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The EndoSign® Cell collection device is to be used for the collection of cells from the surface of the oesophagus for molecular, cytological and histological analyses.

The EndoSign® Cell collection device is to be used for the collection of cells from the surface of the oesophagus for molecular, cytological and histological analyses. It is a non-sterile low risk, transient use, minimally invasive, single use, oesophageal cell collection device designed for use by trained and qualified medical professionals. The device is composed of a clear, size 00 capsule made from vegetable-derived material. The capsule houses a 30mm compressed spherical sponge and is connected to a non-absorbable silicone-coated braided polyester thread, secured to a clear polycarbonate applicator. The patient swallows the capsule along with the bundled thread, and as it travels through the oesophagus, the capsule dissolves allowing the sponge to expand and release. The thread is then gently pulled to retrieve the sponge, which collects cells from the lining of the oesophagus as it is removed. The device is used to collect cell samples which are further analyzed for identification of disease biomarkers. The results of the test will be used to assess patients suspected of oesophageal pathologies such as Barrett's oesophageal cancer, eosinophilic esophagitis, and other abnormalities.

The EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults and adolescents, 12 years of age and older.

The EsoCheck Cell Collection Device is a non-sterile, single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis. The subject device is technologically identical to the previously-cleared predicate device (K222366). The only modification to the subject device is of its sterility, which has been modified to non-sterile (i.e., provided non-sterile and not requiring end-user sterilization before use).

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.

The EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults and adolescents, 12 years of age and older.

The EsoCheck Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophaqus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.

The gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses.

The EsophaCap® Swallowable Cellular Retrieval Device is a non-sterile, non-endoscopic, singleuse Esophageal cell sampling device. The EsophaCap® is composed of an open-cell polyether polyurethane foam sphere attached to a polyester tether cap. The open-cell foam sphere ranging in diameter sizes from 20 mm to 35mm is compressed and encapsulated within a vegetable (hypromellose (HPMC)) capsule. When swallowed the EsophaCap® capsule dissolves releasing the foam sphere. The foam sphere expands to form a cytology and cellular retrieval device that allows a circumferential "bottle brush" collection using the expanded "open cell" foam sphere. The radiopaque polyester tether/stylus is used to slowly withdraw the foam sphere through the esophagus and then to subsequently retrieve the foam sphere with the cellular sample.

The EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults, 22 years of age and older.

The EsoCheck Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis. This version of the device is a modification to the predicate EsoCheck CCD Cell Collection Device that was cleared under K183262. The minor changes made to the device include minor changes to the secondary packaging design change (addition of a tether) to increase tensile stiffness of the catheter during removal. In addition, the previous version of the device utilized 2 syringes, a 20cc syringe and a 5cc syringe, to complete the procedure. The modified device will utilize a single 20cc syringe to streamline the process and the syringe will have markings printed on its surface indicating different volumes.

The CMOS Video Esophagoscope SSU is intended to provide visualization of nasal sinuses, larynx, esophagus and gastroesophageal junction during diagnostic procedures. The E-Box serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

The CMOS Video Esophagoscope SSU System includes three main components: (1) the CMOS Video Esophagoscope SSU (091370-01), (2) E-Box adaptor (TP010) and (3) the CCU. CMOS Video Esophagoscope SSU is compatible with two KARL STORZ CCUs: C-HUB and C-MAC. CMOS Video Esophagoscope SSU is provided sterile single-use.

The EsoCheck CCD Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults, 22 years of age and older.

The Lucid Diagnostics EsoCheck™ CCD Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.

The Strome-Blitzer Cytology Balloon device is indicated for use in the 4-quadrant collection and retrieval of surface cells from the esophagus in adults (22 years of age or older). The device may be delivered transorally under direct endoscopic visualization.

The Strome-Blitzer Cytology Balloon is an inflatable biopsy platform. It consists of a catheter with a silicone balloon at its distal end. The balloon has 6 collection pleats on its surface. Inside each pleat are 2 cytology collection strips for specimen collection. While the balloon is uninflated, the strips are covered by the balloon pleats. When inflated, the strips are exposed. The balloon inflates and deflates with the use of a syringe and attached catheter, and is a sterile, single-use device. There are 4 location indicator dots on the proximal balloon surface for orientation during esophagoscopy.

The PrimeSight™ UNITY 9000 Series Video Processors, when used in conjunction with a Cogentix Medical flexible videoscope, are indicated for the display and management of video and images during trans-nasal esophagoscopy, cystoscopy, bronchoscopy and nasopharyngoscopy procedures.

The PrimeSight™ UNITY 9000 and PrimeSight™ UNITY 9100 Video Processors (herein referred to as "UNITY 9000", "UNITY 9000 Processor" or "UNITY 9000 Series Video Processors") are video processing units designed to work exclusively with the Cogentix Medical TNE-5000, CST-5000, CST-5000i. BRS-5100 and ENT-5000 models of flexible videoscopes (herein referred to as "5000 Series Videoscopes") to display images and videos during endoscopic procedures. The UNITY 9000 Processor consists of two modules which are physically connected with a hinge mechanism. The all-inone computer (AIO PC) unit is used for the presentation and display of images and includes a large 19'' wide screen display with an integrated touchscreen. The Camera Interface Module (CIM) base unit allows for the connection of a videoscope or camera to the Processor, as well as any endoscopic peripherals being used during the procedure, as well as image processing. There are two different model configurations available for the UNITY 9000. These models are offered specific to the type of endoscopic procedure being performed. The Base Configuration model (UVP-9000) supports urology and bronchoscopy applications, while the Airway Configuration model (UVP-9100) offers an integrated air pump for trans-nasal esophagoscopy and a stroboscopy interface for use during Ear, Nose, and Throat (ENT) stroboscopy examinations.