Not Cleared Direct

DEN190020 - iTind System (FDA 510(k) Clearance)

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

DEN190020 · Medi-Tate , Ltd. · Gastroenterology & Urology device
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Feb 2020
Decision
329d
Days
Class 2
Risk

DEN190020 is an FDA 510(k) submission (not cleared) for the iTind System. Classified as Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia (product code QKA), Class II - Special Controls.

Submitted by Medi-Tate , Ltd. (Or-Akiva, IL). The FDA issued a Not Cleared (DENG) decision on February 25, 2020 after a review of 329 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5510 - the FDA gastroenterology and urology 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 329 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 DEN190020 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 02, 2019
Decision Date February 25, 2020
Days to Decision 329 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 130d · This submission: 329d
Pathway characteristics

Device Classification

Product Code QKA Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5510
Definition A System Intended For The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above.
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 Gastroenterology & Urology devices follow this clearance model.