QUART ARTERIAL FILTER WITH BIOLINE COATING

K082544 · Maquet Cardiopulmonary, AG · DTM · Oct 3, 2008 · Cardiovascular

Device Facts

• Record ID: K082544
• Device Name: QUART ARTERIAL FILTER WITH BIOLINE COATING
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTM · Cardiovascular
• Decision Date: Oct 3, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4260
• Device Class: Class 2

Intended Use

The Quart Arterial Filter with Bioline Coating is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flow rates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician. The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.

Device Story

Arterial filter for extracorporeal circulation systems; used during cardiopulmonary bypass surgery. Input: blood flow from bypass circuit. Function: mechanical filtration of particulate and gaseous micro-embolisms; gas removal via purge line. Output: filtered blood returned to patient. Operated by perfusionists/surgeons in clinical/OR settings. Bioline coating applied to surface to improve blood compatibility. Device limited to 6-hour maximum duration. Benefits: reduction of embolic load during bypass, potentially improving patient outcomes by preventing systemic embolization.

Clinical Evidence

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

Technological Characteristics

Arterial blood filter for cardiopulmonary bypass. Features Bioline surface coating. Max flow rate 7 L/min. Mechanical filtration principle. Sterile, single-use device.

Indications for Use

Indicated for patients undergoing surgical procedures requiring cardiopulmonary bypass. Used in extracorporeal circulation systems to remove particulate and gaseous micro-embolisms. Max flow rate 7 L/min. Contraindicated for continuous use exceeding 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

Special Controls

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

Predicate Devices

• Quart Arterial Filter (K001787)
• Quadrox D Diffusion Membrane Oxygenator with Bioline Coating (K071774)

Submission Summary (Full Text)

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Ko 82544

MAQUET

# OCT 3 - 2008

#### Special 510(k): Device Modification: Quart Arterial Filter with Bioline Coating

510(k) SUMMARY

SUBMITTER:

Maquet Cardiopulmonary AG Hechinger Strasse 38

CONTACT PERSON: Katrin Schwenkalenks Phone: [phone] Fax: [phone] DATE PREPARED: August 27, 2008 DEVICE TRADE NAME: Quart Arterial Filter with Bioline Coating COMMON/USUAL NAME Arterial Filter, coated CLASSIFICATION NAME Filter, Blood, Cardiopulmonary Bypass, Arterial

Line

PREDICATE DEVICES OR LEGALLY MARKETED DEVICES

Quart Arterial Filter (K001787)

72145 Hirrlingen, Germany

Quadrox D Diffusion Membrane Oxygenator with Bioline Coating (K071774)

:

## DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT

The Quart Arterial Filter with Bioline Coating is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flow rates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line.

The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.

The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.

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# MAOI

The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

## STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The Quart Arterial Filter with Bioline Coating is identical to the Quart Arterial Filter, uncoated with the only exception that the Quart Arterial Filter with Bioline Coating has been coated with Bioline. The Bioline Coating is the same as with the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating. Besides this difference the both Quart Arterial Filters are the same in design, indications for use, method of operation, components, packaging, and fundamental scientific technology.

### DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Evaluation and testing on safety and effectiveness was executed to demonstrate that the Quart Arterial Filter with Bioline Coating described in this submission is substantially equivalent to the Quart Arterial Filter as an arterial filter and to the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating the Bioline coating.

The following areas have been tested and / or evaluated:

- ・ Integrity
- ı Performance
- Biocompatibility® -
- Sterility -

#### Conclusion

The data given demonstrate that the Quart 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.

OCT 3 - 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Maquet Cardiopulmonary AG Ms. Katrin Schwenkglonks Regulatory Affairs Manager llechinger Strasse 38 72145 Hirrlingen, Germany

Re: K082544

Trade/Device Name: Quart Arterial Filter with Bioline Coating Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: DTM Dated: August 27, 2008 Received: September 3, 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 intestate 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, Dr to 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 Ac1 . 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 devins, 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. Please e advised that FDA's issuance of a substantial equivalence determination does not mean fDA has made a determination that your device complies with other requirements of the Act 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 CFF) Part

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Page 2 -- Ms. Katrin Schwenkglenks

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 dcsire 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,

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): _ K082544

Device Name: Quart Arterial Filter with Bioline Coating___

Indications for Use:

The Quart Arterial Filter is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, the Quart Arterial Filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The max. flow rate of the Quart Arterial Filter is 7 1/min.

The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.

The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.

Prescription Use Over-The-Counter Use × 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)

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(Posted November 13, 2003)

Duna 2-10

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko82544