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Natural Cycles is a stand-alone software application, intended for women 18 years and older, to monitor their fertility. Natural Cycles can be used for preventing a pregnancy (contraception) or planning a pregnancy (conception).

Natural Cycles is an over-the-counter and prescription web and mobile-based standalone software application that monitors a woman's menstrual cycle using information entered by the user and informs the user about her past, current and future fertility status. The following information is used by the Natural Cycles software: daily temperature measurements, information about the user's menstruation cycle (i.e., start date, number of days), and optional ovulation or pregnancy test results. A proprietary algorithm evaluates the data and returns the user's fertility status. Users can choose to use Natural Cycles in various modes based on their goals. Natural Cycles is available in three modes: Contraception (NC° Birth Control), Conception (NC° Plan Pregnancy), and Pregnancy (NC° Follow Pregnancy). For NC° Birth Control mode, the device provides predictions of "not fertile," shown as green days, and "use protection," shown as red days, that allow the user to determine the days on which her risk of conception is highest, and then make contraception to prevent pregnancy. Inputs to the device include user-inputted daily basal body temperature measured with an oral thermometer with two decimal points or a compatible wearable device (e.g., Oura Ring and Apple Watch). Natural Cycles can be used by women 18 years and older. Women who have been on hormonal birth control within 60 days prior to using Natural Cycles have a higher risk of becoming pregnant when compared to women who have not been on hormonal birth control within the 12 months prior to using the device. This device may not be right for women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus

Natural Cycles is a stand-alone software application, intended for women 18 years and older, to monitor their fertility. Natural Cycles can be used for preventing a pregnancy (contraception) or planning a pregnancy (conception).

Natural Cycles is an over-the-counter web and mobile-based standalone software application that monitors a woman's menstrual cycle using information entered by the user and informs the user about her past, current and future fertility status. The following information is used by the Natural Cycles software: • daily temperature measurements • information about the user's menstruation cycle (i.e., start date, number of days) • optional ovulation or pregnancy test results. A proprietary algorithm evaluates the data and returns the user's fertility status. Natural Cycles is available in three modes: Contraception (NC° Birth Control), Conception (NC° Plan Pregnancy), and Pregnancy (NC° Follow Pregnancy). For NC° Birth Control mode, the device provides predictions of "not fertile," shown as green days, and "use protection," shown as red days, that allow the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. In addition to measuring daily basal body temperature with an oral thermometer with two decimal points, previous submissions cleared the Oura Ring and Apple Watch for automatic temperature input to the Natural Cycles algorithm. Natural Cycles can be used by women 18 years and older. Women who have been on hormonal birth control within 60 days prior to using Natural Cycles have a higher risk of becoming pregnant when compared to women who have not been on hormonal birth control within the 12 months prior to using the device. This device may not be right for women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus. The subject of this submission is the proposed inclusion of a Predetermined Change Control Plan (PCCP) that enables use of a broader range of temperature measuring devices for future wearable integrations with the Natural Cycles application. There are no changes to the Natural Cycles application from the application cleared in K231274.