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510(k) Data Aggregation

    K Number
    K150951
    Device Name
    aeris Balloon Dialation Catheter
    Manufacturer
    Bryan Medical , Inc.
    Date Cleared
    2015-06-25

    (77 days)

    Product Code
    KTI
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear, Nose, and Throat (EN)
    Reference & Predicate Devices
    K090660,K023337
    Why did this record match?
    Reference Devices :

    Inspira AIR Balloon Dilation System (K090660), Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337

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

    The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.

    Device Description

    The aeris Balloon Dilation Catheter is comprised of a sinqle lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A luer lock at the proximal end is used for placement of the stylet and injecting sterile water into the balloon. Two radiopaque markers, located on the catheter, inside the balloon, can be used to confirm balloon placement under Fluoroscopy.

    The aeris Balloon Dilation Catheter includes inflation balloons of diameters 5, 7, 8, 9, 10, 12, 14, and 16 mm with complementing characteristics as shown in Table 1.

    AI/ML Overview

    The provided text describes the acceptance criteria and the results of various bench tests for the aeris Balloon Dilation Catheter as part of a 510(k) submission for substantial equivalence. It does not include information about a study involving human readers, AI, or specific details on studies for ground truth establishment for a test set. This is a technical device submission, not an AI/algorithm-based diagnostic device.

    Here's the breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document provides multiple tables summarizing the bench testing results for different sizes of the aeris Balloon Dilation Catheter and a comparison with predicate devices. For conciseness, a combined table of the types of tests and their general acceptance criteria and performance will be presented, referencing the detailed tables for specific values.

    Test CategoryStudy EndpointRequirementAcceptance RequirementReported Device Performance (aeris Balloon Dilation Catheter)
    Functional Performance
    Balloon Working LengthBalloon pressure at 1 ATMBalloon working length within tolerance5x30mm: 30 ± 1 mm
    9x30mm: 30 ± 0.6 mm
    16x40mm: 40 ± 1 mmPass
    Inflation TimeBalloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm)Balloon able to inflaterecommended use pressure5x30mm & 9x30mm: Balloon failure pressure > 17 ATM
    16x40mm: Balloon failure pressure > 10 ATMPass
    Balloon Hub MeasurementBalloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm)Measure diameter of hub and working length5x30mm & 9x30mm: Hub diameter minus working length diameter
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