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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
    Predicate For
    K232464
    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 (< 24hrs). These tests are standard for evaluating biological safety of materials that contact the body.
    Electrical SafetyComplies with AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012.Standard for electromedical equipment safety. The LaparoLight™ Veress Needle includes an LED indicator, necessitating electrical safety testing.
    EMC (Electromagnetic Compatibility)Complies with IEC 60601-1-2 Edition 4.0 2014-02.Standard for electromedical equipment immunity and emissions. Relevant due to the LED component.
    Design ValidationOperates as intended. Test included: puncturing of simulated tissue, operation of blunt tip position indicator, saline and gas delivery.Confirms the basic functional requirements of the device.
    Force EquivalencyForce of spring-loaded blunt stylet and puncture force are similar to the predicate device.Demonstrates functional similarity to the predicate device in terms of mechanical forces.
    Tip Pull TestEquivalent to predicate device performance regarding strength of bond between components.Confirms structural integrity similar to the predicate device.
    Switch Operation TestEquivalent to predicate device performance by testing control of gas flow with stop cock/flow controller assembly.Confirms the functionality of gas flow control similar to the predicate device.
    Spring Obturator Operation TestEquivalent to predicate device performance – testing covered "click" of the needle and blunt tip extension once the needle enters open internal volume.Confirms the haptic and functional feedback mechanism similar to the predicate device.
    Puncture Force TestEquivalent to predicate device performance – testing covered puncture force required to puncture tissue simulator.Confirms the mechanical force required for insertion similar to the predicate device.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not specified in the document for any of the performance tests. These are typically bench tests, and the "sample size" would refer to the number of devices tested.
    • Data Provenance: Bench testing performed on the device itself.
      • No patient data (retrospective or prospective) is involved, as this is a physical medical instrument, not a diagnostic algorithm.
      • No country of origin of data is specified, as it's laboratory testing.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Not Applicable. This is a physical device, and "ground truth" as it relates to expert consensus for diagnostic tasks is not relevant. The "ground truth" for these tests would be the design specifications and established engineering principles.

    4. Adjudication Method for the Test Set

    • Not Applicable. Again, this concept applies to diagnostic or interpretative tasks where expert agreement is needed to establish a correct answer. For bench testing of a physical device, the outcome is typically objectively measurable (e.g., force, electrical parameters).

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • No. This is a physical surgical instrument and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is not relevant.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • No. This device is not an algorithm. It's a physical medical instrument used by a human surgeon. Standalone performance as it relates to AI is not applicable.

    7. The Type of Ground Truth Used

    • Engineering Specifications and Industry Standards: For the performance tests (e.g., electrical safety, EMC, biocompatibility), the "ground truth" is compliance with recognized engineering standards (e.g., ISO, AAMI/ANSI, IEC) and the device's own design specifications. For the comparative tests (force, bond strength), the "ground truth" is equivalence to the performance of the predicate device.

    8. The Sample Size for the Training Set

    • Not Applicable. This is not an AI/ML device that requires a training set.

    9. How the Ground Truth for the Training Set was Established

    • Not Applicable. See point 8.
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