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510(k) Data Aggregation

    K Number
    K030443
    Device Name
    MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
    Manufacturer
    NASTECH PHARMACEUTICAL COMPANY, INC.
    Date Cleared
    2003-05-09

    (87 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MASCT device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.

    Device Description

    The Nastech MASCT device is similar to the non-powered breast aspirators manufactured by Nastech Pharmaceutical Company, Inc. and Pro-Duct Health, Inc. used to elicit and collect nipple aspirate fluid (NAF) from the excretory ducts (tubuli lactiferi or galactophori). The device is comprised of a rigid polycarbonate cup in which the sample collection container is inserted. Negative pressure (vacuum) is produced by nonpowered (hand) actuations of a lever like handle. The expressed NAF sample is collected on a membrane filter and washed into the sample container using an appropriate fixative solution.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nastech Pharmaceutical Company, Inc. Mammary Aspiration Specimen Cytology Test (MASCT) device:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly derived from the study's stated objective to demonstrate the device's ability to collect sufficient samples for cytological analysis and to support the claim that the collected cells can be used to identify differences associated with premalignant or malignant conditions.

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Sample Collection SuccessAll breasts evaluated yield nipple aspirate fluid (NAF).100% of breasts evaluated yielded nipple aspirate fluid.
    Sample Sufficiency for Cytological AnalysisAll collected samples are clinically useful and sufficient for cytological analysis by a pathologist.All samples were sufficient for cytological analysis; the pathologist was able to read all samples and obtain cytology results.
    Cytological Data QualityThe device enables the collection of cells that can be used to identify differences (normal, premalignant, malignant) through cytological examination.97% of samples were Class I (normal/benign); 3% were Class IIa (benign). These results support the claim for identifying cell differences.
    Sample Weight (Implicit)While not an explicit "acceptance criterion," the viability of collecting samples above a minimal weight threshold for practical handling/analysis is implied.Mean sample weight was 6.6 mg, range
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