Not Cleared Direct

DEN130036 - PROSTATE IMMOBILIZER RECTAL BALLOON (FDA 510(k) Clearance)

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

DEN130036 · Radiadyne · Radiology device
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Jan 2014
Decision
197d
Days
Class 2
Risk

DEN130036 is an FDA 510(k) submission (not cleared) for the PROSTATE IMMOBILIZER RECTAL BALLOON. Classified as Prostate Immobilizer Rectal Balloon (product code PCT), Class II - Special Controls.

Submitted by Radiadyne (Washington, US). The FDA issued a Not Cleared (DENG) decision on January 28, 2014 after a review of 197 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5720 - the FDA radiology and imaging software oversight 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 Radiology review framework.

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Submission Details

510(k) Number DEN130036 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 15, 2013
Decision Date January 28, 2014
Days to Decision 197 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 107d · This submission: 197d
Pathway characteristics

Device Classification

Product Code PCT Prostate Immobilizer Rectal Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5720
Definition Intended To Be Used For The Temporary Positioning Of The Rectal Wall And Adjacent Structure In The Male Human Anatomies. The Purpose Is To Stabilize The Prostate During Computed Tomography (ct) Exam, X-ray, Or Radiation Therapy (rt) Treatments. The Placement Of The Balloon Requires A Physician Or A Physician-directed Healthcare Professional, And Is Performed As A Separate Procedure Apart From The Standard Ct Exam And Rt Treatment.
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 Radiology devices follow this clearance model.