Search Results
Found 1 results
510(k) Data Aggregation
(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 12/12BPM 12, TV 500ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 5.17% (Closed)/4.78% (Inserted), RR 12/12BPM 12, TV 500ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.40%, RR 12BPM 12, TV 500ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 1.00%, RR 12BPM 20, TV 300ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 8.23% (Closed)/7.07% (Inserted), RR 20/20BPM 20, TV 300ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 6.17% (Closed)/4.40% (Inserted), RR 20/20BPM 20, TV 300ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.63%, RR 20BPM 20, TV 300ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 1.13%, RR 20Pediatric:BPM 12, TV 500ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.40% (Closed)/6.13% (Inserted), RR 12/12BPM 12, TV 500ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 3.40% (Closed)/3.17% (Inserted), RR 12/12BPM 12, TV 500ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.10%, RR 12BPM 12, TV 500ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.73%, RR 12BPM 20, TV 300ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.40% (Closed)/6.23% (Inserted), RR 20/20BPM 20, TV 300ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 3.10% (Closed)/2.23% (Inserted), RR 20/20BPM 20, TV 300ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.23%, RR 20BPM 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 12BPM 12, TV 500ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 2.50%, RR 12BPM 12, TV 500ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.20%, RR 12BPM 12, TV 500ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.47%, RR 12BPM 20, TV 300ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.77%, RR 20BPM 20, TV 300ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 3.37%, RR 20BPM 20, TV 300ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.27%, RR 20BPM 20, TV 300ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.60%, RR 20Pediatric:BPM 12, TV 500ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.17%, RR 12BPM 12, TV 500ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 4.07%, RR 12BPM 12, TV 500ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.07%, RR 12BPM 12, TV 500ml, O2 Flow 8 Lpm, 1% CO2: EtCO2 0.77%, RR 12BPM 20, TV 300ml, O2 Flow 1 Lpm, 5% CO2: EtCO2 6.03%, RR 20BPM 20, TV 300ml, O2 Flow 8 Lpm, 5% CO2: EtCO2 3.97%, RR 20BPM 20, TV 300ml, O2 Flow 1 Lpm, 1% CO2: EtCO2 1.17%, RR 20BPM 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 (< 24 hrs) external communicating/surface contact. | Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Intracutaneous/Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017) – All results acceptable. | Similar testing conducted for predicate. |
| Mechanical Integrity | Drop test | Performed, results indicate no adverse effect on performance. | Not explicitly detailed in the comparative table for the predicate, but implied in general device safety. |
| Shelf-Life | 3 years real-time aging and shelf-life. | Testing supports the claim, no effects of aging on performance. Storage: -20° to +50°C. | Not specified for predicate. |
| Luer Connector | ISO 594 Luer connector | Testing performed, results acceptable. | Not explicitly detailed for predicate, but similar connection type (Luer lock) mentioned. |
| Internal Volume | Comparison of internal volume between new device and predicate. | Child: 93 ml; Adult: 198 ml. The difference in internal volume does not affect performance of oxygen delivery or monitoring of exhaled gases. | Child: 73 ml; Adult: 159 ml. |
| Entrainment Vents | Design of entrainment vents to prevent rebreathing. | One-way valves to prevent rebreathing. Without one-way valves, exhaled gas monitoring performance is reduced. For intended use, designs are similar. This does not raise different questions of safety or effectiveness. | Open vents allowing room entrainment. |
| Access Ports | Allowance for introduction of instruments while delivering supplemental oxygen and sampling expired gases. | Oral port: 60 mm ID / 20 mm OD; Nasal: 36 mm ID / 12 mm OD. Access port allows introduction of instruments while delivering supplemental oxygen and sampling expired gases. Impact on monitoring is characterized. Labeling ensures compatibility of scopes. | Not available for predicate, but predicate's "CapnoVue Scope model" implies similar functionality. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical comparative performance testing under simulated patient settings. Thus, there are no human patient test sets.
- Sample Size for Test Set: Not applicable as real patient data was not used. Instead, in-vitro bench testing was performed with simulated patient settings. Detailed quantitative results are provided for various scenarios (e.g., adult/pediatric, different BPM, Tidal Volumes, O2 flows, CO2 concentrations).
- Data Provenance: The data is generated from bench testing under controlled, simulated conditions. This is not retrospective or prospective patient data, nor is it tied to a specific country of origin in terms of patient population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the performance parameters (EtCO2, RR, FiO2) was established by the precise, controlled input parameters of the simulated breathing model (e.g., 5% CO2 gas mixture, set BPM). This is a physical or engineering ground truth, not one based on expert medical interpretation.
4. Adjudication Method for the Test Set
Not applicable. There was no human interpretation or adjudication required as the "ground truth" was the known input parameters of the test setup, and the device output was measured directly.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done. The study was non-clinical bench testing comparing the device's performance to that of a predicate device in a controlled, simulated environment, not human readers with or without AI assistance.
6. Standalone Performance
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done in the sense that the device's physical performance characteristics (e.g., CO2 accuracy, FiO2 delivery) were measured independently of human involvement during the testing itself. The data presented in Tables 2, 3, and 4 represent the performance of the device in these controlled bench environments.
7. Type of Ground Truth Used
The ground truth used was physical parameters/engineering ground truth. Specifically:
- For CO2 accuracy and respiration rate: known gas concentrations (e.g., 5% CO2, 1% CO2) and programmed breathing rates (e.g., 12 BPM, 20 BPM) and tidal volumes (e.g., 500ml, 300ml) in a simulated lung model.
- For FiO2: known oxygen flow rates and simulated breathing parameters.
- For biocompatibility, mechanical testing, and shelf-life: adherence to established international standards (e.g., ISO 10993) and internal protocols.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device (mask), not an AI/ML algorithm that requires a training set. The term "training set" is typically used in the context of machine learning model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML algorithm.
Ask a specific question about this device
Page 1 of 1