QuickSleeper 5

The QuickSleeper 5 is a reusable electronic jet injector for administering local anesthesia in dental procedures. It features a computer-controlled handpiece with adjustable injection speed, aspiration capability, and rotational needle movement for intraosseous injections, along with a wireless foot pedal for operator control.

The QuickSleeper 5 uses an electronic motor with programmable settings and three injection modes (Hi, IO, Lo), compared to the predicate's air-driven and electrical motors requiring manual dosage lever presses. Key differences include wireless foot pedal control, computer-regulated aspiration and flow rates, and an electronic interface providing real-time feedback on injection speed and tissue resistance.

IEC 60601-1, IEC 60601-1-2, IEC 60601-4-2, IEC 60601-1-6 for electrical safety; IEC 62304 for software; ISO 11499 for anesthetic cartridge compatibility. Testing included software verification, injection and perforation performance, biocompatibility, cleaning/disinfection/sterilization validation, and usability evaluation.

Both devices share identical indications for use (local anesthesia injection in dentistry), target the same patient population (adult and pediatric), and operate in professional healthcare settings. Although the QuickSleeper 5 adds computer-controlled delivery and a wireless foot pedal compared to the predicate's manual injection method, these technological differences do not raise new safety or effectiveness questions because the fundamental mode of action—needle placement through mucosa for local anesthetic delivery—remains unchanged and comparable performance has been demonstrated through non-clinical testing.