Not Cleared Direct

DEN160056 - Philips IntelliSite Pathology Solution

DEN160056 is an FDA 510(k) submission for Philips IntelliSite Pathology Solution, manufactured by Philips Medical Systems Nederland B.V.. The device is a Class 2 Pathology device with product code PSY cleared through the Direct 510(k) pathway after a 132-day FDA review.

DEN160056 · Philips Medical Systems Nederland B.V. · Pathology device
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Apr 2017
Decision
132d
Days
Class 2
Risk

DEN160056 is an FDA 510(k) submission (not cleared) for the Philips IntelliSite Pathology Solution. Classified as Whole Slide Imaging System (product code PSY), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Not Cleared (DENG) decision on April 12, 2017 after a review of 132 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology 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 Pathology review framework.

FDA 510(k) Submission Details - DEN160056

510(k) Number DEN160056 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 01, 2016
Decision Date April 12, 2017
Days to Decision 132 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 78d · This submission: 132d
Pathway characteristics

PSY Device Classification - Class 2, Special Controls

Product Code PSY Whole Slide Imaging System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3700
Definition The Whole Slide Imaging System Is An Automated Digital Slide Creation, Viewing, And Management System Intended As An Aid To The Pathologist To Review And Interpret Digital Images Of Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear).
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 Pathology devices follow this clearance model.

DEN160056 · Philips IntelliSite Pathology Solution
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