(344 days)
The Benesta ™ Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
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This document is a 510(k) clearance letter for the Benesta™ Hysteroscope. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
A 510(k) clearance signifies that the FDA has determined the device is substantially equivalent to a predicate device already on the market, meaning it has the same intended use and technological characteristics, or different technological characteristics but does not raise different questions of safety and effectiveness. The information provided in this clearance letter is primarily administrative, confirming the regulatory approval based on the comparison to a predicate device, rather than providing details of a direct clinical or standalone performance study with defined acceptance criteria for the new device.
Therefore, I cannot provide the requested information from the provided text. To answer your questions, you would typically need to review the 510(k) summary or detailed submission documents, which contain the specific performance data and comparisons to the predicate device.
§ 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.