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510(k) Data Aggregation

    K Number
    K032386
    Device Name
    UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Date Cleared
    2004-03-26

    (235 days)

    Product Code
    BTL,PRE
    Regulation Number
    868.5925
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K931473,K981668
    Why did this record match?
    Device Name :

    UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)

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

    The Model 730 AEV ™ is intended to provide continuous ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. It is appropriate for use with adults and children- in clinical, field hospital, fransport, aeromedical and pre-hospital (BLS through ATLS) environments.

    Device Description

    Model 730 AEVTM is a portable, electronically controlled ventilator. It is controlled by an internal microprocessor (CPU), which continuously monitors and displays airway pressure, control settings, high-pressure alarm setpoint, gas volumes, and power signals. Two CPR and two Quick-Start Modes are available- one each is for use with unintubated patients (Mask) and one each is for use with intubated patients (Tube). This product operates from internal rechargeable batteries, external AC and 11-15 volts DC.

    AI/ML Overview

    The provided text for the Uni-Vent® AEVTM Model 730 device describes its performance standards and guidelines but does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a study.

    Instead, the document states:

    • Performance Standards: The Model 730 AEVTM complies with various voluntary standards like ASTM F920-99, ASTM F1100-97, ISO9703-1, ISO 9703-2, CGA V-5:2000, ISO 5356-1, EN1441, MIL-STD-1472F, ANSI/AAMI HE74:2001, MIL- STD-810F, and EN60601-1. It explicitly states, "No applicable mandatory performance standards or special controls exist for this device."
    • Substantial Equivalence: The primary basis for its clearance is a "comparative examination and analysis of similarities and differences to its predicate devices" concluding that "no new safety and/or effectiveness issues have been raised."

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as the information is not present in the provided text. The device received 510(k) clearance based on its substantial equivalence to predicate devices and compliance with voluntary consensus standards, rather than a standalone performance study with defined acceptance criteria and human evaluation metrics.

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