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510(k) Data Aggregation

    K Number
    K122337
    Device Name
    OVUSENSE
    Manufacturer
    FERTILITY FOCUS LTD
    Date Cleared
    2013-08-06

    (369 days)

    Product Code
    LHD
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERTILITY FOCUS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fertility Focus OvuSense Fertility Monitor (Fertility Focus OvuSense Fertility Monitor Starter Kit M009-US, which includes Reader M010-US and Personal Sensor M011) is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
    Device Description
    The Fertility Focus OvuSense Fertility Monitor is intended for measuring and recording core body temperature intra-vaginally on a nightly basis during the non-menstruating phases of the monthly female reproductive cycle. The Fertility Focus OvuSense Fertility Monitor consists of two components made of silicone - a Personal Sensor, which collects the data, and a Reader (with LCD display), which establishes a communication link to the Personal Sensor whereupon the data is transferred to the Reader. Electromagnetic induction communications hardware transmits the stored temperature data from the Personal Sensor to the receiving device, the Reader, activated when the Sensor is placed on the Reader cradle and the Reader's dedicated download button is pressed. The microprocessor based Reader filters the overnight data, then calculates and stores the 25th percentile value, representative of the average basal (lowest) overnight temperature. The Reader then displays these nightly temperature readings on a graph using a relative scale - the kev information for necessary calculations being the temperature changes relative to other recorded temperatures within a cycle for a particular user, and not absolute temperature value. At the start of the next cycle, indicated by the User inputting first day of the bleeding in the cycle, the Reader algorithm calculates the date of ovulation in the prior cycle, and uses this to predict the fertile period for the cycle which has just started. The Reader then displays fertility information in a verbal summary, including: An indication of the day ovulation occurred in the prior cycle, or if ovulation was not detected it displays this information instead. An indication whether the cycle length was within the expected normal parameters.
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