Not Cleared Direct

DEN140017 - SENSIMED TRIGGERFISH (FDA 510(k) Clearance)

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

DEN140017 · Sensimed AG · Ophthalmic device
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Mar 2016
Decision
668d
Days
Class 2
Risk

DEN140017 is an FDA 510(k) submission (not cleared) for the SENSIMED TRIGGERFISH. Classified as Ocular Pattern Recorder (product code PLZ), Class II - Special Controls.

Submitted by Sensimed AG (Waltham, US). The FDA issued a Not Cleared (DENG) decision on March 4, 2016 after a review of 668 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1925 - the FDA ophthalmic 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 668 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.

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Submission Details

510(k) Number DEN140017 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 06, 2014
Decision Date March 04, 2016
Days to Decision 668 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
558d slower than avg
Panel avg: 110d · This submission: 668d
Pathway characteristics

Device Classification

Product Code PLZ Ocular Pattern Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1925
Definition A Diurnal Pattern Recorder System Is A Non-implantable, Prescription Device Incorporating A Telemetric Sensor Intended To Detect Changes In Ocular Dimension For Monitoring Diurnal Patterns Of Iop Fluctuation.
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 Ophthalmic devices follow this clearance model.