Cleared Traditional

K222972 - BioProtect Balloon Implant™ System (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence.

K222972 · Bioprotect, Ltd. · Radiology device
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Aug 2023
Decision
332d
Days
Class 2
Risk

K222972 is an FDA 510(k) clearance for the BioProtect Balloon Implant™ System. Classified as Hydrogel Spacer (product code OVB), Class II - Special Controls.

Submitted by Bioprotect, Ltd. (Tzur Yigal, IL). The FDA issued a Cleared decision on August 25, 2023 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5725 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioprotect, Ltd. devices

Submission Details

510(k) Number K222972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2022
Decision Date August 25, 2023
Days to Decision 332 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 107d · This submission: 332d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT00918229 Completed Interventional Industry-sponsored

Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects

One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

24
Patients (actual)
1
Site
Prevention
Purpose
Open label
Masking
Condition studied Prostate Cancer
Study design Single group
Eligibility Male only · 45 Years+
Principal investigator Yossi Muncher, Dr.
Sponsor BioProtect (industry)
Started 2009-06-01 → Primary completion 2011-05-01
Primary outcome
Proportion of Subjects Achieving a Reduction of at Least 25% of the Volume of the Rectum Receiving at Least 70 Gy.
Secondary outcome
Rate of Occurrence of Grade 2 or Greater Rectal Adverse Event or Procedure Related Adverse Events.
View full study on ClinicalTrials.gov