(189 days)
The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures.
The Conceptus hysteroscope has a rigid shaft with a flexible articulating tip. The device is equipped with a separate eyepiece plug and light guide plug. The optical system conveys an image to the user's eye or to a video camera.
This document is a summary of safety and effectiveness for a medical device (Conceptus Hysteroscope) submitted in accordance with SMDA 1990. It is a pre-market notification (510(k)) and not a study report detailing performance metrics against specific acceptance criteria.
Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment.
A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, as stated in the document: "The intended use, optics, design, materials, specifications and mode of operation of the Conceptus Hysteroscope were found to be substantially equivalent to several predicate hysteroscopes."
To provide the information you requested, a different type of document, such as a clinical study report or a validation study report, would be necessary.
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MAR 12 1996
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Conceptus Hysteroscope Summary of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures.
The Conceptus hysteroscope has a rigid shaft with a flexible articulating tip. The device is equipped with a separate eyepiece plug and light guide plug. The optical system conveys an image to the user's eye or to a video camera.
The intended use, optics, design, materials, specifications and mode of operation of the Conceptus Hysteroscope were found to be substantially equivalent to several predicate hysteroscopes,
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Conceptus, Inc.• 1021 Howard Avenue, San Carlos, CA 94070 Phone:415/802-7240 Fax:415/802-7272
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§ 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.