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The Disposable Grasping Forceps FG-52D/54D are intended to be used to retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope.

The Disposable Grasping Forceps FG-52D/FG-54D are designed to retrieve foreign bodies, calculus, or tissue specimens endoscopically within the tracheobronchial tree when used in conjunction with a compatible endoscope. Each device is provided sterile and consists of a handle and an insertion portion. The handle (proximal portion) of the Disposable Grasping Forceps includes a ring which can be pushed or pulled to open or close the grasping portion of the device. The distal end of the insertion portion consists of the grasping portion of the device. The grasping portion, manufactured from stainless steel, is provided in two shapes: spiral basket type (model FG-52D) and three nail type (model FG-54D) and has limited contact with the patient. The user will select the device model depending on procedural needs.

The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. Intended patient population: Adults

The Disposable Cytology Brush is a sterile, single-use device as a kind of accessories for bronchial endoscopy. The Disposable Cytology Brush is intended to be used in conjunction with a bronchoscope to collect cells from the bronchi. The Disposable Cytology Brush is designed to insert through suitable endoscope's accessory channel to collect cells from the bronchi. The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/ pull rod. The Disposable Cytology Brush has two different models depending on different design of the brush head. The WB series is a cytology brush with straight type of brush head and the XA series is a cytology brush with oval type of brush head. Each model has different specifications depending on different working length.

METIC™ – Airway Balloon Catheter is intended to dilate strictures of the airway.

The METIC™ – Airway Balloon Catheter is comprised of a single lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A Luer at the proximal end is used for the placement of the stylet and injecting sterile water into the balloon.

The Praxis Medical EndoCore is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. For any patient 18 years and older - requiring tissue sampling.

The EndoCore is intended to be used with endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.

The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure. The single use ANDORATE® Biopsy Valve is used to cover the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.

The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.

MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.

The MultiStage Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree. Balloons designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon material is made of Pebax material. The MultiStage Balloon Dilatation Catheter designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through a minimum 2.8mm working channel bronchoscope. The Catheter hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture.

The Compass Steerable Needle is a steerable biopsy needle intended 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 Needles (CSN) are sterile, single use, 22-gauge needles with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions. The Steerable Needle consists of a handle, shaft, and needle. The handle provides the user with control of device rotation, extension, retraction, distal tip articulation of 70°±10° unidirectionally within a plane and a sampling mechanism to extend and retract the needle out of the shaft to obtain tissue samples. A Luer connector on the proximal end of the device provides the connection for the stylet or a syringe for aspiration during sampling. There are two models of the Compass Steerable Needle. Model CSN1001 can be coupled to Olympus® 190 or Pentax® bronchoscopes with a 2.0 working channel and 600 mm working length. It is packaged with a stylet, and adapters. Model CSN1002 can be coupled to the Medtronic Illumisite™ Extended Working Channel (EWC) with a 2.0 mm working channel. It is packaged with a stylet. The Compass Steerable Needles with stylet are inserted and coupled to either a bronchoscope or a Medtronic Illumisite EWC. The translation arm advances the device into the lung. Depressing the plunger articulates the distal end of the shaft. The sampling mechanism is depressed extending the needle to obtain a sample.

The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.

The proposed device Endobronchial Ultrasound Aspiration Needle is a sterile, single-use bronchoscopic device, is designed to sample targeted submucosal and extramural lesions of the tracheobronchial tree. The Endobronchial Ultrasound Aspiration Needle consists of an Aspiration Needle, Adaptors and Negative suction device (Stopcock and Syringe). Wherein, the Aspiration Needle consists of a handle, sheath, needle, and stylet. The handle is connected to the channel port of a bronchoscope via the proper adaptor. The needle is deployed in the sheath and projected from the sheath to penetrate the target lesion to serve sample by advancement of handle. The stylet is in place in order to provide protection to the inside of the needle tube and sheath during device passage, and also used to expel the sample after the procedure. The adaptors are provided different bronchoscopes with compatibility and attached onto the channel port as the middleware between a bronchoscope and the aspiration needle. The negative suction device is connected to the proximal end of the handle to aspirate the removed tissue. The Endobronchial Ultrasound Aspiration Needle has echogenic features and is visible under ultrasound at the distal end to facilitate real time visualization of the device under ultrasound. The proposed device has six models, and the main differences of these models are diameter and tip type of the needle. The Endobronchial Ultrasound Aspiration Needle offers 19G, 22G, 25G needles by size or gauge to respond various clinical options of accessing and sampling. There are two kinds of different tip design (bevel and trident) of needles for FNA (Fine Needle Aspiration) and FNB (Fine Needle Biopsy). The device is identified as is Areus™ Endobronchial Ultrasound Aspiration Needle and Trident™ Endobronchial Ultrasound Aspiration Needle by trade name. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10th and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The Elation™ Pulmonary Balloon Dilation Catheter is intended to be used to endoscopically dilate strictures of the trachea and bronchi.

The Pulmonary Balloon Catheters are multi-lumen catheters with a dilation balloon on the distal tip. The catheters have two extension legs with luer connectors on the proximal end. The catheter is designed to pass through the working channel of a bronchoscope and accept a 0.035 in (0.89 mm) X 260 cm guidewire lumen. Two redundant inflation lumens are used to inflate and deflate the dilation balloon. The dilation balloon will be available in a 7.5F catheter with a length of 1.5 cm and in one additional balloon diameter of 4mm range that will be added to the current range from to 20 mm. Each balloon size will inflate to three different diameters for the specified inflation pressures. The balloon will be identifiable with both endoscopic and radiopague marker bands. A glow-in-the-dark tag that can be read in low light conditions is attached to the catheter shaft. The tag indicates diameter and corresponding pressure of the balloon.

The Trachealator is indicated for use in dilatation techniques to open or expand stenosis in the airway.

The D35 Airway Dilation Catheter (marketing name: Trachealator) is a sterile single-use device used during airway dilatation procedures. The proposed device consists of a series of parallel balloons on a catheter which, when deployed, provides an outward radial force while also creating an inter balloon space or passage for airflow. Thus, airway occlusion is avoided. The D35 Airway Dilation Catheter is also packaged with a double-ended PTFE-coated stainlesssteel guidewire. The guidewire consists of a two-tip configuration with a length of 1500 mm. One end has a straight tip configuration, while the other end consists of a J-tip with a 6 mm diameter. The catheter is also used with an inflation device that is not provided with the catheter. The D35 Airway Dilation Catheter is provided in nine models. The only differences between the models are the balloon length and diameter.