(98 days)
The Optivia Hysteroscopic Introducer is used to establish and maintain distention in the uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as: Diagnostic Hysteroscopy (Infertility and Pregnancy Wastage, Abnormal Uterine Bleeding, Evaluation of Abnormal Hysterosalpingogram, Intrauterine Foreign Body, Amenorrhea, Pelvic Pain) and Operative Hysteroscopy (Removal opf Submucous Fibroids and Large Polyps, Direct Biopsy, Transection of Intrauterine Adhesions, Submucous Myomectomy, Transection of Intrauterine Septa, Endometrial Ablation).
The Optivia Steerable Working Channel is used only in conjunction with the Optivia Hysteroscopic Introducer to establish and maintain distention in the uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as: Diagnostic Hysteroscopy (Infertility and Pregnancy Wastage, Abnormal Uterine Bleeding, Evaluation of Abnormal Hysterosalpingogram, Intrauterine Foreign Body, Amenorrhea, Pelvic Pain) and Operative Hysteroscopy (Removal opf Submucous Fibroids and Large Polyps, Direct Biopsy, Transection of Intrauterine Adhesions, Submucous Myomectomy, Transection of Intrauterine Septa, Endometrial Ablation). The Optivia Steerable Working Channel aids in visualization and gives the health care professional the ability to more precisely control the position of the diagnostic or therapeutic device than is achievable without the Steerable Working Channel.
Not Found
This document is a 510(k) premarket notification letter from the FDA to OptiVia Medical, LLC, regarding their Optivia Hysteroscopic Introducer and Optivia Steerable Working Channel. It establishes that the devices are substantially equivalent to legally marketed predicate devices.
The document does not contain any information about acceptance criteria, device performance, or any studies. It is a regulatory approval document and not a technical report detailing performance metrics or clinical study results.
Therefore, I cannot provide the requested information from this document.
§ 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.