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510(k) Data Aggregation

    K Number
    K260119

    Validate with FDA (Live)

    Date Cleared
    2026-02-10

    (27 days)

    Product Code
    Regulation Number
    892.5725
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SpaceOAR Vue 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 SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum.

    The SpaceOAR Vue System 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.

    Device Description

    The SpaceOAR Vue System consists of components for the preparation of an absorbable hydrogel spacer and a delivery mechanism packaged in a single use system. Upon injection, between the anterior rectal wall and prostate, the precursor (trilysine buffer solution with PEG-SG-TIB) and accelerator (a buffered solution) mix in the device Y-connector where the formation of SpaceOAR Vue hydrogel is initiated. The SpaceOAR Vue hydrogel is formed through cross-linking of the polyethylene glycol with succinimidyl glutarate and triiodobenzoate (PEG-SG-TIB) and Trilysine. This reaction gives off no measurable heat. The hydrogel temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum. The hydrogel is biodegradable and maintains space for the entire course of prostate radiotherapy treatment. The hydrogel degrades via hydrolysis and is excreted via renal filtration.

    AI/ML Overview

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