Search Results

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 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.