Kalypto Medical Seeks 510(k) Ban for Smith & Nephew Inc.'s Wound Device

Kalypto Medical is asking FDA not to grant Smith & Nephew marketing clearance for its new single-use negative pressure wound therapy device, known as PICO. A citizen petition from the company says PICO, an electrically-powered negative pressure wound therapy system that uses the wound dressing or kit to collect wound exudates, is second-in-class to Kalypto’s first-in-class NPD 1000. The company also has submitted a petition for a stay of action. Attorneys representing Kalypto acknowledge in the petition that they don’t know the specifics of the Smith & Nephew 510(k) submission. However, they do offer general commentary on the issues relating to the substantial equivalence of the Smith & Nephew and Kalypto devices.