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510(k) Data Aggregation

    K Number
    K201077
    Device Name
    Strados Remote Electronic Stethoscope Platform (RESP)
    Manufacturer
    Strados Labs
    Date Cleared
    2020-12-20

    (242 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K083903,K110525
    Predicate For
    K220893
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RESP is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients in a healthcare setting. The device stores the data for later playback, review, and analysis by a clinician on a mobile app.

    Device Description

    The RESP is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients in a healthcare setting. The device stores the data for later playback, review, and analysis by a clinician on a mobile app. The Strados Remote Electronic Stethoscope Platform (RESP) is comprised of the Strados Wearable Device (SWD), Strados Charging Station (SCS) and external power supply, and Strados Patient Adhesive (SPA) used to adhere the SWD to the patient. The SWD is controlled by a mobile device running the Strados Mobile Application (SMA) via Bluetooth connection. The Strados Wearable Device (SWD) sits on the chest wall and passively records the patient's lung sounds. The Strados Mobile App (SMA) on a smartphone allows playback of lung sounds from the wearable device in order for clinicians to listen to the patient's lung sounds. The device is used in a healthcare setting.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is an FDA 510(k) clearance letter and associated marketing submission documents for the Strados Remote Electronic Stethoscope Platform (RESP).

    The document mainly focuses on establishing substantial equivalence to a predicate device, as required for 510(k) clearance. This involves comparing the device's indications for use, technological characteristics, and non-clinical performance data (e.g., electrical safety, biocompatibility, functional testing).

    Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The text explicitly states: "Clinical performance testing was performed to validate the quality of the subject device's recorded lung sounds." However, no details about this clinical performance testing, acceptance criteria, or specific study results are included in the provided document sections.

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