AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
Device Facts
| Record ID | K111191 |
|---|---|
| Device Name | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE |
| Applicant | Wet Nose Technologies, LLC |
| Product Code | CBP · Anesthesiology |
| Decision Date | Jul 28, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.5870 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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.
Device Story
Audible Pressure Release Valve (APRV) is a disposable, single-patient use safety device for pediatric/infant respiratory circuits (CPAP/HFNC). Placed in-line upstream of the patient; device monitors circuit pressure. Upon detecting pressure exceeding set thresholds (10, 20, or 40 cm H2O), valve opens to release pressure and emits an audible alert to notify healthcare professionals of the need for corrective action. Device reacts instantaneously to occlusions and resets automatically upon release. Supplied sterile via gamma irradiation with custom adapters (humidifier/oxygen nipple). Benefits include prevention of excessive inspiratory pressure and immediate notification of system failure.
Clinical Evidence
No clinical data submitted. Bench testing only: relief pressure vs. flow rate, audible alert sound levels, leak testing, and response time to occlusion. Compliance with ISO 11137 (sterilization), ISO 11607 (packaging), and ISO 10993-4 (blood interaction) verified.
Technological Characteristics
Disposable, non-adjustable, in-line pressure relief valve. Available in 10, 20, and 40 cm H2O activation thresholds. Mechanical sensing/actuation. Sterilized via gamma irradiation. Complies with ISO 11137, ISO 11607, and ISO 10993-4. Includes custom humidifier and oxygen nipple adapters.
Indications for Use
Indicated for pediatric/infant patients on positive pressure breathing gas delivery systems (e.g., HFNC, bubble CPAP) with continuous flow rates up to 15 L/min. Used to protect patients from excessive inspiratory pressure during downstream occlusions or system over-pressurization.
Regulatory Classification
Identification
A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.
Predicate Devices
- Wet Nose Technologies Pressure Release Valve, 20 cm H2O (K091538)
Submission Summary (Full Text)
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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 Technologies<br>Audible Pressure Release Valves<br>(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
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.
- 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
- 2. Changes in audible alert sound levels with flow rate
- 3. Leak Testing
- 4. Response time to an occlusion
In addition, testing for compliance to the applicable sections of the following voluntary standards was performed:
- 5. 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.
- 6. ISO 11607;2003 Packaging for terminally sterilized medical devices
- 7. 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
