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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.

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.

The PillCam Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures. The PillCam Patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system. Therefore, the PillCam Patency System is intended to be used: - prior to PillCam SB capsule in adults and children from 2 years of age, or - prior to PillCam UGI, COLON, and Crohn's capsules in adults

The PillCam Patency System is an accessory to the PillCam capsule endoscopy (CE) System and it is used for verifying the patency of the Gastrointestinal (GI) tract. The PillCam Patency System consists of the following components; The PillCam Patency capsule, the Patency scanner and TesTag (interference tester). The Patency capsule is an ingestible and dissolvable capsule, similar in size to the PillCam CE. It is comprised of a body that surrounds a small Radio Frequency Identification (RFID) tag. The body is coated with an impermeable membrane, except for two small windows that are plugged by the Timer Plugs. The Timer plugs seal the capsule's body. If the Patency capsule is excreted structurally whole, then this confirms patency of the GI tract of the patient for objects similar in size to the capsule. However, if the capsule is retained in the GI tract, the Timer Plugs erode, allowing the penetration of body fluids into the capsule and the dissolution of the capsule's body. The remaining fragments of the capsule can pass even small orifices. The Patency scanner may be utilized to detect RF signals from the RFID tag, to verify the PillCam Patency capsule presence in the body. The only difference between the PillCam Patency System and the predicate device is the proposed labeling modification, to allow the use of the existing Patency capsule with the PillCam capsules that are slightly longer (PillCam COLON, Crohn's and UGI capsules). The intention of the proposed change is to offer physicians a clinical tool to evaluate the suitability of patients for CE, as an alternative to magnetic resonance enterography (MRE) or Computed Tomography (CT) which are already used in practice for this purpose.

The PillCam SBC capsule is intended for visualization of the small bowel and colonic mucosa. • It may be used in the visualization and monitoring of lesions in the small bowel that may indicate Crohn's disease not detected by upper and lower endoscopy, and for the visualization of inflammation of the colon in patients with colonoscopy-diagnosed Crohn's disease. • It may be used in the visualization and monitoring in the small bowel of lesions that may be a source of obscure bleeding (either overt or occult) or that may be potential causes of iron deficiency anemia (IDA) not detected by initial upper and lower endoscopy. • The PillCam SBC capsule may be used as a tool in the detection of abnormalities of the small bowel. It is intended for use in adults. PillCam Desktop Software 9.0 indications for use: With PillCam SB 2/ SB 3 Capsule The PillCam SB 2/ 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 2/ 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. With PillCam UGI Capsule The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age. With PillCam COLON 2 Capsule The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower GI origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy. With PillCam SBC Capsule The PillCam SBC capsule is intended for visualization of the small bowel and colonic mucosa. - It may be used in the visualization and monitoring of lesions in the small bowel that may indicate Crohn's disease not detected by upper and lower endoscopy, and for the visualization of inflammation of the colon in patients with colonoscopy-diagnosed Crohn's disease. - It may be used in the visualization and monitoring in the small bowel of lesions that may be a source of obscure bleeding (either overt or occult) or that may be potential causes of iron deficiency anemia (IDA) not detected by initial upper and lower endoscopy. - The PillCam SBC capsule may be used as a tool in the detection of abnormalities of the small bowel. It is intended for use in adults.

The PillCam SBC capsule endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam SBC capsule, (2) the PillCam Recorder DR3, (3) the PillCam Software (a new version of the formerly branded "RAPID" software), and (4) the Workstation and/or accessories. 1. Ingestible PillCam SBC Capsule The disposable, ingestible PillCam SBC 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 Recorder located outside the body. 2. PillCam Recorder DR3 The PillCam Recorder DR3 is an external receiving/recording unit that receives and stores the acquired images from the capsule. 3. PillCam Software The PillCam Software (previously branded as "RAPID" Software) 9.0 is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam 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 Desktop Software 9.0 supports PillCam capsule endoscopy of the gastrointestinal (GI) tract with all PillCam video capsules (SB, COLON, UGI and SBC). 4. Workstation and Accessories The Workstation is a 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.

With PillCam SB 2 and SB 3 Capsules The PillCam Capsule Endoscopy System with a PillCam SB 2 and SB 3 capsules is intended for visualization of the small bowel mucosa. - o PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. - PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules ● 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. - PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules 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 Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules 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. With PillCam ESO 3 Capsule The PillCam Capsule Endoscopy System with PillCam ESO 3 capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.. With PillCam UGI Capsule The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age. With PillCam COLON Capsule The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower GI origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

The RAPID Web is a client server based version of the RAPID video review and report creation components of the cleared RAPID 8 software. The RAPID Web is designed to allow users to review and analyze videos created using the cleared RAPID software, and to create reports over a private intranet network or over a secure internet connection. The PillCam capsule studies are created at workflow-relevant locations and stored at a central repository. The RAPID Web server is installed on a central server in an intranet or internet environment with access to the study repository. After the capsule endoscopy procedure was conducted using the cleared RAPID software, Given Workstation/User PC, PillCam capsule, and DR 3 PillCam recorder, end users will use an internet browser with authorization login to access, review, and manage the studies in the repository using workstation, user PC, a laptop or an Apple™ (screen size > 9.7").

The ManoScan System provides mapping of pressures and, optionally, impedance within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophageal sphincter (LES), stomach, Sphincter of Oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures and then store the corresponding data for visualization and analysis. The real-time data as well as the analysis information can be viewed by trained personnel for diagnostic and analytic purposes. The ManoScan HRM modules provide high-resolution mapping of the pressure and impedance data. The ManoScan CLT module provides conventional line trace mapping of the pressure data.

The ManoScan System provides hardware and software for performing gastrointestinal (GI), sphincter of Oddi, and colorectal manometry. The ManoScan System comprises two sub-systems: the ManoScan HRM System and the ManoScan CLT System. The ManoScan HRM modular series is a high resolution manometry system used for GI manometry. The base system includes a manometric catheter probe, a ManoScan HRM module (A120 module), and software for data acquisition and analysis. Various probe configurations are available depending on the application (esophageal or anorectal manometry), size (regular or small), and catheter diameter. The ManoScan A200 module enables measuring pressure and impedance data using different dedicated catheters. The ManoScan A300 module is used for high-definition 3D catheters which pass pressure data through to the ManoScan A120 module. When enabled, the optional ManoScan A400 module will enable video acquisition through video inputs that originate in typical medical imaging equipment. The ManoScan 3.0 software supports display of video from the ManoScan A400 module (or other video input) and displays it concurrently with pressure (and impedance if enabled) to allow for improved physiological review of the esophageal or anorectal motility function. The ManoScan CLT series is a conventional line trace system used for GI manometry. The system includes a manometric catheter probe, the ManoScan CLT module (A550), and software for data acquisition and analysis. The system is supplied as an integrated cart system consisting of: a cart, manometric catheter, ManoScan CLT A550 module, Computer, monitor and computer peripherals (keyboard, mouse, etc.), power isolation station, ManoScan 3.0 and ManoView CLT software. The ManoScan CLT A550 module acquires pressure data from three catheter types: water-perfused, solid state, and air-charged, manufactured by specific vendors. Each catheter type is connected to the ManoScan CLT A550 module by means of corresponding transducer cable.

The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible, In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower Gl origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

The Given PillCam Endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam capsule, (2) the DR 3 PillCam Recorder, (3) the RAPID software, and (4) the Given Workstation and Accessories. 1. Ingestible PillCam Capsule The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the PillCam Recorder located outside the body. 2. DR 3 PillCam Recorder Recorder is an external The DR 3 PillCam receiving/recording unit that receives and stores the acquired images from the capsule. The Sensor Array/belt receives data from the PillCam capsule and transfers the data to the PillCam Recorder. 3. RAPID Software The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam Recorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, inservice training videos, and patient instruction forms. 4. Given Workstation and Accessories The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. Other accessories include a flat panel LCD monitor, a highcapacity mass storage device, and a high-capacity USB portable storage device.

The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least18 years of age.

The Given PillCam Endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam capsule, (2) the DR 3 PillCam Recorder, (3) the RAPID software, and (4) the Given Workstation and Accessories. 1. Ingestible PillCam Capsule: The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the PillCam Recorder located outside the body. 2. DR 3 PillCam Recorder: DR 3 PillCam Recorder is an external The receiving/recording unit that receives and stores the acquired images from the capsule. 3. RAPID Software: The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam Recorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, inservice training videos, and patient instruction forms. RAPID 8.0 supports PillCam capsule endoscopy of the GI tract with all PillCam video capsules. In addition, RAPID 8.0 supports PillCam Recorder DR 2C and PillCam Recorder DR 3. 4. Given Workstation and Accessories: The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The PillCam Recorder is an external receiving/recording unit that receives acquired images from the capsule. The Sensor Array receives data from the PillCam capsule and transfers the data to the PillCam Recorder. Other accessories include a flat panel LCD monitor, a highcapacity mass storage device, and a high-capacity USB portable storage device.

The PillCam COLON 2 Capsule Endoscopy System is indicated to provide visualization of the colon. It is intended to be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.

The PillCam® COLON 2 capsule endoscopy system includes a single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the complex anatomy of the colon. The PillCam COLON 2 capsule is designed to withstand the mechanical forces and chemical environment of the digestive system. The system is comprised of four main subsystems; (1) the ingestible PillCam COLON 2 capsule, (2) the DR 3 PillCam® Recorder, (3) the RAPID® software, and (4) the Given® Workstation.