JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030

K061628 · Maquet Cardiopulmonary, AG · DTZ · Aug 22, 2006 · Cardiovascular

Device Facts

• Record ID: K061628
• Device Name: JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTZ · Cardiovascular
• Decision Date: Aug 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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.

Device Story

Extracorporeal membrane oxygenator used during open-heart surgery; component of heart-lung machine. Inputs: venous blood from patient. Transformation: gas exchange via tight diffusive membrane (non-porous) to oxygenate blood and remove carbon dioxide; integrated heat exchanger for temperature control. Output: oxygenated blood returned to patient. Operated by perfusionists/physicians in clinical OR setting. Prevents air bubble passage and plasma leakage due to non-porous membrane design. Benefits patient by maintaining gas exchange during cardiopulmonary bypass.

Clinical Evidence

Bench testing only. Evaluated integrity, performance, coating stability, biocompatibility, and sterility per ISO 10993-1 and ISO 7199:1996 standards.

Technological Characteristics

Diffusion membrane oxygenator; non-porous membrane material; 1.8 m² gas exchange surface; 0.6 m² heat exchanger surface. Complies with ISO 10993-1 and ISO 7199:1996. Standalone device; single-use; non-pyrogenic.

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.

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 Safeline Hollow Fiber Membrane Oxygenator (K992559, K030264)

Reference Devices

• venous hardshell cardiotomy reservoir (K003551, K982136)

Submission Summary (Full Text)

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K061628
Page 1 of 3

AUG 2 2 2006

# 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: | James Collie<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | June 09, 2006 |
| Device Trade Name: | Jostra Quadrox D Safeline Diffusion Membrane<br>Oxygenator |
| Common/Usual name: | Quadrox D |
| Classification names: | Oxygenator, cardiopulmonary bypass<br>Heat Exchanger, cardiopulmonary bypass |
| Predicate Devices: | Jostra Quadrox Safeline Hollow Fiber Membrane<br>Oxygenator (K992559, K030264) |

Device Description:

The Quadrox D Safeline 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 heartlung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Safeline 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.

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206/628
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# MAQUET

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is a model of the Quadrox Safeline Hollow Fiber Membrane Oxygenator. In contrast to the Quadrox, a tight diffusive membrane instead of a microporous membrane is used for the gas exchange.

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 diffusive membrane has the same outer diameter as the open-pored membrane. The outer diameters are 1.8 m² gas exchange surface and 0.6 m² heat exchanger surface available.

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

The complete construction, priming volume and the connections are the same for the Quadrox D Safeline as well as for the Quadrox Safeline Oxygenator.

It may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to Jostra Quadrox Safeline Oxygenator (K992559). The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator will be provided with a Jostra Manifold Sampling Line.

#### Indications for Use:

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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.

### Statement of Technical Comparison:

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator has the same intended use, design, principals of operation, and performance as the Jostra Quadrox Safeline Oxygenator. The only difference is that the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator uses a tight diffusive membrane instead of a microporous membrane for the gas exchange.

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KC61628
Page 3 of 3

# MAQUET

## Non-clinical Testing:

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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).

### Determination of Substantial Equivalence

Testing and evaluation on safety and effectiveness was executed to demonstrate that the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator described in this submission is substantially equivalent to the Jostra Quadrox Safeline 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 Safeline Diffusion Membrane Oxygenator is substantially equivalent to the named predicate device which holds currently market clearance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2006

Maquet Cardiopulmonary AG c/o Mr. James R. Collie J.R. Collie Associates, Inc. 414 Maryjoe Way Warrington, PA 18976

Re: K061628

Quadrox D Safeline Diffusion Membrane Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: August 7, 2006 Received: August 8, 2006

Dear Mr. Collie:

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 haft or bin 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. James R. Collie

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I DTC issuazes or our device complies with other requirements of the Act that I DA has made a detel masulations administered by other Federal agencies. You must of any I catal stutures and registments, including, but not limited to: registration and listing (21 comply with an the 10t 3 requirements)01); good manufacturing practice requirements as set CITY art 607); laboring (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This letter will anow you to begin mailioning of substantial equivalence of your device to a legally promatics notification: "The PDF interessification 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 If you desire specific at not 10. Jose [phone]. Also, please note the regulation entitled, Colliact the Office of Comphance as (21 transmit (21CFR Part 807.97). You may obtain Milsolalling of Yelerone to premainsnibilities under the Act from the Division of Small other general information on your response in its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Bram D. Zudkerman M

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Jostra Quadrox D Safeline Diffusion Membrane Oxygenator_

Indications for Use:

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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.

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)

(Division Sign-Off)
Division of card

510(k) Number K061625

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