Livi Device

The Livi Device is an over-the-counter, single-use, non-sterile intravaginal absorptive device made of polyurethane foam with a flower/tulip shape. It is intended for insertion into the vagina following sexual intercourse to absorb semen or other vaginal discharge for up to 15 minutes, and explicitly does not prevent pregnancy or protect against sexually transmitted infections.

The Livi device uses polyurethane foam (versus cotton/viscose in the predicate), has a flower-shaped design with three petals and smooth rounded tip (versus cylindrical bullet-tip tampon), features a polyethylene applicator (versus cardboard), and uses multi-layer laminate packaging with PET outer wrapper (versus polyethylene and PET). Both are single-use, non-sterile, intravaginal absorptive devices with light absorbency (<6g) and cotton/polyester removal strings.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (vaginal irritation), ISO 10993-11:2017 (acute systemic toxicity), 21 CFR 801.430 (absorbency testing via Syngyna method), and FDA guidance documents on menstrual tampons and pads (July 27, 2005) and biological evaluation of medical devices (September 4, 2020).

The Livi device is substantially equivalent because it shares similar technological characteristics with predicate K241064 (intravaginal placement, absorbent material, single-use, non-sterile design) and performs comparable safety and effectiveness testing. Although intended for post-coital absorption rather than menstrual use, the differences do not raise new safety or effectiveness questions, as risks from potential misuse are adequately addressed through labeling and demonstrated user comprehension in clinical studies.