SuperNO2VA Device

K163277 · Revolutionary Medical Devices, Inc. · BSJ · Oct 13, 2017 · Anesthesiology

Device Facts

• Record ID: K163277
• Device Name: SuperNO2VA Device
• Applicant: Revolutionary Medical Devices, Inc.
• Product Code: BSJ · Anesthesiology
• Decision Date: Oct 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5550
• Device Class: Class 1
• Attributes: Therapeutic

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 SuperNO2VA™ 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.

Device Story

SuperNO2VA™ is a 2-piece anesthesia face mask (nasal and oral chambers) for delivering anesthesia gas, air, or oxygen to adult patients. Device features a rigid polypropylene shell and PVC seal; incorporates one-way duck-bill valves allowing the oral chamber to be removed while maintaining gas flow through the nasal portion. Used in hospital and out-patient surgery settings under clinical supervision; connected to anesthesia gas machines, manual resuscitators, or hyperinflation bags. Clinicians use the mask to establish a seal for positive pressure delivery; output is the directed flow of gases to the patient's upper airway. Benefits include flexibility for oral access during procedures while maintaining airway support. Not for use with CPAP/bi-level equipment.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included internal volume/dead space, resistance through connector, duck-bill valve seal integrity, drop testing, age/shelf-life, and biocompatibility (cytotoxicity, sensitization, irritation) per ISO 10993-1.

Technological Characteristics

2-piece mask; shell: polypropylene; seal: PVC. Features one-way duck-bill valves. 15mm connector. Dimensions: 2 sizes (Medium/Large). Connectivity: manual connection to anesthesia circuits. Biocompatibility: ISO 10993-1 (surface contact, mucosal membrane, externally communicating, limited duration <24h). Non-sterile.

Indications for Use

Indicated for adult patients (>30 kg) requiring delivery of anesthesia gas, air, or oxygen to the upper airway during the continuum of anesthesia care. Contraindicated for long-term ventilation and treatment of sleep apnea.

Regulatory Classification

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.

Predicate Devices

• Medical Marketing Concepts – Anesthesia Respiratory Face Mask (K953107)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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 [phone] or [phone] 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 [phone] or [phone] 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 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.

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 [phone]

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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 mask<br>21CFR 868.5550, Class 1 |
| Device: | SuperNO2VATM Device |
| Predicate Device: | K953107 - Medical Marketing Concepts – Anesthesia<br>Respiratory Face Mask |

#### 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.

#### 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 | Predicate<br>K953107<br>Anesthesia mask | Proposed<br>SuperNO2VA™ |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | BSJ – anesthetic face mask<br>21 CFR 868.5550 | BSJ – anesthetic face mask<br>21 CFR 868.5550 |
| Indications for Use | An Anesthesia / Respiratory face mask that<br>is positioned over a patient's nose or mouth<br>to direct anesthetic gases, air, and oxygen<br>to the upper airway. | The SuperNO2VA™ Device is a mask that<br>creates a seal when positioned over a<br>patient's nose and mouth, or nose only, to<br>direct anesthesia gas, air, and / or oxygen to<br>the upper airway during the continuum of<br>anesthesia care. To be used under clinical<br>supervision with adequate alarms and safety<br>systems for monitoring and treatment of<br>ventilatory failure.<br><br>The SuperNO2VA™ Device is intended for<br>short-term (<24 hours) use on adult patients<br>(>30 kg.) It is a single patient use,<br>disposable.<br><br>The SuperNO2VA™ Device is<br>contraindicated for use in long-term<br>ventilation conditions and treatment of sleep<br>apnea. |
| Patient Population | All age patients | Adults > 30 kg |
| Environment of Use | Hospital<br>Sub-acute | Hospital<br>Sub-acute |
| Duration of Use | Single patient use, disposable | Single patient use, disposable |
| Equipment | Anesthesia gas machine<br>Manual resuscitators<br>Not intended to be used with CPAP or bi-<br>level equipment | Anesthesia gas machine<br>Manual resuscitators<br>Not intended to be used with long-term<br>ventilations conditions and with CPAP<br>equipment intended for long-term use. |
| Anatomical seal | Nasal and Oral | Nasal and Oral<br>Nasal Only |
| Components | Single part<br>Non-vented connector<br>Headstrap | 2 parts – nasal and oral chamber<br>Non-vented connector<br>Headstrap |
| Other feature | | Can be separated to be nasal only<br>Contains duck-bill valves which seal when<br>the oral chamber is removed |
| Oxygen or pressure port | Yes | Yes |
| Monitoring of airway / circuit<br>pressures | Yes | Yes |
| Sizes | Multiple - more than 2 | 2 |
| 510(k) Summary | | |
| K163277 | | |
| October 12, 2017 | | |
| Feature | Predicate | Proposed |
| | K953107 | SuperNO2VA™ |
| | Anesthesia mask | |
| Biocompatibility | ISO 10993-1<br>Externally communicating / Tissue<br>Surface Contact<br>Skin / Mucosal<br>Limited duration (< 24 hours) | ISO 10993-1<br>Externally communicating / Tissue<br>Surface Contact<br>Skin / Mucosal<br>Limited duration (< 24 hours) |
| Materials | Shell - Flexible PVC<br>Cushion - PVC | Shell - polypropylene<br>Seal – 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 –<br>Nasal - 53 ml<br>Full mask – 84 ml<br>Large –<br>Nasal - 87 ml<br>Full mask - 137 ml |
| Therapy Pressure Range | This mask does not have a defined<br>pressure limitation | The device does not provide therapy but the<br>maximum pressure range is recommended to<br>be 30 cmH2O in order to maintain a seal. |
| Connectors and<br>Resistance at connector | 15 mm and 22 mm<br>< $1 cmH_{2}O$ @ 60 lpm | 15 mm<br>$0.46 cmH_{2}O$ @ 50 lpm<br>$1.8 cmH_{2}O$ @ 100 lpm |
| Per ISO 17501 acceptance is a<br>reported value. | | Note subject device will not be used with<br>CPAP / bi-level equipment. |
| Operating /<br>Storage Conditions | No stated conditions are available | -28 to + 60°C<br>15 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.