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    K Number
    K984638
    Device Name
    PARAGON BOLUS ACCESSORY SET
    Manufacturer
    I-FLOW CORP.
    Date Cleared
    1999-02-09

    (40 days)

    Product Code
    FPA,DEC
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K884505,K935811
    Why did this record match?
    Device Name :

    PARAGON BOLUS ACCESSORY SET

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

    The Paragon Bolus Accessory Set is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The routes of administration are intravenous, epidural, intramuscular and subcutaneous.

    Device Description

    The Bolus Accessory may connect to any Paragon administration set to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands. The bolus button allows patient controlled administration of medication as needed. The Bolus Accessory is available in 0.5 ml bolus volume. The Bolus Accessory is a mechanical device that requires no external power.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Paragon Bolus Accessory Set, based on the provided document:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Bolus Volume Accuracy: ±10% at 95% confidence interval at the identified lockout times."All models performed within the specified accuracy when tested at nominal conditions." (Implies meeting the ±10% at 95% CI for the 0.5 mL bolus volume)
    Priming/Residual Volume:
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