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510(k) Data Aggregation

    K Number
    K160950
    Device Name
    MINISCAV
    Manufacturer
    Sedation Systems LLC
    Date Cleared
    2017-05-05

    (395 days)

    Product Code
    CBN,BTA
    Regulation Number
    868.5430
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K150134
    Why did this record match?
    Device Name :

    MINISCAV

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

    The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.

    This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.

    Device Description

    The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.

    The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study information for the MINISCAV™ device, based on the provided document:

    The document describes a 510(k) premarket notification for the MINISCAV™ waste gas evacuation apparatus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical efficacy studies in the same way a PMA would. Therefore, the "study" mentioned here refers primarily to the non-clinical testing performed to show the device meets its performance specifications and is as safe and effective as the predicate.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state "acceptance criteria" in a tabulated format for each performance aspect. Instead, it describes various tests and what they demonstrated. I've extracted the implied criteria and the reported performance from the "Non-Clinical Testing Summary" and "Technology, Construction, Performance" sections.

    Acceptance Criteria CategorySpecific Criterion / RequirementReported Device Performance
    Electrical SafetyCompliance with AAMI/ANSI/ES60601-1 standard.Demonstrated compliance with AAMI/ANSI/ES60601-1.
    Electromagnetic Compatibility (EMC)Compliance with IEC 60601-1-2 standard.Demonstrated compliance with IEC 60601-1-2.
    Durability - Continuous RunningMaintain specifications for at least 10,000 hours of continuous running.Continuous running demonstrated the vacuum pump stays within its specifications for at least 10,000 hours.
    Durability - Real-time Unit LifeMeet performance specifications after 2 years of use.Real-time testing of the complete unit supports that the device meets its performance specifications after 2 years use.
    Vacuum and Flow - Constant VacuumProvide a constant vacuum of
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