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510(k) Data Aggregation

    K Number
    K171139
    Device Name
    LaparoLight Veress Needle
    Manufacturer
    Buffalo Filter, LLC
    Date Cleared
    2017-05-18

    (30 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K111441
    Why did this record match?
    Reference Devices :

    K111441

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

    The LaparoLight™ 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 LaparoLight™ Veress Needle is a Veress needle that includes an LED indicator. This product is used to establish pneumoperitoneum prior to start of laparoscopic procedure. LaparoLight™ Veress Needle is available in two lengths: 120mm and 150mm to use in different size patients and applications. LaparoLight" Veress Needle is provided sterile and intended for single-use only in a healthcare facility/hospital.

    LaparoLight™ Veress Needle includes a spring loaded blunt stylet mechanism. When pressure is applied on blunt tip, it retracts and allows the sharp edge of cannula to cut through the tissue. Product also includes a slip sheet which when pulled activated the LED indicator. LED will turn ON and stay ON as long as the blunt tip of the product is extended forward past sharp edge of cannula. Thus during the puncture of peritoneum wall the LED will turn OFF while there is a pressure against blunt tip and turn back ON when cannula has entered a cavity allowing the blunt tip to spring forward.

    In addition LaparoLight™ Veress Needle includes a luer lock for syringe connection to perform saline flow test and insufflation tubing for gas delivery. Stop cock is present downstream of luer lock to control the flow of liquid or gas through the needle with possible positions ON and OFF.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called the LaparoLight™ Veress Needle. It does not present acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/ML-driven diagnostics. Instead, it describes tests performed to demonstrate substantial equivalence to a predicate device for regulatory approval.

    Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and device.

    However, I can extract the relevant information regarding performance data presented for the substantial equivalence determination.

    1. Table of Acceptance Criteria and Reported Device Performance

    For a traditional medical device like the Veress Needle, "acceptance criteria" are usually framed as meeting design specifications, industry standards, and demonstrating equivalence to a predicate device through various tests.

    Acceptance Criteria CategoryReported Device Performance / EvaluationNotes
    BiocompatibilityComplies with ISO 10993-1. Passed: In Vitro Cytotoxicity, Maximization Sensitization, Intracutaneous Reactivity, Systemic Toxicity Testing, Rabbit Pyrogen Testing.The device is considered to contact Tissue/bone/dentin for a limited duration (
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