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The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

The TX1 Tissue Removal System is an ultrasonic surgical aspirator that emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, tube set, and foot pedal: The system has been designed to work with commercially available accessories and consumables including cautery pencils and forceps, ultrasonic handpiece tips, and silicone sleeves. The console provides control over the four modes of operation including irrigation, aspiration, cutting, and coagulation. It has a large, color LCD and employs a touch-screen for selection of required settings. The console also provides audible tones for confirmation of selections. The console also houses the irrigation and aspiration pumps, thereby eliminating the need for a dedicated service cart or suction/waste source within the operating room. Two USB ports are available for loading software upgrades. An Ethernet port is also available for future system expandability. The ultrasonic handpiece connects to the console for power. and to the tube set for both delivering irrigation fluid directly to the surgical site and for removing emulsified tissue. The handpiece is constructed from both 316L stainless steel and TiAl6V4 Titanium Alloy components, and can be sterilized by steam and reused multiple times. The tube set employs an external tubing cartridge design that can be easily installed or removed in a single step. The tubing is made of biomedical grade silicone. The tube set can be sterilized by steam and reused multiple times. Irrigation fluid is delivered under pressure to ensure adequate cooling of the ultrasonic tip, as well as adequate flushing of the surgical site, by operation of an air pump residing in the console. The regulated output of the air pump pressurizes a cuff that is fitted around the irrigating fluid bag, thus providing irrigation at a fixed pressure regardless of the height of the fluid bag. The foot pedal is used to control each of the four functions of the system. Simple in design, it offers on/off functionality and is rated IPX5 for protection against liquids.

The Vizual™ Phacoemulsification System is intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy; a process known as phacoemulsification.

The Vizual™ Phacoemulsification system is a complete anterior segment surgical system, offering Irrigation, Phaco or Ultrasonic (U/S), Irrigation/Aspiration (I/A), Vitrectomy, and Coagulation modes of operation. The device can be operated as a standalone unit, or connected to an optional cart with electric I/V pole where bottle height can be controlled by the software. The Vizual™ Phacoemulsification System includes the Phaco unit, U/S handpiece, tubing cartridge, and foot pedal. The device has been designed to work with commercially available (and 510k cleared) components and accessories including Phaco tips and sleeves, vit cutters, cautery pencils, and cautery forceps. The Vizual™ Phacoemulsification System utilizes a non-invasive vacuum sensing system including an external tubing cartridge that vents to the bottle versus air, thus minimizing the possibility of introducing contamination into the fluid path. The external tubing cartridge design is advantageous as the fluid path is visible to the user, and can be easily installed or removed in a single step. The Vizual™ Phacoemulsification System uses a LCD touch panel interface to allow access to all modes of operation. The system software allows for storing up to twenty-four different user profiles.

ISurg Disposable Subdermal Needle Electrodes are intended for use with monitoring, recording and electrical stimulation equipment specifically designed for the recording of biopotential signals from electroencephalography (EEG), electromyography (EMG) and nerve potential studies. ISurg Disposable Subdermal Needle Electrodes are "Rx Only", intended for "Single Use Only" and "Sterile".

1Surg Disposable Subdermal Needle Electrodes are the conduit between the monitoring equipment and a patient. The electrode has a small gauge stainless steel needle on one end (which is subdermally positioned by a licensed physician or technologist under his (which is subcoman) pointener on the other (a safety connector which is connected to the monitoring equipment) with a small gauge wire connecting the two. The safety connector is an industry standard DIN 42802 protected connector and cannot be connected to an AC outlet. 1Surg Disposable Subdermal Needle Electrodes are used in the study of biopotentials such 13ang Disposable Daoublik (FG), electromyography (EMG), nerve conduction and evoked as crootials. They are "Rx Only", disposable (for "Single Use Only"), sterile and invasive as they are placed subcutaneously in or near nerve and muscle tissue.

The Horizon Phacoemulsification System performs phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye.

The Horizon Phacoemulsification System utilizes the same technology as the currently marketed predicate devices that employ ultrasonic energy to emulsify a cataractous lens and remove it from the eye. The intended use and performance specifications are also comparable to the predicate devices. The subject of this 510(k) is the Horizon Phacoemulsification System's design configuration of a non-invasive vacuum sensing system that maintains sterile fluids, and the unit's software controlled user interface. The Horizon Phacoemulsification System utilizes an external tubing cartridge venting to the bottle versus air, to minimize the possibility of introducing contamination into the fluid path. The external tubing cartridge design is advantageous as the fluid path is visible to the user, easily removed/ replaced at the end of the case. The Horizon system uses a software-controlled interface that assists the user in not only system set up but in all modes of operation during surgery. The advanced microprocessors allow the surgeon to program surgical parameters for up to six different users by an LCD touch panel display. The Horizon Phacoemulsification System has similar operation modes as the predicate devices, i.e. Ultrasonic (U/S), Irrigation, Irrigation/ Aspiration (I/A), Vitrectomy, and Diathermy or Coagulation modes utilized in cataract extraction. The component parts of the Horizon Phacoemulsification System include the U/S handpiece, the tubing cartridge, and the footswitch as these items can only be used with this system. The Cautery, Vitrectomy, and Irrigation/ Aspiration devices are universal-type handpieces that are considered additional accessories to the Horizon system.