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510(k) Data Aggregation

    K Number
    K030547
    Device Name
    MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
    Manufacturer
    GUARDIAN ANGEL PRODUCTS, INC.
    Date Cleared
    2003-07-11

    (141 days)

    Product Code
    DRL
    Regulation Number
    870.5325
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K896985
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K896985

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

    The ZAP GUARD II is intended to be used for the testing of the continuity and the integrity of the wires of Biphasic Defibrillator Systems.

    Device Description

    The ZAP GUARD II device consists of an electrical circuit incorporating resistors and a neon light within the pathway. Upon contact with the paddles of a biphasic defibrillator system which is operational, energy is delivered through the circuit. If the defibrillator system's wires are intact and energy delivery is continuous, then the neon lamp will illuminate.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (ZAP GUARD II, a defibrillator testing probe) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a clinical study with acceptance criteria and device performance in the way typically required for AI/software-as-a-medical-device (SaMD) clearances.

    Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

    Here's an attempt to answer based only on the provided document:

    Acceptance Criteria and Study to Prove Device Meets Criteria

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Conforms to original voltage and amperage design specifications of the ZAP GUARD."Bench testing demonstrated that the ZAP GUARD II conforms to the original voltage and amperage design specifications."
    Functionally tests biphasic defibrillator systems as intended."The ZAP GUARD II was also functionally tested using a biphasic defibrillator and performed as expected."
    Demonstrates safety and effectiveness comparable to the predicate device."Performance data demonstrates that the ZAP GUARD II is as safe and effective as the original ZAP GUARD."

    2. Sample size used for the test set and the data provenance:

    • Sample Size: Not specified. The document mentions "bench testing" and "functionally tested using a biphasic defibrillator" but does not quantify the number of tests or devices involved.
    • Data Provenance: The testing was conducted by Guardian Angel Products, Inc. (the manufacturer). No information on country of origin of data or whether it was retrospective or prospective. It appears to be an internal, prospective validation of the device design.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable/Not specified. The testing described for this device is physical and electrical performance rather than interpretation by human experts. The "ground truth" seems to be the expected electrical behavior and physical function.

    4. Adjudication method for the test set:

    • Not applicable/Not specified. No expert adjudication method is mentioned as the testing is non-clinical.

    5. 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:

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hardware testing probe, not an AI or imaging diagnostic tool that would typically involve human readers.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Not applicable directly in the context of AI/algorithms. However, the performance described is that of the standalone device (ZAP GUARD II) functioning independently to test a defibrillator, without human interpretation of its internal workings to achieve the test result (i.e., the neon light illuminates or not).

    7. The type of ground truth used:

    • The ground truth for the performance testing appears to be based on:
      • Design Specifications: Conformance to pre-defined voltage and amperage requirements for the electrical circuit.
      • Expected Functional Behavior: The verifiable illumination of the neon lamp when connected to an operational biphasic defibrillator with intact wiring, indicating correct function.

    8. The sample size for the training set:

    • Not applicable. This device is a hardware product, not a machine learning model, so there is no "training set."

    9. How the ground truth for the training set was established:

    • Not applicable. As noted above, there is no training set mentioned.
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