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U.S. Department of Health and Human Services

Product Classification

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Device light source system, diagnostic endoscopic
Definition A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer.Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test.
Physical State System includes a PPD light source, specific PDD telescopes for cystoscopy), camera system (PDD camera control unit, and PDD camera heads) fluid light cable, and PC based software communication program
Technical Method 1. excitation and emission filters in the PDD telescopes and PDD camera heads limit light to the blue portion of the visible spectrum The combination of these 2 filters in conjunction with the photo- fluorescent drug Hexvix? enables visualization of carcinoma in situ (CIS) as a red fluorescent image against normal tissue that appears blue.
Target Area Urinary Bladder
Review Panel Gastroenterology/Urology
Product CodeOAY
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible