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510(k) Data Aggregation

    K Number
    K991513
    Manufacturer
    Date Cleared
    1999-06-21

    (52 days)

    Product Code
    Regulation Number
    880.5440
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural.
    2. The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggy back infusions. The routes of administration include intravenous, subcutaneous and intramuscular.
    Device Description

    The Homepump C-Series is an elastomeric infusion pump with an integrated administration set. The elastomeric membranes function as the fluid reservoir and the pressure source. The pressure that pumps the fluid comes from the strain energy of the elastomeric membranes which are forced to expand when the pump is filled. The incorporation of fixed diameter flow control tubing or glass orifice combined with the elastomeric pressure source produces the desired flow rate. Homepump C-Series models are available in fill volumes from 50 to 500 ml and flow rates from 0.5 to 10 ml/hr. The One•Step KVO models of the Homepump C-Series have an optional Y-site and optional check valve attached to the distal end of the administration set. The following accessories are available: carry case, E-clip and power ring.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study details for the I-Flow Homepump C-Series device based on the provided document:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Priming/Residual Volume:
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