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510(k) Data Aggregation

    K Number
    DEN220017
    Device Name
    BioXmark
    Manufacturer
    Nanovi A/S
    Date Cleared
    2022-12-23

    (294 days)

    Product Code
    QUV,OUV
    Regulation Number
    892.5727
    Type
    Direct
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BioXmark is indicated for use to radiographically mark lung, bladder and lymph nodes in adult patients for whom it has been determined that radiographical marking of tissue for radiation treatment is indicated for their cancer treatment.

    BioXmark is implanted via image guided injection into tissue relevant for radiotherapy planning at a healthcare facility. BioXmark can be implanted in the tumor, lymph nodes or tissue adjacent to the tumor subject to irradiation or healthy tissue which should not be irradiated.

    BioXmark is intended to mark tissue for at least 3 months after implantation.

    Device Description

    The device is a single-use, implantable device consisting of a sterile transparent liquid in a onepoint-cut (OPC) glass ampoule. Upon injection of the liquid into soft tissue, efflux of alcohol leads to the formation of a radiopaque, sticky, gel-like fiducial marker in vivo, which is visible using fluoroscopy, CT. MRI, and ultrasound. The subject device is a mixture of ethanol, sucrose acetate isobutyrate (SAIB) and an iodinated and acylated derivative of sucrose (x-SAIB). Each ampoule contains 1 mL of liguid and is steam sterilized. On injection, a miniscule amount of ethanol diffuses in 1 to 2 hours, causing an increase in marker viscosity and resulting in a hydrophobic semisolid gel-like marker at the injection site.

    AI/ML Overview

    Here's a summary of the acceptance criteria for BioXmark and the studies performed to demonstrate that the device meets those criteria, based on the provided text:

    Acceptance Criteria and Device Performance for BioXmark

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Special Controls & Clinical Study Endpoints)Reported Device Performance (as demonstrated by studies)
    Risk of marker migration in tissue during the course of radiation therapy through post-treatment follow-up.Lung Cancer Study (310-01): Migration of BioXmark in lung cancer patients in this use case is less than 15% (calculated with 95% certainty). No migration observed in any of the 29 markers followed. Positional shifts were observed only in patients with large anatomical changes, with markers still at the anatomically right spot.
    Bladder Cancer Study: All 60 visible markers (from a total of 76 implanted) remained detectable without displacement through week four of follow-up. Blurring, migration, and fading did not occur during treatment.
    Animal Study (Porcine model): BioXmark markers did not migrate and retained their 3D shape over the course of a 6-week study.
    Animal Study (Pancreatic tumor mouse model): Position of BioXmark was stable over 4 months.
    Animal Study (Mice subcutaneous implantation): Followed positional stability at 1 hour, 24 hours, 1 month, and 5 months without adverse events.
    Ability to visualize the marker to allow for adequate localization during the course of radiation therapy through post-treatment follow-up.Lung Cancer Study (310-01): BioXmark was visible on all defined imaging modalities (ultrasound, CT, CBCT, 4D CT, 2D kV, fluoroscopy) during the entire treatment period. All markers had a Contrast-to-Noise Ratio (CNR) > 2 (cutoff for visibility), and CNR remained constant.
    Bladder Cancer Study: 79% (95% CI 70-88%) of implanted markers were visible on treatment planning CT scan. All separate spots were continuously classified as clearly visible without artifacts. All visible markers remained detectable through treatment.
    Bench Study (X-ray imaging): All markers (10 ul, various shapes) were clearly visible with mean contrast levels in the range of 700-1200 HU (spherical), 400-800 HU (flat cylindrical), and 500-900 HU (elongated cylindrical), resulting in CNR > 110.
    Bench Study (MR): All volumes of markers tested (10 ul, 25 µl, 50 µl, 100 ul) were identified with low degrees of artifacts as hypo-intense spots in both T1w FFE and T2w MRI.
    Animal Study (Porcine model): Visualizable using Ultrasound, fluoroscopy, and CT-imaging.
    Animal Study (Pancreatic tumor mouse model): Detectable by CBCT (SARRP and Skyscan).
    Risk of device interference with tumor response assessment post-treatment.Bench Study (Artifacts): Data support CNR and streaking artifacts comparable to currently marketed fiducial markers. SI of BioXmark for volumes
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