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510(k) Data Aggregation

    K Number
    K961225
    Device Name
    CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    1996-06-21

    (84 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K860272
    Why did this record match?
    Reference Devices :

    K860272

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

    Not Found

    Device Description

    Baxter Healthcare Corporation intends to manufacture and market solution administration sets with an alternate design of the spike and drip chamber components.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device (Modified Solution Administration Sets). This document focuses on the description of the device and a summary of nonclinical tests. It does not contain information about clinical studies, acceptance criteria for performance metrics like sensitivity or specificity, or details about ground truth establishment.

    Therefore, I cannot fulfill your request for the following reasons:

    • No Acceptance Criteria or Reported Device Performance for Clinical Metrics: The document only mentions "functional requirements" for nonclinical tests (air passage, air leakage, tensile strength) and states the device "will meet or exceed all functional requirements." It does not provide specific numerical acceptance criteria (e.g., "sensitivity > 90%") or reported device performance for these types of clinical metrics.
    • No Clinical Study Details: The document describes nonclinical tests only. There is no mention of a study involving human subjects, diagnostic accuracy, or any performance metrics that would require ground truth, expert review, or statistical analysis of clinical outcomes.
    • No Information on Sample Sizes, Data Provenance, Experts, MRMC Studies, or Standalone Performance: Since no clinical study is described, there's no information about sample sizes for test sets or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance. The device described (solution administration sets) is a physical medical device, not an AI/algorithm-based diagnostic tool.

    In summary, the provided text does not contain the type of information required to answer your specific questions, which are geared towards evaluating AI/diagnostic software performance using clinical study data.

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