(241 days)
Saber's Rigid Fiber Optic Laparoscopes are used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Saber Endoscopy's Rigid Fiber Optic Laparoscopes are small diameter endoscopes which consist of fiber optic imaging fibers and illumination fibers contained within a stainless steel jacket. Light from a high intensity light source is transmitted to the scope by a detachable light carrying cable. The light is then carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the image fiber bundle. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an optical eyepiece. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.
This document is a 510(k) summary for a medical device called "Rigid Fiber Optic Laparoscope". It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment relevant to the request. The document describes the device, its intended use, and compares its technological characteristics to predicate devices for the purpose of demonstrating substantial equivalence for regulatory approval. It does not present data from a study demonstrating the device meets specific performance acceptance criteria.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.