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510(k) Data Aggregation

    K Number
    K071165
    Device Name
    ISCALERT SENSOR SYSTEM
    Manufacturer
    ALERTIS MEDICAL AS
    Date Cleared
    2007-11-07

    (195 days)

    Product Code
    CCC
    Regulation Number
    868.1150
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K980308,K953893
    Why did this record match?
    Reference Devices :

    K980308, K953893

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

    The IscAlert™ sensor system measures the partial pressure of carbon dioxide in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended for monitoring trends in this parameter as an adjunct in the evaluation of the perfusion status of tissue in patients at risk of developing ischemia. IscAlert values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy. The IscAlert™ sensor system should not be used in peripheral brain tissue, intra cranial tissue, all organ tissues including cardiac and kidney, and other peripheral muscle tissues other than forearm muscle.

    Device Description

    The IscAlert sensor system measures partial pressure of CO2 (pCO2) in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended to monitor pCO2 trends as an adjunct in the evaluation of perfusion status of tissue in patients at risk of developing ischemia.

    Ischemia is a medical term for a shortage of blood supply to tissue. If severe, it can lead to death of the affected tissue (infarction). The tissue pCO2 increases significantly during the early and reversible stages of ischemia. This methodology provides the ability to identify the onset of ischemia events through real-time data.

    The IscAlert sensor system consists of three parts:

      1. The sterile disposable Sensors
      1. The Connection Unit (CU)
      1. Software to be installed in an off-the-shelf PC unit

    The sterile, disposable, catheter tip sensors are placed 2-5 cm into organ tissue with a split-off needle that is removed after insertion.

    The sensor is connected via a cable to the Connection Unit (CU). The CU processes the signals from the sensor unit. It is connected via a cable to a PC with the IscAlert software application installed. The software enables visualisation of the monitoring results.

    AI/ML Overview

    The provided text describes the IscAlert Sensor System (K071165), which measures partial pressure of CO2 (pCO2) in peripheral tissue, specifically forearm muscle. The system is intended to monitor pCO2 trends as an adjunct in evaluating the perfusion status of tissue in patients at risk of ischemia.

    Unfortunately, the provided text does not contain detailed acceptance criteria or the specific results of a study that proves the device meets these criteria in a structured format. It mentions that "The IscAlert Sensor System has been tested for function according to the product requirements" and that "The results of these tests and a proof-of-concept clinical study using Neurotrend as comparative device show the IscAlert Sensor System to be safe and effective for its intended use." However, it does not elaborate on what those product requirements (acceptance criteria) were or the specific performance metrics achieved.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance.

    Here's a breakdown of what can be extracted from the provided text regarding a study, even without specific performance metrics:

    Study Information (Based on text)

    • Study Type: A "proof-of-concept clinical study" was conducted.
    • Comparative Device: The Neurotrend Cerebral Tissue Monitoring System (K980308) was used as a comparative device.
    • Purpose: To demonstrate the safety and efficacy of the IscAlert Sensor System for its intended use.
    • Outcome (General): The study results, along with other tests (EMC and safety), "show the IscAlert Sensor System to be safe and effective for its intended use."

    The remaining requested information (sample size, data provenance, expert details, adjudication, MRMC, standalone performance, ground truth type, training set details) is not available in the provided document.

    Here is a summary of the information that could be extracted and the information that is missing:

    Information TypeDetails from Provided Text
    1. Acceptance criteria and reported device performanceMISSING. The text states: "The IscAlert Sensor System has been tested for function according to the product requirements." However, the specific product requirements (acceptance criteria) and the quantitative results demonstrating compliance are not provided.
    2. Sample size and data provenance (test set)MISSING. The text mentions a "proof-of-concept clinical study" but does not specify the sample size, country of origin, or whether the data was retrospective or prospective.
    3. Number of experts and qualifications (ground truth for test set)MISSING. There is no mention of experts or their qualifications for establishing ground truth in the clinical study.
    4. Adjudication method (test set)MISSING. No mention of any adjudication method for establishing ground truth or interpreting results in the clinical study.
    5. MRMC comparative effectiveness study, effect sizeUnlikely to be applicable / MISSING details. This device measures pCO2 trends, not an interpretation task typically suited for MRMC studies with human readers. The clinical study used a comparative device (Neurotrend), but not in an "AI vs. without AI assistance" context as described for MRMC. The effect size of human readers with/without AI assistance is not relevant to the described device.
    6. Standalone (algorithm only without human-in-the-loop) performancePARTIALLY ADDRESSED, but no metrics. "The IscAlert sensor system measures partial pressure of CO2 (pCO2) in peripheral tissue... The system is intended to monitor pCO2 trends..." This implies standalone measurement capability. However, specific standalone performance metrics (e.g., accuracy, precision against a gold standard) are not provided.
    7. Type of ground truth usedMISSING (for clinical study). The text indicates the device measures pCO2, and a "proof-of-concept clinical study using Neurotrend as comparative device" was done. This implies that the Neurotrend data might have served as a comparative reference, but it's not explicitly stated as the "ground truth" and no details are given for how Neurotrend's measurements were validated as ground truth within this study.
    8. Sample size for the training setNOT APPLICABLE / MISSING. The device is described as an electrochemical sensor system, not an AI/machine learning algorithm that typically requires a distinct training set. If there are internal calibration or signal processing algorithms developed using data, this is not specified.
    9. How ground truth for the training set was establishedNOT APPLICABLE / MISSING. (See point 8).
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