Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K971988
    Date Cleared
    1997-07-11

    (43 days)

    Product Code
    Regulation Number
    878.4960
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEN MEDICAL SYSTEMS, INC.

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

    Devices are intended to attach boot stirrups to operating revm table rail or cysto table rail during surgical or diagnostic procedures requiring positioning and support of the patient's legs.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the "Allen®, Ultra™ and SMART Sockets" devices. This document does not contain information about specific acceptance criteria or a study proving the device meets them.

    The letter explicitly states:
    "We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

    This indicates that the clearance was based on substantial equivalence to a predicate device, rather than a new study demonstrating performance against a set of acceptance criteria. For devices cleared through the 510(k) pathway via substantial equivalence, the rigorous performance studies you've requested are often not submitted to the FDA in the same way they would be for a Pre-Market Approval (PMA) pathway or a de novo classification.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This information would typically be found in the 510(k) summary or the full submission, which is not included here.

    Ask a Question

    Ask a specific question about this device

    K Number
    K964273
    Date Cleared
    1997-01-08

    (72 days)

    Product Code
    Regulation Number
    878.4960
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEN MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K960027
    Date Cleared
    1996-03-12

    (70 days)

    Product Code
    Regulation Number
    880.6990
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEN MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1