Not Cleared Post-NSE

DEN100023 - AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN100023 · National Center For Pelvic Pain Research Devices, · Physical Medicine device
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Nov 2012
Decision
823d
Days
Class 2
Risk

DEN100023 is an FDA 510(k) submission (not cleared) for the AHIP INTERNAL TRIGGER POINT WAND MODEL: 1. Classified as Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature (product code OSD), Class II - Special Controls.

Submitted by National Center For Pelvic Pain Research Devices, (Sebastopol, US). The FDA issued a Not Cleared (DENG) decision on November 20, 2012 after a review of 823 days.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5670 - the FDA physical medicine 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: Regulatory edge-case submission. High predicate equivalence gap. With 823 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all National Center For Pelvic Pain Research Devices, devices

Submission Details

510(k) Number DEN100023 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 20, 2010
Decision Date November 20, 2012
Days to Decision 823 days
Submission Type Post-NSE
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
708d slower than avg
Panel avg: 115d · This submission: 823d
Pathway characteristics

Device Classification

Product Code OSD Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5670
Definition Rectal Or Vaginal Use Manual Therapeutic Massager Device To Massage Irritable, Sore Trigger Points (trps) In The Pelvic Floor Musculature In Order To Reduce Internal Pelvic Floor Trigger Point Sensitivity
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 Physical Medicine devices follow this clearance model.