(100 days)
Not Found
No
The summary describes a mechanical valve for positive end expiratory pressure and does not mention any AI or ML components or functionalities.
Yes
The device is used to increase end lung pressure in infant patients, which is a therapeutic intervention.
No
The device is a positive end expiratory pressure valve designed to increase lung pressure, and its function is therapeutic (to assist breathing), not diagnostic (to identify a disease or condition).
No
The device description explicitly states it is a "Single patient use water seal positive end expiratory pressure device," indicating a physical hardware component.
Based on the provided information, the Babi*Plus Bubble PAP Valve is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Babi*Plus Bubble PAP Valve is a mechanical device used to provide positive end expiratory pressure to infant patients' lungs. It directly interacts with the patient's respiratory system.
- Intended Use: The intended use describes a therapeutic intervention (increasing end lung pressure) rather than a diagnostic test performed on a sample.
Therefore, the Babi*Plus Bubble PAP Valve falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Babi*Plus Bubble PAP 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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string reads 'Kopo317' in a cursive style.
A Plus Medical
Solutions for Respiratory Care
510(k) Summary
Owner:
A Plus Medical 5431 Avenida Encinas, STE G Carlsbad, CA 92008-4411 + 760-930-4025 Tel: + 760-930-0040 Fax:
Owner/Operator Number: 10023166
Official Contact:
Thomas C. Loescher Tel: + 760-930-4025 Fax: + 760-930-0040
Trade Names: Babi*Plus Bubble PAP Valve
Common/Usual Name: PEEP Valve, CPAP Valve, PAP Valve, Bubble CPAP
Classification Name:
Device Name: Attachment, Breathing, Positive End expiratory Pressure Product Code: BYE Regulation: 868.5965 Device Class: 2
Device: Babi*Plus Bubble CPAP Valve
Predicate Devices:
| Number: | Preamendment device |
|---|---|
| Product Name: | Water Seal PEEP Valve |
| Manufacturer: | unknown - believed to be McGaw Laboratories |
| Product Codes: | Unknown |
| Number: | K082092 |
| Product Name: | Disposable PEEP Valve |
| Manufacturer: | GaleMed Corporation |
| Product Codes: | 2421-2425, inclusive and 2461-2481, inclusive |
| Number: | K902062 |
| Product Name: | Disposable PEEP Valve |
| Manufacturer: | Hudson RCI, Temecula, CA (Teleflex Medical, Research Triangle Park, NC) |
| Product Codes: | LIFESAVER® PEEP Valve Models 5383 and 5385 |
5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 図 +740-930-4025 Fax: +760-930-0040 ~ 13 ~
MAY 20 2009
1
Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical Solutions for Respiratory Care. The logo features the letter "a" in a circle on the left, followed by the words "A Plus Medical" in a larger font. Below "A Plus Medical" is the text "Solutions for Respiratory Care" in a smaller font. The logo is black and white.
Device Description:
Single patient use water seal positive end expiratory pressure device.
Indications for Use:
The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing X 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-Uff) Division of Anesthesiology, General Hospital Intection Control, Dental Devices
510(K) Number: _______________________________________________________________________________________________________________________________________________________________