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510(k) Data Aggregation

    K Number
    DEN140030
    Device Name
    SpaceOAR System
    Manufacturer
    AUGMENIX , INC.
    Date Cleared
    2015-04-01

    (182 days)

    Product Code
    OVB
    Regulation Number
    892.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUGMENIX , INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SpaceOAR 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 System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR 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
    SpaceOAR System is a polyethylene glycol (PEG) hydrogel that upon injection creates a space that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR System consists of components for the preparation of a synthetic, absorbable hydrogel spacer and a delivery mechanism provided in a sterile, single use package. Once assembled as shown in the figure above, the Y-connector allows for hydrogel injection via an 18 gauge needle. The spacer is formed by mixing two solutions, the Precursor and the Accelerator. The Precursor solution is formed through the mixing of the Diluent solution (Trilysine buffer solution) with the PEG powder. The Accelerator solution is a salt buffer solution.
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    K Number
    K121964
    Device Name
    MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
    Manufacturer
    AUGMENIX , INC.
    Date Cleared
    2013-01-23

    (202 days)

    Product Code
    NEU, BIO
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUGMENIX , INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TraceIT™ Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. TracelT hydrogel is intended to mark tissue for at least 3 months after injection.
    Device Description
    TracelT Tissue Marker is a sterile, single use, polymerized polyethylene glycol (PEG) hydrogel that is delivered to mark a surgical location via a needle or cannula. The hydrogel material is visible under MRI, CT, and ultrasound for up to three months after the injection: The material hydrolyzes and is cleared from the body approximately six (6) months after injection.
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