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The PENTAX Medical Video Colonoscope EC38-i20cWL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.

The PENTAX Medical Video Colonoscope EC38-i20cWL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract.

PENTAX Medical Video Duodenoscope ED34-i10T2s: The PENTAX Medical Video Duodenoscope ED34-i10T2s is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations. PENTAX Gas/Water Feeding Valve OF-B194: Gas/water feeding valve is attached in place of air/water feeding valve to the gastrointestinal endoscope, in order to prevent the leaking of the nonflammable gas into the room, and feed the gas or water into the gastrointestinal tract or abdominal cavity. It also prevents back flow/splashing of body fluids. PENTAX Medical Video Processor EPK-i8020c: The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes. PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63: The PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 fully integrates a movable elevator, whose function it is to guide endoscopic devices. The OE-A63 is controlled by the PENTAX Medical Video Duodenoscopes and is necessary to meet the intended use of the duodenoscope.

PENTAX Medical Video Duodenoscope ED34-i10T2s is designed to be used with a PENTAX Medical Video Processor, documentation equipment, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the biliary tract via the upper gastrointestinal tract. The PENTAX Medical Video Duodenoscope ED34-i10T2s is compatible with the hydrogen peroxide gas plasma sterilizer STERRAD 100NX.

The C2 CryoBalloon™ Ablation System is intended to be used as a cryosurgical tool in the field of general surgery. specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia and treatment and management of Gastric Antral Vascular Ectasia (GAVE).

The subject device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working chamel inner diameter of 3.7 mm and maximum length of 105 cm. The subject device is a cryosurgical system comprised of four components including a Catheter (sterile, single use), Controller (non-sterile, reusable), Foot Pedal (non-sterile, reusable), and Cartridge (non-sterile, single use). The system also includes NitroClip as an accessory that is intended to reduce the nitrous oxide exposure in the room. The subject device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors ancillary equipment for gastrontestinal and pulmonary endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment. The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling. The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

PENTAX Medical Single Use Video Bronchoscope EB-S01 are sterible endoscopes intended for use with PENTAX Medical mobile processor, therapeutic accessories, and other ancillary equipment for endoscopy and endotherapeutic procedures within the airways and tracheobronchial tree. PENTAX Medical Mobile Processor ONE-M is intended to be used with PENTAX Medical endoscopes and other peripheral devices for endoscopic diagnosis, treatment and video observation. PENTAX Medical Mobile Processor Plug-in ONE-Dock is intended to the PENTAX Medical Mobile Processor to provide additional ports for hardware interface.

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is intended to provide the optical visualization of the airways and tracheobronchial tree for diagnostics and therapeutic applications. The PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System consist of the following three component devices: - . PENTAX Medical Single Use Video Bronchoscope EB11-S01 / EB15-S01 - . PENTAX Medical Mobile Processor ONE-M - PENTAX Medical Mobile Processor Plug-in ONE-Dock The EB11-S01 / EB15-S01 endoscopes are connected to the ONE-M and video images captured with the bronchoscope are displayed on the touch screen of the ONE-M. The ONE-M is also connected to the Plug-in ONE-Dock, which has several interfaces, such as an external monitor to display captured images by the bronchoscope and a connection with an external network.

The Gas/Water Feeding Valve OE-B14 is intended to be attached in place of Air/Water Feeding Valve (OE-B12) to PENTAX Medical GI endoscopes and used to feed the gas/water to the body (via the air/water channel).

The Gas/Water Feeding Valve OE-B14 is intended to be attached in place of Air/Water Feeding Valve (OE-B12) to PENTAX Medical GI endoscopes and used to feed the gas/water to the body (via the air/water channel). The OE-B14 is attached onto the air/water feeding cylinder of the control body of PENTAX Medical endoscope. The endoscope is linked to non-flammable gas cylinder and the water bottle assembly via air/water feeding circuit. The device descriptions for the PENTAX Medical EPK-i8020c Video Imaging System remain unchanged from K231249. They include the PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, and PENTAX Medical Video Colonoscope EC38-i20cL.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes. The PENTAX Medical Video Upper Gl Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems: esophagus, stomach, and duodenum. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight. The PENTAX Medical Video Colonoscope EC38-120cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment. The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling. The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is supposed to be found in the instructions for use (IFU) and/or in the commercial materials such as brochures. The PENTAX Medical Video Upper GI Scope EG29-i20c is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the upper gastrointestinal tract. The PENTAX Medical Video Colonoscope EC38-i20cL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract. The device is equipped with stiffness setting mechanism for the insertion tube. This feature enables the physician to choose the stiffness of the insertion tube, depending on the preferred level.

PENTAX Medical Single Use Video Bronchoscope EB-S01 is sterile single use flexible endoscopes intended for use with PENTAX Medical mobile processor, therapeutic accessories, and other ancillary equipment for endoscopy and endo-therapeutic procedures within the airways and tracheobronchial tree. PENTAX Medical Mobile Processor ONE-M is intended to be used with PENTAX Medical endoscopes and other peripheral devices for endoscopic diagnosis, treatment and video observation. PENTAX Medical Mobile Processor Plug-in ONE-Dock is intended to be attached to the PENTAX Medical Mobile Processor to provide additional ports for hardware interface.

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is intended to provide the optical visualization of the airways and tracheobronchial tree for diagnostics and therapeutic applications. The PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System consist of the following three component devices: - . PENTAX Medical Single Use Video Bronchoscope EB11-S01 / EB15-S01 - . PENTAX Medical Mobile Processor ONE-M - . PENTAX Medical Mobile Processor Plug-in ONE-Dock The EB11-S01 / EB15-S01 endoscopes are connected to the ONE-M and video images captured with the bronchoscope are displayed on the touch screen of the ONE-M. The ONE-M is also connected to the Plug-in ONE-Dock, which has several interfaces, such as an external monitor to display captured images by the bronchoscope and a connection with an external network.

The PENTAX Medical Video Esophagoscope EE17-J10 is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems of esophagus and gastro-esophageal junction. This endoscope is introduced via the mouth or nose when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

The PENTAX Medical Video Esophagoscope EE17-J10 is intended to be used with a PENTAX Video Processor, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the esophagus and Gastro-Esophageal Junction. This anatomy includes, the following organs, tissues; and subsystems: Esophagus and Gastro-Esophageal Junction. The EE17-J10 is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion is inserted into the body cavity of patient. The insertion portion includes the distal end and bending section. The objective lens, light guide, instrument channel and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connected to the video processor via electrical contacts. The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned. The remote button is used to operate the functions of the video processor and any external device from the control body, as necessary. Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel. The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guides the light from light guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the monitor. The PENTAX Medical Video Processors EPK-i7010 and EPK-3000 are compatible with PENTAX Medical Video Esophagoscope EE17-J10. The PENTAX Medical Video Esophagoscope EE17-J10 is provided with the following accessories: - Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill the chemical solution inside the channel. - Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination. - Suction Control Valve - intended to control suction. - Air/Water Valve - intended to control air and water feeding. Additional accessories for reprocessing are provided with the device. These include a Cleaning Adapter, Soaking Cap, Ventilation Cap, Endoscope Cleaning Brush Kits, and replacement O-Rings.

PENTAX Medical EPK-3000 Video Processor is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy. The PENTAX Medical EPK-3000 Video Processor includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL-1570STK, VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy. The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i- Scan™, a digital, post-processing imaging enhancement technology.

PENTAX Medical EPK-3000 and ENT Video Imaging Systems are used for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation. The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a video processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on the system's control panel. The light from a xenon lamp at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor. The new component to be added to the subject system is the PENTAX Medical Camera Head, model PVK-J10. The PVK-J10 is used in conjunction with a non-video endoscope, video processor, and light guide. The non-video endoscope is connected to the video processor via the camera head and the light guide. The light supplied from the video processor is transmitted to the distal end of the endoscope via the light guide and connector in order to illuminate the patient's body cavity. Light captured by the endoscope are converted into the video signals by the camera head, and the signals are transferred to the video processor to display the video images on the monitor. The PVK-J10 camera head connects to rigid, non-video sinuscopes (K142249). It takes images formed on the ocular lens by CCD sensor inside the control head, and transmits the image signal to the video processor. Image signal from CCD sensor is adjusted in terms of color, contrast, etc., inside the video processor, and displayed on video equipment such as a monitor. The camera head has a zoom function with focal lengths of 6.5 mm for the wide end and 13mm for the telephoto end. The video processors to be connected to the PVK-J10 camera head and light guides are PENTAX Medical Video Processors EPK-i5010 and EPK-3000, both of which have been cleared. PENTAX Medical sinuscopes 8890, 8891,8892, 8893, manufactured by Schoelly Fiberoptic GmbH and cleared under K142249. The light guides 8899HT used to connect PVK-J10 with these endoscopes are also manufactured by Schoelly Fiberoptic GmbH.