SuperNO2VA Et Device
Device Facts
| Record ID | K173147 |
|---|---|
| Device Name | SuperNO2VA Et Device |
| Applicant | Revolutionary Medical Devices, Inc. |
| Product Code | CCK · Anesthesiology |
| Decision Date | Jun 20, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The SuperNO2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient's nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care. It has a means for sampling expired gases from the patient's exhaled breath from the oral / nasal areas. The SuperNO2VA Et™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.). It is a single patient use, disposable. The SuperNO2VA Et™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea. To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
Device Story
Nasal mask device for anesthesia care; provides seal over nose to deliver anesthesia gas, air, or oxygen to upper airway; includes sampling port for nasal expired gases and 'hood' for oral expired gases. Used in hospital/sub-acute settings under clinical supervision. Clinician connects device to gas source via 15mm connector and to monitor via luer fitting. Enables oral cavity access during procedures while maintaining gas delivery and monitoring. Benefits include simultaneous airway management and capnography in non-intubated patients. Single-patient use, disposable.
Clinical Evidence
Bench testing only. Evaluated dead space, pressure drop, pressure/leakage, and O2/CO2 sampling performance against predicates using mannequin models. Results showed comparable EtCO2 measurement accuracy across various flow rates (1-5 lpm) and tidal volumes (300-500 ml) for both nasal and oral sampling paths. Biocompatibility testing performed per ISO 10993-1.
Technological Characteristics
Nasal mask with integrated oral sampling hood. Features 15mm male circuit connector, luer fitting for gas sampling, and slip-fit port for pressure monitoring/oxygen. Materials meet ISO 10993-1 for limited duration (<24h) mucosal/tissue contact. Mechanical design provides seal for gas delivery up to 30 cmH2O.
Indications for Use
Indicated for adult patients (>30 kg) requiring anesthesia gas, air, or oxygen delivery and expired gas sampling during the continuum of anesthesia care. Contraindicated for long-term ventilation and sleep apnea treatment.
Regulatory Classification
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.
Predicate Devices
Reference Devices
- Medline Anesthesia Face Mask (Class 510(k) exempt)
- Monitor Mask - M1 (K133806)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Revolutionary Medical Devices, Inc. % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K173147
Trade/Device Name: SuperNO2VA EtTM Device Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, BSJ Dated: May 23, 2018 Received: May 24, 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 comprehensive regulatory information about medical devices and radiation-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.
## Todd D. Courtney -S
Tina Kiang, Ph.D. for 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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See PRA Statement on last page.
Expiration Date: 06/30/2020
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
### K173147
Device Name
### SuperNO2VA Et™ Device
Indications for Use (Describe)
The SuperNO2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient's nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care.
It has a means for sampling expired gases from the patient's exhaled breath from the oral / nasal areas.
The SuperNO2VA Ef™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.). It is a single patient use, disposable.
The SuperNO2VA Ef™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea.
To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
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)
### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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### 510(k) Summary Page 1 of 9 20-Jun-18
| Revolutionary Medical Devices, Inc.<br>4090 E. Bujia Primera | | | | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--|--|--|
| Tucson, AZ 85718 | Tel - (520)-844-3729 | | | |
| Official Contact: | David M. Kane - President and CEO | | | |
| Proprietary or Trade Name: SuperNO2VA EtTM Device | | | | |
| Common/Usual Name: | Nasal anesthesia face mask with gas sampling | | | |
| Classification Code/Name: | CCK - analyzer, gas, carbon-dioxide, gaseous-phase<br>21CFR 868.1400, Class 2 | | | |
| Device: | SuperNO2VA EtTM Device | | | |
| Predicate Devices: | Primary - K011050 - Oridion Microstream (CapnoLine) - CCK<br>Secondary - K163277 - RMD - SuperNO2VATM Device - BSJ | | | |
| Reference Devices: | Class 510(k) exempt - Medline - Anesthesia Face Mask<br>K133806 - Monitor Mask - M1 | | | |
### Device Description:
The SuperNO2VA Et™ Device is a nasal mask with a sampling port for the nasal portion and a sampling "hood" for over the mouth.
The subject device is similar to an anesthesia or oxygen mask with gas sampling port. Instead of covering the full face the SuperNO2VA Et™ Device design is to allow the clinician to have access to the oral cavity during a procedure but still be able to provide air, oxygen or anesthesia gases to the patient while also sampling expired gases from the nasal or oral areas.
The design incorporates the standard 15 mm male circuit connector, luer fitting for the gas sampling line and a slip-fit port for pressure monitoring or oxygen if the mask is used with a manual resuscitator or hyperinflation bag.
The mask is not considered a long-term use device as it would only be used from pre- to postoperative care. This would be similar to the standard anesthesia mask.
It is not for use in long-term ventilation conditions or the treatment of sleep apnea.
#### Indications for Use:
The SuperNQ2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient's nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care.
It has a means for sampling expired gases from the patient's exhaled breath from the oral / nasal areas.
The SuperNO2VA Et™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.). It is a single patient use, disposable.
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### 510(k) Summary Page 2 of 9 20-Jun-18
The SuperNO2VA Et™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea.
To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
Patient Population: Adult patients (>30 kg)
Environment of Use: Hospital, Sub-acute
Substantial Equivalence Discussion: Table 1 below compares the key features of the proposed SuperNO2VA Et™ Device mask with the identified primary and secondary predicates and reference devices to demonstrate that the proposed device can be found to be substantially equivalent.
Indications for Use – SuperNO2VA Et™ Device combines indications for use from the predicates, namely expired gas sampling - oral and nasal, with the secondary predicate SuperNO2VA, K163277, which provides a seal to delivery of gases.
Discussion - The proposed indications are a combination of the predicate and reference devices and there are no differences in the indications which raise new concerns of safety and effectiveness when compared to the predicates.
Technology and construction - SuperNO2VA Et™ Device is a nasal mask with a means, a "hood" to also sample expired exhaled from the mouth.
Like the predicate and reference devices they all sample exhaled gases via a port which is a conduit for the samples gases to be delivered to the monitor.
Discussion - The difference is the combination of a nasal mask and the "hood" over the mouth. The predicate uses nasal cannula and an additional sampling means for the mouth. However, the comparison performance testing has demonstrated equivalence.
The difference of delivering gases is similar to the secondary predicate SuperNO2VA, K163277, which provides a seal to delivery of gases. Delivery of gases under pressure to only the nasal area only is consistent with the secondary predicate and thus does not raise different concerns of safety or effectiveness than the predicates.
Environment of Use - The environment of use is similar to the predicates and reference devices. Discussion - The subject device does not include the pre-hospital setting.
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### 510(k) Summary Page 3 of 9
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### Table 1 – Comparison to Predicate and Reference Devices
| Feature | Proposed | Primary Predicate | Secondary Predicate | Reference | Reference | | |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------|
| | SuperNO2VA Et™ | K011050 | K163277 | Exempt | K133806 | | |
| | Device | Oridion - Capnostream | RMD SuperNO2VA | Medline Anesthesia | Monitor Mask - M1 | | |
| | | Oral / Nasal Cannula | Mask | mask | | | |
| Product | CCK | CCK | | | CCK | | |
| Classification | 868.1400 | 868.1400 | | | 868.1400 | | |
| | BSI | | BSI | BSI | | | |
| | 868.5550 (Secondary) | | 868.5550 | 868.5550 | | | |
| Indications for | The SuperNO2VA Et™ Device | Is used whenever the | The SuperNO2VA™ Device | Positioned over a | The M1 Capnagraphy Mask | | |
| Use | is a nasal mask that creates a | physician needs to | is a mask that creates a seal | patient's nose or mouth | is a single-use device | | |
| | seal when positioned over a | measure the CO2 in a | when positioned over a | to direct anesthetic | intended for delivering | | |
| | patient's nose to direct | patient's breathing in a | patient's nose and mouth, or | gases to the upper | supplemental oxygen and | | |
| | anesthesia gas, air, and / or | non-intubated patient. | nose only, to direct anesthesia | airway. | monitoring exhaled carbon | | |
| | oxygen to the upper airway | | gas, air, and / or oxygen to the | | dioxide in non-intubated | | |
| | during the continuum of | Intended to conduct a | upper airway during the | | spontaneously breathing | | |
| | anesthesia care. | sample of the patient's | continuum of anesthesia care. | | patients. Standard oxygen | | |
| | It has a means for sampling | breathing from the patient | To be used under clinical | | tubing and two female luer | | |
| | expired gases from the patient's | to the gas measurement | supervision with adequate | Port for expired gas | ports for gas sample line | | |
| | exhaled breath from the oral / | device for measuring the | alarms and safety systems for | sampling | attachment are Included. | | |
| | nasal areas. | percentage of CO2 in the | monitoring and treatment of | | | | |
| | To be used under clinical | patient's exhalation. | ventilatory failure. | | | | |
| | supervision with adequate | | | | | | |
| | alarms and safety systems for | | The SuperNO2VA™ Device | | | | |
| | monitoring and treatment of | | is intended for short-term | | | | |
| | ventilatory failure. | | (<24 hours) use on adult | | | | |
| | The SuperNO2VA Et™ Device | | patients (>30 kg.) It is a single | | | | |
| | is intended for short-term (<24 | | patient use, disposable. | | | | |
| | hours) use on adult patients | | | | | | |
| | (>30 kg.). It is a single patient | | The SuperNO2VA™ Device | | | | |
| | use, disposable. | | is contraindicated for use in | | | | |
| | The SuperNO2VA Et™ Device | | long-term ventilation | | | | |
| | is contraindicated for use in | | conditions and treatment of | | | | |
| | long-term ventilation | | sleep apnea. | | | | |
| | conditions and treatment of | | | | | | |
| | sleep apnea. | | | | | | |
| Feature | Proposed<br>SuperNO2VA EtTM<br>Device | Primary Predicate<br>K011050<br>Oridion - Capnostream<br>Oral / Nasal Cannula | Secondary Predicate<br>K163277<br>RMD SuperNO2VA<br>Mask | Reference<br>Exempt<br>Medline Anesthesia<br>mask | Reference<br>K133806<br>Monitor Mask – M1 | | |
| Patient<br>Population | Adult Patients > 30 kg | All patients | Adult Patients > 30 kg | All patients | All patients | | |
| | Environment of<br>Use | Hospital<br>Sub-acute | Hospital<br>Sub-acute<br>Pre-hospital | Hospital<br>Sub-acute | Hospital<br>Sub-acute<br>Pre-hospital | Hospital<br>Sub-acute<br>Pre-hospital | |
| Duration of Use | | Single patient use,<br>Disposable < 24 hours | Single patient use,<br>disposable | Single patient use,<br>Disposable < 24 hours | Single patient use,<br>disposable | Single patient use,<br>disposable | |
| Technological Characteristics | | | | | | | |
| Where expired<br>gas sampled | Nasal<br>Oral | Nasal<br>Oral | No sampling | No sampling | Nasal<br>Oral | | |
| | Where is gas<br>delivered | Nasal | Nasal | Nasal<br>Oral | Nasal<br>Oral | Nasal<br>Oral | |
| Technology for<br>directing gases<br>under pressure | | Seal at nasal area | No seal | Seal at both nasal and oral | Seal at both nasal and<br>oral | No seal | |
| | Technology for<br>sampling expired<br>gases | Luer port in nasal mask<br>Open hood for oral portion | Open sampling in nasal<br>area<br>Open hood for oral<br>portion | No sampling port | Luer port in mask | Luer port in mask | |
| | | Provides a seal<br>for delivery of<br>gas | Yes<br>Nasal only | No | Yes<br>Nasal and Oral | Yes<br>Nasal and Oral | No |
| Oxygen or<br>pressure<br>monitoring port | | | Yes | No | Yes | No | Yes |
| | | | Method of<br>sampling expired<br>gases | At nasal portion via a port<br>At oral via a hood | At nasal via a cannula<br>At oral via a hood | Does not sample | At oral and nasal via a<br>port |
| | Patient<br>connector | 15 mm connector for delivered<br>gas source | | No patient connector | 15 mm connector for<br>connecting delivered gases | 15 / 22 mm connector<br>for delivered gas source | Oxygen tubing connector<br>for delivered gas source |
| Feature | | Proposed<br>SuperNO2VA EtTM<br>Device | | Primary Predicate<br>K011050<br>Oridion - Capnostream<br>Oral / Nasal Cannula | Secondary Predicate<br>K163277<br>RMD SuperNO2VA<br>Mask | Reference<br>Exempt<br>Medline Anesthesia<br>mask | Reference<br>K133806<br>Monitor Mask – M1 |
| Performance Comparison | | | | | | | |
| Internal volume | Nasal mask only<br>Medium – 53 ml<br>Large - 87 ml | Not applicable | Nasal mask only<br>Medium – 53 ml<br>Large - 87 ml | Full mask<br>~ 158 ml | Not applicable | | |
| Pressure to<br>maintain a seal<br>for gas delivery | Up to 30 cmH2O | Not applicable | Up to 30 cmH2O | Not specified | Not applicable | | |
| Resistance to<br>flow | 0.46 cmH2O @ 50 lpm<br>1.8 cmH2O @ 100 lpm | Not applicable | 0.46 cmH2O @ 50 lpm<br>1.8 cmH2O @ 100 lpm | 30 lpm – 0.13 cmH2O<br>60 lpm – 0.25 cmH2O<br>90 lpm – 0.51 cmH2O | Not tested | | |
| Leak rate under<br>pressure | 0.8 Lpm @ 20 cmH2O | Not applicable | 0.8 Lpm @ 20 cmH2O | Not tested | Not tested | | |
| Biocompatibility | ISO 10993-1<br>Externally communicating<br>Tissue<br>Surface Contact<br>Skin / Mucosal<br>Limited duration (< 24<br>hours) | ISO 10993-1<br>Externally<br>communicating Tissue<br>Surface Contact<br>Skin / Mucosal<br>Prolonged duration | ISO 10993-1<br>Externally communicating<br>Tissue<br>Surface Contact<br>Skin / Mucosal<br>Limited duration (< 24 hours) | ISO 10993-1<br>Externally<br>communicating Tissue<br>Surface Contact<br>Skin / Mucosal<br>Limited duration | ISO 10993-1<br>Externally<br>communicating Tissue<br>Surface Contact<br>Skin / Mucosal<br>Prolonged duration | | |
| Performance<br>testing | Internal volume<br>Resistance to flow through<br>the connector<br>Leakage under simulated<br>seal conditions with a<br>mannequin face<br>Connector – 15 mm testing<br>– pre- and post-aging<br>Drop<br>Environmental – Operating | EtCO2 performance | Internal volume<br>Resistance to flow through<br>the connector<br>Leakage under simulated seal<br>conditions with a mannequin<br>face<br>Connector – 15 mm testing –<br>pre- and post-aging<br>Drop<br>Environmental – Operating / | Resistance to flow<br>through the connector<br>Leakage under simulated<br>seal conditions with a<br>mannequin face<br>Connector – 15 mm<br>testing | EtCO2 performance | | |
| Feature | Proposed<br>SuperNO2VA EtTM<br>Device | Primary Predicate<br>K011050<br>Oridion - Capnostream<br>Oral / Nasal Cannula | Secondary Predicate<br>K163277<br>RMD SuperNO2VA<br>Mask | Reference<br>Exempt<br>Medline / Ventlab<br>Anesthesia mask | Reference<br>K133806<br>Monitor Mask – M1 | | |
| Dead space | Nasal mask only<br>Medium – 53 ml<br>Large – 87 ml | – – N/A | Nasal mask only<br>Medium – 53 ml<br>Large – 87 ml | Large – 158 ml<br>(Nasal and Oral)<br>Medium – | – – N/A | | |
| Pressure / Leak | Can maintain pressure of ><br>20 cmH2O with 10 lbs. force<br><br>Leakage < 2 Lpm | | Can maintain pressure of ><br>20 cmH2O with 10 lbs. force<br><br>Leakage < 2 Lpm | Can maintain pressure of ><br>20 cmH2O with 10 lbs. force<br><br>Leakage ave. 2.6 Lpm | | | |
| Pressure Drop<br>Acceptance<br>< 5 cmH2O @60 Lpm | 30 lpm – 0.13 cmH2O<br>60 lpm – 0.38 cmH2O<br>90 lpm – 1.15 cmH2O | – – N/A | 30 lpm – 0.13 cmH2O<br>60 lpm – 0.38 cmH2O<br>90 lpm – 1.15 cmH2O | 30 lpm – 0.13 cmH2O<br>60 lpm – 0.25 cmH2O<br>90 lpm – 0.51 cmH2O | – – N/A | | |
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# 510(k) Summary
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### 510(k) Summary Page 5 of 9
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### 510(k) Summary Page 6 of 9
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### 510(k) Summary Page 7 of 9
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### Table 2 – Comparative O2 / CO2 Performance Nasal and Oral Sampling
| Feature | Proposed<br>SuperNO2VA EtTM<br>Nasal Sampling | K011050<br>Oridion - Capnostream<br>Nasal Sampling | Proposed<br>SuperNO2VA EtTM<br>Oral Sampling | K011050<br>Oridion - Capnostream<br>Oral Sampling |
|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Adult | | | | |
| BPR = 12<br>TV (ml) = 500 ml<br>CO2% - 1%<br>O2 Flow rate – 1 and 5 lpm | EtCO2 @ 1% and 1 Lpm<br>Ave. - 1.00%<br>EtCO2 @ 1% and 5 Lpm<br>Ave. - 4.93% | EtCO2 @ 1% and 1 Lpm<br>Ave. - 0.93%<br>EtCO2 @ 1% and 5 Lpm<br>Ave. - 0.88% | EtCO2 @ 1% and 1 Lpm<br>Ave. - 0.98%<br>EtCO2 @ 1% and 5 Lpm<br>Ave. - 4.95 | EtCO2 @ 1% and 1 Lpm<br>Ave. - 0.86%<br>EtCO2 @ 1% and 5 Lpm<br>Ave. - 4.19% |
| BPR = 12<br>TV (ml) = 500 ml<br>CO2% - 5%<br>O2 Flow rate – 1 and 5 lpm | EtCO2 @ 5% and 1 Lpm<br>Ave. - 0.94%<br>EtCO2 @ 5% and 5 Lpm<br>Ave. - 4.92% | EtCO2 @ 5% and 1 Lpm<br>Ave. - 4.22%<br>EtCO2 @ 5% and 5 Lpm<br>Ave. - 4.07% | EtCO2 @ 5% and 1 Lpm<br>Ave. - 0.90%<br>EtCO2 @ 5% and 5 Lpm<br>Ave. - 4.46% | EtCO2 @ 5% and 1 Lpm<br>Ave. - 0.79%<br>EtCO2 @ 5% and 5 Lpm<br>Ave. - 3.59% |
| Pediatric | | | | |
| BPR = 20<br>TV (ml) = 300 ml<br>CO2% - 1%<br>O2 Flow rate – 1 and 5 lpm | EtCO2 @ 1% and 1 Lpm<br>Ave. 0.91%<br>EtCO2 @ 1% and 5 Lpm<br>Ave. - 4.62% | EtCO2 @ 1% and 1 Lpm<br>Ave. - 0.82%<br>EtCO2 @ 1% and 5 Lpm<br>Ave. - 4.02% | EtCO2 @ 1% and 1 Lpm<br>Ave. 0.87%<br>EtCO2 @ 1% and 5 Lpm<br>Ave. - 4.67% | EtCO2 @ 1% and 1 Lpm<br>Ave. - 0.77%<br>EtCO2 @ 1% and 5 Lpm<br>Ave. - 4.01% |
| BPR = 20<br>TV (ml) = 300 ml<br>CO2% - 5%<br>O2 Flow rate – 1 and 5 lpm | EtCO2 @ 5% and 1 Lpm<br>Ave. - 0.88%<br>EtCO2 @ 5% and 5 Lpm<br>Ave. - 4.60% | EtCO2 @ 5% and 1 Lpm<br>Ave. -0.81<br>EtCO2 @ 5% and 5 Lpm<br>Ave - 3.96% | EtCO2 @ 5% and 1 Lpm<br>Ave. 0.91%<br>EtCO2 @ 5% and 5 Lpm<br>Ave. 4.06% | EtCO2 @ 5% and 1 Lpm<br>Ave. - 0.72%<br>EtCO2 @ 5% and 5 Lpm<br>Ave. 3.35% |
| Note: Testing of the Secondary Predicate for EtCO2 is not applicable as the device does not have this feature | | | | |
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### 510(k) Summary Page 8 of 9 20-Jun-18
| Feature | Proposed<br>SuperNO2VA EtTM<br>Both Nasal / Oral Sampling | Reference - Exempt<br>Medline Anesthesia mask<br>Both Nasal / Oral Sampling |
|---------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------|
| Adult | | |
| BPR = 12 | EtCO2 @ 1% | EtCO2 @ 1% |
| TV (ml) = 500 ml | Ave. - 0.98% | Ave. - 0.97% |
| CO2% - 1% | | |
| Pressure - 20 cmH2O | | |
| BPR = 12 | EtCO2 @ 5% | EtCO2 @ 5% |
| TV (ml) = 500 ml | Ave. - 4.96% | Ave. - 4.90% |
| CO2% - 5% | | |
| Pressure - 20 cmH2O | | |
| Pediatric | | |
| BPR = 20 | EtCO2 @ 1% | EtCO2 @ 1% |
| TV (ml) = 300 ml | Ave. - 1.00% | Ave. - 0.95% |
| CO2% - 1% | | |
| Pressure - 20 cmH2O | | |
| BPR = 20 | EtCO2 @ 5% | EtCO2 @ 5% |
| TV (ml) = 300 ml | Ave. - 5.00% | Ave. - 4.62% |
| CO2% - 5% | | |
| Pressure - 20 cmH2O | | |
### Table 3 - Comparative O2 / CO2 Performance under Positive Pressure
Note: Testing of the Secondary Predicate for EtCO2 is not applicable as the device does not have this feature
#### Non-Clinical Testing Summary -
#### Bench Testing
We performed testing which evaluated the design. These tests included:
- . Dead space / volume
- Pressure drop
- Pressure and leakage ●
- O2 / CO2 performance at various simulated settings including positive pressure, oral / nasal sampling only
- . Age and shelf-life
- . Drop testing
### Biocompatibility
SuperNO2VATM based upon ISO 10993-1 is considered:
Surface Co…
