The SuperNOsY A™ Device is a mask that creates a seal when positioned over a patient's nose and mouth, or nose only, to direct anesthesia gas, air, and / or oxygen to the continum of anesthesia care. To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.

The SuperNOsVA™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.) It is a single patient use, disposable.

The SuperNOsY A™ Device is contraindicated for use in long-term ventilation and treatment of sleep apnea.

Device Description

The SuperNO>VA™ is a 2-piece construction with a nasal and an oral portion. When assembled together the oral portion is connected to the nasal portion (chamber) contains 2 one way (duck bill) valves which are normally closed until the oral chamber is connected. Then gas passes through each portion to the patient. If one desires to remove the oral chamber during a procedure which requires oral access, then gas can still be provided via the nasal portion. Depending upon the equipment and the clinician's desire one can provide non-invasive positive pressure ventilation as well.

AI/ML Overview

This document (K163277) is a 510(k) summary for the SuperNO2VA™ Device, an anesthetic gas mask. It focuses on demonstrating substantial equivalence to a predicate device (K953107) rather than proving the device meets specific acceptance criteria based on a clinical study or AI performance metrics.

Therefore, the provided text does not contain the information necessary to answer the questions about acceptance criteria and a study proving a device meets those criteria, especially in the context of an AI/ML device study.

The document describes a medical device (an anesthetic gas mask) and its regulatory review for market clearance. It outlines:

Device Name: SuperNO2VA™ Device
Regulation Number: 21 CFR 868.5550 (Anesthetic Gas Mask, Class I)
Indications for Use: Creating a seal over a patient's nose and mouth (or nose only) to direct anesthesia gas, air, and/or oxygen to the upper airway during anesthesia care. Also for short-term (<24 hours) use on adult patients (>30 kg), single patient use, disposable. Contraindicated for long-term ventilation and sleep apnea.
Predicate Device: K953107 - Medical Marketing Concepts – Anesthesia Respiratory Face Mask
Comparison to Predicate: A detailed table comparing features like product classification, indications for use, patient population, environment of use, duration of use, anatomical seal, components, and other features.
Non-Clinical Testing Summary: Internal volume/dead space, resistance through connector, age and shelf-life, seal of duck-bill valves, drop testing, and biocompatibility testing. These are physical/performance tests of the mask itself, not a study evaluating diagnostic or prognostic capabilities (which would be relevant for an AI device).
Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation.

In summary, the provided document does not support answering the questions about acceptance criteria and study design for an AI/ML device. It pertains to the regulatory clearance of a physical medical device (anesthetic mask) based on substantial equivalence to a predicate, predominantly through non-clinical performance and material testing.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 13, 2017

Revolutionary Medical Devices, Inc. % Paul Dryden Consultant Promedic. LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134

Re: K163277

Trade/Device Name: SuperNO2VATM Device Regulation Number: 21 CFR 868.5550 Regulation Name: Anesthetic Gas Mask Regulatory Class: Class I Product Code: BSJ Dated: September 8, 2017 Received: September 11, 2017

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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tara A. Ryan -S

for Tina Kiang, PhD 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

510(k) Number (if known)

K163277

Device Name

SuperNO2VA™ Device

Indications for Use (Describe)

The SuperNOsVA™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.) It is a single patient use, disposable.

The SuperNOsY A™ Device is contraindicated for use in long-term ventilation and treatment of sleep apnea.

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

EF PSC Publishing Services (301) 443-6740

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510(k) Summary K163277 October 12, 2017

Revolutionary Medical Devices, Inc. 6363 N Swan Rd. Tucson AZ 85718 Tel - (520)-820-3749

Official Contact:	Cassie Vollmer, Director of RA/QA
Proprietary or Trade Name:	SuperNO2VATM Device
Common/Usual Name:	Patient interface Nasal and Nasal / Oral mask
Classification Code/Name:	BSJ – Anesthesia face mask21CFR 868.5550, Class 1
Device:	SuperNO2VATM Device
Predicate Device:	K953107 - Medical Marketing Concepts – AnesthesiaRespiratory Face Mask

Device Description:

Indications for Use:

The SuperNO2VA™ Device is a mask that creates a seal when positioned over a patient's nose and mouth, or nose only, to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care. To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.

The SuperNO VA™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.) It is a single patient use, disposable.

The SuperNO2VA™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea.

Patient Population: Adult patients (>30 kg)

Environment of Use: Hospital and Out-patient surgery settings

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510(k) Summary

Feature	PredicateK953107Anesthesia mask	ProposedSuperNO2VA™
Product Classification	BSJ – anesthetic face mask21 CFR 868.5550	BSJ – anesthetic face mask21 CFR 868.5550
Indications for Use	An Anesthesia / Respiratory face mask thatis positioned over a patient's nose or mouthto direct anesthetic gases, air, and oxygento the upper airway.	The SuperNO2VA™ Device is a mask thatcreates a seal when positioned over apatient's nose and mouth, or nose only, todirect anesthesia gas, air, and / or oxygen tothe upper airway during the continuum ofanesthesia care. To be used under clinicalsupervision with adequate alarms and safetysystems for monitoring and treatment ofventilatory failure.The SuperNO2VA™ Device is intended forshort-term (<24 hours) use on adult patients(>30 kg.) It is a single patient use,disposable.The SuperNO2VA™ Device iscontraindicated for use in long-termventilation conditions and treatment of sleepapnea.
Patient Population	All age patients	Adults > 30 kg
Environment of Use	HospitalSub-acute	HospitalSub-acute
Duration of Use	Single patient use, disposable	Single patient use, disposable
Equipment	Anesthesia gas machineManual resuscitatorsNot intended to be used with CPAP or bi-level equipment	Anesthesia gas machineManual resuscitatorsNot intended to be used with long-termventilations conditions and with CPAPequipment intended for long-term use.
Anatomical seal	Nasal and Oral	Nasal and OralNasal Only
Components	Single partNon-vented connectorHeadstrap	2 parts – nasal and oral chamberNon-vented connectorHeadstrap
Other feature		Can be separated to be nasal onlyContains duck-bill valves which seal whenthe oral chamber is removed
Oxygen or pressure port	Yes	Yes
Monitoring of airway / circuitpressures	Yes	Yes
Sizes	Multiple - more than 2	2
510(k) Summary
K163277
October 12, 2017
Feature	Predicate	Proposed
	K953107	SuperNO2VA™
	Anesthesia mask
Biocompatibility	ISO 10993-1Externally communicating / TissueSurface ContactSkin / MucosalLimited duration (< 24 hours)	ISO 10993-1Externally communicating / TissueSurface ContactSkin / MucosalLimited duration (< 24 hours)
Materials	Shell - Flexible PVCCushion - PVC	Shell - polypropyleneSeal – PVC
Provided sterile	No	No
Performance testing	Not available	Comparative - Internal Volume
		Comparative - Pressure Drop Testing
		Comparative - Pressure and Leak Rate Test
		Comparative - Strap and Anchor
		Connector Testing (unaged and aged)
		Drop Test
		Age / Shelf-life
Internal Volume	~ 150 ml - medium	Medium –Nasal - 53 mlFull mask – 84 mlLarge –Nasal - 87 mlFull mask - 137 ml
Therapy Pressure Range	This mask does not have a definedpressure limitation	The device does not provide therapy but themaximum pressure range is recommended tobe 30 cmH2O in order to maintain a seal.
Connectors andResistance at connector	15 mm and 22 mm< $1 cmH_{2}O$ @ 60 lpm	15 mm$0.46 cmH_{2}O$ @ 50 lpm$1.8 cmH_{2}O$ @ 100 lpm
Per ISO 17501 acceptance is areported value.		Note subject device will not be used withCPAP / bi-level equipment.
Operating /Storage Conditions	No stated conditions are available	-28 to + 60°C15 to 85% RH

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The above table compares the key features of the proposed SuperNO2VA™ mask with the identified predicate device to demonstrate that the proposed device can be found to be substantially equivalent.

Indications for Use - SuperNO2VA™ indications for use of the predicate that is Class 1 exempt. The subject device is an accessory that can be used with anesthesia gas machine, manual resuscitators, or Hyperinflation bags. It is intended to deliver anesthesia gases, air, or oxygen to the patient's upper airway. In order to do so, the mask must provide a positive seal so that the clinician can deliver the gases to the patient. The delivery of these gases is under positive pressure.

Discussion - The proposed indications are an expansion of the anesthesia face mask predicate. The expanded indications for use the anesthesia face mask is within the current practice and use of the device. The proposed device is contraindicated for use in long-term ventilation and with CPAP / bilevel equipment for long-term use.

Technology and construction – SuperNO2VA™ is a 2-part mask with a nasal and oral chamber but each must provide a proper seal for the device to be effective for the intended use. Like the predicate devices it incorporates a rigid shell with a soft sealing surface which contacts the patient's

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510(k) Summary K163277 October 12, 2017

face. They contain a standard fitting to connect to a circuit. The subject device is connected to devices which operate as significantly lower flow rates and the equipment has one-way valves and flow which prevent rebreathing.

Discussion - The difference of a 2-part configuration is that it allows the proposed device to represent 2 separate configurations, nasal and full face. Whether they are a full face mask or a nasal only mask the SuperNO2VATM can serve as either one. The use of connecting channels to allow for gas to pass to the oral chamber yet is sealed off when the oral chamber is removed has been evaluated for its effectiveness of the seal.

Environment of Use - The environment of use is similar to the predicate device. Discussion - An Anesthesia / Respiratory face mask can and is used in the hospital and sub-acute settings where the equipment to which it is attached may be used.

Discussion of Overall Differences -

We have identified differences which have been tested and compared to the predicate devices and they do not raise new risk concerns for the proposed indications for use.

Non-Clinical Testing Summary -

We performed testing which evaluated the comparative performance and some tests specific to the subject device. These tests included:

. Internal volume / Dead space
Resistance through the connector
Age and shelf-life
. Seal of duck-bill valves (only the subject device)
Drop testing .
Biocompatibility testing ●

Differences -

Since the proposed device is limited in the equipment to which it would be used, namely, anesthesia gas machines with appropriate alarms and safety features; manual resuscitators, and Hyperinflation bags, which do not include an exhalation port.

Anesthesia gas machines provide one-way flow with directional valves and the flow rates have builtin pressure relieve features. This same one-way directional flow is in the manual resuscitators and Hyperinflation bags.

Biocompatibility

SuperNO2VATM based upon ISO 10993-1 is considered:

Surface Contact Mucosal membrane Limited Duration (< 24 hours)

And

Externally Communicating Tissue Limited Duration (< 24 hours)

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Testing would include:

Cytotoxicity ●
. Sensitization
. Irritation

Substantial Equivalence Conclusion -

Based upon the presented information the sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent and there are no new concerns raised.

Regulation Number and Section

§ 868.5550 Anesthetic gas mask.

(a)
Identification. An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.