(141 days)
The Galileo Micro Coupler is indicated for use with endoscopy. It is an interface which allows the transmission of optical image from the endoscope to a video camera for video recording or viewing on a monitor.
The Galileo Micro Couplers are a line of reusable optical couplers used in the transfer of image from an endoscope to a video camera for either image recording or viewing on a monitor. The Galileo Micro Couplers are available in several configurations which will allow coupling to different Endoscopes and camera.
This document is a 510(k) Summary for the Galileo Micro Coupler. It's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on comparing the new device to an existing one, rather than presenting a detailed study proving performance against specific acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. It focuses on:
- Device Identification: Proprietary and common names, classification.
- Sponsor/Applicant Information.
- Date of Summary Preparation.
- Predicate Device: Identification of a legally marketed device to which the new device claims substantial equivalence (Precision Optics Corp. Coupler K903458).
- Device Description: What the device is (reusable optical couplers for transferring images from endoscopes to video cameras) and its basic function.
- Intended Use: How the device is to be used (interface to transmit optical images from endoscope to camera for viewing/recording).
- Comparison of Technological Characteristics: Stating that the new device and predicate are "identical in intended use" and "identical in various mechanical interfaces" and both use similar optical components (lenses, prisms, windows).
- FDA Response Letter: Confirmation from the FDA that the device is substantially equivalent and can proceed to market.
- Indications for Use Statement.
In summary, there is no clinical study, performance data, or explicit acceptance criteria presented in this 510(k) summary. It is a regulatory submission for substantial equivalence, not a detailed performance study.
§ 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.