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 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.

AI/ML Overview

This 510(k) summary describes a device modification rather than the development of a new AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device submissions, are not applicable here.

The submission focuses on demonstrating substantial equivalence of the modified device (QUART Arterial Filter with SOFTLINE COATING) to its predicate devices by comparing technical characteristics and performance based on standard medical device testing, not AI/ML algorithm validation.

However, I can extract the relevant information presented in the document regarding the device modification and the testing performed to demonstrate substantial equivalence.

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, reducing patient risk from micro-embolisms.

Device Modification:
The QUART Arterial Filter with SOFTLINE COATING is identical to the QUART Arterial Filter with Safeline Coating, with the only exception that it has been coated with SOFTLINE. The SOFTLINE COATING is the same as that used with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE COATING. Besides this difference, both QUART Arterial Filters are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology.

Acceptance Criteria and Reported Device Performance (as implied by the substantial equivalence determination):

The submission does not list specific numerical acceptance criteria in a table format, as would be expected for AI/ML performance metrics. Instead, it asserts that the modified device's performance aligns with the predicate devices through evaluation and testing. The "reported device performance" is essentially that it meets the expected standards for an arterial filter and is substantially equivalent to the predicate devices.

Acceptance Criteria Category (Implied)	Reported Device Performance (Demonstrated Equivalence)
Integrity	Demonstrated to be equivalent to predicate devices.
Performance	Demonstrated to be equivalent to predicate devices.
Biocompatibility	Demonstrated to be equivalent to predicate devices.
Sterility	Demonstrated to be equivalent to predicate devices.

Study Information (for a device modification, not an AI/ML algorithm):

Sample sizes used for the test set and the data provenance: Not applicable. This submission concerns a physical device modification, not a software algorithm tested on data sets. The "testing" refers to bench testing and material compatibility, not analysis of a data set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is relevant for diagnostic AI/ML algorithms, not for evaluating a physical device modification.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in AI/ML studies to resolve disagreements among experts in ground truth labeling.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to the physical properties and biological interactions of the device materials and function, assessed through standard engineering and biological testing (e.g., biocompatibility testing, flow rate performance, particulate removal efficiency against a known standard).
The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable. This pertains to AI/ML algorithm development.

Conclusion stated in the 510(k):
"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."

Summary

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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: (011) 49 7478 921- 337 Fax: 011 49 7478 921- 400

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 (800) 638-2041 or (301) 796-7100 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 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

AND/OR

OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page 1 of _1

013

Regulation Number and Section

§ 870.4260 Cardiopulmonary bypass arterial line blood filter.

(a)
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.(b)
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.”