JFord Speculum Sleeve™

The JFord Speculum Sleeve™ is a single-use, non-sterile, inflatable vaginal wall retraction sleeve designed to work with standard vaginal specula (medium or large sizes). It uses bilateral expandable pouches filled with water or saline via a 30 mL syringe to laterally displace redundant vaginal tissue, improving visualization during pelvic examinations and gynecological procedures.

The subject device is a flexible polyurethane sleeve with bilateral expandable pouches that inflate with fluid, whereas the predicate (ClearSpec) is a complete disposable speculum with a built-in flexible sheath. Both are non-sterile, single-use, and made of clear polyurethane for patient contact. The key difference is that the subject device is an accessory sleeve compatible with existing specula, while the predicate is a standalone speculum device.

ISO 10993-1 (Biological evaluation framework), ISO 10993-5:2099 (Cytotoxicity), ISO 10993-10:2021 (Sensitization), and ISO 10993-23:2021 (Vaginal Irritation). The device was also evaluated for visualization performance, mechanical durability (cycling, pull force, burst testing), and usability.