Not Cleared Direct

DEN130015 - PIXEL 3 SYSTEM (FDA 510(k) Clearance)

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

DEN130015 · Gauss Surgical, Inc., · General & Plastic Surgery device
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May 2014
Decision
459d
Days
Class 2
Risk

DEN130015 is an FDA 510(k) submission (not cleared) for the PIXEL 3 SYSTEM. Classified as Image Processing Device For Estimation Of External Blood Loss (product code PBZ), Class II - Special Controls.

Submitted by Gauss Surgical, Inc., (Los Altos, US). The FDA issued a Not Cleared (DENG) decision on May 9, 2014 after a review of 459 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.2750 - 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 459 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 Gauss Surgical, Inc., devices

Submission Details

510(k) Number DEN130015 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 04, 2013
Decision Date May 09, 2014
Days to Decision 459 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
345d slower than avg
Panel avg: 114d · This submission: 459d
Pathway characteristics

Device Classification

Product Code PBZ Image Processing Device For Estimation Of External Blood Loss
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2750
Definition An Image Processing Device For Estimation Of External Blood Loss Is A Device To Be Used As An Aid In Estimation Of Patient External Blood Loss. The Device May Include Software And/or Hardware That Is Used To Process Images Capturing Externally Lost Blood To Estimate The Hemoglobin Mass And/or The Blood Volume Present In The Images.
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.