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The PillCam SB 3 capsule is intended for visualization of the small bowel mucosa. - . It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. - . It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. The PillCam SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

The subject device, PillCam Cloud Reader SW, is an additional cloud data management option which enables users to review PillCam CE videos stored on the public cloud repository. The PillCam Cloud Reader SW utilizes Amazon Cloud Services (also referred to as "HCP Cloud" or "AWS") offering a vast standardized, robust, and verified platform that facilities multiple containers while utilizing various cloud services. AWS enables easy and efficient scaling up and down, leveraging the system's efficiency for the PillCam Cloud Reader SW. The AWS cloud environment is comprised of 2 components: the Cloud Reader Video Storage and HCP Software Application, refer to Section 5.3 for further technological details of each component. The PillCam Sync Agent is a local software component that is installed in the PillCam Software 9.0E workstation. The PSA continuously sycronizes the local data from the local database (predicate component #4 in the figure below) back and forth to the PillCam Cloud Reader Video Storage component.

The PillCam SB 3 capsule is intended for visualization of the small bowel mucosa. - It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. The PillCam SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

The PillCam SB 3 Capsule endoscopy system is a device that provides visualization of the small bowel mucosa. The device was previously cleared under 510(k) submission K123864 for the SB 3 Capsule, PillCam DR3 recorder and accessories, and K170210 incorporated the PillCam Software 9.0 to the device is comprised of four main subsystems further described below. Ingestible PillCam SB 3 Capsule: The disposable, ingestible PillCam SB 3 Capsule is designed to acquire images during the natural propulsion through the digestive system. The capsule transmits the acquired images via a RF communication channel to the PillCam DR3 recorder located outside the body. PillCam DR3 Recorder: The PillCam DR3 recorder is an external receiving/recording unit that receives and stores the acquired images from the capsule. PillCam Software: The PillCam Software 9.0E is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam DR3 recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms. PillCam Software 9.0E supports PillCam capsule endoscopy of the gastrointestinal (GI) tract with all PillCam capsules (SB, COLON, UGI and SBC (renamed Crohn's)). Workstation and Accessories: The Workstation is a user-provided modified standard personal computer, that is the operational platform for the PillCam software. The Sensor array or sensor belt receive data from the PillCam capsule and transfer the data to the PillCam Recorder DR3.