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510(k) Data Aggregation

    K Number
    K971013
    Device Name
    CHASE TEMPERATURE PROBE
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    1997-10-28

    (222 days)

    Product Code
    DTN
    Regulation Number
    870.4400
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K813271
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Temperature Probe is indicated for use during open-heart surgery to monitor myocardial temperature.

    Device Description

    The Chase Temperature Probe consist of a 15mm stainless steel needle connected to 8 ft. of cable with a dual prong plug.
    The Chase Temperature Probe consist of a 15mm, .032 O.D. stainless steel needle. The needle is attached to a cable support and eight feet of insulated twin lead cable. The rable ends in a dual prong connector plug.

    AI/ML Overview

    The device is the Chase Temperature Probe, indicated for use during open-heart surgery to monitor myocardial temperature.

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Functional CharacteristicsNon-differentiable compared to the predicate device (Webster Labs Temperature Probe, K813271) due to similar fit, form, and function.
    Material CompositionIdentical to the predicate device.
    SterilizationValidated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶.
    Package IntegrityTyvek/Polymylar passed burst test per ASTM F 1 40-88.
    Shipping & Distribution TestingPassed National Safe Transit Ass. vibration and drop tests.
    Accelerated AgingTwo-year shelf life established.

    Study Details

    The provided document describes the substantial equivalence of the Chase Temperature Probe to a predicate device, rather than a standalone clinical study with specific performance metrics against defined acceptance criteria in the traditional sense. The "study" here is a comparative one against a predicate device.

    1. Sample size used for the test set and the data provenance: Not applicable. The "testing" primarily involved comparing functional characteristics, materials, and performing engineering tests (sterilization, package integrity, shipping, aging) on the device itself. No patient data or test set in the context of clinical performance data is mentioned.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in a clinical sense with expert consensus is not described for this type of device and submission.

    3. Adjudication method for the test set: Not applicable.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a temperature probe, not an AI-powered diagnostic tool.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical instrument, not an algorithm.

    6. The type of ground truth used: For functional characteristics, the "ground truth" was established by comparison to the predicate device's fit, form, and function. For sterilization, packaging, shipping, and aging, the ground truth was based on adherence to established standards and validation methods (e.g., SAL 10⁻⁶, ASTM F 1 40-88).

    7. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.

    8. How the ground truth for the training set was established: Not applicable.

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