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    K Number
    K990856
    Device Name
    HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
    Manufacturer
    BIRD PRODUCTS CORP.
    Date Cleared
    2000-01-11

    (302 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K930656
    Why did this record match?
    Device Name :

    HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The nasal CPAP unit is intended for treatment of adult Obstructive Sleep Apnea (OSA). Obstructive sleep apnea is defined as the absence of air movement for ten seconds during sleep. Obstructive sleep apnea is usually diagnosed by a sleep study. The study obtains the optimum level of pressure required to maintain an unobstructed airway, the positive pressure allows the is ve or prosuropen. The nasal CPAP unit is intended only for spontaneously breathing adult patients.

    Device Description

    The SoftAire Nasal CPAP System is intended to provide continuous positive airway pressure for the care and treatment of individuals suffering from obstructive sleep apnea. The positive pressure is clinician adjustable within the designated operating range and a clinician adjustable timer will allow timed rise to pressure ("Ramp" mode). The user controls will be limited to an on/off switch and option of using the timed pressure rise. This product is designed to be used with a 22 millimeter (smooth bore) tube air delivery system and user selected nasal mask. This mask is not marketed by Bird. Power will be provided by AC to DC adapter s which accommodate a variety of input voltages and frequencies. This adapter will plug into a 12 VDC connector on the side of the unit. The SoftAire Nasal CPAP System does not utilize an actively controlled exhalation valve. The patient circuit consists of two essential parts: a large-bore tube from the ventilator to the patient and a required exhaust port. The exhaust is an orifice which may be part of the adapter between the tubing an the patient mask, or may be an orifice which is part of the patient mask.

    AI/ML Overview

    Acceptance Criteria and Device Performance for SoftAire Nasal CPAP System

    1. Table of Acceptance Criteria and Reported Device Performance

    SpecificationRequirementReported Device Performance
    Adjustable Therapeutic Pressure Range4-18 cmH2O☑ (Verified to operate as designed and intended)
    Adjustable Beginning Pressure Range4 and 18 cmH2O and below therapeutic range☑ (Verified to operate as designed and intended)
    Pressure Accuracy± 10% to the nearest displayed digit (calibrated at 500ft elevation)☑ (Verified to operate as designed and intended)
    Timer0, 5, 10, 15, 20 minutes, ± 2 minutes☑ (Verified to operate as designed and intended)
    Input Voltage12 ± 10% VDC, 2A☑ (Verified to operate as designed and intended)
    Noise Level
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