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510(k) Data Aggregation

    K Number
    K250697
    Device Name
    Electric Nasal Aspirator (BC026, BC025, BC023)
    Manufacturer
    Shenzhen Kingboom Technology Co., Ltd
    Date Cleared
    2025-04-23

    (47 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    Ear, Nose, and Throat (EN)
    Reference & Predicate Devices
    K222547
    Why did this record match?
    Device Name :

    Electric Nasal Aspirator (BC026, BC025, BC023)

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

    The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

    Device Description

    Electric nasal aspirator (model: BC026, BC025 and BC023) consists of main unit, and suction portion working together as one unit. The Electric nasal aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.

    The differences between BC026, BC025, and BC023 are as follows:

    1. BC026 has 5 suction levels, while BC023 and BC025 have 3 suction levels.
    2. BC026 and BC023 have "Light" function for distracting and pacifying the child. BC025 does not have this function.
    3. BC026 and BC023 can pause suction during the suction process. BC025 does not have this feature.
    4. BC026 and BC023 have 4 buttons, BC025 has 2 buttons.
    5. In addition, BC026, BC025, and BC023 have different Display, Size, Weight, and Appearance.
    AI/ML Overview

    The provided FDA 510(k) clearance letter and summary for the Electric Nasal Aspirator do not contain specific acceptance criteria for device performance such as sensitivity, specificity, accuracy, or other diagnostic metrics. This device is a powered suction pump and not a diagnostic device that would typically have such performance criteria. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical safety and performance testing.

    Therefore, many of the requested fields cannot be extracted directly from the provided text as they pertain to clinical performance studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth establishment) that were explicitly not performed.

    Here's the information that can be extracted, and an explanation for what cannot:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Test Type)Standard Designation Number / DescriptionReported Device Performance
    SafetyES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]Conforms
    EMC (Electromagnetic Compatibility)IEC 60601-1-2:2020 IEC TR 60601-4-2: 2016Conforms
    Home healthcare environmentIEC 60601-1-11:2020Conforms
    PerformanceEnterprise standardConforms
    BiocompatibilityISO 10993-1:2018Conforms
    SoftwareANSI AAMI IEC 62304:2006/A1:2016Conforms
    Safety of Lithium batteryIEC 62133-2:2017Conforms
    Safety of lampsIEC 62471: 2006Conforms
    Vacuum pressure52-60 Kpa (Predicate comparison)52-60 Kpa (Subject device) - Identical to predicate
    Noise Level
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