LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K173891
    Device Name
    Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2018-01-19

    (29 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K133237,K171946
    Why did this record match?
    Device Name :

    Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume

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

    Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.

    Device Description

    The Gel-Bead embolization spheres product consists of biodegradable gelatin spheres pre-filled in a 20 ml syringe. The syringe contains either 1 ml or 2 ml of spheres suspended in 5 ml or 4 ml of saline, respectively. Offered in five nominal size ranges (100-300 µm, 500-700 µm, 600-800 µm, and 700-1000 um), the spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.

    AI/ML Overview

    This document describes the acceptance criteria and supporting study for the Gel-Bead Embolization Spheres (600-800um - 1 ml and 2 ml sphere volumes) device.

    The study presented focuses on demonstrating the substantial equivalence of the new 600-800 µm sphere size and new 1ml sphere volume, to previously cleared Gel-Bead embolization spheres (K133237 and K171946). This is primarily achieved through bench testing of key device characteristics.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Deliverability: The device must be able to be delivered through compatible catheters.The verification tests demonstrated that the Gel-Bead embolization spheres (600-800 µm) met the specified acceptance criteria for deliverability. (Specific quantitative results are not provided in the document, but it states the criteria were met.)
    Sphere Diameter: The spheres must fall within the specified size range of 600-800 µm.The verification tests demonstrated that the Gel-Bead embolization spheres (600-800 µm) met the specified acceptance criteria for sphere diameter. (Specific quantitative results are not provided in the document, but it states the criteria were met, specifically for the 600-800 µm size.)
    Sphericity: The spheres must exhibit an acceptable level of sphericity.The verification tests demonstrated that the Gel-Bead embolization spheres (600-800 µm) met the specified acceptance criteria for sphericity. (Specific quantitative results are not provided in the document, but it states the criteria were met.)
    No New Safety or Performance Issues: The introduction of the new sphere size and volume should not raise any new safety or performance concerns compared to the predicate device.The verification test results demonstrated that the Gel-Bead embolization spheres (600-800 µm) did not raise new safety or performance issues.

    Detailed Information on the Study:

    The provided document describes a bench test study rather than a clinical study involving human or animal subjects for evaluating performance in a biological context. The primary goal of this submission is to demonstrate substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics and performance in a controlled laboratory environment.

    1. Sample Size Used for the Test Set and Data Provenance:

      • The document does not specify the exact sample sizes used for each of the bench tests (Deliverability, Sphere Diameter, Sphericity).
      • Data Provenance: The study appears to be an in-vitro (bench) study conducted by the manufacturer, Vascular Solutions. There is no indication of country of origin for the data in the context of clinical trials, as this is a laboratory-based evaluation.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

      • This information is not applicable to this type of study. Bench tests rely on objective measurement and predefined specifications (acceptance criteria) rather than expert interpretation of data points to establish a "ground truth." The "ground truth" for these tests is the physical measurement itself against the defined thresholds.

    3. Adjudication Method for the Test Set:

      • This information is not applicable to this type of study. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers independently assess data and discrepancies need to be resolved. Bench tests involve direct measurements against predefined criteria.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

      • No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (embolization spheres), not an AI or imaging diagnostic tool that would typically involve human readers.

    5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

      • Not applicable. This device is not an algorithm or AI. The performance tested is the inherent physical and functional characteristics of the embolization spheres themselves.

    6. Type of Ground Truth Used:

      • The "ground truth" for this study is based on pre-defined engineering specifications and measurable physical properties of the device (e.g., specific diameter ranges, mechanical properties related to deliverability, and optical properties related to sphericity). These are verified through direct measurement and laboratory testing, rather than expert consensus, pathology, or outcomes data which are typical for clinical performance evaluation.

    7. Sample Size for the Training Set:

      • This concept is not applicable to this study. "Training set" refers to data used to train machine learning models. This study is a bench test verification of a physical device against engineering specifications.

    8. How the Ground Truth for the Training Set Was Established:

      • Not applicable, as there is no training set for this type of device and study.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1