The FDA said significant modifications have been made to the device since it was introduced in 1988, the Cleveland Plain Dealer reported Thursday.
"The agency's review of the collected documents shows several additional changes to the SS1, including changes to the following: the sterile water filter housing; lid header block; material on the PV sleeves of the pinch valve; pressure relief added to the high pressure pump; the heater element changed from copper to stainless steel; and check valve on the drain block," the FDA said in a letter to the company last month. "These changes cumulatively result in a change in the overall device design that could significantly affect safety and effectiveness."
Steris said the changes made to System 1 did not warrant a new 510(k) filing.
"The good news is that this isn't the result of any customer complaints or adverse patient events," Stephen Norton, corporate communications director for Steris, told the newspaper.