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The CarbonAid® CO2 diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism which can result in organ damage.

The CarbonAid®CO2 diffuser is a disposable surgical device for effective insufflation of carbon dioxide (CO2) into an open surgical wound to create a topical atmosphere of 100% CO2 during open heart surgery. Air will enter in the heart and great vessels during conventional open heart surgery and is difficult to evacuate with current de-airing techniques. Trapped air will be mobilized to the arterial vessels during weaning from cardiopulmonary bypass and will thus embolize to the brain and other organs. Since air dissolves poorly in blood and tissue, air bubbles will obstruct blood flow and cause tissue hypoxia and injury. CO2 is more than 25 times more soluble than air in blood and tissue and arterial CO2 emboli will thus be fewer, dissolve more quickly and decrease the risk of organ injury. A 100% CO2 atmosphere can be created and maintained in an open surgical wound, since CO2 is 50% heavier (denser) than air, provided that tube transports the CO2 gas from the gas source/humidifier to the surgical wound and has the standard width / internal diameter of medical tubes for this purpose (¼ inch). The hydrophobic gas filter (pore size

The provided text is a 510(k) Pre-market Notification for a medical device, the "CarbonAid® CO2 diffuser." This type of document is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than to prove its effectiveness against specific acceptance criteria through a clinical study in the way a PMA (Pre-market Approval) would.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria. Specifically:

• No acceptance criteria are provided.
• No study is described that details device performance against specific metrics.
• No information regarding sample size for testing or data provenance is available.
• No information about experts, adjudication methods, MRMC studies, or standalone algorithm performance is present.
• No details on training set size or ground truth establishment for a training set are found.

The document focuses on demonstrating substantial equivalence to a predicate device (Cardia Innovation AB CarbonAid™ gas diffuser K052125).

Here's what the document does state:

• Device Description: The CarbonAid® CO2 diffuser is a disposable surgical device for insufflation of CO2 into an open surgical wound during open heart surgery to create a topical 100% CO2 atmosphere, aiming to reduce air embolism risk.
• Indications for Use: The CarbonAid® CO2 diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism which can result in organ damage.
• Technological Characteristics: States that "Technologically, both the new device and the predicate device are the same... Any differences between the two devices do not raise new questions of safety and effectiveness."
• Performance Data (General Statement): "Sufficient data has been gathered from testing to assess that the CarbonAid® CO2 diffuser performs as clinically intended. Biocompatibility testing has been performed to ensure that this device, its component parts and materials are biocompatible." However, specific data or a study report is not included in this summary.
• Conclusion: The device is concluded to be "substantially equivalent to the existing legally marketed device."

In summary, this 510(k) notification is a regulatory document focused on demonstrating similarity to an existing device, not a report of a study designed to prove performance against pre-defined acceptance criteria.

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