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The Tenex Health TX System with the TXP MicroTip is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery. The Tenex Health TX System with the TXP MicroTip is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.

The Tenex Health TX System with the TXP MicroTip is an ultrasonic surgical instrument that fragments, emulsifies and aspirates soft and hard tissue. It also provides sharp debridement of soft and hard tissue in wounds such as neuropathic ulcers. The Tenex Health TX System with the TXP MicroTip is intended for use in an office-based setting, clinical environment or hospital environment. The system consists of a console, ultrasonic MicroTip, inflation cuff, foot pedal and supply kit. The console provides power and control for the user functions including irrigation, aspiration, and ultrasonic fragmentation/emulsification. It has a large, color LCD and employs a touch-screen with a graphical user interface for selection of required settings. The console provides audible tones for confirmation of selections. The console also houses the irrigation valve, the irrigation pump and the aspiration pump. The Console is non-sterile when used and does not require processing. The ultrasonic MicroTip connects to the console for electrical power, the transfer of irrigation fluid to the surgical site and the aspiration of emulsified tissue back to the collection bag. The MicroTip is single use, sterile packaged. A single use, disposable collection bag is integrated into the MicroTip tubing to collect the aspirated materials. The connections are made via an integrated wiring connector and tubing set. The handpiece is constructed from various biocompatible polymers and metals. The tubing is made of biomedical grade PVC. The handpiece and tubing are provided sterile, via electron beam irradiation. The handpiece and tubing are a single use disposable component of the system. Irrigation fluid is delivered from a user-provided surgical saline bag, under pressure to the surgical site by operation of an air pump residing in the console. The regulated output of the air pump pressurizes an inflation cuff that is fitted over the saline bag. The foot pedal is used by the user to remotely control the function of the console. It connects to the back of the console via an electrical cable. It provides on/off functionality and is rated IPX8 for protection against liquids. The System also includes accessories. A Travel Case is provided for shipping, handling and storage of the TX Console. A power cord is provided for connecting the Console to facility electrical power in order to operate the device. A replacement fuse set is also provided in case of the need for replacement of electrical fuses in the TX Console. The accessories are non-sterile when used and does not require processing. The supply kit contains sterile packaged, single use, OEM surgical supply items for use in the surgical site preparation and closure. These include a syringe and needle, scalpel, an ultrasound probe cover, gauze, closure strips and dressing. The itemized contents of the kit with their manufacturer and regulatory information are provided in Table 4 below. The Tenex Health TX System with the TXP MicroTip is an upgrade to the Tenex Health TX System (K153299), with the addition of the TXP MicroTip, an upgraded handpiece with indications for use for the treatment of hard tissue and the sharp debridement of wounds such as neuropathic ulcers.

The Tenex Health TX System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

The Tenex Health TX System is an ultrasonic surgical aspirator that fragments, emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, inflation cuff and foot pedal. The console provides control over the user functions including irrigation, aspiration, and ultrasonic fragmentation/emulsification. It has a large, color LCD and employs a touch-screen with a graphical user interface for selection of required settings. The console provides audible tones for confirmation of selections. The console also houses the irrigation valve, the irrigation pump, and the aspiration pump, thereby eliminating the need for a dedicated service cart or suction/waste source within the operating room. The ultrasonic handpiece connects to the console for power, as well as for delivering irrigation fluid directly to the surgical site and for aspirating emulsified tissue by way of integrated tubing set. The handpiece is constructed from various polymers and metals, while the tubing is made of biomedical grade PVC. The handpiece and tubing are provided sterile. The handpiece and tubing are a single use disposable component of the system. Irrigation fluid is delivered under pressure to the surgical site by operation of an air pump residing in the console. The regulated output of the air pump pressurizes an inflation cuff that is filled around the irrigating fluid bag, thus providing irrigation at a fixed pressure. The foot pedal is used to control each of the functions (irrigation, aspiration, ultrasonic fragmentation/emulsification) of the system. It offers on/off functionality and is rated IPX8 (by the supplier) for protection against liquids.