(107 days)
The A4907 Lens Cleaning Sheath has been specifically designed to be used with the Olympus A4908 Valve and LTF-V OES V Laparo-Thoraco Videoscope to clean of the objective lens surface.
The A4907 Lens Cleaning Sheath has been specifically designed for use with the Olympus A4908 Valve and LTF-V OES Laparo-Thoraco Videoscope. It will be included in the standard set of LTF-V Laparo-Thoraco Videoscope and will also be marketed separately.
When connected to the main body of LTF-V videoscope, it offers lens cleaning, irrigation, and suction capabilities to the user during endoscopic procedures. It is substantially equivalent in design, intended use, and method of operation to the "Lens Cleaner" manufactured by Cook, "Optic Shaft" manufactured by Wiest, and "Lap Wash System" manufactured by DevMed Group Inc.
This document is a 510(k) summary for the Olympus A4907 Lens Cleaning Sheath. It describes the device's intended use and design, comparing it to predicate devices. However, this document does not contain any information about acceptance criteria, device performance results from a study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
Therefore, I cannot provide the requested table and information as these details are not present in the provided text. The summary explicitly states: "When compared with the predicate devices, Olympus A4907 Lens Cleaning Sheath does not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness of the subject device." This suggests the approval relied on substantial equivalence rather than a new performance study demonstrating specific 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.