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    K Number
    K013367
    Device Name
    CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
    Manufacturer
    REYNOLDS MEDICAL LTD.
    Date Cleared
    2001-12-13

    (64 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K002459
    Why did this record match?
    Device Name :

    CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH

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

    The Reynolds CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a printer. The unit meets all specifications for 12-lead electrocardiographs and has a provision for entry of patient data using its keypad.

    Device Description

    CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a printer. Typical recording time is ten seconds; all leads are recorded prince. Typical "recording" time "is "is "ifications for 12-lead electrocardiographs. It has a provision for entry of patient data using its keypad. Records include basic data on patients (name, number, and date of birth) as well Records morade basis and these can be printed with the tracing.

    AI/ML Overview

    Here's an analysis of the provided information regarding the acceptance criteria and study for the Reynolds Medical Ltd. CardioCollect device:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Non-clinical tests:
    Compliance with ANSI/AAMI EC11 (safety)Passed ANSI/AAMI EC11 tests.
    Compliance with EN 60601-1-2 (electromagnetic compatibility)Passed EN 60601-1-2 tests.
    Clinical tests:
    Quality of tracings made"A series of electrocardiograms has been taken with CardioCollect to show the quality of the tracings made." (No specific quantitative metrics or thresholds are provided for "quality.")
    Overall Conclusion:
    Equivalence in safety and efficacy to legally-marketed predicate devices (Agilent M2662A, K002459)Stated that CardioCollect is equivalent in safety and efficacy to legally-marketed predicate devices.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: The document mentions "A series of electrocardiograms has been taken with CardioCollect." However, it does not specify the exact sample size (i.e., number of patients or ECGs) used for this clinical testing.
    • Data Provenance: Not explicitly stated. There's no information about the country of origin of the data or whether the study was retrospective or prospective.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    • None specified. The document mentions "A series of electrocardiograms has been taken with CardioCollect to show the quality of the tracings made," but it does not detail how the "quality" was assessed or by whom. There is no mention of experts establishing a ground truth.

    4. Adjudication Method for the Test Set

    • None specified. Given that there is no mention of experts or ground truth establishment, there is no adjudication method described.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No such study was conducted or reported. The submission does not describe any study comparing human readers' performance with and without AI assistance. The CardioCollect device is an acquisition device, not an AI-based interpretation device.

    6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

    • Yes, in the sense that the device's ability to acquire "quality tracings" was assessed independently. However, the CardioCollect is an ECG acquisition device, not an interpretation algorithm. The "performance" in this context refers to its ability to capture ECG signals meeting certain standards. An algorithm for interpretation would be a different category. The test described, "to show the quality of the tracings made," is an evaluation of the device's standalone capability to generate a readable ECG.

    7. Type of Ground Truth Used

    • Implicitly, a subjective assessment of "quality" of tracings. The document only states that the clinical tests were "to show the quality of the tracings made." There's no mention of a formal, objective ground truth (e.g., expert consensus on specific abnormalities, pathology, or outcomes data) being used. It appears to be an assessment against general expectations for a readable ECG tracing.

    8. Sample Size for the Training Set

    • Not applicable / not specified. The CardioCollect is an ECG acquisition device. It does not contain an AI algorithm that would require a "training set" in the machine learning sense. Its functionality is to record and store ECGs, not to interpret them or learn from data.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. As the device does not use a training set for an AI algorithm, this question is not relevant.
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