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510(k) Data Aggregation

    K Number
    K992015
    Device Name
    FREEDOM INFUSION SYSTEM
    Manufacturer
    NOVACON CORP.
    Date Cleared
    1999-09-10

    (87 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K930404,K941766,K955849
    Why did this record match?
    Device Name :

    FREEDOM INFUSION SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Freedom™ is intended to provide continuous infusion of a local anesthetic I rectly into the intraoperative site for postoperative pain management.
    2. Freedom™is intended to deliver pain medication percutaneously via a catheter attached to the pump.
    3. Freedom™is a single use only device.
    4. Freedom™is intended for use as an ambulatory device and is intended for, but limited to, use in the home environment.
    5. Freedom™is not intended for epidural, subcutaneous, or vascular drug delivery.
    6. Freedom™is not intended for use with chemotherapy drugs.
    7. Freedom™is not intended for use with blood, blood products, or TPN.
    Device Description

    The Freedom™ Infusion System pump will conform to the AMMI Draft Infusion Device Standard. The intended use of the Freedom™ Infusion System is identical to the legally marketed PainBuster system.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the Freedom™ Infusion System. It indicates that the device is substantially equivalent to a legally marketed predicate device (PainBuster system). However, the document does not contain the detailed information requested to describe specific acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/ML powered device.

    The document discusses:

    • Standards and Intended Use: The device will conform to the AAMI Draft Infusion Device Standard, and its intended use is identical to the legally marketed PainBuster system.
    • Manufacturing and Testing Procedures: Mentions Class 10,000 clean room manufacturing, 100% testing of silicone balloons to 110±5 mmHg (clinical operating pressure ~70 mmHg), and traceability.
    • Prior In-Vitro Tests and Clinical Experience: References FDA file numbers (K930404, K941766, K955849) for burst testing, flow rate, flow profile, and accuracy bench tests. It also mentions clinical experience with DIB pumps for obstetrical analgesia, post-operative pain, chronic pain, and intravenous infusions in the USA.

    Therefore, based on the provided text, I cannot complete the requested table and answer the specific numbered questions concerning acceptance criteria and a study proving the device meets those criteria, as the document does not contain the necessary information.

    Here's why and what's missing:

    • Acceptance Criteria Table: The document states conformity to an AAMI Draft Infusion Device Standard and internal pressure testing for balloons. However, it does not quantify specific performance metrics as acceptance criteria (e.g., accuracy +/- X%, error rate
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