LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K141793
    Device Name
    PULMONE MINIBOXPFT 2.0
    Manufacturer
    PULMONE ADVANCED MEDICAL DEVICES, LTD.
    Date Cleared
    2015-03-06

    (247 days)

    Product Code
    BZG,BZC
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K133051
    Why did this record match?
    Device Name :

    PULMONE MINIBOXPFT 2.0

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

    The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician.

    Device Description

    The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.

    The MiniBoxPFT™ 2.0 measures all common spirometric measurements as well as relative and absolute lung volumes, including the following (the full list is detailed in Section 11 - Device Description):

    Absolute Lung Volumes:
    Total lung capacity (TLC) L
    Thoracic Gas Volume (TGV) L
    Residual volume (RV) L

    Relative Lung Volumes:
    Inspiratory capacity (IC) L
    Expiratory reserve volume (ERV) L

    Spirometry:
    Forced vital capacity (FVC) L
    Forced inspiratory vital capacity (FIVC) L
    Slow vital capacity (SVC) L
    Slow inspiratory vital capacity (IVC) L
    Forced expiratory volume in 1 second (FEV1) L
    Forced inspiratory volume in 1 second (FIV1) L
    Ratio of FEV1 to SVC (FEV1/SVC) %
    Ratio of FEV1 to FVC (FEV1/FVC) %
    Forced expiratory volume in 6 seconds (FEV6) L
    Ratio of FEV1 to FEV6 (FEV1/FEV6) %
    Peak expiratory flow (PEF) L/s
    Peak inspiratory flow (PIF) L/s
    Forced Expiratory Flow at 50% of FVC (FEF50) L/s
    Maximum Voluntary Ventilation (MVV) L/min

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study details for the PulmOne MiniBoxPFT™ 2.0 device, based on the provided FDA 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Feature/TestAcceptance CriteriaReported Device Performance
    Spirometry MeasurementsMet ATS guidelines for accuracy and repeatability.Successfully met ATS guidelines.
    Lung Volume Measurement Repeatability & ReproducibilityInter-device repeatability and intra-device reproducibility within accepted known range.Validated to be within the accepted known range.
    Total Lung Capacity (TLC) Measurement (vs. Predicate)Met pre-defined success criteria demonstrating substantial equivalence to predicate.Successfully met study success criteria and demonstrated substantial equivalence.
    Flow range+/- 16 L/s (Predicate)+/- 16 L/s (Proposed Device)
    Volume accuracy+/- 3% or 50mL (Predicate)+/- 3% or 50mL (Proposed Device)
    Flow accuracy+/- 5% or 200 mL/s (Predicate)+/- 5% or 200 mL/s (Proposed Device)
    Dynamic resistance
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1