JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030

K071774 · Maquet Cardiopulmonary, AG · DTZ · Jan 23, 2008 · Cardiovascular

Device Facts

• Record ID: K071774
• Device Name: JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTZ · Cardiovascular
• Decision Date: Jan 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is used for extracorporeal circulation during cardiopulmonary bypass in the field of openheart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours. The application and use of the oxygenator is the sole responsibility of the attending physician.

Device Story

Extracorporeal membrane oxygenator; used during cardiopulmonary bypass in open-heart surgery. Device integrates into heart-lung machine circuit; facilitates gas exchange via diffusion through non-porous membrane wall; prevents air bubble passage and plasma leakage. Bioline coating applied to membrane surface. Operated by perfusionists/physicians in clinical settings. Provides oxygenation and CO2 removal for up to six hours. Output is oxygenated blood returned to patient circulation; supports patient physiological stability during surgery.

Clinical Evidence

Bench testing only. Evaluated for integrity, performance, coating stability, biocompatibility (ISO 10993-1), and sterility. Performance data compared to predicate oxygenator confirms equivalence.

Technological Characteristics

Diffusion membrane oxygenator; non-porous membrane wall. Bioline coating. Sterile, single-use. Complies with ISO 7199:1996 (cardiovascular implants/artificial organs - blood gas exchangers).

Indications for Use

Indicated for patients undergoing open-heart surgery requiring extracorporeal circulation during cardiopulmonary bypass for blood oxygenation and carbon dioxide removal. Restricted to 6-hour use. Physician-prescribed.

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

• Jostra Quadrox D Safeline Hollow Fiber Membrane Oxygenator (K061628)

Reference Devices

• Venous hardshell cardiotomy reservoir (K003551)
• Venous hardshell cardiotomy reservoir (K982136)

Submission Summary (Full Text)

{0}------------------------------------------------

## K071774 MAQUET

### JAN 2 3 2008

### 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 |
| | Phone: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Date Prepared: | June 22, 2007 |
| Device Trade Name: | Jostra Quadrox D Diffusion Membrane<br>Oxygenator with Bioline Coating |
| Common/Usual name: | Quadrox D Bioline |
| Classification names: | Oxygenator, cardiopulmonary bypass<br>Heat Exchanger, cardiopulmonary bypass |
| Predicate Device: | Jostra Quadrox D Safeline Hollow Fiber<br>Membrane Oxygenator (K061628) |

#### Device Description:

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

:

The Quadrox D Bioline is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.

In open heart surgery it is used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Bioline is therefore a component in the extracorporeal perfusion circulation system, for oxygenation of blood and removal of carbon dioxide. The utilization period of this device is restricted to six hours.

{1}------------------------------------------------

# MAQUET

The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different. The new device comes with a Bioline coating, the already cleared device comes with the Safeline Coating.

With this diffusive membrane the gas exchange takes place by diffusion through the membrane wall. This membrane has no pores, therefore a passover of air bubbles or plasma leakage is not possible.

The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.

The Quadrox D Bioline may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to the Jostra Quadrox D Safeline (K061628).

#### Indications for Use:

The Membrane Oxygenator Jostra Quadrox D is used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours. The application and use of the oxygenator is the sole responsibility of the attending physician.

#### Statement of Technical Comparison:

The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating has the same intended use, design, principals of operation, and performance as the Jostra Quadrox D Safeline Oxygenator. Only difference is that the new device comes with a Bioline coating, the already cleared device comes with the Safeline Coating.

#### Non-clinical Testing:

The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline 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).

{2}------------------------------------------------

# MAQUET

#### Determination of Substantial Equivalence

Testing and evaluation on safety and effectiveness was executed to demonstrate that the Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating described in this submission is substantially equivalent to the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator.

The following areas have been tested:

- Integrity
- Performance
- Stability of the Coating
- Biocompatibility
- Sterility

#### Conclusion

The data given demonstrate that the Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is substantially equivalent to the named predicate device which holds currently market clearance.

{3}------------------------------------------------

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

JAN 2 3 2008

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

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

Re: K071774

Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating Regulation Number: 21 CFR 870.43500 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: January 14, 2008 Received: January 18, 2008

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.

{4}------------------------------------------------

#### Page 2 – Ms. Katrin Schwenkglenks

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,

Dana R. bochner

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

Enclosure

{5}------------------------------------------------

### Indications for Use

510(k) Number (if known): ¸¼០ገ | 774

Device Name: Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating Coating ______________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is used for extracorporeal circulation during cardiopulmonary bypass in the field of openheart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

The application and use of the oxygenator is the sole responsibility of the attending physician.

Over-The-Counter Use Prescription Use 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. Vales

Page _1_ of _1_

Division of Cardiovascular Devices

(Division Sign-Off

510(k) Number_K02) 774

(Posted November 13, 2003)

Confidential

033