(258 days)
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.
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.
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 Category | Specific Criteria/Test Description | POM Device Performance | Predicate Device Performance |
|---|---|---|---|
| CO2 Accuracy & RR | Evaluation 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 (
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).