The Wet Nose Technologies (WNT) Audible Pressure Release Valve (APRV) is intended for use with 'positive pressure' breathing gas delivery systems (e.g., High Flow nasal Cannula or bubble CPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up, and including 15 L/min. The device is intended for use when a disposable, low pressure (10 cm H2O +/- 2 cm H2O), low-moderate pressure (20 cm H2O +/- 4 cm H2O) or a moderate/high pressure (40 cm H2O +/- 8 cm H2O), audible, non-adjustable pressure relief valve is needed to be placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Intended to alert the healthcare provider(s) of a need to take corrective action to reduce system pressure, the device emits an audible sound when circuit pressure is above relief pressure.

Device Description

The Audible Pressure Release Valve (APRV) is a custom valve designed specifically for pediatric/infant use within a Continuous Positive Airway Pressure (CPAP), High/Heated Flow Nasal Cannual (HFNC) and other pressure systems. This valve is a safety feature designed to limit the system pressure of the circuit to pressures below the APRV relief pressure range. The device is intended for use with flow rates greater than 0 L/min up to, and including, 15 L/min. The device is placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure.

Thus, this device may be used to regulate the maximum pressure achievable within a pressure system. Opening the APRV will activate an audible sound to alert Healthcare professionals of over pressurization and the possible need to take corrective action.

The activation pressure of 10 cm H2O +/- 2 cm H2O is based on a relief pressure at 8 L/min is 8 and is 12 cm H2O at 15 L/min. The 20 cm H2O +/- 4 cm H2O is based on a relief pressure at 8 L/min is 16 cm H2O and at 15 L/min the relief pressure is 24 cm H2O. The activation pressure of 40 cm H2O +/-8 cm H2O is based on a relief pressure at 8 L/min is 32 cm H2O and at 15 L/min the relief is 48 cm H2O. The valve instantaneously reacts to an occlusion and automatically reset upon release of the occlusion. The device is disposable, single-patient use and is prescription only. WNT has custom Adaptors (Humidifier Adaptor and Oxygen Nipple) to interface with the Audible Pressure Release Valve and the appropriate inspiratory tubing.

The Audible Pressure Release Valve and the custom adapter (Humidifier Adapter and Oxygen Nipple) are sterilized by gamma irradiation and supplied sterile in a bag pouch. Twenty-five bag pouches are packaged in a dispenser box. Each bag pouch and dispenser box is labeled with the contents and appropriate information per the FDA's Quality System Regulation and Labeling requirements.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Wet Nose Technologies Audible Pressure Release Valve, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are described in terms of its activation pressure ranges at varying flow rates and its ability to emit an audible alarm. The performance data presented in the document directly aligns with these criteria, confirming the device operates within the specified ranges.

Acceptance Criteria Category	Specific Acceptance Criteria (from Device Description)	Reported Device Performance (from Device Description and Conclusions)
Activation Pressure (10 cm H2O Valve)	At 8 L/min: 8 cm H2O. At 15 L/min: 12 cm H2O. Overall range: 10 cm H2O +/- 2 cm H2O.	The device's activation pressures are designed to meet these specifications. "The activation pressure of 10 cm H2O +/- 2 cm H2O is based on a relief pressure at 8 L/min is 8 and is 12 cm H2O at 15 L/min." The "Conclusions" section states, "The WNT Audible Pressure Relief Valve is available for a pressure activation level of 10 cm H2O... The Instructions for Use provide the pressure activation levels by flow rate for the device."
Activation Pressure (20 cm H2O Valve)	At 8 L/min: 16 cm H2O. At 15 L/min: 24 cm H2O. Overall range: 20 cm H2O +/- 4 cm H2O.	The device's activation pressures are designed to meet these specifications. "The 20 cm H2O +/- 4 cm H2O is based on a relief pressure at 8 L/min is 16 cm H2O and at 15 L/min the relief pressure is 24 cm H2O." The "Conclusions" section states, "The WNT Audible Pressure Relief Valve is available for a pressure activation level of... 20 cm H2O... The Instructions for Use provide the pressure activation levels by flow rate for the device."
Activation Pressure (40 cm H2O Valve)	At 8 L/min: 32 cm H2O. At 15 L/min: 48 cm H2O. Overall range: 40 cm H2O +/- 8 cm H2O.	The device's activation pressures are designed to meet these specifications. "The activation pressure of 40 cm H2O +/-8 cm H2O is based on a relief pressure at 8 L/min is 32 cm H2O and at 15 L/min the relief is 48 cm H2O." The "Conclusions" section states, "The WNT Audible Pressure Relief Valve is available for a pressure activation level of... 40 cm H2O. The Instructions for Use provide the pressure activation levels by flow rate for the device."
Audible Alert	Device emits an audible sound when circuit pressure is above relief pressure.	"Opening the APRV will activate an audible sound to alert Healthcare professionals of over pressurization and the possible need to take corrective action." Performance testing included "Changes in audible alert sound levels with flow rate." The Conclusions state: "The device has been tested and found to meet all product specifications and requirements."
Response Time	Valve instantaneously reacts to an occlusion and automatically resets upon release.	"The valve instantaneously reacts to an occlusion and automatically reset upon release of the occlusion." Performance testing included "Response time to an occlusion." The Conclusions state: "The device has been tested and found to meet all product specifications and requirements."
Leak Testing	No specific criteria mentioned, but implied requirement for proper sealing.	Performance testing included "Leak Testing." The Conclusions state: "The device has been tested and found to meet all product specifications and requirements."
Durability/Aging	Device maintains performance over its lifespan.	"Accelerated aging was used to verify the performance of the product over the life of the device." The Conclusions state: "The device has been tested and found to meet all product specifications and requirements."

Study Details:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the exact sample size for the test set (number of devices tested).
- The data provenance is not explicitly stated, but the testing was conducted by Wet Nose Technologies, LLC, a U.S.-based company, suggesting the testing was performed in the United States.
- The testing appears to be prospective in nature, as it describes performance testing conducted on the devices themselves to demonstrate compliance with specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This device is a mechanical component (a valve). Its performance (e.g., activation pressure, audible alert level) is determined by objective physical measurements, not by expert interpretation or consensus. Therefore, "ground truth" in the clinical diagnostic sense, requiring expert human judgment, is not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As stated above, this is a mechanical device whose performance is measured objectively. There is no human interpretation or subjective assessment that would require an adjudication method.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No such study was done. This device is a passive mechanical pressure relief valve and does not involve AI, human readers, or image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This product is a physical medical device, not an algorithm. Its performance is inherent to its mechanical design and function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by objective physical measurements against predefined engineering specifications and standards (e.g., pressure transducers, flow meters, sound level meters).
- Compliance with voluntary standards (like ANSI/AAMI/ISO 11137, ISO 11607, ISO 10993-4) also forms a basis for evaluating performance relative to established benchmarks for sterility, packaging, and biocompatibility.
The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI or machine learning model. There is no "training set" in this context. The product design is based on engineering principles.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant. The device's design and performance are validated through physical testing against pre-defined specifications.

Summary

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K 111191

JUL 2 8 2011

Image /page/0/Picture/2 description: The image shows the logo for Wet Nose Technologies, LLC. The logo includes a stylized water droplet with a heart inside. The address "3750 2nd Avenue Los Angeles, CA 90018" is printed below the company name.

510(k) Summary

(As required by 21 CFR 807.92(a))

	A. Submitter Information	Wet Nose Technologies, LLC
		3750 2nd Avenue
		Los Angeles, CA 90018
	Establishment Number:	3007521506
	Contact:	Lionel Newman Jr.
	Phone Number:	909-957-7924
	Fax Number:	323-733-0406
	Date Summary Prepared:	July 27, 2011
	B. Device Information
	Trade/Proprietary Name:	Wet Nose TechnologiesAudible Pressure Release Valves(10 cm H2O, 20 cm H2O and 40 cm H2O)

Audible Pressure Release Valve Common name of device: Classification Name: Nonrebreathing Valve CBP Product Code: Regulatory Class: l I 868.5870 Classification Number: Reason for 510(k): New Device C. Predicate Device: Wet Nose Technologies

Predicate 510(k) #: Predicate product code: Pressure Release Valve, 20 cm H2O

K091538

СВР

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D. Device Description

E. Statement of Indications for Use
The Wet Nose Technologies (WNT) Audible Pressure Release Valve (APRV) is intended for use with 'positive pressure' breathing gas delivery systems (e.g., High Flow nasal Cannula or bubble CPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up, and including 15 L/min. The device is intended for use when a disposable, low pressure (10 cm H2O +/- 2 cm H2O). low-moderate pressure (20 cm H2O +/- 4 cm H2O) or a moderate/high pressure (40 cm H2O +/- 8 cm H2O), audible, non-adjustable pressure relief valve is needed to be placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Intended to alert the healthcare provider(s) of a need to take corrective action to reduce system pressure, the device emits an audible sound when circuit pressure is above relief pressure.

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F. Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Wet Nose Technologies Audible Pressure Release Valves (10 cm H2O, 20 cm H2O or 40 cm H2O) and the cited predicate device.
G. Discussion of Nonclinical Tests:
The intended use of the Wet Nose Technologies Audible Pressure Release Valve (10 cm H2O, 20 cm H2O or 40 cm H2O) is identical to that of the cited predicate device. Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness.

Performance testing consisted of the following:

1. Change in relief pressure with flow rate
1. Changes in audible alert sound levels with flow rate
1. Leak Testing
1. Response time to an occlusion

In addition, testing for compliance to the applicable sections of the following voluntary standards was performed:

1. ANSI/AAMI/ISO 11137 Sterilization of health care products -- Radiation --Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
1. ISO 11607;2003 Packaging for terminally sterilized medical devices
1. ISO 10993-4:2006 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
H. Discussion of Clinical Tests:

None submitted

Conclusions Demonstrating Safety, Effectiveness and Performance: L
The WNT Audible Pressure Relief Valve is available for a pressure activation level of 10 cm H2O. 20 cm H20 or 40 cm H2O. The Instructions for Use provide the pressure activation levels by flow rate for the device.

The design of the Audible Pressure Release Valve, Humidifier Adapter and Oxygen Nipple minimize the chance of user error. The device has been tested and found to meet all product specifications and requirements. Accelerated aging was used to verify the performance of the product over the life of the device.

Instructions for Use detail how to use the devices and the conditions of use. Product labeling clearly shows that the device is for single patient use only.

The Wet Nose Technologies Audible Pressure Release Valves (10 cm H2O, 20 cm H2O and 40 cm H2O), Humidifier Adapter and Oxygen Nipple have been found to be safe and effective for their intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem with three stylized human figures. The emblem is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Mr. Lionel Newman Chief Executive Officer Wet Nose Technologies, LLC 3750 2nd Avenue Los Angeles, California 90018

JUL 2 8 2011

Re: K111191

Trade/Device Name: Audible Pressure Release Valves, 10 cm H20, 20 cm H20 and 40 cm H20 Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP

Dated: June 24, 2011

Received: June 28, 2011

Dear Mr. Newman:

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.

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Page 2 - Mr. Newman

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDR HOffices/ucm115 809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Susan Russey

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): K11191

Device Name: Audible Pressure Release Valves (10 cm H2O, 20 cm H2O and 40 cm H2O)

Indications For Use:

The Wet Nose Technologies (WNT) Audible Pressure Release Valve (APRV) is intended for use with 'positive pressure' breathing gas delivery systems (e.g., High Flow nasal Cannula or bubble CPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up, and including 15 L/min. The device is intended for use when a disposable, low pressure (10 cm H2O +/-2 cm H2O), low-moderate pressure (20 cm H2O +/- 4 cm H2O) or moderate-high pressure (40 cm H2O +/- 8 cm H2O), audible, non-adjustable pressure relief valve is needed to be placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Intended to alert the healthcare provider(s) of a need to take corrective action to reduce system pressure, the device emits an audible sound when circuit pressure is above relief pressure.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

L. Schulthe

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
S10(k) Number: K111191

Regulation Number and Section

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).