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510(k) Data Aggregation

    K Number
    K143507
    Device Name
    NFANT Feeding Solution
    Manufacturer
    NFANT Labs, LLC
    Date Cleared
    2015-09-09

    (273 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NFANT Labs, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NFANT® Feeding Solution is intended to measure movement of the nipple during non-nutritive suck (NNS) or nutritive suck (NS).
    Device Description
    NFANT® Feeding Solution is comprised of a portable multi-use electronics unit (NFANT SSB Sensor) powered by a non-rechargeable coin cell battery, single use bottle coupling (NFANT Coupling) and mobile application which acts as a user interface and data display (NFANT App). Nipple movement data during Non-Nutritive Suck or Nutritive Suck is transmitted to a mobile device and displayed for clinician interpretation from past feedings can also be securely transferred, stored and retrieved by authorized users from a cloud based database (NFANT DBMS) for comparisons between feedings. When in use, the NFANT Coupling has a commercially available or prescribed bottle or pacifier nipple placed on one end and a normal bottle on the other. The NFANT SSB Sensor is snapped in place to mate with the NFANT Coupling. The user "wakes-up" (activates) NFANT SSB Sensor for streaming and data collection. An infant then undergoes normal nonnutritive sucking with a pacifier (no liquid swallow) and/or nutritive sucking with a bottle nipple during normal feeding sessions (liquid swallow). Nipple movement data is garnered and displayed on the mobile application for clinical interpretation. Safe oral feeding requires coordination of sucking, swallowing and breathing which involves integration, maturation and coordination of multiple sensorimotor systems. NFANT provides clinicians with objective data reqarding nipple movement during non-nutritive (NNS) and nutritive sucking (NS). As the infant sucks, the NFANT Coupling allows bottle fluid (when applicable) to flow from the bottle to the nipple. The NFANT Coupling maintains a plug insert that provides a two compartment membrane sealing the NFANT Coupling and separating the bottle fluid from pressure sensors contained in the NFANT SSB Sensor housing. With assembly, ports on the NFANT SNAP housing engage each respective membrane creating a seal between the NFANT SSB Sensor and NFANT Coupling while also creating two sealed chambers between the membrane and a respective pressure sensor. NFANT has one disposable component, the NFANT Coupling that comes in contact with the fluid. After a single use by a patient, the NFANT Coupling is disposed of in waste. The NFANT SSB Sensor does not come in contact with the feeding fluids and is reused specific to the infant with each NFANT Coupling usage. The NFANT App component is software only. NFANT is sold non-sterile.
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