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510(k) Data Aggregation

    K Number
    K220703
    Device Name
    F&P 950 Respiratory Humidifier
    Manufacturer
    Fisher & Paykel Healthcare
    Date Cleared
    2023-06-16

    (463 days)

    Product Code
    BTT,BZE
    Regulation Number
    868.5450
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K050927,K173770,K131895,K211096,K982454,K031745,K091111,K133666,K110019,K122432,K162553,K103767,K212031,K020332
    Why did this record match?
    Reference Devices :

    K050927, K173770, K131895, K211096, K982454, K031745, K091111, K133666

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

    The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional.

    F&P 950 Breathing Circuit Kits: 950A80J, 950A81J, 950A82J, 950A61J, 950A61J, 950A40J, AA451SU
    The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications.

    F&P 950 Breathing Circuit Kits: 950P81J, 950P40J
    The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant, child and adolescent patients of its stated technical specifications.

    F&P 950 Breathing Circuit Kits: 950N80J, 950N81J, 950N61J, 950N40J
    The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its stated technical specifications.

    Device Description

    The F&P 950 Respiratory Humidifier is designed to warm and humidify air after it leaves a commercially available flow source and to maintain the air in a warmed and humidified condition to the point of delivery into the patient via heated tubing.

    The F&P 950 Respiratory Humidifier is made up of a heaterbase, sensor cartridge and expiratory heater wire adapter with breathing circuit kits to support the use with adult, pediatric and neonatal patients. Breathing circuit kits enable the use of the F&P 950 Respiratory Humidifier with clinical procedures such as invasive ventilation and nasal high flow.

    The device is a programmable electrical medical device that uses sensors throughout the system to humidify the gas. Gas travels through the chamber where it is humidity is requlated through monitoring the gas temperature exiting the chamber to achieve the target humidity level. The gas is then transported to the patient through a heated delivery tube. The gas temperature exiting the heated delivery tube is monitored to minimize the formation of condensate.

    AI/ML Overview

    The document is a 510(k) Summary for the F&P 950 Respiratory Humidifier and its accessory breathing circuit kits. It outlines the device's indications for use and compares its technological characteristics to a primary predicate device (F&P MR850 Respiratory Humidifier) and several secondary predicate devices for the various breathing circuit kits. The summary also details the non-clinical tests performed to demonstrate substantial equivalence.

    Here's the requested information based on the provided text, focusing on acceptance criteria and supporting studies:

    1. Table of acceptance criteria and the reported device performance:

      Acceptance CriteriaReported Device Performance
      Delivered humidity level (Bypassed airway)>33mg/L for flow 12mg/L for flow
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