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Substantial Equivalence...

The most critical aspect for a Class II "approval" is the device must be comparable to a predicate device and it must be determined substantial equivalent to a currently marketed device. You must identify a predicate device that either has a 510(K) or is grand fathered (prior to passage of the act in the U.S. Congress in 1976). This is an art and a science. You compare the similarities, differences and comment about these similarities or differences.

For purposes of a comparison (your device to a predicate device) you could compare a Ferrari to a race horse- if all you want is to go down the street to buy some milk. The focus is on the result not the object. Notice the requirement is to get milk. Both the Ferrari and the race horse accomplish the same basis application.

The Ferrari has four wheels, the race horse has four feet. The Ferrari seats two, the race horse carriers two. The Ferrari goes faster than 60 miles per hour, the race horse goes under 10 miles per hour. A great many things are comparable - they do not have to be equal - just comparable.

copyright by Compliance Consultants, Stamford, CT USA, September 2001