleared) for the NSS-2 System. Classified as Percutaneous Nerve Stimulator For Opioid Withdrawal (product code PZR), Class II - Special Controls.

Submitted by Innovative Health Solutions (Ihs), Inc. (Versailles, US). The FDA issued a Not Cleared (DENG) decision on November 15, 2017 after a review of 243 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5896 - 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 DEN170018 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 17, 2017
Decision Date November 15, 2017
Days to Decision 243 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 148d · This submission: 243d
Pathway characteristics

Device Classification

Product Code PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5896
Definition Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders.
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.

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