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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.

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 body 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 (NCº Follow Pregnancy). For NCº 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, the predicate submission cleared the Oura Ring for automatic temperature input to the Natural Cycles algorithm, and the current submission expands to allow the device to utilize automatic temperature inputs from the 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 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 body 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, and Pregnancy. For Contraception 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, the device allows automatic temperature input from the Oura ring, a wearable temperature monitor. 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 preqnant when compared to women who have not been on hormonal birth control within the 12 months prior to using the 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.

Clue Birth Control is a software application for women ages 18 - 45 years old, to monitor their fertility and prevent pregnancy. Clue Birth Control is suitable for women with predictable 20 - 40 day cycles, who have not recently used hormonal birth control.

Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control's proprietary algorithm uses period start date information entered by the user to provide predictions of "high risk days" and "low risk days" for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows 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. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.

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 entered into the application by the user: - daily basal body temperature (BBT) 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.