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510(k) Data Aggregation

    K Number
    K152884
    Device Name
    DermaTherapy Bed Linens
    Manufacturer
    PRECISION FABRICS GROUP, INC.
    Date Cleared
    2016-06-20

    (264 days)

    Product Code
    FMW
    Regulation Number
    880.6190
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K061242
    Why did this record match?
    Device Name :

    DermaTherapy Bed Linens

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

    Bed linens made with DermaTherapy® fabrics are intended for use by patients 18 years of age and older in hospital settings who are susceptible to pressure ulcers. The DermaTherapy Bed Linens help to reduce the likelihood of patients developing pressure ulcers by reducing moisture, friction and shear on the patient's skin.

    Device Description

    DermaTherapy uses a silk-like fabric to minimize moisture, friction, and shear between the skin and the bedsupport surface. Continuous-filament yarns woven into the silk-like synthetic DermaTherapy fabric provide a smooth surface, free of broken or discontinuous fibers. This enhanced smoothness helps minimize the potential for irritation and abrasion of sensitive skin.

    DermaTherapy Bed Linens consists of pillow cases, top flat sheets, and underpads. The subject devices are made from DermaTherapy fabrics which are plain-weave constructions of 100% continuous-filament yarns. The polyester yarns have a non-round fiber cross-section to create micro-channels to facilitate moisture wicking and rapid drying. The yarns used in DermaTherapy fabrics are commercially available products, typically used in apparel.

    The only technological difference in the fabric construction between the subject device and the predicate device is the addition of a secondary static-dissipative polyester yarn at 0.8% of the total fabric weight. The static-dissipative yarn is incorporated to reduce the potential for static electricity that may occur during institutional laundering processes. The company has made no other modifications to the fabric or the manufacturing process of turning the fabric into the final product.

    AI/ML Overview

    This document describes data for a medical device called "DermaTherapy Bed Linens," which are intended to reduce the likelihood of pressure ulcers in hospital patients. Here's a breakdown of the requested information:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state "acceptance criteria" with numerical targets for each performance characteristic. Instead, it lists the "Performance Characteristics" and the "Test Method / Standard" used to evaluate the device. The conclusion states that "bench testing demonstrated that the device met performance specifications" and "demonstrated substantially equivalent device performance." It also includes clinical study results showing a reduction in pressure ulcer incidence.

    Given the information, the table below will combine the performance characteristics (which can be inferred as criteria for evaluation) and the clinical performance results.

    Performance CharacteristicTest Method / Standard (Acceptance Criteria are implied by meeting these standards)Reported Device Performance
    Weave PatternVisualNot explicitly stated, implied to meet visual standards.
    WeightASTM-D-3776Not explicitly stated, implied to meet standards.
    EndsASTM-D-3775Not explicitly stated, implied to meet standards.
    PicksASTM-D-3775Not explicitly stated, implied to meet standards.
    Grab Tensile - Warp & FillASTM-D-5034Not explicitly stated, implied to meet standards.
    Tongue Tear - Warp & FillASTM-D-2261Not explicitly stated, implied to meet standards.
    Circular BendASTM-D-4032Not explicitly stated, implied to meet standards.
    Pore SizeASTM-E-1294Not explicitly stated, implied to meet standards.
    Moisture RegainASTM-D-2654Not explicitly stated, implied to meet standards.
    Geometric RoughnessKawabata KES-FB4 Surface Tester (measured in microns)Not explicitly stated, implied to meet intended smoothness.
    Fabric Wicking RateDistance water travels in five minutes (measured in millimeters)Not explicitly stated, implied to meet intended wicking rate.
    % Dry after 0-60 minutes% moisture loss of fabric until dryness (measured in 15-minute intervals)Not explicitly stated, implied to meet intended rapid drying.
    Coefficient of FrictionKawabata KES-FB4 Surface Tester (values of 0 to 1)Not explicitly stated, implied to meet intended low friction.
    BiocompatibilityISO 10993 consensus standards (Cytotoxicity, sensitization, and irritation testing)Test results demonstrated biocompatibility.
    Antimicrobial Agent LeachingPFG conducted leachability studyTest results demonstrated substantially equivalent amount of antimicrobial agent leaching, with no safety risk to the patient.
    Reduction in Pressure Ulcers (Clinical)Clinical studies comparing control vs. DermaTherapyStudy 1: Control: 12.3%, DermaTherapy: 4.6% (P = .01)
    Study 2: Control: 7.5%, DermaTherapy: 0.0% (P = .01)
    Study 3: Control: 11.5%, DermaTherapy: 3.1% (P
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