in2 Smart (in2S)

The in2 Smart is a wearable device for managing premature ejaculation in males. It consists of reusable control components (Smart Pod and Smart Case) paired with disposable Contact Pads applied to the perineum. During intercourse, the device delivers short-duration, low-intensity electrical muscle stimulation to contract pelvic floor muscles and delay ejaculation, with user-adjustable intensity settings.

The in2 Smart uses electrical muscle stimulation at two intensity levels (9.9 mA ±10% for low; 14.3 mA ±10% for high) with a maximum 30-minute stimulation duration. It features reusable electronics with disposable single-use Contact Pads containing hydrogel and biocompatible electrode layers. Key differences from the predicate vPATCH include user-adjustable intensity (versus pre-configured), longer maximum duration (30 vs. 15 minutes), and a hybrid reusable/disposable kit design.

Hardware physical and functional testing including electrical safety and EMC testing; software verification and validation per IEC 62304:2006+A1:2015; biocompatibility testing per ISO 10993-1:2018; and usability testing following applicable standards.

The in2 Smart is substantially equivalent to the predicate vPATCH (K223595) because both share identical indications for use, the same principle of operation (perineal patch stimulation prior to intercourse), identical stimulation current levels, non-sterile construction with single-use components, and biocompatibility testing. Differences in maximum duration and user-adjustability do not raise new safety or effectiveness questions, as demonstrated by completed performance and usability testing.