(62 days)
The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures. The device can be used with or without monopolar diathermic energy,
The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.
This document is a 510(k) clearance letter for the Lariat Snare, an electrosurgical device. It outlines the FDA's determination of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML or diagnostic device performance.
Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance process for a traditional medical device, not a device with AI components or one that requires validation through clinical study performance metrics in the way your prompt describes.
§ 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).