QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000

K082117 · Maquet Cardiopulmonary, AG · DTZ · Feb 18, 2009 · Cardiovascular

Device Facts

• Record ID: K082117
• Device Name: QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTZ · Cardiovascular
• Decision Date: Feb 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow 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 the 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 with integrated heat exchanger and optional arterial filter; used in extracorporeal circulation during cardiac surgery. Device oxygenates blood, removes CO2, regulates temperature, and filters air/particles (in filtered version). Operates via gas inlet for oxygenation and volatile anesthetic delivery (isoflurane/sevoflurane) via external vaporizer. Used in clinical settings by perfusionists/surgeons. Provides real-time physiological support during bypass; output is oxygenated, temperature-regulated blood returned to patient. Benefits include maintenance of gas exchange and hemodynamic stability during surgery.

Clinical Evidence

Bench testing only. Device evaluated for integrity, performance, biocompatibility, and sterility per ISO 10993-1, ISO 7199:1996, and ISO 15675:2001 standards.

Technological Characteristics

Microporous membrane oxygenator with integrated heat exchanger and optional arterial filter. Features Softline biopassive coating. Flow range 0.5-7 L/min. Complies with ISO 7199 and ISO 15675. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring extracorporeal circulation during cardiopulmonary bypass. Suitable for use with flow rates between 0.5 and 7 L/min for up to six hours. Version with integrated filter removes air bubbles and particles >40 µm.

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 Hollow Fiber Membrane Oxygenator with Safeline Coating (K030264)
• Quart Arterial Filter (K001787)
• Synthesis Ph.I.S.I.O. Adult Membrane Oxygenator With Integrated Arterial Filter with Ph.I.S.I.O. Coating (K073380)

Submission Summary (Full Text)

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Kor 2117

FEB 1 8 2009

# MAQUET

# . 510 (K) Summary [as required by 21 CFR 807.92(c) ]

| Submitter: | Maquet Cardiopulmonary AG<br>Hechinger Strasse 38<br>72145 Hirrlingen<br>Germany |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Katrin Schwenkglenks<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | July 18, 2008 |
| Device Trade Name: | Quadrox-i Adult Microporous Membrane<br>Oxygenator with and without Integrated Arterial<br>Filter with Softline Coating |
| Common/Usual name: | Oxygenator with integrated heat exchanger and<br>optional integrated arterial filter |
| Classification names: | Oxygenator, cardiopulmonary bypass<br>Heat Exchanger, cardiopulmonary bypass<br>Filter, blood, cardiopulmonary bypass, arterial line |
| Predicate Devices: | Quadrox Hollow Fiber Membrane Oxygenator with<br>Safeline Coating (art.code HMO 2030), K030264,<br>Quart Arterial Filter (art.code HBF 140), K001787<br>by Maquet Cardiopulmonary AG and<br>Synthesis Ph.I.S.I.O. Adult Membrane Oxygenator<br>With Integrated Arterial Filter with Ph.I.S.I.O.<br>Coating by Sorin Group Italia S.r.l., K073380. |

## Device Description:

The Quadrox-i Adult is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.

The Quadrox-i Adult may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136).

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# MAQUET

### Indications for Use:

The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range. the device oxygenates the blood, eliminates carbon dioxide and requlates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 mm The device's utilization period is limited to six hours.

The oxygenator is suitable for the 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 Softline Coating is well comparable to the Quadrox Hollow Fiber Membrane Oxygenator with Safeline Coating regarding the intended use. design, principals of operation, biocompatibility and performance as related to the oxygenator and heat exchanger part, as well as to the Quart Arterial Filter as related to the filter part. The Softline Coating is a biopassive coating comparable to other coatings on the market, as e.g. the Ph.I.S.I.O. Coating by the Sorin Group Italia S.r.I.

#### Non-clinical Testing

The Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating has been tested to and met the requirements of ISO 10993-1 Biologic Evaluation of Medical Devices as well as the requirements of ISO 7199: 1996 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators) as well as the requirements of ાડવ 15675: 2001 "Cardiovascular implants and artificial organs -Cardiopulmonary Bypass - Arterial line blood filters".

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# MAQUET

### Determination of Substantial Equivalence

Testing and evaluation on safety and effectiveness was executed to demonstrate that the Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating described in this submission is substantially equivalent to the Quadrox Hollow Fiber Membrane Oxygenator with Safeline Coating as well as to the Quart Arterial Filter with regards to the filter function.

The following areas have been tested:

- Integrity -
- Performance
- Biocompatibility
- Sterility

### Conclusion

The data given demonstrate that the Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating is substantially equivalent to the named predicate devices which currently hold market clearance.

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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 (HHS). The logo features the HHS emblem, which is a stylized depiction of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2009

Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany

Re: K082117

Quadrox-i Adult Microporous Membrane Oxygenatotor with and without Integrated Arterial Filter with Softline Coating

Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator

Regulatory Class: Class II (two)

Product Code: DTZ

Dated: February 12, 2009

Received: February 17, 2009

Dear Ms. Schwenkglenks:

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 - Ms. Katrin Schwenkglenks

Enclosure.

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.

buna R. Laches

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices

Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K082)17

Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating _

Indications for Use:

The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood المهابة 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 the 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 Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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)

Duna R. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number: K082117

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(Posted November 13, 2003)