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510(k) Data Aggregation

    K Number
    K970491
    Manufacturer
    Date Cleared
    1997-05-30

    (109 days)

    Product Code
    Regulation Number
    890.5525
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    DUPEL II BUFFERED IONTOPHORESIS ELECTRODES

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

    The Dupel® II Buffered Iontophoresis Electrodes are designed for use with the Dupel Iontophoresis System (K903093) which is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.

    Device Description

    The Dupel® II Buffered Iontophoresis Electrode System consists of an active drug delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to a 160mAmin treatment session. These electrodes are designed for single patient, one application use. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same for all drug delivery electrode sizes.

    AI/ML Overview

    This document describes the safety and effectiveness information for the Dupel® II Buffered Iontophoresis Electrode System.

    Here's an analysis of the provided text based on your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document states that the modified Dupel® II electrode was compared to the predicate Empi Buffered Iontophoresis Electrode (K912015). The performance was assessed against product specifications.

    Acceptance Criterion (Specification)Reported Device Performance (Dupel® II)
    pH Buffering AbilityRemains the same as predicate
    Fill RateRemains the same as predicate
    Active AreaEssentially the same as predicate
    Material BiocompatibilitySame level as predicate
    Electrical ResistanceLowered specification compared to predicate
    Fill VolumeIncreased slightly compared to predicate

    Note: The document explicitly states, "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements, is acceptable for its intended use and is equivalent to the predicate electrodes."

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

    • Sample Size: Not explicitly stated. The document refers to "functional testing" and "design qualification tests" but does not provide specific numbers for units tested.
    • Data Provenance: The study was conducted as part of the 510(k) submission by Empi, Inc., based in St. Paul, Minnesota, USA. It is a retrospective analysis comparing a modified device to a previously cleared predicate device.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    Not applicable. This is not a study involving human interpretation of medical images or data where expert ground truth is typically established. The testing focused on technical performance parameters of an electrode.

    4. Adjudication Method for the Test Set

    Not applicable. This is not a study requiring adjudication of expert opinions.

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

    No. An MRMC study is typically used for diagnostic or screening devices where human readers interpret medical data. This study is an engineering and functional performance assessment of an electrode.

    6. Standalone (Algorithm Only) Performance Study

    No. This device is an electrode, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

    7. Type of Ground Truth Used

    The ground truth or reference standard for this study was product specifications and the performance of the predicate device. The modified device was evaluated against these established benchmarks for equivalence.

    8. Sample Size for the Training Set

    Not applicable. This is a medical device performance study, not an AI/Machine Learning model that requires a training set.

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

    Not applicable, as there is no training set for this type of device study.

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