(264 days)
No
The 510(k) summary describes a physical medical device (a nasal mask) for gas delivery and sampling. There is no mention of software, algorithms, or any form of data processing that would suggest the use of AI or ML. The performance studies focus on physical and gas measurement characteristics, not algorithmic performance.
Yes.
This device delivers anesthesia gas, air, and/or oxygen to a patient's upper airway during anesthesia care, which is a therapeutic intervention.
No
The device is primarily a nasal mask for directing gases and sampling expired breath. While it samples expired gases, the description emphasizes its function in gas delivery and patient access during procedures, rather than diagnosing conditions. The performance studies focus on the efficiency of gas measurement and physical properties, not diagnostic accuracy.
No
The device is a physical nasal mask with sampling ports and connectors, clearly described as hardware.
Based on the provided information, the SuperNO2VA Et™ Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SuperNO2VA Et™ Device Function: The SuperNO2VA Et™ Device is a medical device used to deliver gases (anesthesia, air, oxygen) to a patient's airway and sample expired gases from the patient's breath. It is a physical interface for gas delivery and sampling, not a test performed on a biological sample.
- Intended Use: The intended use is for directing gases to the airway and sampling expired gases during anesthesia care. This is a respiratory support and monitoring function, not a diagnostic test on a biological sample.
- Device Description: The description clearly states it's a nasal mask with sampling ports, similar to an anesthesia or oxygen mask.
- Performance Studies: The performance studies focus on the physical and functional performance of the mask (dead space, pressure, leakage, gas delivery, gas sampling accuracy compared to other devices), not on the diagnostic accuracy of a test performed on a biological sample.
The device is used in conjunction with monitoring equipment that analyzes the sampled expired gases (like CO2), but the SuperNO2VA Et™ Device itself is the interface for collecting the sample, not the diagnostic test itself.
N/A
Intended Use / 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 (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.
Product codes (comma separated list FDA assigned to the subject device)
CCK, BSJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, Oral, Upper Airway
Indicated Patient Age Range
Adult patients (>30 kg)
Intended User / Care Setting
Hospital, Sub-acute
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- 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
Key Results summarized in tables:
- Table 1 – Comparison to Predicate and Reference Devices (includes Internal volume, Pressure to maintain a seal for gas delivery, Resistance to flow, Leak rate under pressure, Biocompatibility, Performance testing, Dead space, Pressure / Leak, Pressure Drop Acceptance)
- Table 2 – Comparative O2 / CO2 Performance Nasal and Oral Sampling (includes data for Adult and Pediatric patients at different BPR, TV, CO2%, and O2 Flow rates)
- Table 3 – Comparative O2 / CO2 Performance under Positive Pressure (includes data for Adult and Pediatric patients at different BPR, TV, CO2%, and Pressure)
Comparative testing demonstrated that performance was substantially equivalent to predicate and reference devices for:
- Delivery of gases, despite differences in design (e.g., nasal mask with "hood" vs. nasal cannula or full-face mask).
- Measuring expired gases via a combination of sampling technologies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Values reported for:
- Internal volume: Medium – 53 ml, Large - 87 ml (Nasal mask only)
- Pressure to maintain a seal for gas delivery: Up to 30 cmH2O
- Resistance to flow: 0.46 cmH2O @ 50 lpm, 1.8 cmH2O @ 100 lpm (Proposed device and K163277)
- Leak rate under pressure: 0.8 Lpm @ 20 cmH2O
- Pressure / Leak: Can maintain pressure of > 20 cmH2O with 10 lbs. force, Leakage
§ 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).
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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);
1
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 (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.
| 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 | |||
| 21CFR 868.1400, Class 2 | ||||
| Device: | SuperNO2VA EtTM Device | |||
| Predicate Devices: | Primary - K011050 - Oridion Microstream (CapnoLine) - CCK | |||
| Secondary - K163277 - RMD - SuperNO2VATM Device - BSJ | ||||
| Reference Devices: | Class 510(k) exempt - Medline - Anesthesia Face Mask | |||
| 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 (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
20-Jun-18
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. | (30 kg.) It is a single | ||||||
| is intended for short-term (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 | ||||||
| SuperNO2VA EtTM | |||||||
| Device | Primary Predicate | ||||||
| K011050 | |||||||
| Oridion - Capnostream | |||||||
| Oral / Nasal Cannula | Secondary Predicate | ||||||
| K163277 | |||||||
| RMD SuperNO2VA | |||||||
| Mask | Reference | ||||||
| Exempt | |||||||
| Medline Anesthesia | |||||||
| mask | Reference | ||||||
| K133806 | |||||||
| Monitor Mask – M1 | |||||||
| Patient | |||||||
| Population | Adult Patients > 30 kg | All patients | Adult Patients > 30 kg | All patients | All patients | ||
| Environment of | |||||||
| Use | Hospital | ||||||
| Sub-acute | Hospital | ||||||
| Sub-acute | |||||||
| Pre-hospital | Hospital | ||||||
| Sub-acute | Hospital | ||||||
| Sub-acute | |||||||
| Pre-hospital | Hospital | ||||||
| Sub-acute | |||||||
| Pre-hospital | |||||||
| Duration of Use | Single patient use, | ||||||
| Disposable | |||||||
| 20 cmH2O with 10 lbs. force |
Leakage
20 cmH2O with 10 lbs. force
Leakage
20 cmH2O with 10 lbs. force
Leakage ave. 2.6 Lpm | | | |
| Pressure Drop
Acceptance