(69 days)
MEDIVISION HYSTEROSCOPE MV400/MV415/MV430/MV470 INDICATIONS for USE NOTE: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. Diagnostic Hysteroscopy - . Abnormal Uterine Bleeding - Infertility & Pregnancy Wastage . - Evaluation of Abnormal Hysterosalpingogram # - Intrauterine Foreign Body - . Amenontiea - Pelvic Pain . - Operative Hysteroscopy - . Directed Blopsy - Removal of Submucous Fibroids and Large Polyps . - . Submucous Myomectorny - . Transection of Intrauterine Adhesions - o Transection of Intrauterine Septa - . Endometrial Ablation Medical disease, cervical stenosis, and pelvic infection may alter the choice of location for hysteroscopy {i.e., office setting vs. Hospital),
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This document is a 510(k) clearance letter from the FDA for Medivision Hysteroscopes. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it confirms that the device is substantially equivalent to a predicate device already on the market.
Therefore, I cannot provide the requested information.
§ 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.