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    K Number
    K201604
    Device Name
    Plasdent Disposable Barrier Sleeves and Barrier Film
    Manufacturer
    Plasdent Corporation
    Date Cleared
    2020-12-23

    (191 days)

    Product Code
    PEM
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K151123
    Why did this record match?
    Applicant Name (Manufacturer) :

    Plasdent Corporation

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

    Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.

    Device Description

    Plasdent Disposable Barrier Sleeves and Barrier Film are made of polyethylene film (PE), and come in various shapes and sizes as dental accessories intended to fit over and cover dental instruments and equipment. The Disposable Barrier Sleeves cover small hand-held dental instruments such as air/water syringes, curing lights, hand pieces, computers, sensors, dental instrument trays, and other similar handheld instruments to provide as a physical barrier or cover during a dental procedure. In other forms, the Disposable Barrier Film Covers are used to cover equipment, such as dental chairs, headrests, X-Ray heads, and other devices. The device is non-sterile, prepackaged, and is disposable, for single patient and one time use only.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA for a medical device: "Plasdent Disposable Barrier Sleeves and Barrier Film." It is primarily focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

    It is important to note that this document does NOT describe the validation of an AI/ML powered medical device. It describes the testing of a physical barrier device. Therefore, many of the requested elements for an AI/ML device validation (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, sample size for training set, ground truth for training set) are not applicable or present in this context.

    However, I can extract the relevant information for the physical device based on the provided text, focusing on acceptance criteria and performance data from the non-clinical testing.

    Acceptance Criteria and Device Performance (for a physical barrier device)

    The document presents non-clinical testing results to demonstrate that the Plasdent Disposable Barrier Sleeves and Barrier Film are substantially equivalent to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestStandardPurposeAcceptance CriteriaReported Device PerformanceResults Summary
    BIOCOMPATIBILITY TESTING:
    In-Vitro CytotoxicityANSI/AAMI/ISO 10993-5Evaluate the cytotoxicity of a test article extract.If viability is reduced to 0.5 indicate irritation.Overall Test Group Mean: 0Irritation response category of test article classified as Negligible.
    PERFORMANCE TESTING:
    Tensile StrengthASTM D882-18Determine the tensile properties of Subject device's disposable barrier sleeve compared to that of Predicate device disposable barrier sleeve.Transverse: 35-45 MPa
    Lengthways: 23-28 MPaHL181201: T 39.46, L 26.26
    HL20190601: T 39.84, L 26.46
    HL20190605: T 40.32, L 26.52The tensile strength of both products is in the same range.
    Puncture ResistanceASTM F1342-05Determine the puncture resistance of Subject device's disposable barrier sleeve compared to that of Predicate device's disposable barrier sleeve.4N-5N20190528: 4.56N
    20190601: 4.58N
    20190605: 4.56NThe puncture resistance of both products is in the same range.
    Tear ResistanceASTM D1004-13Determine the tear resistance of Subject device's disposable barrier sleeve compared to that of Predicate device's disposable barrier sleeve.4N-6NHL20190605: 5.026N
    HL20190610: 5.046N
    HL20190615: 5.032NThe tear resistance of both products is in the same range.
    Synthetic Blood PenetrationASTM F1670Evaluate the resistance of test material to penetration by synthetic blood under conditions of continuous liquid contact.Pass determination based on no visual detection of synthetic blood penetration.Material: no synthetic blood penetration seenPass. Test material resistant to synthetic blood penetration.
    Synthetic blood penetration at seams and non-continuous componentsASTM F1670Evaluate the resistance of test material at seams to penetration by synthetic blood under conditions of continuous liquid contact.Pass determination based on no visual detection of synthetic blood penetration.Material seams: no synthetic blood penetration seenPass. Test material seams resistant to synthetic blood penetration.
    Viral PenetrationASTM F1671Evaluate the barrier performance of test material which are intended to protect against blood borne pathogen hazards.Pass determination based on no visual detection of viral penetration and assay titer value
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