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510(k) Data Aggregation

    K Number
    K071079
    Device Name
    SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
    Manufacturer
    GAMBRO BCT, INC.
    Date Cleared
    2007-08-02

    (107 days)

    Product Code
    LKN
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMBRO BCT, INC.

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

    The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.

    Device Description

    Spectra Optia Apheresis System, a blood component separator

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Spectra Optia Apheresis System. It states that the device is substantially equivalent to legally marketed predicate devices for use in therapeutic plasma exchange.

    However, the provided text does not contain any information about acceptance criteria or specific study data that proves the device meets such criteria. The letter is a regulatory approval document and not a performance study report.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study information.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Training set sample size.
    9. How ground truth for the training set was established.

    The document only confirms the FDA's concurrence with the stated Indications for Use.

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