(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.
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April 19, 2018
POM Medical, LLC % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704
Re: K172365
Trade/Device Name: Panoramic Oxygen Mask (POM) Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: March 17, 2018 Received: March 20, 2018
Dear Paul Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K172365
Device Name
Panoramic Oxvgen Mask (POM)
Indications for Use (Describe)
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,
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Page 1 of 7 19-Apr-18
| Company: | POM Medical, LLC1230 Madera Rd., Suite 5, Box 101Simi Valley, CA 92065 |
|---|---|
| Official Contact: | Jeff Voss, VP OperationsTel - (855) 766-0202 |
| Proprietary or Trade Name: | Panoramic Oxygen Mask (POM) |
| Common/Usual Name: | Gas sampling oxygen mask |
| Classification Name: | 21 CFR 868.1400Procode – CCKAnalyzer, gas, carbon-dioxide, gaseous phaseClass II |
| Predicate Device: | K133806 – Monitored Mask, M1 Capnography maskCapnoVue Scope |
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.
Indications for 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.
Patient Population:
For non-intubated, spontaneously breathing patients greater than 30 kg.
Environment of Use:
Locations where procedures are performed where the patient requires supplemental oxygen, monitoring exhaled gases, and scope access
Hospital, sub-acute, clinic, physician offices, pre-hospital.
Contraindications:
None.
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510(k) Summary
K172365
Page 2 of 7
19-Apr-18
Predicate Device Comparison - Table 1 - Comparison to the Predicate
| Attributes | ProposedPOM Panoramic Oxygen Mask | PredicateMonitor Mask – K133806M1 Capnography mask (Scope) | Comments |
|---|---|---|---|
| Indications for Use | The Panoramic Oxygen Mask (POM) isa single patient, disposable deviceintended for delivering supplementaloxygen and monitoring expired gasesfrom the patient, with ports to allow theclinician to insert scopes, probes, ortubes. It is for non-intubated,spontaneously breathing patientsgreater than 30kg. | The M1 Capnography Mask is asingle-use device intended fordelivering supplemental oxygen andmonitoring exhaled carbon dioxide innon-intubated spontaneously breathingpatients. Standard oxygen tubing andtwo female luer ports for gas sampleline attachment are included. | Both provide- supplemental oxygen- monitoring of exhaled gasesSubject device provides- access port(s) for scopes ( CapnoVueScope model) |
| Patient Population | non-intubated spontaneously breathingpatients | non-intubated spontaneously breathingpatientsChild and adult | Similar |
| Environment of Use | Locations where procedures areperformed where the patient requiressupplemental oxygen, monitoringexhaled gases, and scope access | Locations where procedures areperformed where the patient requiressupplemental oxygen, monitoringexhaled gases | Scope access for the subject device |
| Hospital, sub-acute, clinic, physicianoffices, pre-hospital | Hospital, sub-acute, clinic, physicianoffices, pre-hospital | ||
| Duration of Use | Single patient, disposable | Single patient, disposable | Similar |
| Prescriptive | Yes | Yes | Similar |
| Mode of Operation | O2 delivery through standard oxygensupply tubing and simultaneousexhaled gas monitoring via a gassampling line connected from mask tocapnography or oxygen only deliverySlit access ports allowing forintroduction of a scope | O2 delivery through standard oxygensupply tubing and simultaneousexhaled gas monitoring via a gassampling line connected from mask tocapnography or oxygen only delivery | Slit access ports allowing for introductionof a scope are provided in the CapnoVueScope model |
| Attributes | ProposedPOM Panoramic Oxygen Mask | PredicateMonitor Mask – K133806M1 Capnography mask (Scope) | Comments |
| Components which may besupplied or packaged with themask | Standard oxygen tubingGas sampling line | Standard oxygen tubingGas sampling line | Similar |
| Gas sampling connection | Luer slip fit | Luer lock | SimilarBoth connector type accommodatestandard gas sampling luer fittings |
| Sizes | ChildAdult | ChildAdult | Similar |
| Profile | Over the nose / mouth | Over the nose / mouth | Similar |
| Face strap | Yes | Yes | Similar |
| Performance | |||
| Internal volume | Child - 93 mlAdult - 198 ml | Child - 73 mlAdult - 159 ml | The difference in internal volume does notaffect performance of oxygen delivery ormonitoring of exhaled gases |
| Access Ports and Maximuminstrument size | Oral port – 60 mm ID / 20 mm ODNasal – 36 mm ID / 12 mm OD | Not available | Access port allows introduction ofinstruments while delivering supplementaloxygen and sampling expired gases |
| Entrainment Vents | One-way valves to prevent rebreathing | Open vents allowing room entrainment | Without the one-way valves the exhaledgas monitoring performance is reduced.For the intended use the designs aresimilar.There are oxygen masks marketed as non-rebreathing mask with one-way valves toprevent rebreathing. (Teleflex Non-rebreathing mask)This does not raise different questions ofsafety or effectiveness. |
| Attributes | ProposedPOM Panoramic Oxygen Mask | PredicateMonitor Mask – K133806M1 Capnography mask (Scope) | Comments |
| %CO2 accuracy andRespiration rate | Testing was done at different simulatedpatient settings for breath rate, TidalVolume at different CO2 concentrationswith waveforms | The results showed similar performancewith the proposed device. | |
| Biocompatibility | External Communicating (indirect)Tissue contactAndSurface Communicating (direct)Skin contactLimited duration of use (< 24 hours)Testing includedCytotoxicity (ISO 10993-5:2009)Sensitization (ISO 10993-10:2010)Intracutaneous / Irritation (ISO 10993-10:2010)Acute Systemic Toxicity (ISO 10993-11:2017) | External Communicating (indirect)Tissue contactAndSurface Communicating (direct)Skin contactLimited duration of use (< 24 hours) | Similar |
| Storage | -20° to + 50°C | Not specified | Testing supports the claim |
| Shelf-life | 3 years real-time aging and shelf-life | ||
| Effects of Aging | No effects of aging on performance |
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510(k) Summary
K172365
Page 3 of 7
19-Apr-18
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510(k) Summary
K172365
Page 4 of 7
19-Apr-18
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Substantial Equivalence Discussion
The POM is viewed as substantially equivalent to the predicate device (K133806 - M1 Capnography mask) based on the following discussions:
Indications -
- The intended use is to provide supplemental oxygen, monitor exhaled gases, and provide ● scope access is similar to the predicate.
Discussion - Both provide supplemental oxygen, monitoring of exhaled gases The differences of the subject device having access port(s) for scopes or instruments has been shown to not affect performance related to supplemental oxygen delivery and EtCO2 sampling.
Patient Population and environment of Use -
- The intended population is non-intubated spontaneously breathing patients in locations ● where procedures are performed that the patient may require supplemental oxygen, monitoring of exhaled gases and scope access.
- There are 2 sizes Child and adult mask .
Discussion - The population is similar to the predicate Monitor Mask - K133806 - M1 Capnography mask.
Technology –
- Identical technology of utilizing a luer fitting to connect gas sampling lines,
- This device modifies existing masks with ports for scope access. .
Discussion - The technology is similar to the predicate Monitor Mask - K133806 - M1 Capnography mask.
Differences -
The subject device offers access ports for scopes while the mask sits on the patient face. This technological characteristic is a combination of supplemental O2 and CO2 sampling facilitated by cannulas, which still allows scopes to access the patient airway. While access ports are different technological characteristic, the risk is the inability to use scopes to access airway. Labeling is provided to ensure compatibility of scopes with this device for airway access.
The differences between the predicate and the proposed device do not impact the performance of the device for supplemental oxygen delivery and EtCO2 sampling. These differences do not raise different questions of safety or effectiveness.
Non-clinical performance testing
We have performed non-clinical comparative performance testing that included:
- Internal volume ●
- Evaluation of ability to measure EtCO2 and Respiration Rate are various simulated patient settings typical of pediatric and adult users.
- . Storage, Drop and Aging
- . Biocompatibility
Biocompatibility / Materials -
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510(k) Summary Page 6 of 7 19-Apr-18
The materials in patient / drug contact have been tested they are characterized as:
- . External Communicating (Indirect gas pathway), Tissue / Bone / Dentin communicating, And
- Surface Contact, Skin,
- . Duration of Use - limited (< 24 hours)
We performed the following tests with guidance from ISO 10993-1 and the results were acceptable.
- Cytotoxicity ISO 10993-5:2009 .
- Sensitization ISO 10993-10:2010 ●
- . Irritation (for surface contact materials) - ISO 10993-10:2010
- Acute Systemic Toxicity ISO 10993-11:2017 .
Discussion - The materials used in the subject device are familiar and standard materials utilized in devices for this intended use.
Bench / Performance testing -
We performed comparative performance testing the tests included:
- Internal volume ●
- . Evaluation of ability to measure EtCO2 and Respiration Rate are various simulated patient settings typical of pediatric and adult users.
- Biocompatibility of Materials
- Mechanical Drop test ●
- . Effects of Aging on Performance
- Environmental Testing / Shelf-life
- ISO 594 Luer connector .
Tables 2 and 3 presents a summary of the testing performed.
| POM | Predicate M1 | ||||
|---|---|---|---|---|---|
| Adult | EtCO2 | RR | EtCO2 | RR | |
| Closed / Inserted | Closed / Inserted | ||||
| Test conditions | BPM – 12, TV – 500 ml | ||||
| 5% CO2 | O2 Flow – 1 Lpm | 7.37% / 6.57% | 12/12 | 6.43% | 12 |
| O2 Flow – 8 Lpm | 5.17% / 4.78% | 12/12 | 2.50% | 12 | |
| 1% CO2 | O2 Flow – 1 Lpm | 1.40% | 12 | 1.20% | 12 |
| O2 Flow – 8 Lpm | 1.00% | 12 | 0.47% | 12 | |
| BPM – 20, TV – 300 ml | |||||
| 5% CO2 | O2 Flow – 1 Lpm | 8.23% / 7.07% | 20/20 | 6.77% | 20 |
| O2 Flow – 8 Lpm | 6.17% / 4.40% | 20/20 | 3.37% | 20 | |
| 1% CO2 | O2 Flow – 1 Lpm | 1.63% | 20 | 1.27% | 20 |
| O2 Flow – 8 Lpm | 1.13% | 20 | 0.60% | 20 | |
| Internal Volume | 198 ml | 159 ml |
Table 2 - Summary of Comparative Testing - Adult Size
| Table 3 – Summary of FiO2 Testing – Adult Size | |||
|---|---|---|---|
| ------------------------------------------------ | -- | -- | -- |
| POM | |
|---|---|
| Adult | FiO2 |
| Test conditions | |
| BPM - 12, TV - 400 ml | |
| Closed |
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| 510(k) SummaryPage 7 of 719-Apr-18 | ||
|---|---|---|
| 4% CO2 | O2 Flow – 8 Lpm | 77.6% |
| O2 Flow – 10 Lpm | 83.4% | |
| O2 Flow – 12 Lpm | 87.0% |
Table 4 - Summary of Comparative Testing - Pediatric size
| POM | Predicate M1 | ||||||
|---|---|---|---|---|---|---|---|
| Pediatric | EtCO2Closed / Inserted | RRClosed / Inserted | FiO2Closed / Inserted | EtCO2 | RR | ||
| Test conditions | BPM - 12, TV – 500 ml | ||||||
| 5% CO2 | O2 Flow – 1 Lpm | 6.40% / 6.13% | 12 / 12 | 25.0% / 24.33% | 6.17% | 12 | |
| O2 Flow – 8 Lpm | 3.40% / 3.17% | 12 / 12 | 48.67% / 49.0% | 4.07% | 12 | ||
| 1% CO2 | O2 Flow – 1 Lpm | 1.10% | 12 | 1.07% | 12 | ||
| O2 Flow - 8 Lpm | 0.73% | 12 | 0.77% | 12 | |||
| BPM - 20, TV – 300 ml | |||||||
| 5% CO2 | O2 Flow - 1 Lpm | 6.40% / 6.23% | 20 / 20 | 23.67% / 24.67% | 6.03% | 20 | |
| O2 Flow – 8 Lpm | 3.10% / 2.23% | 20 / 20 | 56.0% / 56.33% | 3.97% | 20 | ||
| 1% CO2 | O2 Flow - 1 Lpm | 1.23% | 20 | 1.17% | 20 | ||
| O2 Flow – 8 Lpm | 0.70% | 20 | 0.77% | 20 | |||
| Internal Volume | 93 ml | 73 ml |
The results demonstrated that the device is substantially equivalent.
Discussion of Differences and Substantial Equivalence Conclusion -
The differences in:
- Access ports
- While access ports are different technological characteristic, the risk is the o inability to use scopes to access airway. Labeling is provided to ensure compatibility of scopes with this device for airway access.
- Access ports impact on monitoring is characterized O
- Internal volume
- While the internal volume of the mask is different the measured results show that o the difference does not influence the measured performance.
- . One-way valves for non-rebreathing
- There are standard oxygen masks which contain one-way valves to prevent o rebreathing.
These differences do not raise different questions of safety or effectiveness.
In conclusion, the comparison to the predicate for features, indications for use, population, and comparative testing across the range of oxygen flow, simulated patient conditions for both adult and pediatrics, exposed to different CO2 levels demonstrated that both devices provide representative measurement of EtCO2 and respiratory rate and their respective waveforms were similar.
The results demonstrate equivalence in performance.
§ 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).