(47 days)
These instruments have been designed to be used with an Olympus endoscope for papillotomy and for dilating the major papilla to retrieve biliary stones.
The subject device consists of the balloon and the papillotomy knife for endoscopic sphincterotomy. The only difference from the predicate device which has been cleared under K150142 is the additional balloon diameter offerings. The intended use of the subject device is identical to the predicate device. The subject device used in combination with compatible Olympus endoscopes, A-Cord (power cable), electrosurgical unit and compatible inflation device and the subject device is inserted endoscopically into the body cavity, and a tissue is cut by applying a high frequency current while the cutting wire is tightened. In addition, an inflation device is attached to a balloon port, and the inflation fluid is injected by utilizing an inflation device to dilate the papilla. The insertion portion of this product has a V-marking, and the relative insertion length of this product into the endoscope can be confirmed by the positional relationship between the V-marking and the biopsy valve of the endoscope. The Hook provided on the handle is for attaching the subject device to an endoscope or an inflation device, which assists manipulation of the subject device.
This document describes the premarket notification (510(k)) for the "Single Use Balloon Dilator V (with knife)" device. However, the details provided primarily focus on the device's technical specifications, comparison to a predicate device, and various performance tests conducted to ensure safety and functionality.
Crucially, this document does not contain information related to an acceptance criteria table with reported device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment for a test set, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance. The device described here is a physical medical instrument, not an AI/ML-driven device that would involve such data-centric validation elements.
Therefore, I cannot fulfill your request for the requested information as it is not present in the provided text. The document focuses on traditional medical device clearance processes based on substantial equivalence to a predicate device, bench testing, and compliance with various safety and performance standards for physical devices.
§ 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).