(421 days)
- Directed Biopsy
- Removal of submucous fibroids and large polyps
- Submucous myomectomy
- Transection of intrauterine adhesions
- Transection of intrauterine septa
- Endometrial ablation
Northgate's Cutting Loops and Knife Electrosurgical Electrodes are designed to be used with most major brands of Resectoscopes. The electrodes are used to cut and coagulate soft tissue during electrosurgical procedures.
The Vapor-Tech Series Electrodes are designed with several tip configurations: roller ball, roller barrel, cross grooved, grooved roller, ball, and Sled™
The provided text is a 510(k) premarket notification for electrosurgical electrodes. It describes the device, its intended use, and states its substantial equivalence to other marketed devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study-related details requested in the prompt.
Therefore, I cannot extract the requested information from the provided text. The document is primarily a regulatory submission stating substantial equivalence rather than a detailed report of device performance studies.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.