(108 days)
The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract.
The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract. The SD snares consist of a proximal end control handle, an electrical connection cord (A-cord), a flexible catheter-like tube, and a distal end snare loop. The detachable control handle contains the electrical connections which permit the snare loop to be connected to an electrosurgical generator via the A-cord. The distal end snare loop may be positioned around the target tissue by movement of a slider on the control handle. The tissue is resected by a combination of mechanical strangulation and electrosurgical current.
The provided text describes a 510(k) summary for Olympus SD Series of Reusable Electrosurgical snares. It details the device's intended use and description, and identifies predicate devices. However, it does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert involvement for any clinical or performance studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from the provided input.
§ 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).