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510(k) Data Aggregation

    K Number
    K222330
    Device Name
    The Heart Seat
    Manufacturer
    Casana Care, Inc.
    Date Cleared
    2023-04-24

    (265 days)

    Product Code
    MWI,DQA
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K210086
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Heart Seat is a replacement for a standard toilet seat that is indicated for use in a home environment. The Heart Seat is intended to be used for measuring, reviewing and storing non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) and heart rate (HR) in adults of at least 22 years of age with weight ranging from 90 to 350 pounds. Data from the Heart Seat are collected whenever the seat is used and are automatically uploaded to the Casana Cloud where they can be viewed by the healthcare provider. The Heart Seat is not intended for continuous monitoring.

    Device Description

    The Heart Seat™ is a prescription use remote monitoring system built into a toilet seat. It is intended for physiological monitoring in the home setting. The device and platform are tools intended to support clinicians by providing them with data to help them better manage patients. Monitored users (or Patients) sit on the seat for their data to be captured and sent to the cloud. Clinical users interact with the clinical cloud-based application that provides the patient measurements.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the studies that prove the device meets those criteria, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    SpO2 Measurement Accuracy (ARMS)Acceptance Criteria: Not explicitly stated as a numerical value in the "Performance Data" section, but the predicate device had:
    ±2% (90-100%)
    ±4% (70-89%). However, the comparison table states that the proposed device is ±3.5% (70-100%) and that "clinical data demonstrates equivalent performance" to the predicate. This implies the device aims to meet or be comparable to the predicate's accuracy.Reported Device Performance: ARMS of 2.7% over the range of 70-100%. (This meets or exceeds the implicit expectation of equivalence to the predicate's ±3.5% (70-100%) as listed for the proposed device in the comparison table.)
    Heart Rate Measurement AccuracyAcceptance Criteria: Absolute Accuracy
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