(181 days)
Not Found
No
The summary describes a mechanical valve for delivering positive end-expiratory pressure and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is described as a "positive end expiratory pressure valve" used "to increase end lung pressure above atmospheric in constant flow conditions" for infant patients, which constitutes a therapeutic action.
No.
The device is described as a positive end expiratory pressure valve intended to increase end lung pressure, which is a therapeutic function, not a diagnostic one. It does not analyze patient data to provide diagnostic insights.
No
The device description and performance studies clearly indicate a physical valve component, not a software-only solution.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to increase end lung pressure in infant patients. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's a device used to increase lung pressure, aligning with a therapeutic purpose.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis or monitoring of a disease or condition based on in vitro analysis.
The device is a medical device used for respiratory support, specifically positive end expiratory pressure (PEEP) in infants.
N/A
Intended Use / Indications for Use
The WaterPAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing
§ 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).
0
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SEP 1 2 2011
Section 5
510(K) Summary
| Preparation Date: | Sept 8, 2011 |
|---|---|
| Applicant/Sponsor: | Airways Development LLC |
| 209 North 14th Street | |
| Kenilworth, NJ 07033 | |
| Contact Person: | Wayne W. Disanza |
| President | |
| Phone: 908-931-1333 | |
| Fax: 908-931-0034 | |
| Trade name: | WaterPAP™ Valve |
| Common Name: | Positive Airway Pressure Valve, Bubble CPAP, PEEP Valve |
| Classification Name: | Attachment, Breathing, Positive End Expiratory Pressure |
| 21 CFR §868.5965 | |
| Product Code: | BYE |
| Device Class: | II |
| Predicate Device: | Babi*Plus Bubble PAP Valve |
| A 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:
The WaterPAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing