LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K110608
    Device Name
    SEVOFLURANE VAPORIZER ADAPTOR
    Manufacturer
    PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC)
    Date Cleared
    2011-07-20

    (139 days)

    Product Code
    CAD
    Regulation Number
    868.5880
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K053564
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC)

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

    The Sevoflurane Vaporizer Adaptor is intended to be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.

    Device Description

    The Sevoflurane Vaporizer Adaptor will fit securely to the bottle and the vaporizer, ensuring minimal leakage. The adaptor is designed for use with QuikFil™ vaporizer filling technology and it is intended for multiple uses. The device complies with the requirements of ISO 5360:2006.

    AI/ML Overview

    The provided text is a 510(k) summary for a Sevoflurane Vaporizer Adaptor, which is a medical device for filling anesthetic vaporizers. This document does not contain information about acceptance criteria, device performance, a study design, or ground truth establishment typically associated with an AI/ML medical device. The device described is a physical adaptor, not a software algorithm.

    Therefore, I cannot provide the requested information in the format of acceptance criteria and study details as it pertains to AI/ML device validation.

    Instead, the document details the device's classification, intended use, and its substantial equivalence to a predicate device (Keyed Filler Bottle Adaptor K053564). The evidence provided for its safety and effectiveness relies on its similarity to the predicate device and compliance with ISO 5360:2006 for anesthetic vaporizers.

    The relevant information from the provided text is:

    Device Name: Sevoflurane Vaporizer Adaptor
    Intended Use: To be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.
    Predicate Device: Keyed Filler Bottle Adaptor (K053564)
    Key Statement for Equivalence: "The general design and materials of the Sevoflurane Vaporizer Adaptor is very similar to the predicate device. The only differences are the connection into the vaporizer and the model types... These differences do not make the Sevoflurane Vaporizer Adaptor any less safe or less effective than the predicate device."
    Standard Compliance: "The device complies with the requirements of ISO 5360:2006."

    To reiterate, the original request is designed for AI/ML device submissions, and this document does not contain any information relevant to those specific criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1