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510(k) Data Aggregation

    K Number
    K964143
    Date Cleared
    1997-01-09

    (84 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MINI-SYMM BIPOLAR COAGULATOR

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

    Not Found

    Device Description

    Valley Forge Scientific Corp., the manufacturer of several electrosurgical systems, now plans to introduce a new MINI-SYMM Bipolar System which enables the surgeon to coagulate while irrigating the surgical field.

    AI/ML Overview

    The provided text describes a medical device, the MINI-SYMM Bipolar System, an electrosurgical device for coagulation during surgery. However, the document is a "Summary of Safety and Effective Information" and focuses on the underlying technology, its advantages, historical context, and the expertise of its inventor. It does not contain a specific study designed to prove the device meets acceptance criteria, nor does it present discrete acceptance criteria with reported device performance in a tabular format.

    The document highlights general benefits and characteristics of bipolar electrosurgery, and specifically features of the MINI-SYMM system, but these are presented as inherent design advantages rather than outcomes of a specific performance study.

    Therefore, I cannot provide the requested information in the format specified because the input text does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Details of a specific study to prove acceptance criteria. This includes sample size, data provenance, expert qualifications for ground truth, adjudication methods, MRMC study details, standalone performance results, or detailed training set information.

    The document functions as a background and justification for the device's design based on established principles of bipolar electrosurgery, rather than a report on a new clinical or performance study of the MINI-SYMM Bipolar System itself.

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