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510(k) Data Aggregation

    K Number
    K220641
    Device Name
    Barrigel Injectable Gel
    Manufacturer
    Palette Life Sciences
    Date Cleared
    2022-05-26

    (83 days)

    Product Code
    OVB
    Regulation Number
    892.5725
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K202224
    Why did this record match?
    Applicant Name (Manufacturer) :

    Palette Life Sciences

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

    Barrigel 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 Barrigel to reduce the radiation dose delivered to the anterior rectum. Barrigel is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient's body over time.

    Device Description

    Barrigel Injectable Gel is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid (HA) at a concentration of 20 mg/mL in phosphate buffered saline. The HA, formulated utilizing Q-Med's patented NASHA™ technology, is produced from non-animal hyaluronic acid by fermentation of Streptococcus species of bacteria. The HA gel is cross-linked with 1,4-butanediol diglycidyl ether (BDDE) under alkaline conditions, thereby creating ether bonds between the HA chains, resulting in a three-dimensional network. The gel is insoluble in water and organic solvents. Barrigel is supplied in a single-use glass syringe, containing 3 mL of product. Each syringe is terminally sterilized by moist heat in a heat-sealed pouch of PET/Tyvek® and packaged in a cardboard carton. Barrigel is intended for use by health-care professionals only and should be stored up to 25° C (77° F). Barrigel is manufactured for Palette Life Sciences by O-Med AB, a subsidiary of Galderma AB. The Barrigel needle is a sterile 18G stainless-steel needle, 20 cm in length, provided with an optional stylet and protected by a polyester sheath which is removed prior to use. The needle is sterilized by radiation and two (2) needles are provided in each heat-sealed pouch of PET/Tyvek®, packaged in a cardboard carton. The Barrigel needle is identical to the needle used during the Barrigel IDE study and is manufactured for Palette Life Sciences by R.K. Manufacturing.

    AI/ML Overview

    The provided text describes the acceptance criteria and study results for Barrigel Injectable Gel, an absorbable perirectal spacer.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Primary Effectiveness Endpoint: Achievement of a 25% reduction in the volume of the rectum receiving 90% of the prescription radiation dose. Minimally acceptable success rate established by the predicate device was 70%.98.6% of complete cases in the Barrigel group achieved at least a 25% reduction in the volume of the rectum receiving 90% of the prescription dose. The lower boundary of the 95% confidence interval (LCL) is 0.923, and the one-sided p-value is
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