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The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.

The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of bleeding and nonbleeding 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 and Angiodysplasia.

The subject device, the Barrx™ FLEX RFA Energy Generator is intended to be used with the listed catheters to deliver radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The Generator is provided with a footswitch that can initiate inflation or deflation of the balloon and initiate or cease delivery of RF energy. The Barrx FLEX RFA Energy Generator is designed to function with a family of single use, disposable Ablation Catheters and Sizing Balloons to deliver the intended therapy.

This document is a 510(k) premarket notification for a medical device called the Barrx FLEX RFA Energy Generator. It's a submission to the FDA (Food and Drug Administration) for a device that already has a predicate (K141357), and the current submission is primarily for a labeling change to add new clinical information.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered device or a study involving human readers and AI assistance.

The document pertains to an electrosurgical device used for coagulation of soft tissue, specifically in the gastrointestinal tract. The "study" mentioned (Wolf WA, Pasricha S, Cotton C, et al. Incidence of Esophageal Adenocarcinoma and Causes of Mortality After Radiofrequency Ablation of Barrett's Esophagus. Gastroenterology 2015; Aug 28. [Epub ahead of print]) is a clinical study whose results were added to the device's labeling, not a performance study in the sense of testing an AI algorithm's accuracy or impact on human performance.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML-based device or a comparative effectiveness study involving human readers and AI assistance, as these concepts are not applicable to the content of this 510(k) submission.

The document explicitly states:

• "As the subject of this submission is a labeling change only, the Barrx FLEX RFA Energy Generator has identical technological characteristics as compared to the predicate Barrx FLEX RFA Energy Generator (K141357)."
• "There have been no design or material changes to the generator since the predicate was cleared on."
• "There has been a minor software change since the K141357 however, it did not require a submission and was documented via Letter to File to K141357."
• "The difference between the proposed Barrx FLEX RFA Energy Generator and the predicate device (K141357) is the addition of clinical information to the labeling resulting from one published peer-reviewed clinical study."

This clearly indicates that the submission is not about a new performance study testing an AI component or its impact on human readers.

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