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The Disposable Video Rhinolaryngoscope SP11A is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is used in conjunction with the Endoscopic Video Processor (Models M110B) to provide the images. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

The Endoscopic Video Processor M110B is used in conjunction with corresponding Wesee endoscopes to process and display images for endoscopic procedure.

The Video Rhinolaryngoscope System consists of the Disposable Video Rhinolaryngoscope SP11A, Video Cable, Endoscopic Video Processor M110B and Accessories. To avoid risk of cross-contamination, the insertion part of the Disposable Video Rhinolaryngoscope SP11A is designed as a sterile, single use device. And other parts of the subject system are reusable device.

The endoscope has a long, thin, flexible tube to enter the patient's body, and the CMOS sensor embedded in the distal end of the endoscope is used to capture video signals of body cavity and real-time transfer the video signals to the endoscopic video processor through the video cable. The endoscopic video processor receives and processes the video signals according to the surgeon's operation on the control panel of the video image processor. Meanwhile, the light emitting diode (LED) lamp of the endoscope provides an illumination for the body cavity and the clear video is displayed on the monitor.

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The LungFlow Basket Catheter is intended to be used to endoscopically remove foreign bodies from the airway.

The Free Flow Medical LungFlow Basket Catheter is a sterile, single use disposable foreign body retrieval device. The basket is designed to fully expand to make 360-degree contact with the airway wall to enable removal of foreign bodies which include inhaled objects or material, incidental medical debris, mucus, necrotic or potentially infective tissue or excised tissue from the airway, as the device is retracted proximally.

The LungFlow Basket Catheter consists of a flexible coiled stainless steel wire trunk with a multi-wire 360-degree super-elastic nitinol basket at the distal end. The LungFlow Basket Catheter is designed to be delivered through the working channel (2.0mm and 2.8mm or larger) of an endoscope, such as a rigid or flexible bronchoscope.

The LungFlow Basket Catheter is provided in configurations with a handle to manually assist the distal basket expansion or with a self-expanding distal basket.

The LungFlow Basket Catheter may be delivered into distal lung airways using a compatible airway catheter if the catheter has been advanced through a therapeutic bronchoscope and into lung tissue with guidance provided by bronchoscope. Both manual expansion and self-expanding configurations are intended to be delivered distal to a foreign body before expansion. The LungFlow Basket Catheter will be provided in configurations that can expand up to 30mm in diameter. The basket is designed to fully expand to make 360-degree contact with the airway wall to enable reliable removal of foreign bodies from the airway.

Each LungFlow Basket Catheter is individually packaged and sterilized using electron beam (e-beam) radiation.

The LungFlow Basket Catheter is manufactured in the United States.

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The LIA-1 Catheter is intended for use through a compatible bronchoscope in the tracheobronchial tree for Optical Coherence Tomography (OCT) guided Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) of endobronchial lesions, peripheral lung nodules, and lung masses. The device collects real-time two-dimensional, cross-sectional depth images which are visualized for evaluation of human tissue microstructure on the LIA Console.

Do not use this device for any purpose other than its intended use. This device is intended to provide an image of tissue microstructure in the tracheobronchial tree and parenchyma. The safety and effectiveness of this device for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

LIA-1 Catheter is a sterile, single-use, Optical Coherence Tomography (OCT) image-guided biopsy needle which is an assembly consisting of a Handle, Outer Sheath, Needle, and Imaging Stylet (iStylet). The Outer Sheath and Needle are attached to Actuation Handle and the iStylet is located within the Needle.

Outer Sheath: The LIA-1 Catheter Outer Sheath consists of a clear tube attached to the Handle.

Handle: The LIA-1 Catheter Handle allows the user to actuate the needle from the distal tip of the Outer Sheath, and to actuate the iStylet into or out of the Needle tip, or to be retracted for biopsy collection, as necessary.

Needle: The 21G stainless-steel Needle has a beveled, sharpened tip for puncture and tissue collection.

Imaging Stylet: The iStylet consists of a shaft and imaging core serving as an optical imaging probe. It provides real-time imaging for its intended use.

The LIA-1 Catheter is intended to be used only in conjunction with the LIA Console in order to function as intended.

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This product is an ultrasonic endoscope intended for the observation, diagnosis and endoscopic treatment of the esophagus, trachea, bronchus and lesions adjacent to these structures using ultrasonic images, at medical facilities under the management of physicians.

This product is not intended for use on children and infants.

EB-710US (referred to as 'the device') is a medical ultrasonic electronic endoscope. The device is inserted into a lumen, a coelom, body cavity, or inside of a body, and provides images for observation, diagnosis, photographing, or treatment. It is also used for ultrasonography by visualizing the shape, the characteristic, or the dynamics of the inside of the body.

This product is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion portion is flexible and contains glass fiber bundles, a channel, a complementary metal-oxide semiconductor (CMOS) image sensor and a ultrasonic transducer in its distal end. 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 CMOS image sensor to capture an image and display it on the monitor. The channel in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor.

This product is used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart. And the device drives ultrasonic transducer installed in the distal end of the device by being connected with a ultrasonic processor.

The driven ultrasonic transducer emits ultrasound into the body, and receives the reflected ultrasonic signal from the body. The ultrasonic processor connected to the device performs image processing using the received signal. The electric signal of the image processing is converted into video signal, and it is output to the monitor as a ultrasonic image.

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The Flexible Intubation Video Endoscope – Sterile (FIVE-S) is intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in bronchoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.

E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

The videoscopes in the modified Flexible Intubation Video Endoscope – Sterile (FIVE-S) is sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor (when using the Image1 S CCU), where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into the compatible CCU (Camera Control Unit) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.

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The Compass Steerable Needle is a steerable transbronchial biopsy needle intended to be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.

The Compass Steerable Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions. The Compass Steerable Needle include two model numbers, Model CSN1001 and Model CSN1002. Model CSN1001 includes two accessory adapters for attachment to bronchoscopes.

The subject of this 510(k) is the addition of two new adapters to Model CSN1002. Adapter SRA-1-01 connects the Model CSN1002 to the Ion™ Endoluminal System, and Adapter SRA-2-01 connects the Model CSN1002 to the Monarch™ Platform or Galaxy System™.

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These single-use biopsy forceps are specifically designed to collect tissue endoscopically for histologic examination. These forceps should not be used for any purpose other than their intended function.

The Radial Jaw™ 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) is a sterile, single-use device. The RJ4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8 mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0 mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length, and are offered in Box 5 and Box 20 packaging configurations.

To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.

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The sterile single-use flexible video bronchoscopes are designed to be used with the Himaging endoscopic video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Himaging bronchoscope system is applicable to hospital environment or medical office environment.

The Himaging bronchoscopes are sterile single-use devices designed for use in adults.

The subject device, Himaging Bronchoscope System, is consisting of a single-use flexible video Bronchoscope and an endoscopic video processor. The subject device has been designed to be used for endoscopy within the airways and tracheobronchial tree.

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The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

The Ion Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint Software, a System Cart with System Software, a Controller, Instruments, and Accessories.

The IF1000 Instruments include the Ion Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision Biopsy Needles.

The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint Software.

The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader in the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.

The Controller is the user input device on the Ion Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.

The Ion Endoluminal System integrates an optional Tomosynthesis feature, optimizes the existing Cone Beam CT workflow, improves the Navigation View, troubleshoots the airway tree, and enhances the control algorithm to provide an additional safety margin.

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The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis. The system is indicated for use with adult and pediatric populations. Pediatric use is limited to patients who are 5 ft (152.5 cm) or taller and weigh 102 lbs (46 kg) or greater.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.

The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.

The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader in the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.

The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.

The IF1000 System and PlanPoint Software are modified to enable Remote Software Updates from the Intuitive server via secure network communication.

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