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510(k) Data Aggregation

    K Number
    K171626
    Device Name
    truFreeze System
    Manufacturer
    CSA Medical, Inc.
    Date Cleared
    2017-08-30

    (89 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K152329,K083737,K161202
    Predicate For
    K201183,K222272
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196℃ requiring either active or passive venting during surgical procedures.

    The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett's Esophagus with high grade and/or low grade dysplasia) and malignant lesions.

    Device Description

    The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets them in the context of an Artificial Intelligence (AI) or machine learning (ML) device. The document describes a 510(k) premarket notification for the "truFreeze® System," which is a cryosurgical tool.

    The document discusses:

    • The indications for use for the truFreeze system, including the addition of Barrett's Esophagus with low-grade dysplasia.
    • A clinical study conducted to support the effectiveness and safety of the truFreeze system for ablating Barrett's Esophagus with low-grade dysplasia. This is a study of a physical medical device, not an AI/ML algorithm.
    • Data on the safety and effectiveness of the device, focusing on patient response (complete eradication of dysplasia - CE-D) and adverse events.
    • Comparison to predicate and reference devices to establish substantial equivalence.

    Therefore, I cannot extract the information required for the requested table and study details related to an AI/ML device's acceptance criteria and performance as the provided document does not pertain to such a device.

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