Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical mask for delivering anesthesia gas and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No.
The device directs anesthesia gas, air, and oxygen to a patient but does not treat a disease or condition, making it a delivery device rather than a therapeutic one.

Diagnostic

No

The device is described as a mask that delivers anesthesia gas, air, and/or oxygen to a patient and can be used for non-invasive positive pressure ventilation. It is explicitly indicated for short-term use and contraindicated for long-term ventilation or sleep apnea treatment. Its function is to provide respiratory support and gas delivery, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical mask with valves and a two-piece construction, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this 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. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The SuperNOsY A™ Device is a mask used to deliver gases (anesthesia, air, oxygen) to a patient's respiratory system. It is a physical device that interacts with the patient's body externally to facilitate breathing and gas delivery.
Intended Use: The intended use clearly states it's for directing gases for anesthesia care and potentially non-invasive positive pressure ventilation. This is a therapeutic and supportive function, not a diagnostic one based on analyzing biological samples.
Device Description: The description details the physical construction and function of the mask and its valves, not a process for analyzing biological samples.
Performance Studies: The performance studies listed focus on the physical characteristics and functionality of the mask (volume, resistance, seal, durability, biocompatibility), not on the accuracy or performance of a diagnostic test.

In summary, the SuperNOsY A™ Device is a medical device used for respiratory support and gas delivery, not for performing diagnostic tests on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 (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.

Product codes (comma separated list FDA assigned to the subject device)

BSJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nose and mouth, or nose only (to the upper airway)

Indicated Patient Age Range

Adult patients (>30 kg)

Intended User / Care Setting

Hospital and Out-patient surgery settings

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K953107

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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

2

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 (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 mask
21CFR 868.5550, Class 1
Device:	SuperNO2VATM Device
Predicate Device:	K953107 - Medical Marketing Concepts – Anesthesia
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 (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
K953107
Anesthesia mask | Proposed
SuperNO2VA™ |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | BSJ – anesthetic face mask
21 CFR 868.5550 | BSJ – anesthetic face mask
21 CFR 868.5550 |
| Indications for Use | An Anesthesia / Respiratory face mask that
is positioned over a patient's nose or mouth
to direct anesthetic gases, air, and oxygen
to the upper airway. | 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 (30 kg.) It is a single patient use,
disposable.