| 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 Code | OAY |
|---|
| Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
