The U.S. FDA issued a final rule today placing urethral inserts with pumps to facilitate bladder drainage in Class II with special controls, including biocompatibility testing.
Firms submitting a 510(k) for premarket clearance must show the device is safe and effective in clinical testing and that it performs as intended. They must also document the device acceptance rate and its adverse event profile.
Adverse events associated with these devices include tissue irritation, infection, renal damage, trauma to the bladder wall, urgent urination, urine leakage, and device encrustation, migration or malfunction.
Devicemakers must also verify that components that contact the urinary tract are biocompatible and sterile, the FDA says. Performance data must support the shelf life for continued sterility of the product, its package and its use.
Nonclinical data should look at urine flow rate, valve integrity, bladder neck force retention, pump/valve endurance, encrustation and mechanical reliability, under the final rule.
The rule also spells out requirements for product labeling, such as warnings, recommended treatment regimen and a summary of complications.
The reclassification was requested by Vesiflo for the inFlow Intraurethral Valve-Pump and Activator.