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510(k) Data Aggregation

    K Number
    K222972
    Device Name
    BioProtect Balloon Implant™ System
    Manufacturer
    BioProtect, Ltd.
    Date Cleared
    2023-08-25

    (332 days)

    Product Code
    OVB
    Regulation Number
    892.5725
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BioProtect, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BioProtect Balloon Implant System 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 BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum.

    The BioProtect Balloon Implant System is composed of a balloon made of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

    Device Description

    The BioProtect Balloon Implant™ System is composed of a single use, biodegradable, inflatable balloon implant, designed to act as a spacer between the prostate and the rectum. The BioProtect Balloon Implant System is supplied sterile. The balloon is implanted transperineally using transrectal ultrasound (TRUS) guidance and remains stable throughout the radiation treatment and gradually degrades over time.

    The BioProtect Balloon Implant System consists of single use components detailed below:

    1. Balloon biodegradable, inflatable balloon acts as a spacer between the prostate and rectal wall.
    2. Balloon Deployer delivery system, the balloon is mounted and folded on the deployer
    3. Delivery Kit - an applicator system used to position and deploy the balloon in the intended location. It includes an 18-gauge echogenic needle, blunt-tipped tissue dilator, and balloon introducer sheath.

    The BioProtect Balloon Implant System is for prescription use only.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

    Device Name: BioProtect Balloon Implant™ System

    Indications for Use: The BioProtect Balloon Implant System 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 BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum. The BioProtect Balloon Implant System is composed of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from primary efficacy/safety endpoints)Reported Device Performance
    Efficacy Primary Endpoint: Reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy when compared to pre-implantation values, in 75% of the subjects assigned to the balloon group.97.9% of subjects gained rectal dose reduction >25% in rV70 post-implantation. Relative mean dose reduction of 84.8% of the rectum receiving 70Gy. Rectal radiation dose consistently reduced in all radiation levels (40Gy to 80Gy). Sign test p-values were
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