(261 days)
No
The device description focuses on the physical components and mechanism of action (gas diffusion) and does not mention any computational or data-driven processes indicative of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is intended to reduce the risk of air embolism and organ damage by insufflating CO2 into the thoracic cavity during open heart surgery. This addresses a pathological condition (air embolism) and provides a therapeutic benefit (reducing organ damage).
No
The device is described as a CO2 diffuser for insufflation during open heart surgery to reduce the risk of air embolism. Its function is to deliver CO2, not to diagnose a medical condition or provide information about a disease.
No
The device description clearly details physical components such as a disposable surgical device, tube, hydrophobic gas filter, stainless steel wire, plastic disc, and medical foam plastic. These are hardware components, not software.
Based on the provided information, the CarbonAid® CO2 diffuser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for insufflating carbon dioxide gas into the thoracic cavity during open heart surgery to reduce the risk of air embolism. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a disposable surgical device used to create a topical atmosphere of CO2 within an open surgical wound. This is a physical intervention during surgery.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health or condition. The CarbonAid® CO2 diffuser does not perform any such analysis or testing of specimens.
The device is clearly intended for use in vivo (within the living body) during a surgical procedure, which is characteristic of a surgical device, not an IVD.
N/A
Intended Use / 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.
Product codes
HIF
Device Description
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
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
510K Notification Supplement-Cardia Innovation AB CarbonAid® CO2 diffuser May 9th, 2012
| Revised page 138 of 146 | 510K(k) SUMMARY | K11 2975 |
|---|---|---|
| ------------------------- | ----------------- | ---------- |
| SUBMITTER: | Cardia Innovation AB
Lillskogsvägen 22
S-133 34 Saltsjöbaden
Sweden | JUN 2 2 2012 |
|----------------------|------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Dr. Jeffrey R. Shideman .
Phone : 952 835 4018 | |
| DATE PREPARED: | September 27th, 2011 | |
| DEVICE NAME: | CarbonAid® CO₂ diffuser | |
| CLASSIFICATION NAME: | CarbonAid Gas diffuser | |
| PREDICATE DEVICE: | Cardia Innovation AB
CarbonAid™ gas diffuser K052125 | |
Device Description:
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)
1
510K Notification Supplement-Cardia Innovation AB CarbonAid® CO2 diffuser May 9th, 2012
The hydrophobic gas filter (pore size