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The ultrasonic gastrovideoscope (hereinafter called endoscope) is intended to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs. The endoscope should be used in the medical institution. The operator of the endoscope should be a physician or a medical staff supervised by a physician, both of whom have received sufficient training in clinical endoscopy technology.

The subject device, Ultrasonic Gastrovideoscope, is consisting of insertion, control section and connector section. The insertion is consisting of a distal end, a bending section and an insertion tube. This Ultrasonic Gastrovideoscope is intended to use in conjunction with Endoscopic Image Processor (HD-550Exp, HD-550, HD-550Pro, HD-550S, HD-510 and HD-500Plus), light source (VLS-55Q, VLS-55T, VLS-51D and VLS-51T), ultrasound system (P60 Exp, P60, P60 Pro, P60 CV, P60S and P60 VO) and monitor to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs. The Ultrasonic Gastrovideoscope is a reusable device. The Ultrasonic Gastrovideoscope has only one model EG-UR5. The prospective clinical value of the enhanced imaging modes (EWL, SFI, and VIST) has not been demonstrated, and no clinical claims are made.

The EndoSound Vision System (EVS), when affixed to an endoscope, is intended to provide ultrasonic visualization of, and ultrasound guided therapeutic access to the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The EVS, mounted on an endoscope, is introduced orally when indications consistent with the requirement for a GI procedure are met. The EVS is a prescription only device to be used by a qualified physician. The clinical environments where the system can be used include clinics, hospitals, and ambulatory surgery centers.

The EndoSound Vision System® (EVS) is an add-on ultrasound system designed to attach externally to an upper gastrointestinal (GI) endoscope (gastroscope/upper (EGD) endoscope). Once attached, it temporarily converts an EGD endoscope to a fully capable EUS endoscope. The EVS consists of: - an electronic ultrasound beamformer/image analyzer (EVSScanner), - a reusable transducer assembly (Ultrasound Transducer Module (UTM)), . - . a cable/connector to interface the transducer to the beamformer (Transducer Extension Cable (TEC)). - a sterile, disposable mounting kit with an operator control mechanism (Ultrasound Disposable Kit (UDK-T)) used to externally affix the EVS to a standard gastroscope/upper (EGD) endoscope and to provide needle and transducer angle control. When attached to an upper GI endoscope, the EVS enables real-time ultrasound imaging, ultrasound quided needle aspiration and other EUS quided procedures within the upper gastrointestinal tract and surrounding organs. Native functions of the gastroscope including video imaging, articulation insufflation and suctioning are available after attachment of the EVS device. The system works in tandem with a PC computer/monitor/tablet connected via a USB 3.0 cable that runs custom software (EVSViewer) and provides the user interface and ultrasound display.

The Acquire S Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

The Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is an endoscopic ultrasound biopsy needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The device sheath length can be adjusted to accommodate different model echoendoscopes. The need to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Both the sheath and needle length can be adjusted based on distance to the target lesion. The sheath and needle length adjustments are set and locked by the physician by using the locking knob mechanisms on the handle of the device. A sample is obtained by penetrating the lesion with the needle while applying suction and manipulating the needle in a back and forth motion to acquire a sample. The sample can be prepared per normal institutional protocol. The Acquire™ Needle has echogenic (visible under ultrasound) features at the distal end to facilitate real time visualization of the device under ultrasound. Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.

FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants.

FUJIFILM Ultrasonic Endoscope EG-740UT is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors, and peripheral devices such as monitor, printer, foot switch, and cart.

Endoscope Model EG-580UT FUJIFILM Endoscope Model EG-580UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants. Endoscope Model EG-580UR FUJIFILM Endoscope Model EG-580UR is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants.

Endoscope Models EG-580UT and EG-580UR are comprised of three general sections; a control portion. an insertion portion, and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains class fiber bundles, several channels, and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The qlass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors or diagnostic ultrasound systems, and peripheral devices such as monitor, printer, foot switch, and cart.

The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. Modes of Operation: B-mode This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode

The FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 consists of five components: 1) processor (SP-900), 2) probe (PB2020-M2), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in PB2020-M2, which is inserted through the forceps channel of an endoscope. SP-900 processes the reflected ultrasound signals which PB2020-M2 receives in the body cavity and further converts the processed electrical signals to relay to a monitoring system. SP-900 can acquire and display real-time ultrasound data in B-mode. CP-900 is used to control operational features of SP-900. RS-900 provides the mechanical scanning for acquiring a two-dimensional image. The power cord supplies power to SP-900.

The device is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.

The proposed Endoscopic Ultrasound Aspiration Needle is a sterile single-use device, designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope. The Endoscopic Ultrasound Aspiration Needle consists of an Aspiration Needle and negative suction device. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 2 years.

The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations. The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed) includes three endoscope models EG34-J10U. EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes, and is used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with FDA cleared PENTAX Medical Video Processors (a software-controlled device) and FDA cleared Hitachi Ultrasound Scanners (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air, water, and suction. The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a linear or radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced. The video processor contains a lamp that provides white light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received, and the signals are passed to the ultrasound scanner for processing and display. EG34-J10U, EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes are connected to the ultrasound scanner ARIETTA 70 and the ALOKA ARIETTA 850 via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector. The instrument is immersible (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope Operators Manual cleaning instructions). The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Proposed) connects with a video processor and an ultrasound scanner, both of which are software-controlled devices. The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit. The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position control, and ports for manual balloon insufflation/evacuation, and an accessory inlet. The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a convex array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices may be introduced. The video processor contains a lamp that provides white light focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners ARIETTA 70, ALOKA ARIETTA 850, and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.

The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The EG34-J10U, EG36-J10UR and EG38-J10UT Ultrasound Upper GI Video Scopes, are endoscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with cleared Pentax Video Processors (a softwarecontrolled device) and cleared Hitachi Ultrasound Scanners (a software-controlled device). The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effectively transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a linear or radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced.