LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974454
    Device Name
    CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
    Manufacturer
    TUCSON MEDICAL CORP.
    Date Cleared
    1997-12-18

    (23 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TUCSON MEDICAL CORP.

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

    ClearField Anti-Fog Sterile Wipe is intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation.

    Device Description

    Sterile cloth pre-saturated with 5cc of Anti-Fog solution. Single Use.

    AI/ML Overview

    The provided text is a 510(k) summary for the ClearField Anti-Fog Sterile Wipe, K974454. This document primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.

    Therefore, it is not possible to extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text because it does not describe a performance study in that manner.

    The document states:

    • Intended Use: "Intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation."
    • Substantial equivalence is based upon equivalent technological characteristics of the solution, cloth and ink of this device compared to the predicate device.

    This indicates that the submission relies on demonstrating that the new device is fundamentally the same as a previously cleared device (K904871/B ClearField Anti-Fog Sterile Wipe) in its design and materials, rather than providing new clinical or performance study data with defined acceptance criteria.

    In summary, the document does not contain the information required to populate the table or answer the questions regarding study specifics, acceptance criteria, or performance outcomes.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1