Cleared Traditional

K090321 - RIC CONFORMAL SOURCE, MODEL 100 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090321 · Ri Consultants, LLC · Radiology device
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May 2009
Decision
107d
Days
Class 2
Risk

K090321 is an FDA 510(k) clearance for the RIC CONFORMAL SOURCE, MODEL 100. Classified as Conformal Brachytherapy Source (product code ONL), Class II - Special Controls.

Submitted by Ri Consultants, LLC (Hudson, US). The FDA issued a Cleared decision on May 27, 2009 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K090321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2009
Decision Date May 27, 2009
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONL Conformal Brachytherapy Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
Definition The Intended Use Of The Device Is For The Treatment Of Cancer By Tempeorary Intraoperative Or Surface Irradiation. The Device Contains Radioactive Material With Activity Up To 200 Mci And Is Indicated For Treatment Of Temporary Intraoperative, Interstitial, Intracavitary Or Surface Application To Treat Selected Localized Tumors. This Brachytherapy Source May Be Used Concurrently With Or Following Treatment With Other Interventions, Such As External Beam Therapy. Chordomas, Chondrosarcomas, Soft Tissue Sarcomas, Skin Cancers And Other Accessible Tumors Could Be Commonly Treated By The Device.
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.