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    K Number
    K171492
    Device Name
    B7 2C Occlusion Balloon
    Manufacturer
    Spiration, Inc.
    Date Cleared
    2017-11-20

    (182 days)

    Product Code
    EOQ,EOO,REV
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K962901
    Why did this record match?
    Device Name :

    B7 2C Occlusion Balloon

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

    The B7-2C Occlusion Balloon is to be used for selective endoscopic bronchography, saline injection associated with bronchoalveolar lavage, bronchial hemostasis and airway occlusion to localize air leaks.

    Device Description

    The device is introduced through the instrument channel of the bronchoscope. The device is constructed of the inflatable balloon, catheter, bifurcation, irrigation port, air feed cap and stopcock. The B7-2C device is 1050 mm in working length, with a pre-inflation diameter of 2.55 mm and a post-inflation diameter of 13 mm, with a max volume of 1.7 cc.

    AI/ML Overview

    The B7-2C Occlusion Balloon is intended for use in selective endoscopic bronchography, saline injection associated with bronchoalveolar lavage, bronchial hemostasis, and airway occlusion to localize air leaks.

    1. Table of acceptance criteria and the reported device performance:

    Acceptance CriteriaReported Device Performance
    Airway OcclusionComplete occlusion of the airway in 30 out of 30 tests.
    BiocompatibilityPassed tests for cytotoxicity, intracutaneous irritation, materials mediated pyrogen, sensitization, and systemic toxicity.
    Sterilization/Shelf-LifeAchieved a sterility assurance level of 10⁻⁶.
    Mechanical/FunctionalConformed to mechanical and functional specifications (e.g., burst testing).

    2. Sample size used for the test set and the data provenance:

    • Sample Size for Airway Occlusion Test: N=30 tests.
    • Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It implies bench testing ("Performance testing has been completed on both the predicate device as well as the subject device...").

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • This information is not provided in the document. The tests described are bench tests, not clinical studies involving human assessments.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not applicable as the performance tests described are objective bench tests, not human assessments requiring adjudication.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable. This device is a medical instrument (an occlusion balloon) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is not relevant.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Not applicable as this is a medical device and not an algorithm.

    7. The type of ground truth used:

    • The ground truth for the performance tests (e.g., airway occlusion, burst testing) was based on objective, quantifiable measurements from bench tests. For biocompatibility and sterilization, the ground truth was regulatory standards and established testing protocols.

    8. The sample size for the training set:

    • Not applicable. This device is not an AI/ML model, so there is no concept of a "training set."

    9. How the ground truth for the training set was established:

    • Not applicable.
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