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The BAROnova Access Sheath Kit is used in conjunction with an endoscope for procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract, with or without instruments through the instrument chamel of the endoscope. The BAROnova Access Sheath Kit is used in conjunction with the TransPyloric Shuttle Delivery Device to facilitate insertion and positioning of the device during TPS delivery and deployment. The Access Sheath Kit is NOT indicated for foreign body removal or instrument use alongside the endoscope.

The BAROnova Access Sheath Kit includes the following products: - BAROnova Access Sheath (with obturator) - Endoscope (Seal) Cap - Insufflation Syringe The BAROnova Access Sheath consists of a clean, non-sterile mated Obturator/Access Sheath Assembly. The Access Sheath is composed of thinwalled tubing, a handle and a distal cuff and balloon with an atraumatic tip. The Obturator is made of flexible tubing with an atraumatic tip. The Seal Cap consists of a non-sterile, plastic cap for use with standard endoscopes. A 10cc syringe is also provided with the Access Sheath Kit to enable balloon inflation and deflation.

The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device. The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool is designed to facilitate use of the BAROnova TPS Delivery Device.

The BAROnova Accessory Kit includes the following products: - BAROnova Insufflation System - BAROnova Transpyloric Shuttle (TPS) Stand - Hook Tool The BAROnova Insufflation System is designed to provide pressure-controlled air to the stomach for insufflation within the gastric space during endoscopic procedures for placement of the BAROnova Transpyloric Shuttle (TPS) device. The Insufflation System is used in conjunction with the BAROnova TPS Delivery Device to facilitate TPS skin expansion during deployment once the Delivery Device is inserted. Prior to initiating TPS coil advancement with the handle controls, the TPS Delivery Device is connected to the reusable Insufflation System using the disposable tubing set provided within the TPS Delivery Device Kit. The reusable components of the Insufflation System are composed of a portable air Compressor, a Power Adapter, and Pressure Regulator Box. The air Compressor and Power Adapter are the identical components as utilized in the PARI Trek S nebulizer (K060357). The Pressure Regulator Box includes a precision low-pressure regulator and redundant pressure relief valves to limit system output pressure. The Box also includes a calibrated pressure gauge for testing and monitoring the performance of the system. The BAROnova Insufflation System allows the physician to deliver pressure-controlled air to the patient in a manner consistent with that being done currently in a routine endoscopic procedure with room air which is supplied by an air pump in the console of the endoscopic equipment. The TPS Stand (Class I, regulated under 878.4800 – Manual surgical instrument for general use) and Hook Tool (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology Surgical Instrument and Accessories), are optional accessories included in the Accessory Kit for use with the BAROnova TPS Delivery Device. The TPS Stand is a non-sterile, reusable plastic stand with a weighted aluminum base provided for the convenience of the operator, and can be used to support the TPS Delivery Device handle during TPS deployment. The Hook Tool is a stainless steel reusable tool which may be used to facilitate cutting of tension lines for deployment troubleshooting.

The disposable Overtube is a device used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract. The Endoscope Caps are intended to keep suitable endoscopic view field during endoscopic procedures.

The BAROnova Retrieval Kit includes the following products: - BAROnova Overtube Set (Overtube with a mated Obturator and • Seal Cap) - Endoscope Cap Set (Endoscope Caps, Small and Large) ● - Push Tube ● The BAROnova Overtube Set (BAROnova Overtube) consists of a non-sterile, polymer extrusion with a metallic coil reinforcement, atraumatic tip and handle, in addition to a mated Obturator made of flexible PVC with a tapered tip, and a flexible polymer seal cap. The BAROnova Endoscope Cap Set (BAROnova Endoscope Caps) consists of two non-sterile, plastic caps for use with standard endoscopes. The Endoscope Caps are provided in two sizes to accommodate a range of standard endoscope sizes. The Push Tube (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology-Urology Surgical Instrument and Accessories) and the Endoscope Cap Sizing Guide (Class I, regulated under 876.1500 - Endoscope and Accessories), are optional accessories included in the Retrieval Kit for use with the BAROnova Overtube and BAROnova Endoscope Caps respectively. The Push Tube is a non-sterile, plastic probe with a handle, which may be used to facilitate removal of foreign objects through the BAROnova Overtube. The Endoscope Sizing Cap Guide is an optional accessory for the BAROnova Endoscope Caps to assist the user in selecting the correct size Cap.