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510(k) Data Aggregation

    K Number
    K980171
    Device Name
    DERMASENSE PLUS DISPERSIVE ELECTRODE
    Manufacturer
    HORIZON MEDICAL, INC.
    Date Cleared
    1998-02-27

    (38 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K980171
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A NEUIRAL ELECTRODE AT WHICH NO SURGICAL EFFECT IS INTENDED WHICH PROVIDE A RETURN PATH FOR ELECTRICAL CURRENT TO GENERATOR.

    Device Description

    DermaSense PLUS Dispersive Electrode is a disposable, single use device commonly referred to in the industry as a neutral electrode, patient plate, or return electrode. A split, dual conductive plate design allows this device to be used with Return Electrode Monitor (REM) systems found on most electorsurgical generators being marketed today.

    AI/ML Overview

    This submission (K980171) for the DermaSense PLUS Dispersive Electrode primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. The document states that the device design, materials, nominal specifications, and performance standards are "either identical or substantially equivalent" to predicate devices and that both the Horizon device and predicates "meet the ANSI/AAMI HF-18 and IEC 601-2-2 industry performance standards." However, specific acceptance criteria and the results of a study demonstrating these are not explicitly presented.

    Based on the provided text, the following information can be extracted or inferred:

    1. A table of acceptance criteria and the reported device performance:

    Acceptance Criteria (Inferred from Predicate Equivalence and Standards)Reported Device Performance (Inferred from Substantial Equivalence Claim)
    Intended Use: Provides a return path for high-frequency electrical current to the electrosurgical generator; no electrosurgical effect intended at the electrode.Met: Same intended use as predicate devices.
    Technological Characteristics: Single-use, non-sterile, for monopolar electrosurgical applications, split dual-plate design, Return Monitor compatible, comprised of electrode body and cable assembly. Materials: acrylic adhesive coated thermoplastic film or closed cell polyethylene foam border with hydrogel conductive adhesive layer covering an aluminum metallized/laminated plastic film on a closed cell polyethylene foam backing.Met: Technological characteristics, device design, materials, nominal specifications are either identical or substantially equivalent to predicate devices.
    Performance Standards: Meets ANSI/AAMI HF-18 and IEC 601-2-2 industry performance standards.Met: "The Horizon and predicate devices meet the ANSI/AAMI HF-18 and IEC 601-2-2 industry performance standards." (This implies the new device also meets these, assuming equivalence.)

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

    • Sample Size: Not specified.
    • Data Provenance: Not specified. The submission likely refers to internal testing or comparisons against established predicate device performance and industry standards, rather than a clinical trial with a specific test set.

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

    • Not applicable as no specific test set requiring expert ground truth is described. The evaluation is based on technical specifications and adherence to industry standards, and comparison to legally marketed predicate devices.

    4. Adjudication method for the test set:

    • Not applicable as no specific test set requiring expert adjudication is described.

    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:

    • Not applicable. This device is a medical electrode, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

    • Not applicable. This device is a passive electrical component, not an algorithm.

    7. The type of ground truth used:

    • The "ground truth" here is implied to be adherence to established industry performance standards (ANSI/AAMI HF-18 and IEC 601-2-2) and equivalence to the technological characteristics and performance of legally marketed predicate devices (Valleylab REM PolyHesive II Patient Return Electrode and ConMed ThermoGard PLUS ABC Dual Dispersive Electrode). This would involve engineering testing and comparative analysis against the specifications and known performance of the predicate devices.

    8. The sample size for the training set:

    • Not applicable as this is not an AI/ML device requiring a training set.

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

    • Not applicable.
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