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    K Number
    K120782
    Device Name
    INTERVENTIONAL HEMOSTATIC BANDAGE
    Manufacturer
    Z-MEDICA CORPORATION
    Date Cleared
    2013-03-20

    (370 days)

    Product Code
    QSY,FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K090620,K973036,K060409,K112961,K040208
    Why did this record match?
    Device Name :

    INTERVENTIONAL HEMOSTATIC BANDAGE

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

    QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.

    Device Description

    The QuikClot Interventional-A Hemostatic Bandage that is the subject of this submission is described in detail in K090620 in that it is made of a soft, white, kaolin-impregnated gauze. QuikClot® Interventional-A Hemostatic Bandage may be provided in a kit form that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® bandage (K973036) or equivalent. The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by l 1/2"wide by 1/2" thick multi-layer pad.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and supporting studies for the QuikClot Interventional-A Hemostatic Bandage, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state formal "acceptance criteria" in a quantitative format typical for regulatory submissions (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it presents performance metrics from pre-clinical animal studies and clinical studies. The implicit acceptance criterion is that the device demonstrates efficacy in controlling bleeding in anticoagulated patients, comparable to or superior to control methods, with an acceptable safety profile.

    Metric/Study ObjectiveImplicit Acceptance Criteria (Inferred)Reported Device Performance
    Pre-Clinical Swine Model
    Efficacy in Coumadin-treated pigsEffective control of bleeding94.5% successful control of bleeding (vs 24% for control gauze)
    Efficacy in Plavix-treated pigsEffective control of bleeding91.2% successful control of bleeding (vs 29.7% for control gauze)
    Safety in animal modelSafe use in anticoagulated modelNo animal deaths due to bleeding. Wounds not fully controlled required additional manual compression.
    Trabattoni D, et al. (2010) - Single Arm Pilot Study
    Complete bleeding cessation at 5 minHigh rate of cessationMean cumulative hemostasis time 4.9 ± 1.05 min (diagnostic: 4.2 ± 0.9 min, interventional: 5.3 ± 0.95 min)
    Safe ambulation at 4 hoursAll patients achieve safe ambulationAll patients achieved ambulation at 4 hours
    Serious Adverse EventsLow incidence of adverse eventsOne patient required extra compression and developed a small hematoma ( 5cm
    Politi L, et al. (2011) - Randomized Clinical Trial (Radial)
    Radial Artery Occlusion (RAO)Low to no RAOGroup 1 (QuikClot): 0% RAO; Group 2 (control short time): 5% RAO; Group 3 (control 2 hours): 10% RAO (p = 0.05)
    Active bleeding after compression removalLower incidence than controlGroup 1 (QuikClot): 10 patients (20%); Group 2 (control short time): 18 patients (90%); Group 3 (control 2 hours): 1 patient (2%) (p
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