CARBONAID C02 DIFFUSER

K112975 · Cardia Innovation AB · HIF · Jun 22, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K112975
• Device Name: CARBONAID C02 DIFFUSER
• Applicant: Cardia Innovation AB
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Disposable surgical device for CO2 insufflation during open heart surgery; creates topical 100% CO2 atmosphere in open surgical wounds. CO2 is denser than air; displaces air to prevent emboli formation during cardiopulmonary bypass weaning. Device consists of medical foam plastic diffuser connected to thin tube containing stainless steel wire for stabilization; includes hydrophobic gas filter (<0.2um) to prevent cross-contamination. Operates by reducing gas outflow velocity to enable high flow at low velocity. Used by cardiovascular surgeons in clinical settings. Benefits patient by reducing arterial CO2 emboli, which dissolve more readily than air, thereby decreasing risk of tissue hypoxia and organ injury.

Clinical Evidence

Bench testing only. Biocompatibility testing performed to ensure safety of component parts and materials.

Technological Characteristics

Materials: medical foam plastic, stainless steel wire. Components: hydrophobic gas filter (<0.2um), thin tube, plastic disc. Principle: gas diffusion/insufflation. Connectivity: connects to external CO2 source/humidifier. Form factor: disposable surgical device.

Indications for Use

Indicated for cardiovascular surgeons performing open heart surgery to insufflate CO2 into the thoracic cavity, reducing the risk of air embolism and associated organ damage.

Regulatory Classification

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.

Predicate Devices

• Cardia Innovation AB CarbonAid™ gas diffuser (K052125)

Submission Summary (Full Text)

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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 |
|-------------------------|-----------------|----------|
|-------------------------|-----------------|----------|

| SUBMITTER: | Cardia Innovation AB<br>Lillskogsvägen 22<br>S-133 34 Saltsjöbaden<br>Sweden | JUN 2 2 2012 |
|----------------------|------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Dr. Jeffrey R. Shideman .<br>Phone : [phone] | |
| DATE PREPARED: | September 27th, 2011 | |
| DEVICE NAME: | CarbonAid® CO₂ diffuser | |
| CLASSIFICATION NAME: | CarbonAid Gas diffuser | |
| PREDICATE DEVICE: | Cardia Innovation AB<br>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)

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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) Document<br>Number | Date<br>Cleared | Indications |
|-------------------------------------------------------|---------------------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cardia Innovation<br>AB<br>CarbonAid™ gas<br>diffuser | K052125 | 2/8/2006 | intended for use by<br>cardiovascular surgeons in<br>open heart surgery<br>procedures for the<br>insufflation of carbon<br>dioxide gas into the thoracic<br>cavity to reduce the risk of<br>air embolism which can<br>result in organ damage. |

Table 1. Predicate Device

### Intended Use:

#### Indications:

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

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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 [phone]. 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 [phone] or [phone] 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

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.

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