CARBONAID GAS DIFFUSER

K052125 · Cardia Innovation AB · HIF · Feb 8, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K052125
• Device Name: CARBONAID GAS DIFFUSER
• Applicant: Cardia Innovation AB
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Feb 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CarbonAid™ gas 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.

Device Story

Disposable surgical device for topical CO2 insufflation in open heart surgery. Receives CO2 from external source/humidifier via 1/4 inch tubing; incorporates hydrophobic gas filter (≤0.2µm) to prevent cross-contamination. Features thin tube with internal stainless steel wire for stabilization within wound; connected to medical foam plastic diffuser (30 kg/m3 density). Operated by cardiovascular surgeons in OR. Device creates 100% CO2 atmosphere in thoracic cavity to displace air, reducing risk of air embolism. Output is passive gas diffusion into surgical site.

Clinical Evidence

Bench testing only. Sufficient data gathered to assess performance as clinically intended.

Technological Characteristics

Medical foam plastic (open cell, 30 kg/m3); stainless steel wire for stabilization; hydrophobic gas filter (≤0.2µm); 1/4 inch medical tubing. Passive gas diffusion mechanism. Disposable.

Indications for Use

Indicated for cardiovascular surgeons performing open heart surgery to insufflate CO2 into the thoracic cavity to reduce air embolism risk.

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

• Pall Medical Laparoshield Conditioned Insufflation Set (K030469)

Submission Summary (Full Text)

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K052125

FEB 8 2005

510K Notification -Cardia Innovation AB CarbonAidTM gas diffuser July 27th, 2005

#### 510K(k) SUMMARY

| SUBMITTER: | Cardia Innovation AB<br>Lillskogsv 22<br>S-133 34 Saltsjobaden<br>Stockholm, Sweden |
|----------------------|-------------------------------------------------------------------------------------|
| DATE PREPARED: | July 27th, 2005 |
| DEVICE NAME: | CarbonAid™ gas diffuser |
| CLASSIFICATION NAME: | Carbon Dioxide Gas Insufflator |
| PREDICATE DEVICE: | Pall Medical Laparoshield Conditioned<br>Insufflation Set; K030469 |

#### Device Description:

The CarbonAid™ gas 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. The larger tube transports the gas from the gas source/humidifier to the surgical wound and has the standard width of medical tubes for this purpose (14 inch).

The hydrophobic gas filter (≤0.2µm) prevents cross-contamination between the aas 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 (with open cells, 30 kg/m3) that is connected to the thin tube via a plastic disc

Image /page/0/Figure/8 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, and a gas filter. The ventilation gas is connected to the system and flows through the humidifier and gas filter before being released.

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## Predicate Devices:

There has been a device previously cleared by the FDA in the following 510(K) Notification indicated for use by general surgeons in laparoscopic procedures to provide a path for the insufflation gas from the insufflation device to the patient.

#### Table 1. Predicate Device

| Device | 510(k) Document<br>Number | Date<br>Cleared | Indications |
|----------------------------------------------------------------|---------------------------|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pall Medical<br>Laparoshield<br>Conditioned<br>Insufflator Set | K030469 | 5/09/2003 | Use by general surgeons<br>in laparoscopic<br>procedures to provide a<br>path for the insufflation<br>gas from the insufflation<br>device to the patient |

## Intended Use:

## Indications:

The CarbonAid™ gas 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.

## 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. 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 gas diffuser performs as clinically intended

## 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 exting Iegally marketed device under the Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EEB 8 2006

Cardia Innovation AB c/o Jeffrey R. Shideman, Ph.D. President 7307 Glochester Drive Edina, MN 55435

Re: K052125 CarbonAid™ Gas Diffuser Regulation Number: 21 CFR 870.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: Class II (Two) Product Code: HIF Dated: December 25, 2005 Received: January 10, 2006

Dear Dr. 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 - Jeffrey R. Shideman, Ph.D.

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 vours.

Blummenau for

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 K052125 Supplement -Cardia Innovation AB CarbonAid™ gas diffuser December 27th, 2005

## Indications for Use

510(k) Number (if known): K052125

Device Name: CarbonAid™ gas diffuser

Indications for Use:

The CarbonAid™ gas 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.

Bhimma

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Prescription Use (Part 21 CFR 801 Subpart D)

: : :

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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