The WaterPAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.

Device Description

The WaterPAP Valve is an infant positive end expiratory pressure device used to increase end lung pressure above atmospheric in constant flow conditions.

AI/ML Overview

Here's an analysis of the provided text regarding the WaterPAP™ Valve, structured to address your specific questions about acceptance criteria and the supporting study:

The provided text does not describe traditional "acceptance criteria" in the sense of predefined thresholds for diagnostic accuracy (e.g., sensitivity, specificity), nor does it conduct a study to prove the device meets such criteria for diagnostic performance. Instead, this submission is for a medical device (a Positive Airway Pressure Valve) where the primary evaluation is for substantial equivalence to a predicate device.

The "acceptance criteria" are implicitly derived from the performance of the predicate device and the requirement that the new device performs "in a similar manner" within established specifications. The study described is a comparative performance test to demonstrate this substantial equivalence.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pressure Equivalence: Performance similar to predicate device within established specifications of ± 1 cm H₂O across flow rates of 4-12 L/min and pressures of 1-10 cm H₂O.	Met: "Results indicated both PAP valves performed in a similar manner within established specifications of ± 1cm H20 with comparable test data."
Water Level Change (Accumulation): Rate of water level change during simulated use should be equivalent to the predicate device.	Met: "Results indicated the WaterPAP and Babi*Plus Valves accumulate an equivalent amount of water and therefore the Positive Airway Pressures changes in both valves are essentially equivalent."
Response to Increased Flow Rates (Pressure Increase): Should demonstrate similar behavior to the predicate device in generating increased pressures with increased flow rates.	Met: "The results demonstrate that the WaterPAP and Babi.Plus valves both generate increased pressures with increase flow rates." (The finding that both are predominantly above depth settings and require gauge reliance is an observation about both devices, not a failure of the WaterPAP to meet a comparative criterion).
Resistance to Flow through Air Diffusers: Resistance should be within an acceptable range, ideally comparable to the predicate device, not negatively impacting intended use.	Met: "The results showed that the WaterPAP Valve had slightly higher resistance across the full range of flow rates; however the resistance to flow in both devices is well below a level that could have a negative impact during their intended use." (Despite being slightly higher, it's considered acceptable).

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the traditional sense of patient data. The "test set" consists of multiple configurations of flow and pressure combinations (flow rates 4-12 L/min and pressures 1-10 cm H₂O). The exact number of unique combinations tested is not specified but described as "a full range."
- Data Provenance: The data is from bench testing (simulated use), not clinical or patient data. Therefore, country of origin related to patient data is not relevant. It is a prospective bench study comparing the two devices.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This study is a bench test evaluating physical performance characteristics (pressure, flow, water level changes, resistance) against predefined engineering specifications and comparison to a predicate device. It does not involve expert interpretation or diagnostic ground truth.
Adjudication Method for the Test Set:
- Not applicable. No human interpretation or adjudication was involved in generating the performance data.
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. This is not an AI-assisted diagnostic device, nor is it a multi-reader, multi-case study. It's a bench test of a mechanical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm. The "standalone" performance is the bench testing of the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the measured physical performance characteristics of the predicate device (Babi*Plus Bubble PAP Valve) and the established engineering specifications for such devices (e.g., ± 1 cm H₂O tolerance). The WaterPAP Valve's performance is compared against these established values.
The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning algorithm, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device submission.

Summary

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K118713

SEP 1 2 2011

Section 5 510(K) Summary

Preparation Date:	Sept 8, 2011
Applicant/Sponsor:	Airways Development LLC209 North 14th StreetKenilworth, NJ 07033
Contact Person:	Wayne W. DisanzaPresidentPhone: 908-931-1333Fax: 908-931-0034
Trade name:	WaterPAP™ Valve
Common Name:	Positive Airway Pressure Valve, Bubble CPAP, PEEP Valve
Classification Name:	Attachment, Breathing, Positive End Expiratory Pressure21 CFR §868.5965
Product Code:	BYE
Device Class:	II
Predicate Device:	Babi*Plus Bubble PAP ValveA Plus Medical (Manufacturer)510(k) Number: K090317

Device Description:

The WaterPAP Valve is an infant positive end expiratory pressure device used to increase end lung pressure above atmospheric in constant flow conditions.

Indications for Use:

Comparison of Technological Characteristics:

The WaterPAP Valve is substantially equivalent in indications for use, environment of use, patient population, and function to the BabitPlus Bubble PAP Valve identified as the predicate device. The WaterPAP Valve and the BabiPlus Bubble PAP Valve use the same method of submerging a continuous flow gas conduit under water to generate pressure. Comparative performance testing (simulated use) confirmed the substantial equivalence of the WaterPAP Valve with the BabiPlus device at flow rates of 4 to 12 liters per minute. Additional bench testing resulted in comparative test results.

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Nonclinical Tests:

Performance testing comparing the WaterPAP vs. Babi*Plus PAP Valves during simulated use was conducted. Testing was performed with each valve utilizing a simulated respiratory test circuit. A full range of flow and pressure combinations (flow rates 4-12 L/min and pressures 1-10 cm H20) were tested using both PAP generating valves. Results indicated both PAP valves performed in a similar manner within established specifications of ± 1cm H20 with comparable test data.

Testing was also performed to determine the rate of water level change during simulated use. Continuous flow of heated humidified gas was bubbled through the valves at minimum - mid and maximum flow/pressure combinations for 4 hours. Results indicated the WaterPAP and Babi*Plus Valves accumulate an equivalent amount of water and therefore the Positive Airway Pressures changes in both valves are essentially equivalent.

Testing was performed to document how increasing flow rates can generate unintended increases in PAP pressures delivered to the patient. The results demonstrate that the WaterPAP and Babi.Plus valves both generate increased pressures with increase flow rates. The gauge pressures of both PAP Valves are predominantly above the depth settings and verify the need for clinicians to use the valve's depth settings as a reference and always rely on the pressure gauge for actual PAP pressures.

Testing was performed to compare the resistance to flow through the underwater air diffusers. The testing was performed with the valves dry at a full range of flow rates. The results showed that the WaterPAP Valve had slightly higher resistance across the full range of flow rates; however the resistance to flow in both devices is well below a level that could have a negative impact during their intended use.

Substantial Equivalence:

The WaterPAP™ Valve is substantially equivalent to BabiPlus Bubble PAP Valve with respect to indications, environment of use, patient population, technological characteristics, and principle of operation. Based upon bench testing and comparison of the technological characteristics of both devices, the WaterPAP Valve device is substantially equivalent to the BabiPlus Bubble PAP Valve device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

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

Airways Development LLC C/O Mr. Richard Larkin President R.J. Larkin Consultants, LLC P.O. Box 558 Cedar Knolls. New Jersey 07927

SEP 1 2 2011

Re: KI10713

Trade/Device Name: WaterPAP™ Valve (Positive Airway Pressure Valve) Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: H Product Code: BYE Dated: August 30, 2011 Received: August 31, 2011

Dear Mr. Larkin:

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. Larkin

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 (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 /ucm] 15809.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.

Zh 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

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Indications for Use Statement

510(k) Number (if known):

Device Name: WaterPAP™ Valve (Positive Airway Pressure Valve)

Indications for Use:

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. Schult

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: « « 1107/3

Regulation Number and Section

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).