Nasal Aspirator (NS 13)

The AViTA Nasal Aspirator (NS13) is a battery-powered device designed to remove nasal secretion and mucus in children ages 2–12 years in a home environment. It includes a pump that generates negative pressure suction, a silicone tip, a collection cup, and a sprayer head module that moistens and softens nasal secretions in children over 3 years old to make aspiration easier.

The NS13 operates with two AAA batteries (versus AA batteries in the predicate NS1), produces vacuum pressure of 100–120 mmHg, has a sound level ≤60 dB, spray capacity of 0.4–0.5 ml/10 sec, and weighs approximately 158 g. The subject device includes three interchangeable silicone tips of different sizes and depths suited for children ages 2–12, whereas the predicate had only two tip types.

Biocompatibility per ISO 10993-5, 10993-10, 10993-11, and 10993-23; electrical safety per IEC 60601-1:2005+A1:2012 and IEC 60601-1-11:2010; cleaning/disinfection durability testing of 1000 cycles; and software verification and validation per FDA guidance on medical device software.

Both devices share the same clinical intended use (nasal mucus removal in children ages 2–12 at home), identical working principles, same materials contacting the body, and identical performance specifications for vacuum pressure. Minor technical differences in power supply (AAA vs. AA batteries), dimensions, weight, and tip design do not affect safety or effectiveness because the subject device passed all relevant electrical safety and performance standards, and performance testing confirmed comparable functionality to the predicate.