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.

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 <0.2um) prevents cross-contamination between the gas source/humidifier* and the wound. The thinner tube contains a stainless steel wire and stabilizes the gas diffuser inside the wound. The gas diffuser is made of medical foam plastic that is connected to the thin tube via a plastic disc. The disc also provides a large bonding area for the foam plastic and encapsulates the distal end of the stainless steel wire. The gas diffuser reduces the outflow velocity of the gas thus enabling a high flow at a very low outflow velocity. The elastic and hydrophobic properties of the foam plastic helps to maintain the full function of the gas diffuser and reduces the risk of foaming when the diffuser gets in contact with fluids including blood.

AI/ML Overview

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.

Summary

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510K Notification Supplement-Cardia Innovation AB CarbonAid® CO2 diffuser May 9th, 2012

Revised page 138 of 146	510K(k) SUMMARY	K11 2975
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SUBMITTER:	Cardia Innovation ABLillskogsvägen 22S-133 34 SaltsjöbadenSweden	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 ABCarbonAid™ gas diffuser K052125

Device Description:

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510K Notification Supplement-Cardia Innovation AB CarbonAid® CO2 diffuser May 9th, 2012

The hydrophobic gas filter (pore size <0.2um) prevents cross-contamination between the gas source/humidifier* and the wound. The thinner tube contains a stainless steel wire and stabilizes the gas diffuser inside the wound. The gas diffuser is made of medical foam plastic that is connected to the thin tube via a plastic disc. The disc also provides a large bonding area for the foam plastic and encapsulates the distal end of the stainless steel wire. The gas diffuser reduces the outflow velocity of the gas thus enabling a high flow at a very low outflow velocity.

Image /page/1/Figure/2 description: The image shows a diagram of a ventilation system using CO2. The system includes a CO2 tank, a flowmeter, a humidifier with a humidification agent, a gas filter, and a gas diffuser. The CO2 tank is connected to the flowmeter, which regulates the flow of CO2 into the humidifier. The humidifier adds moisture to the CO2 gas, and the gas filter removes any impurities. Finally, the gas diffuser distributes the CO2 gas into the environment.

Ontional external

The elastic and hydrophobic properties of the foam plastic helps to maintain the full function of the gas diffuser and reduces the risk of foaming when the diffuser gets in contact with fluids including blood

Predicate Device:

There has been a device previously cleared by the FDA in the following 510(K) Notification indicated for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity.

Device	510(k) DocumentNumber	DateCleared	Indications
Cardia InnovationABCarbonAid™ gasdiffuser	K052125	2/8/2006	intended for use bycardiovascular surgeons inopen heart surgeryprocedures for theinsufflation of carbondioxide gas into the thoraciccavity to reduce the risk ofair embolism which canresult in organ damage.

Table 1. Predicate Device

Intended Use:

Indications:

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Technological Characteristics:

Technologically, both the new device and the predicate device are the same (i.e. both are intended for the insufflation of carbon dioxide gas during open heart surgery. Any differences between the two devices do not raise new questions of safety and effectiveness

Performance Data:

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.

Conclusions:

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Public Health Service

JUN 2 2 2 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cardia Innovation AB C/O Intenational Medical Products Corporation Jeffrey R. Shideman 7307 Glochester Drive Edina, MN 55435

Re: K112975

CarbonAid CO2 Diffuser Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: Class II (two) Product Code: HIF Dated: May 9, 2012 Received: May 14, 2012

Dear Mr. Shideman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Shideman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. Zukerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510K Notification -Cardia Innovation AB CarbonAid® CO2 diffuser September 27th, 2011

Indications for Use

510(k) Number (if known): K112975

Device Name: CarbonAid®CO2 diffuser

Indications for Use:

Prescription Use

Prescription Use X AND/OR _______ (21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K112975

149

AND/OR

Over-The-Counter Use

Regulation Number and Section

§ 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.