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510(k) Data Aggregation

    K Number
    K012406
    Device Name
    ACCESS SEQUESTRATION SYSTEM
    Manufacturer
    INTERPORE CROSS INTL.
    Date Cleared
    2002-03-26

    (239 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K963759
    Why did this record match?
    Reference Devices :

    K963759

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

    The Interpore Cross International Access™ Sequestration System is intended to separate and construct an autologous plasma fraction rich in platelets and white cells from the patient's whole blood perioperative to a surgical procedure.

    Device Description

    The Access™ Sequestration System is comprised of two major components: a) Reusable separation apparatus: The Access sequestration machine is an electromechanical microprocessor-controlled device contained in an enclosure which incorporates the following system components: the user display and function keys, centrifuge rotor, centrifuge chamber housing, peristaltic pump, red blood cell sensors, bubble sensor, pinch valves, and the power supply unit. In addition, the system includes the electronic components and system software which controls and monitors the blood processing procedure. b) Single Use Processing Disposable set: The Access Sequestration Disposable Set consists of the separation chamber, two holding bags, and the associated tubing, clamps, connectors and protective caps.

    AI/ML Overview

    The provided text does not contain detailed acceptance criteria, device performance data, or a description of a study designed to prove the device meets specific criteria. The document is a 510(k) summary for the "Access™ Sequestration System," focused on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study against acceptance criteria.

    The key points from the document regarding a "study" are:

    • SUMMARY OF TESTING: "SUMMART OF TESTING Conducted, the proposed device has been demonstrated to be substantially equivalent to the predicate device." This statement is very general and does not provide details about what tests were conducted, what the acceptance criteria were, or what the reported performance was.

    Without further information from the original submission, it is not possible to fill out the requested table and answer the specific questions about acceptance criteria and a study proving their fulfillment. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report with specific metrics.

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