(90 days)
The KSEA HP-Snare is intended for hysteroscopic use by qualified surgeons or physicians for resection of uterine polyps and tumors.
The KSEA HF-Snare is a manual reusable surgical devices provided to the end-user in a non-sterile condition. The body contact materials are surgical grade stainless steel.
The provided text does not contain information about acceptance criteria for device performance or any studies demonstrating that a device meets such criteria. The document is a 510(k) summary for a medical device (KSEA HF-Snare) and focuses on regulatory aspects like device identification, indications for use, and substantial equivalence to predicate devices, rather than detailed performance studies.
Therefore, I cannot populate the requested table and sections with information from the given text.
§ 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.