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510(k) Data Aggregation

    K Number
    K200163
    Device Name
    Ava Fertility Tracker
    Manufacturer
    Ava AG
    Date Cleared
    2021-01-19

    (363 days)

    Product Code
    LHD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ava Fertility Tracker is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
    Device Description
    The Ava Fertility Tracker aids women in ovulation prediction and to facilitate conception. The Ava Fertility Tracker is a non-invasive device made up of the following components: The Ava bracelet incorporating hardware with electronics and embedded software A mobile application running on smartphones (iOS and Android) A backend server software, including algorithms running on remote servers The Ava bracelet is worn by women at night and tracks the following physiological parameters with built-in sensors: Temperature sensor - provides information on skin temperature Photoplethysmography (PPG) sensor – measures the interbeat interval (IBI) providing information on pulse rate (HR), heart rate variability (HRV), breathing rate (BR) and perfusion. Only HR, HRV, and BR are used by the algorithms for prediction of the fertile window. Perfusion information is used to assess the quality of the PPG sensor data. Accelerometer provides information on movement and sleep duration and phases The user synchronizes the bracelet to the mobile app each morning. The mobile app receives the raw datasets via Bluetooth Low Energy (BLE) and transfers this data to the backend server. The algorithm is run on the physiological parameters collected and the prediction of ovulation and the fertile window is determined. This information is transferred and displayed in the mobile app. The mobile app will also display a single mean value for HR, temperature, HRV ratio, BR, and sleep duration from the prior night. The mobile application has three modes: Trying to Conceive Mode - The application shows the user the predicted day of ovulation plus five predicted fertile days leading up to the predicted day of ovulation. Users receive the prior night summary of measured parameters displayed in graphs. Users can track additional information on their cycle, such as sexual intercourse or cervical fluid (this information does not feed into the algorithm). Cycle Tracking Mode– For users not wanting to conceive but wanting to track their cycle. These users receive the same information provided to Trying to Conceive Mode users. Pregnancy Mode - Users receive the prior night summary of measured parameters displayed on graphs. They can also track additional information as relates to their pregnancy, such as their weight or their daily water intake. For each week of their pregnancy, a different piece of informational content gets displayed in the application, such as typical height and weight of a baby at this stage of their pregnancy.
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    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?
    Product Code :

    LHD

    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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    K Number
    K102499
    Device Name
    DUOFERTILITY
    Manufacturer
    CAMBRIDGE TEMPERATURE CONCEPTS LTD.
    Date Cleared
    2011-12-20

    (476 days)

    Product Code
    LHD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DuoFertility Monitor 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 DuoFertility system is a computerized basal body temperature thermometer with the following features: - 1. A temperature Sensor with integrated data logger to monitor temperature throughout sleep and store the temperature readings - 2. Measuring accuracy within +/- 0.05 deg C - 3. Adhesive patches to hold the temperature Sensor against the users skin - 4. Radiofrequency communications hardware to transmit the stored temperature data to a receiving device - 5. Microprocessor based Reader to process and display temperature readings and fertility information.
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    K Number
    K050094
    Device Name
    LADY COMP USA
    Manufacturer
    LADY COMP USA
    Date Cleared
    2006-04-20

    (461 days)

    Product Code
    LHD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lady-Comp® USA is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
    Device Description
    Lady-Comp® USA is a computerized basal body temperature thermometer with the following functions: 1) Alarm clock function for measuring temperature at a consistent time. 2) Measuring accuracy within +/- 0.05°C (0.09°F). 3) Displaying the measured temperature. 4) Generating the measurement completion signal. 5) Memory Capacity of data for 180 days. 6) Transferring the stored data to an external instrument.
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    K Number
    K030961
    Device Name
    MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2003-09-12

    (169 days)

    Product Code
    LHD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Digital Basal Thermometer is a device intended for measuring, and aiding in the monitoring and tracking of basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
    Device Description
    The Microlife Digital Basal Thermometer, which uses the Basal Temperature method can be used for helping in family planning in healthy adults by understanding their menstrual cycle and ovulation and interpreting basal temperature changes. This Thermometer provides easy, quick and highly accurate readings over the body temperature range. The body temperature is measured by the thermistor (inside the probe tip) and displayed as numbers on the LCD (liquid crystal diplay) through microprocessor of IC. The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
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    K Number
    K021978
    Device Name
    PETIT SOPHIA
    Manufacturer
    NISHITOMO CO., INC.
    Date Cleared
    2003-04-08

    (295 days)

    Product Code
    LHD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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
    This device is the clinical thermometer with memory the following functions. (1) Alarm clock function for measuring temperature at constant time. (2) Measuring accuracy within +/-0.05°C(between 35.00°C and 38.00°C) +/-0.1°C(between 34.00°C and 35.00°C, 38.00°C and 40.00°C) (3) Displaying the measured temperature precisely, generating the measurement completion signal(buzz) and warning of a measuring error by buzzer, in case happened. (4) Memory capacity of data for 6 menstrual cycles or 210 days. (5) Displaying the measured temperature value in graph. (6) Transferring the stored data to an external instrument.
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    K Number
    K002726
    Device Name
    TCOYF FERTILITY SOFTWARE VERSION 1.0
    Manufacturer
    OVUSOFT, LLC.
    Date Cleared
    2001-04-06

    (218 days)

    Product Code
    LHD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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