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510(k) Data Aggregation

    K Number
    K172120
    Device Name
    Veress Needle
    Manufacturer
    WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.
    Date Cleared
    2017-09-14

    (63 days)

    Product Code
    FHO,HIF
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K150068
    Predicate For
    K193339
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

    Device Description

    The Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

    AI/ML Overview

    This document is a 510(k) summary for the WickiMed Veress Needle and provides information on its substantial equivalence to a predicate device. It does not describe an AI/ML powered device, therefore no information about acceptance criteria and studies proving the device meets these criteria as would be relevant for an AI/ML system is available.

    The document discusses the following types of non-clinical testing for the Veress Needle:

    • Biocompatibility tests: Conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012. These included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, and Material-Mediated Pyrogenicity.
    • Sterilization validation: Performed per ISO 11135:2014.
    • Performance tests:
      • Tip Pull Test
      • Switch Operation
      • Spring Obturator Operation
      • Needle Puncture Force Test

    The document states that "All the test results demonstrate the performance of Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide the specific numerical acceptance criteria for these tests, nor the reported device performance values. It also does not discuss any of the other specific items from your request (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) as these are not relevant to a traditional medical device submission like a Veress Needle.

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