(262 days)
The intended use of the GIP Medi-Globe Hot Biopsy Forceps is identical to the Wilson-Cook device for removal of small polyps in the GI track.
The GIP/Medi-Globe Hot Biopsy Forceps are similar in design, composition (stainless steel and Teflon), and function and performance to the Wilson-Cook GI Hot Biopsy Forceps. The device is designed to be used in conjunction with numerous FDA Approved endoscopes. The entire device can be autoclaved or ETO gas sterilized. The Hot Biopsy Forceps are shipped assembled and sterile in a peel-open package. The working lengths of all of the GIP/Medi-Globe Hot Biopsy Forceps range from 1,200, 1,800, 2,300.
This document does not describe an AI/ML powered medical device. It describes a hot biopsy forceps, a physical medical instrument used for tissue sampling. Therefore, the requested information regarding acceptance criteria, study design, ground truth, and expert involvement for an AI/ML model is not applicable.
The document discusses the safety and effectiveness of the GIP/Medi-Globe Hot Biopsy Forceps by comparing it to a previously cleared device (Wilson-Cook GI Hot Biopsy Forceps, K874314). The assessment is based on design, materials, intended use, method of operation, cleaning/sterilization, and biological reactivity, rather than algorithmic performance.
§ 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).