This is a brief overview of information related to FDAÃ¢??s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDAÃ¢??s approval.
Product Name: Karl Storz Photodynamic Diagnostic D-Light C (PDD) System
PMA Applicant: Karl Storz Endoscopy-America, Inc.
Address: 2151 E. Grand Avenue, El Segundo, CA 90245
Approval Date: May 28, 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf5/P050027a.pdf
What is it? The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System is used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug CysviewÃ‚® (Photocure ASA, a Norwegian pharmaceutical company).
The system includes:
- D-Light-C light Source and Fluid Light Cable
- PDD Telescopes (cystoscopes)
- Endovision TelecamÃ‚® SL and/or Endovision TricamÃ‚® SL Camera Control Unit and PDD Camera Head
How does it work? Light is transmitted through a fluid light cable connected to an endoscope to light up the area to be observed. Blue light is used to excite CysviewÃ‚® that has collected in cancerous tissue.
When is it used? The D-Light C PDD System when used in combination with the CysviewÃ‚® is used to detect non-muscle invasive papillary cancer of the bladder.
What will it accomplish? Based on evidence collected during a clinical study, CysviewÃ‚® plus blue light cystoscopy has been demonstrated to detect non-muscle invasive papillary cancer of the bladder.
When should it not be used?
- Patients with gross hematuria.
- Patients with porphyria.
- Patients that have hypersensitivity to CysviewÃ‚® solution.
- Patients who have received BCG immunotherapy or chemotherapy with in the last 90 days.
- Patients who have received a previous dose of CysviewÃ‚® solution, as the safety and efficacy of repeated use of CysviewÃ‚® solution has not been established.
Additional information: Summary of Safety and Effectiveness and labeling are available online.