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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.

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.

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.

Study Details:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The Wet Nose Technologies (WNT) Pressure Release Valve 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 to, and including 15 L/min. The device is intended for use when a disposable, low pressure (20 cm H20 +/- 4 cm H2O activation), 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.

The Pressure Release Valve (PRV) 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 PRV 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 PRV will activate an audible sound to alert Healthcare professionals over pressurization and the possible need for corrective action. The activation pressure 20 cm H2O +/- 4 cm H2O is based on the relief pressure at 8 L/min is 16 is 20 cm H2O and at 15 L/min is 24 cm H2O. The valve reacts instantaneously to an occlusion and automatically resets upon release of the occlusion. The device is disposable, single-patient use and is prescription only.

The Pressure Release Valve connects with the pressure tubing by way of a Wet Nose Technologies 'T6' Adapter.

The Pressure Release Valve and the 'T6' Adapter are sterilized by gamma irradiation and supplied sterile in bag pouch. Fifty bag pouches are packaged in a dispenser box. Each bag pouch and dispenser box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

The Wet Nose Technologies Pressure Release Valve is designed as a safety feature for pediatric/infant breathing gas delivery systems to prevent excessive inspiratory pressure. The acceptance criteria and performance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of patient data or clinical trials. Instead, performance testing was conducted on the device itself.

• Sample Size: Not explicitly stated as a number of devices, but implies testing of the manufactured product.
• Data Provenance: The testing was nonclinical and conducted by the manufacturer, Wet Nose Technologies, LLC. The studies are prospective in nature, as they involve testing the device against its specifications. There is no indication of country of origin of patient data, as no clinical data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for this device's performance was established through engineering specifications and objective measurements against those specifications, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies or diagnostic accuracy assessments involving human interpretation. For this device, performance was measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. The device is a mechanical safety valve, and its performance is evaluated against engineering specifications, not human diagnostic performance. Therefore, there is no effect size of human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The performance testing conducted (e.g., change in relief pressure with flow rate, leak testing, response time) assessed the device's functional characteristics independently. This is analogous to a "standalone" evaluation of the device's mechanical and operational performance.

7. The Type of Ground Truth Used

The ground truth used was the engineering specifications and established physical principles for a pressure relief valve. Performance was measured against these predefined thresholds (e.g., activation pressure, response time).

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical safety valve, not an AI or machine learning algorithm requiring a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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