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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.

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