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510(k) Data Aggregation

    K Number
    K193518
    Device Name
    KOSMOS
    Manufacturer
    EchoNous, Inc.
    Date Cleared
    2020-03-26

    (98 days)

    Product Code
    IYN,DPS,DQD,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K180995,K170874
    Predicate For
    K212100
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    KOSMOS is intended to be used by qualified and trained healthcare professionals in the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring, displaying, measuring, and storing synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.

    With respect to its ultrasound imaging capabilities, KOSMOS is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:

    • . Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Peripheral Vascular, and Image Guidance for Needle/Catheter Placement
    • . Modes of Operation: B-mode, Color Doppler, Combined Modes of B+M and B+CD, and Harmonic Imaging

    KOSMOS is intended to be used in clinical care and medical education settings on adult and pediatric patient populations.

    The device is non-invasive, reusable, and intended to be used on one patient at a time.

    Device Description

    KOSMOS consists of a tablet and probe, which connects to the tablet via a cable. Its accessories include a power charger, ECG cable, and binaural headset. KOSMOS can operate on battery or while connected to mains.

    The probe face houses an ultrasound transducer and sealed microphones for auscultation. The tablet can display clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms, and patient data/reports. The tablet also includes speakers for sounds associated with system control and feedback. Additionally, the tablet offers a means of user control with its touchscreen display and buttons.

    Although its intended operation is not dependent on Wi-Fi, KOSMOS supports Wi-Fi connectivity for patient data archival.

    The tablet can be positioned on a flat surface close to the patient while the user holds the probe with one hand to scan the patient. The user's other hand is then free to interact with the tablet using its touchscreen and buttons. The user can also hold the tablet in one hand and the probe in the other hand to scan the patient.

    KOSMOS' ECG capability provides a timing reference with respect to the cardiac cycle as compared with both ultrasound imaging and digital auscultation. Ultrasound imaging, ECG, and DA are all integrated into the probe in a time-synchronized manner.

    KOSMOS' 3-lead single-channel ECG allows for the acquisition and display of a single ECG waveform (lead), which can be any one of the Lead II, or Lead III waveforms. One end of the ECG cable connects to the probe via a custom-designed magnetic connector. The other end has three (3) RA/LA/LL leadwires to be connected to usersupplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for the KOSMOS device. It details the device's technical specifications and its comparison to predicate devices to demonstrate substantial equivalence, but it does not contain a study proving the device meets specific acceptance criteria based on clinical performance data.

    Section 12 explicitly states: "An assessment of clinical performance data for KOSMOS was not required to support a determination of substantial equivalence." This means that the FDA did not require clinical study data to clear this device for market, and therefore, the document does not include information about acceptance criteria for clinical performance, the reported device performance against those criteria, or details regarding the design and execution of such a clinical study.

    Therefore, I cannot fulfill your request for:

    • A table of acceptance criteria and the reported device performance.
    • Sample size used for the test set and data provenance.
    • Number of experts and their qualifications for ground truth.
    • Adjudication method for the test set.
    • MRMC comparative effectiveness study details.
    • Standalone performance details.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    This information is typically found in clinical study reports, which are
    not present in this 510(k) summary given the FDA's "not required" determination for clinical performance data in this instance. The substantial equivalence determination was based on technological characteristics and safety data, as detailed in Section 10 and 11 of the provided document.

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