(62 days)
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).
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.
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.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).