CarbonAid Gas Diffuser
by Cardia Innovation Ab United States EUDAMED510(k)
510(k) K052125
Product code HIF
Overview
The CarbonAid Gas Diffuser is a laparoscopic insufflator designed for controlled delivery of carbon dioxide (CO₂) during minimally invasive surgical procedures. It facilitates uniform gas distribution to reduce residual air within the abdominal cavity, minimizing the risk of air microemboli—particularly critical in obstetrics and gynecology applications.
This device is intended for single-use in sterile surgical settings and is classified as a Class II medical device under FDA regulations (510K clearance) and the Medical Devices Directive (MDD). Supplied as a reusable or disposable component depending on model variant, it operates at specified flow rates (5–10 L/min) to ensure effective de-airing. Compatibility with MRI environments is not specified, and storage adheres to standard sterile medical device protocols. Authorisations include FDA_510K and MDD compliance, with regulatory filing under K052125.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK052125 | Date8 Feb 2006 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring (legacy directive)
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- HIF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1730
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cardia Innovation Ab
Questions
What surgical specialties is the CarbonAid Gas Diffuser primarily designed for, and why is this important?
The CarbonAid Gas Diffuser is specifically designed for use in obstetrics and gynecology procedures. This focus is critical because these specialties often involve laparoscopic surgeries where residual air in the abdominal cavity poses a higher risk of air microemboli, which can be particularly dangerous during procedures involving pregnant patients or complex gynecological interventions.
Is the CarbonAid Gas Diffuser intended for single-use or reusable applications, and how does this affect its clinical workflow?
The CarbonAid Gas Diffuser is intended for single-use in sterile surgical settings. This design choice ensures patient safety by eliminating cross-contamination risks between procedures, simplifying sterilization logistics, and reducing the need for reprocessing validation. Clinically, this aligns with best practices for laparoscopic insufflators to maintain aseptic conditions during minimally invasive surgeries.
What flow rates does the CarbonAid Gas Diffuser operate at, and how does this influence its effectiveness in de-airing the abdominal cavity?
The device operates at specified flow rates of 5–10 liters per minute, which are optimized to ensure uniform gas distribution and efficient removal of residual air from the abdominal cavity. These rates balance effectiveness in de-airing with practical surgical workflow demands, minimizing the risk of air microemboli while maintaining procedural efficiency.
How should the CarbonAid Gas Diffuser be stored, and what considerations should clinicians keep in mind?
The CarbonAid Gas Diffuser must be stored according to standard sterile medical device protocols, as it is intended for single-use in sterile surgical settings. Clinicians should ensure it is kept in a sealed, sterile packaging until use and stored in a clean, dry environment to preserve its integrity and sterility, adhering to general medical device storage guidelines.
What regulatory pathways has the CarbonAid Gas Diffuser followed, and what does this mean for its adoption in clinical practice?
The device has received FDA 510(k) clearance and complies with the Medical Devices Directive (MDD), confirming its classification as a Class II medical device under both regulatory frameworks. This means it has undergone rigorous evaluation for safety and effectiveness, providing confidence in its adoption for laparoscopic insufflation in obstetrics and gynecology. The clearance also ensures alignment with U.S. and EU regulatory standards for minimally invasive surgical tools.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K052125
- EUDAMED