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The ViziLite Blue Oral Exam Product consists of the Vizilite and ViziLite Blue Oral Lesion Identification and Marking System. The Vizilite (OralLite) is a chemiluminescent light source system indicated for use as an adjunct to conventional oral mucosal screening by trained health care providers for the identification, evaluation, and monitoring of oral mucosal abnormalities in a population at increased risk for oral cancer. The ViziLite Blue Oral Lesion Identification and Marking-System, is a threecomponent swab system which is indicated as an adjunct to the ViziLite Test for oral mucosa lesions, for further evaluation and monitoring of lesions already differentially identified with Vizil ite in a population at increased risk for oral cancer The ViziLite Blue Oral Lesion Identification and Marking System is not being proposed for use in the initial oral mucosal examination without initial lesion identification with ViziLite. Furthermore, this ViziLite Blue Oral Lesion Identification and Marking System is not intended to be used as an indicator of lesions warranting further study, including biopsy. Whether a lesion is marked with the dye or not should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination. The marking dye, when positive, acts as a lesion marker that allows for the removal of the ViziLite device while preserving the anatomic character of the lesion.

ViziLite Blue Oral Exam Kit includes the ViziLite used as an adjunct to visual examination of the oral mucosa with incandescent light for identification of oral mucosal abnormalities and ViziLite Blue Oral Lesion Identification and Marking System to further assist with the evaluation and monitoring of ViziLiteldentified oral white mucosal abnormalities in patients at increased risk for oral cancer. The ViziLite-Blue™ Oral Exam Kit is a visualization system that is intended as an adjunct to conventional visual examination with incandescent light of oral mucosa and employs the same components and mechanism of action as the previously cleared ViziLite Test Kit (a.k.a. ViziLite Comprehensive Exam Tray K012070 and the OralLite Test Kit, K03995 and Acetic Acid Rinse) and is indicated for the same patient population and intended use. The ViziLite examination light source and accessories, including the 1% Acetic Acid Rinse, have not been changed nor significantly modified for production of the ViziLite-Blue Oral Exam Kit. The ViziLite Blue Oral Lesion Identification and Marking System, consists of three swab components, two swabs of 1% Acetic Acid Rinse, including a postdye decolorizer, and one swab with a metachromatic vital tissue dye, Tolonium chloride, also called Toluidine Blue. The application of the dye to ViziLite-Identified oral white mucosal lesions in a population at increased risk for oral cancer, during clinical trials was able to assist with evaluation, monitoring, and tissue sampling and helped physically mark and stain 51% of the ViziLite-Identified white lesions to allow the health care provider to visualize lesions with incandescent light.

SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique.

The SpiraBrush Cx is a biopsy instrument consisting of a sampling head and a handle. The sampling head is placed directly onto the exocervical lesion or cervical area to be biopsied, and rotated to collect a tissue sample. The head is then snapped off the handle and placed in a preservative solution for laboratory processing.

The OralLite Test Kit, when used in combination with conventional visual oral mucosal in The OralLite Test Kit, when used in other used in cardification, evaluation, and examination by nealth care providers, improved facilities in the reased risk for oral cancer.

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- Speculoscopy is indicated for use in those women who are currently recommended for cervical screening with pelvic examination and Pap smear. - Speculoscopy is only to be used as an adjunct to the Pap smear, and only the combination of the two tests affords the clinician improved sensitivity in identifying women with mucosal abnormalities visualized on colposcopy. - The combined results of the Pap smear with Speculoscopy in the screening examination, designated Pap Plus Speculoscopy, can allow for the identification of more women who are appropriate referrals for colposcopy or close follow up than Pap smear alone.

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