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510(k) Data Aggregation

    K Number
    K200745
    Device Name
    Lariat, Hot/Cold Snare
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2020-04-21

    (29 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Lariat, Hot/Cold Snare

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

    The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures. The device can be used with or without monopolar diathermic energy.

    Device Description

    The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

    AI/ML Overview

    This document is a 510(k) K200745 Premarket Notification for the Lariat Hot/Cold Snare, which is an electrosurgical device. It outlines the FDA's decision regarding substantial equivalence. However, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria.

    The 510(k) clearance process primarily demonstrates substantial equivalence to a predicate device, rather than requiring extensive clinical trials with strict performance criteria and ground truth validation as would be the case for novel AI/Software as a Medical Device (SaMD) products.

    Therefore, I cannot fulfill your request for the following information based on the provided text:

    1. A table of acceptance criteria and the reported device performance: This information is not present.
    2. Sample sizes used for the test set and data provenance: Not present.
    3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable/present.
    4. Adjudication method for the test set: Not applicable/present.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable/present.
    6. If a standalone (algorithm only) performance was done: Not applicable/present (this is a physical device, not an algorithm).
    7. The type of ground truth used: Not applicable/present.
    8. The sample size for the training set: Not applicable/present.
    9. How the ground truth for the training set was established: Not applicable/present.

    The document is a regulatory clearance letter, not a clinical study report or a technical performance description for an AI/SaMD product. The "Lariat, Hot/Cold Snare" is a physical medical device.

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