PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100

Q: Who is the manufacturer of PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100?

Wet Nose Technologies, LLC filed the 510(k) submission for PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 (K091538).

Q: What is the FDA product code for PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100?

CBP. It is classified under 21 CFR 868.5870 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100?

Fisher & Paykel BC110 Pressure Manifold (K040366).

Q: Who can help prepare an FDA 510(k) submission like PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K091538 · Wet Nose Technologies, LLC · CBP · Mar 25, 2010 · Anesthesiology

Device Facts

Record ID	K091538
Device Name	PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
Applicant	Wet Nose Technologies, LLC
Product Code	CBP · Anesthesiology
Decision Date	Mar 25, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5870
Device Class	Class 2
Attributes	Pediatric

Intended Use

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.

Device Story

Disposable, non-adjustable pressure relief valve for pediatric/infant positive pressure breathing circuits (CPAP/HFNC). Device placed in-line upstream of patient; monitors circuit pressure. Upon downstream occlusion or pressure exceeding 20 cm H2O (+/- 4 cm H2O), valve opens to limit pressure and emits audible alert. Alerts healthcare professionals to perform corrective action. Automatically resets upon occlusion release. Connects via 'T6' adapter. Single-patient use; prescription only.

Clinical Evidence

No clinical data submitted. Bench testing only, including relief pressure vs. flow rate, leak testing, and occlusion response time. Compliance with ISO 11137 (sterilization), ISO 11607 (packaging), and ISO 10993-4 (biocompatibility) verified.

Technological Characteristics

Mechanical pressure relief valve; non-adjustable; audible alarm mechanism. Flow rate range: 0-15 L/min. Activation pressure: 20 cm H2O +/- 4 cm H2O. Sterilization: Gamma irradiation. Single-patient use. Standards: ANSI/AAMI/ISO 11137, ISO 11607, ISO 10993-4.

Indications for Use

Indicated for pediatric and infant patients requiring positive pressure breathing gas delivery systems (e.g., HFNC, Bubble CPAP) with continuous flow rates between 0 and 15 L/min to prevent excessive inspiratory pressure.

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

Fisher & Paykel BC110 Pressure Manifold (K040366)

Related Devices

K111191 — AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE · Wet Nose Technologies, LLC · Jul 28, 2011
K040366 — PRESSURE MANIFOLD, MODEL BC 110 · Fisher & Paykel Healthcare, Ltd. · Mar 4, 2004
K173770 — OJR215 Pressure Relief Manifold · Fisher & Paykel Healthcare Limited · Apr 5, 2019
K110383 — BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 · A Plus Medical · Aug 1, 2011
K050918 — KOO AMERICAS VALVE PEEP, MODEL KM-809 · Koo Americas, Inc. · Jun 6, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ iC0915388 ## 510(k) Summary (As required by 21 CFR 807.92(a)) MAR 2 5 2010 | Application Date: | 3/15/2010 | |-------------------|-----------| |-------------------|-----------| A. Submitter Information | | Wet Nose Technologies, LLC 3750 2nd Avenue Los Angeles, CA 90018 | |-----------------------|------------------------------------------------------------------------| | Establishment Number: | 3007521506 | | Phone Number: | 949-481-5713 | | Fax Number: | 949-481-5745 | | Contact: | Jim Barley | | Trade Name: | Wet Nose Technologies Pressure Release Valve | B. Device Information | Trade/Proprietary Name: | Wet Nose Technologies Pressure Release Valve | |-------------------------|-------------------------------------------------| | Common name of device: | Pressure Relief Valve | | Classification Name: | Nonrebreathing Valve | | Product Code: | CBP | | Regulatory Class: | II | | Classification Number: | 868.5870 | | Reason for 510(k): | New Device | C. Predicate Device: | | Fisher & Paykel BC110 Pressure Manifold | |-------------------------|--------------------------------------------| | Predicate 510(k) #: | K040366 | | Predicate product code: | CBP | {1}------------------------------------------------ ## D. Device Description 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. - Statement of Indications for Use E. 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. {2}------------------------------------------------ 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. - Comparison of Required Technological Characteristics: F. Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Wet Nose Technologies Pressure Release Valve and the cited predicate device. - Discussion of Nonclinical Tests: G. The intended use of the Wet Nose Technologies Pressure Release Valve 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. Leak Testing - 3. Response time to an occlusion In addition, testing for compliance to the applicable sections of the following voluntary standards was performed: - 4. 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 - 5. ISO 11607;2003 Packaging for terminally sterilized medical devices - 6. ISO 10993-4:2006 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood {3}------------------------------------------------ - H. Discussion of Clinical Tests: None submitted - Conclusions Demonstrating Safety, Effectiveness and Performance: I. The WNT Pressure Relief Valves has a pressure activation level of 20 cm H20. The Instructions for Use provide the pressure activation levels by flow rate for the device. The design of the Pressure Release Valve and the T6 Adapter 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 WNT Pressure Release Valve and T6 Adapter have been found to be safe and effective for their intended use. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized wing strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Jim Barley Director of Regulatory Affairs/Quality Assurance Wet Nose Technologies, LLC 3750 2nd Avenue Los Angeles, California 90018 MAR 2 5 2010 Re: K091538 Trade/Device Name: Wet Nose Technologies Pressure Release Valve Regulation Number: 21CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: March 15, 2010 Received: March 19, 2010 Dear Mr. Barley: 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. {5}------------------------------------------------ Page 2- Mr. Barley 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 reprting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/com 115809.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/ReportalProblem/ 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 vours. h for 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 {6}------------------------------------------------ ## Indications For Use 510(k) Number (if known): Device Name: Wet Nose Technologies (WNT) Pressure Release Valve Indications For Use: 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. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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. Schultheis (Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices 510(k) Number: _______________________________________________________________________________________________________________________________________________________________