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The OLYMPUS CAPSULE ENDOSCOPE SYSTEM has been designed to be used for visualization of the small intestine mucosa. The Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.

The OLYMPUS CAPSULE ENDOSCOPE SYSTEM consists of a capsule (OLYMPUS EO TYPE 1), The OLYMPUS RE-1), Antenna lead set (MAJ-1474), Real-time viewer(OLYMPUS I (Cool der Workstation(OLYMPUS WS-1). The composition and features of the devices described below are identical to those of the predicate device.

The Olympus capsule (OLYMPUS EC TYPE 1), has an outer diameter 11mm, a total length 26 mm, and is designed and manufactured with polymer composites that are biocompatible and provide sufficient tolerance to exposure to body fluids (digestive tract juice) and external compression forces.

The clear top cover contains a compact objective lens in front of the charge coupled device (CCD). 6 white light emitting diodes (LEDs) are allocated around the objective lens. The exterior package contains operational circuits for the CCD and LEDs and a radio transmitter and an antenna for radio transmission. In addition, this section of the capsule contains two silver oxide batteries to power the circuit within the capsule.

Recorder unit (OLYMPUS RE-1) is used in combination with Antenna lead set (MAJ-1474), which has 8 antenna pads for receiving the signals from the ingested capsule and for recording the data. The Recorder unit is powered by a detachable battery pack (specific for the Recorder unit) and is capable of receiving image data from the capsule for up to approximately 8-hours and record this data into the Compact Flash (CF) memory card. The Recorder unit has a display panel for displaying patient ID, battery pack level, etc.

Each 8-antenna pads of the Antenna lead set are to be inserted into the Antenna lead cover Lacil o-antennu puds of the exposes an adhesive side. The covered Antenna (who '11 b), which has a )
leads are secured onto the patient's abdominal area according to a labeling diagram provided in the labeling.

The Recorder unit is inserted into a pouch on the recorder unit harness. This unit is powered by the battery pack enabling the patient to move freely about during the endoscopic examination.

The Real-time viewer (OLYMPUS VE-1) is a compact monitoring unit that permits real-time display of recorded images on its color LCD by two different means and user options: receiving signals or room the capsule (by means of an antenna in the Real-time viewer) as well as decoding The Real-time viewer is powered by a battery pack and is signals from the Recorder Unit. portable.

The battery charger (MAJ-1476) is used for charging of the battery pack and is not intended for use during the endoscopic examination.

The Workstation (OLYMPUS WS-1) is composed of a personal computer workstation installed with proprietary EndoCapsule Software), a LCD monitor and printer. An additional software CD (EndoCapsule software light) will be provided with the workstation. The EndoCapsule software light is provided for operator convenience, whereby the user can install this software on their own personal computer and view patient image data from the DVDs created by the Workstation WS-1

The Workstation facilitates the downloading of endoscopic image data recorded in the Recorder unit to the Workstation hardware for observation of patient image data on the LCD monitor. It also provides the following functions such as initialization of the Recorder unit via the recorder unit cradle; image display as a pseudo-animation in 1-25fps; display/store images selected by the user as thumbnail data, user development and printing of diagnostic reports with pictures; image/video clip export; and data storage to a DVD from the Workstation's hard drive archive of the patient image file. In addition, the image processing function of the Workstation hardware offers the following user selectable software functions:

• Red Color Detection Function ■ Software feature which highlights frames suspicious for blood or red lesions based upon analysis of red pixels within the image – Average Color Bar Calculates the average RGB . colors of an image and displays the averaged color composite as a color line.
• Auto Speed Adjustment . Automatically adjusts the speed of frame display based upon an analysis of slow image movement.

The provided document, K063259, describes the Olympus Capsule Endoscope System, but it does not contain any information regarding acceptance criteria or a study proving the device meets specific performance criteria.

This 510(k) submission is for establishing substantial equivalence to predicate devices, focusing on the system's components, functionality, and intended use. The document explicitly states:

• Performance Standard: "None established under Section 514 of FD&C Act for Capsule Endoscope System."
• Voluntary Standard: "Reference is made in submission," but no details are provided about the content of these references or how they relate to the device's performance.
• FDA Guidance: "Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA (November 28, 2001)" is referenced, but the document does not elaborate on how the Olympus system specifically complies with or measures against any performance criteria outlined in this guidance.

Therefore, I cannot provide the requested table or details about a study demonstrating the device meets acceptance criteria, as this information is not present in the provided text. The document is primarily a descriptive submission for market clearance based on substantial equivalence to existing devices.

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