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This instrument has been designed to be used with an Olympus Light Source, documentation equipment, display monitor, suction pump, Endo-Therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.

The subject device, the XCYF-TP3 is basically identical to the predicate device (XCYF-1T3) which is the flexible endoscope for use in the bladder, urethra and kidney. Subject device may be used with three different Light source as follow, · A rechargeable powered Miniature Light source, or, · A battery powered Miniature Light source as predicate device, XENF-DP, or, · Light guide cable as predicate device, XENF-DP. In conclusion, this subject device is technically the same as the predicate device, which we describe in the table above.

The SpectraScience™ Reusable Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for bistological examination. The instruments are intended for endoscopic gastrointestinal and urologic biopsy and should not be used for any purpose other than their intended function.

The current biopsy forceps design has not changed during its long course of past clinical utility. The standard hinged design utilizes cup-shaped jaws to bite or pinch off tissue with minimal complications while providing a viable tissue sample. The cup-shaped jaws also serve to hold the biopsy sample within the forceps until the tissue can be transferred to a biopsy container. The proposed SpectraScience™ Reusable Biopsy Forceps uses the most basic of standard design. The mechanism of action of the SpectraScience™ design is identical to predicate devices in that the same standard mechanical design, materials and sizes are utilized. Using essentially identical mechanisms of action and materials results in identical clinical performance. The SpectraSciences design employs an adjunctive technological characteristic. The SpectraScience design incorporates an optical illumination fiber. The optical illumination fiber is intended to provide the endoscopist with additional light from a different angle compared to the endoscope's light source. In various anatomies under certain circumstances, the endoscope's light angle may not reveal critical structural contours which should be considered before a biopsy is performed. The intent of the SpectraSciences device is to enhance visualization and thus result in more accurate and precise identification and location of the tissue to be sampled.

The auxiliary instruments for ureteroscopes and uretero-renoscopes are used for preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder. Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports. Various diagnostic and therapeutic procedures can be performed, for example: - transurethral extraction of uretero calculi - biopsy for tumor diagnostics - removal of foreign bodies, e.g. ureteral stents The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis. The forceps are used for endoscopically controlled grasping and obtaining tissue specimens for diagnosis. Both flexible and rigid forceps are available. The stone extractors (graspers) are used to grasp stones or stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone. The stone extractors are intended for minimally invasive, diagnostic and therapeutic interventions. They are used e.g. in conjunction with ureteroscopes and uretero-renoscopes. Various electrodes are used for controlling bleeding and for removing or destruction of tissue by use of unipolar high-frequency current under endoscopic view. The bougies are used for the atraumatic distention of tubular organs. The flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis. The bougies are intended for minimally invasive, diagnostic and therapeutic interventions.

The submitted auxiliary instruments for URS are accessories for the ureterrenoscopy. These are rigid or flexible biopsy, grasping, and foreign body forceps, stone extractors, unipolar electrodes for high frequency applications, and bougies.

The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments.

The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments. The Injecto Flush was also designed to have no effect on on the break down of instrumentation nor any possibility of cross contamination. The Injecto Flush is a one time disposable, but totally recyclable flushing unit.

The SpectraScience Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for histologic examination. The instruments are intended for endoscopic gastrointestinal and urologic biopsy and should not be used for any purpose other than their intended function.

The current design of biopsy forceps has not changed during its long course of past clinical utility. The standard hinged design utilizes cup-shaped jaws to bite or pinch off tissue with minimal complications while providing a viable tissue sample. The cup-shaped jaws also serve to hold the biopsy sample within the forceps until the tissue can be transferred to a biopsy container. The proposed SpectraScience biopsy forceps uses the most basic of standard designs in that no teeth or spikes will be employed in the design. The mechanism of action of the SpectraScience design is identical to predicate devices in that the same standard mechanical design, materials and sizes are utilized. Using identical mechanisms of action and materials results in identical clinical performance. The SpectraScience design employs a different technological characteristic. The SpectraScience design incorporates a fiberoptic illumination fiber. The illumination fiber is intended to provide the endoscopist with adjunctive light directed at the tissue biopsy site in addition to the endoscope's light source.