This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Karl Storz Autofluorescence System
Manufacturer: Karl Storz Endoscopy-America, Inc.
Address: 600 Corporate Pointe, Culver City, California 90230
Approval Date: December 12, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020008a.pdf
What is it used? The Karl Storz Autofluorescence System consists of a special light source, a flexible bronchoscope, special fluid light guides, and a camera. This system helps a trained physician looking inside a patient’s bronchus tell the difference between normal and abnormal tissue.
How does it work? The physician inserts a bronchoscope into a patient’s bronchial tubes, while the patient is under anesthesia. The physician looks through the bronchoscope at bronchial tissue in normal white light and special blue light. When a physician uses the blue light, tissues autofluoresce, giving off light that is slightly greener than the blue light shined on them. Under the blue light, autofluorescing normal tissue looks "green" while abnormal tissue looks darker or "reddish-brown" because it does not give off as much green light. The physician may remove small samples of tissue to examine more closely with a microscope (biopsy).
When is it used? A trained physician uses this system to find abnormal bronchial tissue in patients who have known or suspected lung cancer, and to determine how advanced the cancer is. The system is also used to test patients whose sputum has abnormal cells or who have an abnormal chest X-ray, CT scan or similar diagnostic test.
What will it accomplish? The system enables the physician to find suspicious areas for biopsy and helps detect cancer in its earliest states. Earlier detection of cancer may lead to a better outcome for the patient.
When should it not be used? Patients with uncontrolled hypertension, uncontrolled angina, heart failure, serious cardiac arrhythmias (irregular heart beats) or abnormal white blood cell or platelet count should not have this test because it may be too risky.
- Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P020008