7 :名無し草 :2005/07/27(水) 07:10:18
A device recently cleared under 510(k) is usually used as a predicate device. However, any legally U.S. marketed device may be used as a predicate.
A Premarket Notification [510(k)] is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA). Submitters must compare their 510(k) device to a similar legally marketed U.S. device(s). A device recently cleared under 510(k) is usually used as a predicate device. However, any legally U.S. marketed device may be used as a predicate. This includes: a device that has been cleared through the 510(k) process; a device that was legally marketed prior to May 28, 1976 (preamendments device); a device that was originally on the U.S. market as a Class III device (Premarket Approval) and later downclassified to Class II or I; or a 510(k) exempt device.
"Polarizer" means a permanently dichroic, polarizing glass article
having a sharp spectral cut-off at about 400 nm, and a precipitated
halide crystal phase that includes elongated metal halide crystallites
a portion of which crystallites near the surface of the glass article
are at least partially reduced to colloidal metal.