Not Cleared Post-NSE

DEN090007 - BIO-SEAL LUNG BIOPSY TRACT SYSTEM (FDA 510(k) Clearance)

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

DEN090007 · Angiotech · Anesthesiology device
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Dec 2012
Decision
1342d
Days
Class 2
Risk

DEN090007 is an FDA 510(k) submission (not cleared) for the BIO-SEAL LUNG BIOPSY TRACT SYSTEM. Classified as Absorbable Lung Biopsy Plug (product code OMT), Class II - Special Controls.

Submitted by Angiotech (Vancouver, Bc, CA). The FDA issued a Not Cleared (DENG) decision on December 19, 2012 after a review of 1342 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 878.4755 - the FDA anesthesiology and respiratory 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 1342 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 DEN090007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 17, 2009
Decision Date December 19, 2012
Days to Decision 1342 days
Submission Type Post-NSE
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1203d slower than avg
Panel avg: 139d · This submission: 1342d
Pathway characteristics

Device Classification

Product Code OMT Absorbable Lung Biopsy Plug
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4755
Definition A Pre-formed (polymerized) Absorbable Lung Biopsy Plug Is Intended To Provide Accuracy In Marking A Biopsy Location For Visualization During Surgical Resection And Closure Of Pleural Punctures Associated With Percutaneous, Transthoracic Needle Lung Biopsies. Upon, Deployment Into The Biopsy Tract, The Plug Expands To Fill The Biopsy Void And Remains In Place Until Resorbed.
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 Anesthesiology devices follow this clearance model.