LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971421
    Device Name
    BARD ISOFLOW BLOOD PUMP
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    1998-05-14

    (393 days)

    Product Code
    DWA
    Regulation Number
    870.4380
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IsoFlow Blood Pump System is indicated as a component of an extracorporeal circuit to initiate and maintain blood flow for up to six hours.

    Device Description

    The Blood Pump Console is made up of the console, one power cord, and an Operator's Guide. The console is a microprocessor based system which drives and controls the speed of the disposable centrifugal blood pump in the extracorporeal circuit. Each console operates off of single phase AC power and is capable of a flow rate of up to 8 LPM against a maximum pressure head of 600 mmHG. In addition each console comes with an internal battery which is capable of running the pump for a minimum of 30 minutes when fully charged in the event of a loss of AC power.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (Bard® IsoFlow® Blood Pump), not an AI/ML device. Therefore, the requested information on acceptance criteria and study details related to AI/ML device performance (such as sample sizes for test/training sets, expert qualifications, MRMC studies, etc.) is not applicable to this document.

    The document describes performance testing for a traditional medical device, specifically:

    • Acceptance Criteria/Performance Goal: Not explicitly stated as a table with numerical goals in the provided text. However, the performance characteristics mentioned represent the device's capabilities:

      • Capable of a flow rate of up to 8 LPM against a maximum pressure head of 600 mmHG.
      • Internal battery capable of running the pump for a minimum of 30 minutes when fully charged.
      • Flow Sensor can detect flows from 0-10 LPM and retrograde flow of ≥ 40 cc/min.
      • Hand Crank provides sufficient power to deliver 7 LPM of blood flow against a 600 mmHg pressure head.

    • Study Proving Device Meets Criteria:

      • Performance Testing: "To verify that the changes did not adversely impact the performance of the console the affected boards were validated and the system validation was repeated."
      • EMC Testing: "In addition EMC testing was conducted per EN60601-1-2 to verify the device's resistance to EMC."

    Since this is not an AI/ML device, the following points are not applicable (N/A):

    1. Sample sizes for the test set and data provenance: N/A for a hardware device.
    2. Number of experts used to establish ground truth: N/A.
    3. Adjudication method: N/A.
    4. Multi-reader multi-case (MRMC) comparative effectiveness study: N/A.
    5. Standalone (algorithm-only) performance: N/A.
    6. Type of ground truth used: N/A.
    7. Sample size for the training set: N/A.
    8. How the ground truth for the training set was established: N/A.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1