QUART ARTERIAL FILTER WITH SOFTLINE COATING

K090518 · Maquet Cardiopulmonary, AG · DTM · Dec 18, 2009 · Cardiovascular

Device Facts

• Record ID: K090518
• Device Name: QUART ARTERIAL FILTER WITH SOFTLINE COATING
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTM · Cardiovascular
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The QUART Arterial Filter with SOFTLINE COATING is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, 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 max. flow rate of the QUART Arterial Filter is 71/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.

Device Story

QUART Arterial Filter with SOFTLINE COATING functions as an in-line blood filter during cardiopulmonary bypass procedures. Device removes gaseous and particulate micro-embolisms from arterial blood lines; captured gas is evacuated via integrated purge line. Operated by perfusionists or surgeons in clinical/OR settings. SOFTLINE COATING applied to filter surfaces to improve hemocompatibility. Device limited to 6-hour maximum continuous use. Output is filtered blood returned to patient circulation; clinical benefit includes reduced risk of embolic injury.

Clinical Evidence

Bench testing only. No clinical data provided. Testing evaluated device integrity, performance, biocompatibility, and sterility to confirm equivalence to predicates.

Technological Characteristics

Arterial blood filter for cardiopulmonary bypass. Features SOFTLINE COATING for hemocompatibility. Max flow rate 7 L/min. Mechanical filtration principle. Single-use, sterile. No software or electronic components.

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 with Safeline Coating (K061546)
• QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE COATING (K082117)

Submission Summary (Full Text)

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K090078

# MAQUET

## Special 510(k): Device Modification: QUART Arterial Filter with Softline Coating

510(k) SUMMARY [as required by 21 CFR 807.92]

DEC 1 8 2009

SUBMITTER:

יין או יוני אוני

MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen, Germany

CONTACT PERSON:

Dr. Ingrid Richter Phone: [phone] Fax: [phone]

Arterial Filter, coated

DATE PREPARED: DEVICE TRADE NAME:

February 24, 2009 QUART Arterial Filter with SOFTLINE COATING

COMMON/USUAL NAME

CLASSIFICATION NAME

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

## PREDICATE DEVICES OR LEGALLY

MARKETED DEVICES

QUART Arterial Filter with Safeline Coating (K061546)

QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE COATING (K082117)

#### DEVICE DESCRIPTION

The QUART Arterial Filter serves as a filter during extracorporeal circulation procedures to safely remove gaseous embolisms and aggregates from blood components in the arterial blood line.

Utilization of the QUART Arterial Filter therefore reduces the patient risk of injury from a micro-embolism resulting from gases or solids.

#### INDICATONS FOR USE

The QUART Arterial Filter with SOFTLINE COATING is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flow rates, 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 71/min.

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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.

#### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The QUART Arterial Filter with SOFTLINE COATING is identical to the QUART Arterial Filter, with Safeline `Coating with the only exception that the QUART Arterial Filter with SOFTLINE COATING has been coated with SOFTLINE. The SOFTLINE COATING is the same as with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE COATING. Besides this difference the both QUART Arterial Filters are the same in design, intended 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 SOFTLINE COATING described in this submission is substantially equivalent to the QUART Arterial Filter with Safeline Coating as an arterial filter and to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE COATING regarding the SOFTLINE COATING.

The following areas have been tested and / or evaluated:

- Integrity •
- Performance -
- -Biocompatibility
- Sterility -

#### CONCLUSION

The data given demonstrate that the QUART Arterial Filter with SOFTLINE 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Maquet Cardiopulmonary AG c/o Dr. Ingrid Richter Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirringen Germany

DEC 1 8 2009

Re: K090518

Maquet OUART Arterial Filter with Softline Coating Regulation Number: 21 CFR 870.4260 Regulation Name: Filter, Blood, Cardiopulmonary Bypass, Arterial Line Regulatory Class: Class II (two) Product Code: DTM Dated: November 23, 2009 Received: November 25, 2009

Dear Dr. Richter:

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 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 - Dr. Ingrid Richter

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

- If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

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): Kr90518

Device Name: QUART Arterial Filter with SOFTLINE COATING_

Indications for Use:

The QUART Arterial Filter with SOFTLINE COATING is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, 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 max. flow rate of the QUART Arterial Filter is 71/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 (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

vision Sigh-Off) Division of Cardiovascular Devices 510(k) Number 140406

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