LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040256
    Device Name
    PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005
    Manufacturer
    BIO-DETEK, INC.
    Date Cleared
    2004-04-09

    (65 days)

    Product Code
    MKJ,MLN
    Regulation Number
    870.5310
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K960676
    Why did this record match?
    Device Name :

    PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005

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

    The pedirpadz™ Radiolucent MFE's are intended to be used on pediatric patients, 0-8 years of age at

    Device Description

    The pediepadz™ Radiolucent Pediatric Multi-Function Electrodes consist of a pair of liquid gel electrodes with permanently attached lead wires that join together at a proprietary ZOLL connector. The connector interfaces with ZOLL the Pacemaker/Defibrillator multifunction cable.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for the pedi•padz™ Radiolucent Pediatric Multi-Function Electrode. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific, novel acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an algorithm or AI.

    The document discusses the technological characteristics of the device and its compliance with standards, which are a type of acceptance criteria for medical devices (e.g., IEC 60601-2-4 Medical Electrical Equipment, ANSI/AAMI DF-2: 1996, Cardiac Defibrillator Devices). However, these are general engineering and safety standards, not performance metrics based on data analysis from a study as would be relevant for an AI/algorithm.

    Here's why the requested information cannot be extracted from this document:

    • Device Type: The pedi•padz™ is a physical medical electrode, not a digital algorithm, AI, or software-as-a-medical-device (SaMD).
    • Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies for efficacy or diagnostic accuracy.
    • Focus of the Document: The document focuses on the device's description, intended use, and compliance with existing electrical and safety standards, and its equivalence to predicate physical electrodes. There is no mention of an "algorithm" or "AI."

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/algorithm, because this information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1