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510(k) Data Aggregation

    K Number
    K240937
    Device Name
    AIM (N/A)
    Manufacturer
    Inventeur, LLC
    Date Cleared
    2024-12-16

    (255 days)

    Product Code
    CCK,CAT,MNK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K140473
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inventeur, LLC

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

    AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.

    Device Description

    AIM is a single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing for patients undergoing procedures where supplemental oxygen and expired gas sampling is required expired. When paired with an oxygen supply and a capnography monitor, AIM can be left in place after the procedure to deliver oxygen and monitor CO2 levels.

    AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.

    AI/ML Overview

    The provided text describes a 510(k) summary for a medical device named AIM, which is a bite block with integrated oxygen delivery and expired gas sampling tubing. The summary compares AIM to a predicate device, DualGuard™ (K140473), to demonstrate substantial equivalence.

    Here's an analysis of the acceptance criteria and study proving the device meets these criteria, based on the provided document:

    Acceptance Criteria and Device Performance Study for AIM

    1. Table of Acceptance Criteria and the Reported Device Performance

    The document describes performance tests by comparing the AIM device to its predicate, DualGuard™. The acceptance criteria appear to be equivalent or better performance than the predicate device.

    Acceptance Criteria (Internal/Predetermined)Reported Device Performance
    Biocompatibility: Meet ISO 10993 standards (ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021, ISO 18562-2:2017, ISO 18562-3:2017) for surface contact, skin and mucosal, externally communicating tissue, limited use (
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