LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K072592
    Device Name
    PERFORMAX TOTAL FACE MASK
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Date Cleared
    2007-12-19

    (96 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K992969
    Predicate For
    K091271,K092043,K101130,K103395
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.

    Device Description

    The Respironics Performax Total Face Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. An integrated entrainment valve is provided for exhalation. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The entrainment valve is unchanged from K992969. The mask when used with the integrated entrainment valve has two integrated exhalation features, which includes the one port on the faceplate and an exhalation site on the elbow. A separate exhalation device is not required for the integrated entrainment valve design. Similar to the device predicate, Total Face Mask, the mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.

    The Respironics Performax Total Face Mask is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a 510(k) summary for a medical device (Respironics Performax Total Face Mask), and it primarily focuses on establishing substantial equivalence to a predicate device. It describes:

    • Device identification and contact information.
    • Substantial equivalence: Comparing the new mask to an older one (K992969) and listing design modifications.
    • Intended use: Who the mask is for and what it does.
    • Device description: Components and general characteristics.
    • FDA correspondence: The FDA's letter of clearance.

    The text does not contain any of the specific details requested in your prompt regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement. These types of details would typically be found in a separate study report or a more detailed section of a 510(k) submission that is not included in this excerpt.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1