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The PillCam™ Genius SB Capsule Endoscopy Kit with the PillCam Genius SB 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 PillCam Genius SB Capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults.

The subject device introduces the PillCam Genius Capsule Endoscopy Kit (PillCam Genius SB Capsule and the PillCam Genius Link Device), the PillCam Genius Sync Agent, and the Real Time View Application.
The PillCam Genius Link Device is a single use device that is adhered to the patient's abdomen throughout the PillCam Genius SB procedure that connects to the PillCam Genius SB Capsule. Each Genius Link Device is paired and packaged with a single PillCam Genius SB Capsule. At the end of the procedure, the Link Device is removed and returned to the clinic.
The PillCam Genius Sync Agent is software used by the healthcare provider to setup and manage PillCam Genius SB endoscopy procedures and converts data from the PillCam Genius Link Device to the workstation.
The optional Real Time View Application allows the healthcare provider to view real time images from the capsule for a short period of time during the procedure to estimate the location of the capsule in the gastrointestinal tract.
The PillCam Desktop Software and HCP Software Application have been updated to display PillCam Genius SB Capsule procedures. The HCP Software Application has also been updated to be compatible with the PillCam Genius SB System and allow for uploading multiple procedures.

This 510(k) summary does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria. Specifically, it states that "No clinical testing was conducted in support of this 510(k) submission." Therefore, it's not possible to provide the requested details from the given text.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, including biocompatibility, bench testing, electrical safety, EMC, and software documentation.

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