(51 days)
The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.
The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.
This document is a 510(k) summary for a medical device called "Papillotome." It describes the intended use, contraindications, potential complications, and manufacturing overview of the device. However, it does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered device.
Therefore, I cannot provide the requested information based on the provided text. The document is solely focused on the regulatory submission for a physical medical device and lacks any data or details pertaining to an AI/ML study.
§ 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).