Cleared Special

K202224 - SpaceOAR System (FDA 510(k) Clearance)

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

K202224 · Boston Scientific Corporation · Radiology device
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Aug 2020
Decision
21d
Days
Class 2
Risk

K202224 is an FDA 510(k) clearance for the SpaceOAR System. Classified as Hydrogel Spacer (product code OVB), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on August 28, 2020 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5725 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K202224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2020
Decision Date August 28, 2020
Days to Decision 21 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OVB Hydrogel Spacer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5725
Definition The Perirectal Spacer Is Intended To Temporarily Position The Anterior Rectal Wall Away From The Prostate During Radiotherapy For Prostate Cancer And In Creating This Space It Is The Intent Of The Perirectal Spacer To Reduce The Radiation Dose Delivered To The Anterior Rectum. The Perirectal Spacer Is Composed Of Biodegradable Material And Maintains Space For The Entire Course Of Prostate Radiotherapy Treatment And Is Completely Absorbed By The Patient’s Body Over Time.
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.