Not Cleared Direct

DEN220052 - BrachyGel Vaginal Hydrogel Packing System (FDA 510(k) Clearance)

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

DEN220052 · Brachyfoam, Inc. D/B/A Advaray · Radiology device
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Aug 2023
Decision
362d
Days
Class 2
Risk

DEN220052 is an FDA 510(k) submission (not cleared) for the BrachyGel Vaginal Hydrogel Packing System. Classified as Vaginal Hydrogel Packing System (product code QXR), Class II - Special Controls.

Submitted by Brachyfoam, Inc. D/B/A Advaray (Charlottesville, US). The FDA issued a Not Cleared (DENG) decision on August 22, 2023 after a review of 362 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5735 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 362 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 Brachyfoam, Inc. D/B/A Advaray devices

Submission Details

510(k) Number DEN220052 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 25, 2022
Decision Date August 22, 2023
Days to Decision 362 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 107d · This submission: 362d
Pathway characteristics

Device Classification

Product Code QXR Vaginal Hydrogel Packing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5735
Definition A Vaginal Hydrogel Packing System Is A Non-powered Positioning Device Composed Of A Flexible Container Filled With A Hydrogel. The Device Is Intended To Reduce The Radiation Dose Delivered To Adjacent Pelvic Organs By Temporarily Displacing The Vaginal Wall And Adjacent Pelvic Tissues During Radiation Therapy Treatment Planning And Delivery.
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.