LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K083233
    Device Name
    THE PFT FILTER
    Manufacturer
    PULMONARY FILTRATION TECHNOLOGIES LLC
    Date Cleared
    2009-03-02

    (119 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K013123,K934475
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment. Single patient use, single session, disposable.

    Device Description

    The PFT Filter is filter for use with PFT equipment and testing. It is intended to interface between the equipment and the patient during the test. It has a lightweight, compact housing with electrostatic filter media.

    AI/ML Overview

    The provided text describes a 510(k) summary for "The PFT Filter," a device intended for use with pulmonary function testing equipment to filter air between the patient and the equipment.

    Here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    AttributeAcceptance Criteria (Predicate Device)Reported Device Performance (The PFT Filter)
    Indications for UseFor use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment.For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment.
    Environments of useHospital, Sub-acute Institutions, Doctor's offices, LaboratoriesHospital, Sub-acute Institutions, Doctor's offices, Laboratories
    Single patient use, single session, disposableYesYes
    May be used on different PFT testing machinesYes - not specified (for predicate EMS - PFT - K013123)Yes
    Filter media typeElectrostaticElectrostatic
    Internal volume50 ml (for predicate PDS KoKo – K934475)51 ml
    Resistance to flow @ 60 Lpm0.5 cm H2O0.5 cm H2O
    Resistance to flow @ 720 Lpm0.7 cm H2O0.7 cm H2O
    Bubble test per ASTM F316-031.2 cm H2O @ 0.26 Lpm (Reference only)1.0 cm H2O @ .26 Lpm
    Bacterial Filtration Efficiency (BFE)99.99+%99.9+%
    Viral Filtration Efficiency (VFE)99.99+% (for predicate PDS - KoKo-K934475)99.9+%
    Weight41 gm (for predicate PDS-KoKo – K934475)46 gm
    Duration of use
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1