Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)

The Hyaluronic Acid Vaginal Suppository (HA 5 mg and HA 10 mg) is an over-the-counter vaginal lubricant designed to moisturize and lubricate the vagina, enhance comfort and ease during intimate sexual activity, and supplement the body's natural lubrication. The device is a solid suppository (1.8 g each) that dissolves in the vaginal cavity due to body temperature, releasing hyaluronic acid sodium salt to create a moist environment. The product is not compatible with condoms.

The subject device contains hyaluronic acid sodium salt, vitamin E, cocoa butter, and semi-synthetic glycerides in a glyceride base, compared to the predicate's hyaluronic acid, glycerides, and sweet almond oil. Both are non-sterile vaginal suppositories in PVC/PE blister packaging. The subject device offers 5 mg or 10 mg HA content with a 1-year shelf life, versus the predicate's 10 mg HA with 24 months shelf life. Microbial limits are identical (aerobic microbial count <100 cfu/g, mold/yeast <10 cfu/g), and both are absent of pathogenic organisms.

Biocompatibility testing was performed per ISO 10993-1:2018 and the 2023 FDA guidance, including cytotoxicity (ISO 10993-5:2009), vaginal irritation (ISO 10993-23:2021), skin sensitization (ISO 10993-10:2021), and acute systemic toxicity (ISO 10993-11:2017). Shelf life and stability were evaluated via real-time aging studies.

The subject device is substantially equivalent to the predicate (Revaree plus vaginal suppositories, K213220) because both share the same intended use—vaginal lubrication during intimate sexual activity—and the same over-the-counter status and delivery mechanism. Although formulation ingredients and shelf life differ, these differences do not raise different questions of safety or effectiveness. Biocompatibility testing confirmed the subject device is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic, demonstrating safety and effectiveness equivalent to the predicate.