(54 days)
The Angled Tip Polypectomy Snare will be used in Flexible Endoscopy in order to grasp and electrosurgically dissect and transect flat (sessile) or stalked polyps during endoscopic procedures.
A polypectory snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp. The Angled Tip Polypectomy Snare will be used in Flexible Endoscopy in order to grasp and electrosurgically dissect and transect flat (sessile) or stalked polyps during endoscopic procedures.
This 510(k) summary (K970945) describes a polypectomy snare, which is a medical device, not an AI/ML algorithm. Therefore, the requested information regarding acceptance criteria and studies proving device performance, especially those related to AI/ML specific aspects, are not applicable in this context.
The document discusses the product's intended use, contraindications for the procedure, manufacturing processes, quality assurance, and sterility testing for this physical medical device. It does not mention any software, algorithms, AI, or machine learning components.
Therefore, I cannot provide the requested information in the format specified, as the input document does not contain data relevant to AI/ML device performance studies.
§ 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).