LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033771
    Device Name
    BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
    Manufacturer
    BIO-DETEK, INC.
    Date Cleared
    2004-02-27

    (86 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR

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

    The BIO-DETEK Modified Adult Multi-Function Electrode with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 500, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cables, for defibrillation, cardioversion, non-invasive pacing, and electrocardingraph monitoring.

    Device Description

    The BIO-DETEK Modified Adult Multi-Function Electrodes with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable, for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.

    AI/ML Overview

    The provided document does not contain information about specific acceptance criteria, device performance, a study conducted to demonstrate the device meets acceptance criteria, sample sizes, ground truth establishment, or human expert involvement.

    Instead, this document is a 510(k) Premarket Notification Submission for the BIO-DETEK Modified Adult Multi-Function Electrodes with Connector. It focuses on demonstrating substantial equivalence to a previously marketed predicate device (BIO-DETEK Adult Multi-Function Electrodes, K931801).

    The core of this submission is to show that the new device has "operation and technological characteristics" that are sufficiently similar to the predicate device, not necessarily to present a study proving the new device meets specific, quantifiable performance acceptance criteria.

    The information provided includes:

    • Device Name: BIO-DETEK Modified Adult Multi-Function Electrodes with Connector
    • Intended Use: For use with specific Medtronic Physio-Control Defibrillator Models (LIFEPAK 9, 10C, 11, 12, 20) with QUIK-COMBO Therapy Cables for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.
    • Predicate Device: BIO-DETEK Adult Multi-Function Electrodes (K931801)
    • Compliance with Standards: The device is designed to comply with applicable portions of IEC 60601-2-4, ANSI/AAMI/ISO DF39-1993, ANSI/AAMI EC53:1995, and 21 CFR Part 898. These standards would contain performance requirements that the device should meet, but the document does not explicitly state the acceptance criteria derived from these standards or present test results against them.
    • FDA Decision: The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

    Therefore, based on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance study details. The document is a regulatory submission for substantial equivalence, not a detailed technical report of a performance study.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1