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510(k) Data Aggregation

    K Number
    K244061
    Device Name
    X-Wire Guidewire
    Manufacturer
    Imperative Care, Inc.
    Date Cleared
    2025-08-26

    (238 days)

    Product Code
    MOF
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K231954,K220398
    Why did this record match?
    Device Name :

    X-Wire Guidewire

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

    The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

    Device Description

    The Imperative Care's X-Wire Guidewires are guidewires with shapeable tips to aid in accessing the peripheral and neuro vasculature. The guidewires are available in 200cm - 300cm lengths, standard (S) and support (T) stiffness profiles, and 0.014", 0.018" and 0.024" diameters. The distal portion of the guidewire tip includes a radiopaque marker to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment and PTFE coating on the proximal segment serve to reduce friction during manipulation in vessels. The X-Wire Guidewire is supplied with a shaping mandrel, introducer, and torque device.

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device and therefore does not contain acceptance criteria and study data in the format typically found in clinical efficacy studies for AI/software devices. The acceptance criteria and "study" described herein relate to the safety and performance of the physical guidewire device (X-Wire Guidewire) based on bench testing, biocompatibility testing, sterilization validation, and shelf-life testing, rather than a clinical study evaluating the performance of an AI algorithm.

    Here's a breakdown of the requested information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document summarizes the performance testing done in Table 2: Summary of Bench Tests and Performance Specifications and Table 3: Biocompatibility Test Summary – X-Wire Guidewire.

    Table: Acceptance Criteria and Reported Device Performance (Synthesized from document)

    Test AttributeAcceptance Criteria (Specification)Reported Device Performance (Results)
    Dimensional VerificationAll defined guidewire dimensions are within the specified tolerances.Pass
    Visual InspectionThe guidewire shall be free of visual defects when removed from packaging.Pass
    TorqueabilityThe guidewire shall transmit rotation from the proximal end to the distal tip to allow users to select branches of the vasculature and reach the target location.Pass
    Torque StrengthDevice shall not fail under expected torsional input when distal end is unable to move/rotate.Pass
    Tip FlexibilityTip of guidewire shall not cause vessel damage; defined by ability to buckle to reduce contact pressure and prevent perforation.Pass
    Tensile Strength and Tip PullGuidewire shall withstand tensile forces expected in clinical use without breaking.Pass
    Kink ResistanceGuidewire shall be able to traverse through clinically relevant bends without kinking.Pass
    Coating IntegrityCoating shall remain intact during clinical use.Pass
    Coating LubricityCoating shall be lubricious to reduce frictional forces for navigation.Pass
    Particulate EvaluationGuidewire shall not generate particles at a level greater than the range generated by the predicate.Pass
    Corrosion ResistanceGuidewire shall not corrode from time of manufacture through its shelf life.Pass
    RadiopacityOpacity to x-ray shall allow physicians to visualize guidewire under fluoroscopy.Pass
    Simulated UseGuidewire must be able to reach anatomical locations and deliver catheters and other interventional devices used in common neurovascular procedures.Pass
    CytotoxicityTest article extracts must yield grade 2 or lower.Pass, Noncytotoxic
    SensitizationOverall pattern, intensity, duration, character of reactions compared to control conditions.Pass, Nonsensitizer
    Irritation or Intracutaneous ReactivityDifference between test extract mean score and corresponding control mean score ≤1.Pass, Nonirritating
    Acute Systemic ToxicityNone of the animals treated with test article extracts must show significantly greater biological reactivity than control-treated animals.Pass, Non-toxic (acute systemic)
    Material Mediated PyrogenicityTest article extract must yield
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