Natural Cycles

Natural Cycles is a software application for smartphones that monitors a woman's menstrual cycle using daily temperature measurements and cycle information to determine fertility status. It can be used by women 18 and older to prevent pregnancy (contraception) or plan pregnancy (conception), displaying fertile (red) and non-fertile (green) days to guide contraceptive decisions.

The subject device has identical technology to the predicate device K231274, using the same inputs (manual basal body temperature, menstruation cycle data, optional ovulation/pregnancy test results) and producing the same outputs across three modes (Birth Control, Plan Pregnancy, Follow Pregnancy). The only difference is the expansion from over-the-counter use to both prescription and over-the-counter use.

Not stated in this summary.

No changes were made to the device technology itself; the software application functions identically to the predicate. The applicant argues that adding prescription use as an option alongside existing over-the-counter use does not raise different questions of safety and effectiveness because the underlying algorithm, inputs, outputs, and clinical performance remain unchanged. Since there are no technological modifications and no new or increased risks introduced, substantial equivalence is established without additional performance testing.