Béa Applicator (BAP-GB-01)

The Béa Applicator is an over-the-counter cervical cap device for home use by couples unable to conceive naturally due to low sperm count, poor sperm motility, or unfavorable vaginal environment. Users load semen into the silicone cervical cap via a funnel-equipped applicator, insert it to position the cap at the cervix, then remove the applicator while leaving the cap in place for up to 5 hours to facilitate sperm transport.

Key differences from the predicate (FERTI.LILY Conception Cup) include: pre-assembled applicator with funnel for loading semen before insertion (versus placement after intercourse); single-use design with 7-month shelf life (versus reusable with 3-month use life and 36-month shelf life); longer wear time of up to 5 hours (versus 1 hour); different materials including ABS and polyester in addition to silicone; and sperm compatibility testing conducted over 24 hours (versus 2 hours).

Biocompatibility testing per ISO 10993-5:2009/R 2014 (cytotoxicity), ISO 10993-10:2010/R 2014 (sensitization and vaginal irritation); shelf-life validation per USP <61> and USP <62> for bioburden assessment; human factors validation study with label comprehension and simulated/actual use testing; Human Sperm Survival Assay (HSSA) per 2023 FDA guidance.

Despite technological and use-model differences, the devices are substantially equivalent because both target the same patient population and intended use (retaining semen near the cervical opening as an aid to conception in OTC home settings). The differences in delivery method, wear time, reusability, materials, and sperm testing duration do not raise different safety and effectiveness questions; biocompatibility, shelf-life stability, and human factors testing all demonstrated safe and effective performance comparable to the predicate. The clinical studies confirmed users could correctly position the cap over the cervical os, retain semen, and use the device without vaginal trauma.