QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000

K090511 · Maquet Cardiopulmonary, AG · DTZ · Jun 12, 2009 · Cardiovascular

Device Facts

• Record ID: K090511
• Device Name: QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTZ · Cardiovascular
• Decision Date: Jun 12, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

Device Story

Blood-gas exchanger; integrated heat exchanger; optional integrated arterial filter. Inputs: venous blood from patient; oxygen/anesthetic gas mixture. Operation: microporous membrane facilitates gas exchange; heat exchanger regulates blood temperature; arterial filter removes air/particles >40 um. Used in cardiac surgery; operated by perfusionists/physicians. Output: oxygenated, temperature-regulated blood returned to patient. Benefits: maintains physiological gas exchange and temperature during bypass; reduces embolic risk via filtration. BIOLINE coating applied to surfaces to improve biocompatibility.

Clinical Evidence

Bench testing only. Evaluation included integrity, performance, biocompatibility, and sterility testing to demonstrate equivalence to predicate devices.

Technological Characteristics

Microporous membrane oxygenator; integrated heat exchanger; optional integrated arterial filter. BIOLINE coating applied for biocompatibility. Flow rate range 0.5-7 l/min. Mechanical gas exchange and heat transfer. Sterilized device.

Indications for Use

Indicated for patients undergoing extracorporeal circulation during cardiopulmonary bypass in cardiac surgery requiring blood oxygenation, CO2 removal, and temperature regulation at flow rates of 0.5-7 l/min. Integrated filter version indicated for removal of air bubbles and particles >40 um. Limited to 6-hour use.

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

Predicate Devices

• QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117)
• QUART Arterial Filter with BIOLINE Coating (K082544)

Submission Summary (Full Text)

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K090511

MAQUET

# 510(k) Summarv

[as required by 21 CFR 807.92(c)]

JUN 1 2 2009

Submitter

MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germanv

Contact Person

Frank Moehrke Phone: [phone] 011 49 7478 921 400 Fax:

Filter with BIOLINE Coating

February 24, 2009

Date Prepared

Device Trade Name

Common/Usual Name

Oxygenator with integrated heat exchanger and optional integrated arterial filter

QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial

Classification Names

Cardiopulmonary bypass oxygenator (21 CFR 870.4350 - Product Code: DTZ) Cardiopulmonary bypass heat exchanger (21 CFR 870.4240 - Product Code: DTR) Cardiopulmonary bypass arterial line blood filter (21 CFR 870.4260 - Product Code: DTM)

Legally Marketed Devices QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117), QUART Arterial Filter with BIOLINE Coating (K082544)

# Device Description

The QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.

# Indications for Use

The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature.

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The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.

The device's utilization period is limited to six hours. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

#### Statement of Technical Comparison

The QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is identical to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating with the only exception that the QUADROX-i Adult with BIOLINE Coating have been coated with BIOLINE Coating instead of Softline Coating. However, the BIOLINE Coating is the same as with the QUART Arterial Filter with BIOLINE Coating. Besides this difference the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating.

#### Determination of Substantial Equivalence

Evaluation and testing on safety and effectiveness was executed to demonstrate that the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating as oxygenator and to the QUART Arterial Filter with BIOLINE Coating regarding the BIOLINE coating.

The following areas have been tested and / or evaluated:

- Integrity
- Performance
- Biocompatibility
- Sterilitv

#### Conclusion

The data given demonstrate that the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is substantially equivalent to the named predicate devices which hold currently market clearance.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2009

Maquet Cardiopulmonary AG c/o Mr. Frank Mohrke Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany

Re: K090511

Quadrox-i Adult Microporous Membrane Oxygenatotor with and without Integrated Arterial Filter with Bioline Coating Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II (two) Product Code: DTZ . Dated: May 13, 2009 Received: May 15, 2009

#### Dear Mr. Mohrke:

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. Frank Mohrke

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.

suma R. Vohrer

- 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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# Indications for Use

510(k) Number (if known): K0905) |

Device Name:

# QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating

#### Indications for Use:

The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature.

The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.

The device's utilization period is limited to six hours. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

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)

Page 1 of 1

Duana R. Vachner

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number k090511

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