Not Cleared Direct

DEN170056 - Parathyroid Detection (Model PTeye) System (FDA 510(k) Clearance)

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

DEN170056 · Aibiomed, Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
403d
Days
Class 2
Risk

DEN170056 is an FDA 510(k) submission (not cleared) for the Parathyroid Detection (Model PTeye) System. Classified as Parathyroid Autofluorescence Detection Device (product code QDF), Class II - Special Controls.

Submitted by Aibiomed, Corp. (Santa Barbara, US). The FDA issued a Not Cleared (DENG) decision on November 2, 2018 after a review of 403 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4550 - the FDA general and plastic surgery 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 403 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 Aibiomed, Corp. devices

Submission Details

510(k) Number DEN170056 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 25, 2017
Decision Date November 02, 2018
Days to Decision 403 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
289d slower than avg
Panel avg: 114d · This submission: 403d
Pathway characteristics

Device Classification

Product Code QDF Parathyroid Autofluorescence Detection Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4550
Definition An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis.
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 General & Plastic Surgery devices follow this clearance model.