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510(k) Data Aggregation

    K Number
    K173559
    Device Name
    Barrx SB RFA Endoscopic Catheter
    Manufacturer
    Covidien llc
    Date Cleared
    2018-01-18

    (62 days)

    Product Code
    KNS,GEI
    Regulation Number
    876.4300
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K160360,K130623
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Barrx™ SB RFA Endoscopic Catheter is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

    Device Description

    The Barrx™ SB RFA Endoscopic Catheter is a sterile, single use, focal ablation catheter used to deliver radiofrequency (RF) energy to treatment tissue within the gastrointestinal tract. The design of the Barrx™ SB RFA Endoscopic Catheter is a modification to the legally marketed Barrx™ Channel RFA Endoscopic Catheter (cleared under K130623 on 7/26/13). The Barrx™ SB RFA Endoscopic Catheter incorporates design modifications which enable the catheter to access the small bowel within the gastrointestinal tract. The Barrx™ SB RFA Endoscopic Catheter is used in connection with the Barrx™ Flex RFA Energy Generator (cleared under K160360 on 4/5/16) which includes an output cable and footswitch.

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not describe an AI/ML powered medical device, nor does it contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.

    The device in question, the Barrx™ SB RFA Endoscopic Catheter, is for coagulating bleeding and non-bleeding sites in the gastrointestinal tract using radiofrequency ablation. The document discusses its substantial equivalence to a predicate device based on design modifications, materials, principle of operation, and various performance tests (in-vitro functional, in-vivo animal, biocompatibility, sterilization, packaging, shelf life, electrical safety, design and user validation).

    Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving an AI-powered device meets those criteria based on the provided text, as the document is not about an AI-powered device.

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