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    K Number
    K172365
    Device Name
    Panoramic Oxygen Mask (POM)
    Manufacturer
    Pom Medical, LLC
    Date Cleared
    2018-04-19

    (258 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K133806
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pom Medical, LLC

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

    The Panoramic Oxygen Mask (POM) is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.

    Device Description

    The Panoramic Oxygen Mask (POM) is a multi-port mask that serves several functions:

    • A standard oxygen mask for when a patient requires supplemental oxygen
    • Sampling of exhaled gases for monitoring, typically end-tidal CO2
    • Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases.
      The design of the POM's oral or nasal membranes allow access of a scope and are soft and pliable to help maintain the oxygen concentration to the patient while having scopes, etc. inserted through these oral or nasal membranes.
    AI/ML Overview

    The Panoramic Oxygen Mask (POM) is a single-patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow clinicians to insert scopes, probes, or tubes. It is designed for non-intubated, spontaneously breathing patients greater than 30 kg.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the POM device are primarily based on demonstrating substantial equivalence to a predicate device (K133806 – Monitored Mask, M1 Capnography mask) in terms of performance for CO2 accuracy, respiration rate (RR), and FiO2 delivery, across various simulated patient settings, as well as meeting biocompatibility, mechanical durability, and shelf-life standards.

    Acceptance Criteria CategorySpecific Criteria/Test DescriptionPOM Device PerformancePredicate Device Performance
    CO2 Accuracy & RREvaluation of EtCO2 and Respiration Rate at various simulated patient settings (adult and pediatric).Adult:
    BPM 12, TV 500ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 7.37% (Closed)/6.57% (Inserted), RR 12/12
    BPM 12, TV 500ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 5.17% (Closed)/4.78% (Inserted), RR 12/12
    BPM 12, TV 500ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.40%, RR 12
    BPM 12, TV 500ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 1.00%, RR 12
    BPM 20, TV 300ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 8.23% (Closed)/7.07% (Inserted), RR 20/20
    BPM 20, TV 300ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 6.17% (Closed)/4.40% (Inserted), RR 20/20
    BPM 20, TV 300ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.63%, RR 20
    BPM 20, TV 300ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 1.13%, RR 20

    Pediatric:
    BPM 12, TV 500ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.40% (Closed)/6.13% (Inserted), RR 12/12
    BPM 12, TV 500ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 3.40% (Closed)/3.17% (Inserted), RR 12/12
    BPM 12, TV 500ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.10%, RR 12
    BPM 12, TV 500ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.73%, RR 12
    BPM 20, TV 300ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.40% (Closed)/6.23% (Inserted), RR 20/20
    BPM 20, TV 300ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 3.10% (Closed)/2.23% (Inserted), RR 20/20
    BPM 20, TV 300ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.23%, RR 20
    BPM 20, TV 300ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.70%, RR 20 | Adult:
    BPM 12, TV 500ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.43%, RR 12
    BPM 12, TV 500ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 2.50%, RR 12
    BPM 12, TV 500ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.20%, RR 12
    BPM 12, TV 500ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.47%, RR 12
    BPM 20, TV 300ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.77%, RR 20
    BPM 20, TV 300ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 3.37%, RR 20
    BPM 20, TV 300ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.27%, RR 20
    BPM 20, TV 300ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.60%, RR 20

    Pediatric:
    BPM 12, TV 500ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.17%, RR 12
    BPM 12, TV 500ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 4.07%, RR 12
    BPM 12, TV 500ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.07%, RR 12
    BPM 12, TV 500ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.77%, RR 12
    BPM 20, TV 300ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.03%, RR 20
    BPM 20, TV 300ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 3.97%, RR 20
    BPM 20, TV 300ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.17%, RR 20
    BPM 20, TV 300ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.77%, RR 20 |
    | FiO2 Delivery | Evaluation of FiO2 at various simulated patient settings (adult and pediatric). | Adult:
    BPM 12, TV 400ml, O2 Flow 8 Lpm, 4% CO2: 77.6%
    BPM 12, TV 400ml, O2 Flow 10 Lpm, 4% CO2: 83.4%
    BPM 12, TV 400ml, O2 Flow 12 Lpm, 4% CO2: 87.0%

    Pediatric:
    BPM 12, TV 500ml, O2 Flow 1 Lpm, 5% CO2: 25.0% (Closed)/24.33% (Inserted)
    BPM 12, TV 500ml, O2 Flow 8 Lpm, 5% CO2: 48.67% (Closed)/49.0% (Inserted)
    BPM 20, TV 300ml, O2 Flow 1 Lpm, 5% CO2: 23.67% (Closed)/24.67% (Inserted)
    BPM 20, TV 300ml, O2 Flow 8 Lpm, 5% CO2: 56.0% (Closed)/56.33% (Inserted) | Not provided for predicate in summary. |
    | Biocompatibility | Compliance with ISO 10993 for limited duration (

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