(90 days)
The KSEA Semi-Rigid Hysteroscope and Accessories are designed to view the uterus, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken Motion Control Device attaches to an instrument channel to precisely guide the introduction of small instrument into the patient.
The Karl Storz Semi-Rigid Hysteroscope and Accessories are indicated in the following conditions:
Diagnostic
infertility and pregnancy wastage abnormal uterine bleeding intrauterine foreign body pelvic pain monitoring of IUD status evaluation of abnormal hysterosalpingogram evaluation of abnormalities of the endometrium
Operative
directed biopsy transection of intrauterine septa transection of intrauterine adhesions
Absolute Contraindications for Use: acute PID
Relative Contraindications for Use:
inability to distend uterus cervical/vaginal infection known pregnancy uterine bleeding or menses invasive carcinoma of the cervix recent uterine perforation medical contraindication intolerance to anesthesia cervical stenosis
The KSEA Semi-Rigid Hysteroscope is a straight, graduated shaft endoscope with a remote eyepiece. The Alken Motion Control Device is an attachment to the instrument channel to control the introduction and movement of accessories. All devices are manually operated, reusable surgical devices. Body contact materials are stainless steel (chromium-plated Monel 400®).
This document is a 510(k) Summary of Safety and Effectiveness for a Semi-Rigid Hysteroscope and Accessories. It seeks to demonstrate substantial equivalence to predicate devices, not to present a study with acceptance criteria and device performance. Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document describes a medical device (Semi-Rigid Hysteroscope and Accessories) and its intended use, focusing on demonstrating substantial equivalence to existing legally marketed devices. It is a regulatory submission, not a study report.
Therefore, I cannot populate the requested sections as the information is not present in the provided 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.