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510(k) Data Aggregation

    K Number
    DEN140022
    Device Name
    GLAUCOMA COMPANION
    Manufacturer
    INNOVATEX, INC.
    Date Cleared
    2016-04-20

    (642 days)

    Product Code
    PLX
    Regulation Number
    886.5838
    Type
    Direct
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Nasolacrimal Compression Device (NCD) is indicated to temporarily occlude the nasolacrimal ducts in adult patients to reduce outflow through the nasolacrimal ducts.

    Device Description

    The Nasolacrimal Compression Device is a modified spectacle frame made of polyvinyl chloride (PVC) coated soft carbon steel wire covered with silicone rubber where the device contacts the nose bridge. The fastening bands are made from flame-retardant nylon hook and loop fabric. The frame width, nose bridge width, and nose pad shape of the subject device may be adjusted. The nose pad is contoured such that it lies over the nasal aspect of the orbital rims where the nasolacrimal systems are underneath. There are fastening bands attached to each temple that allow the user to adjust pressure applied to the nasolacrimal system.

    AI/ML Overview

    The provided text does not describe acceptance criteria for a study demonstrating device performance. Instead, it outlines bench testing and limited clinical observations to support the classification of a Nasolacrimal Compression Device as Class I (exempt from premarket notification).

    The document is primarily a regulatory submission (DE NOVO CLASSIFICATION REQUEST), not a detailed study report with formal acceptance criteria and a comprehensive study to prove those criteria were met.

    However, based on the information provided, I can extract the closest equivalents to acceptance criteria and performance as presented in the document:

    Acceptance Criteria and Reported Device Performance (Bench Testing & Limited Clinical Observations)

    Acceptance Criteria (Implied from "Expected Outcome" or "Objective and Pass/fail Criteria")Reported Device Performance
    Spring Test: No deformation of the spring under normal use, when the imposed force is smaller than the yield force of the spring.Fyield ($W_1$): b(4) CCL (Specific numerical value redacted)
    Fnormal ($W_2$): b(4) CCI (Specific numerical value redacted)
    Pressure Tests:
    1. Pressure applied on the nasolacrimal ducts under normal use is $\le$ the pressure exerted by a standard eyewear.Pnormal: b(4) CCI (Specific numerical value redacted) below safety limit from literature
    2. No discomfort.Not explicitly quantified, but implied by "Pnormal... below safety limit" and "should not cause adverse effects."
    3. Maximum pressure applied to nasolacrimal ducts $\le$ 6 psi (skin tolerable pressure).Maximum pressure point (at center of nose pad) is below b(4) (Specific numerical value redacted, but stated to be
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