(28 days)
The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and billiary tracts.
The ELRA Electrode is a bipolar electrode. ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators.
The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.
The lengths of the flexible tube available for the ELRA Electrode length are 400 mm and 1,750 mm. The tip exposures available for the ELRA Electrode length are 11 mm, 18 mm, 22mm and 33 mm. The diameter available for the ELRA Electrode diameters is 7 French.
The model with longer length(1,750 mm) are used with endoscopes. This electrode is inserted into the body through the oral rout, and are used at the application site. The shorter length(400 mm) models are performed by percutaneous resection directly at the site of application. Both methods have to be used with fluoroscopy during the procedure.
This document is a 510(k) summary for a medical device (ELRA Electrode) and focuses on expanding its shelf-life. As such, it does not contain information related to an AI/ML powered device, and therefore cannot provide data on acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies for AI/ML performance.
The content primarily addresses technical aspects of the ELRA Electrode and its equivalence to a predicate device, specifically for extending its shelf-life through performance testing.
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about an AI/ML powered device and its performance evaluation against acceptance criteria.
§ 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).