The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature.

The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.

The device's utilization period is limited to six hours. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

Device Description

The QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria through a clinical study. Therefore, most of the requested information (e.g., sample size for test sets, number of experts for ground truth, MRMC studies) is not applicable to this type of regulatory submission.

The "acceptance criteria" in this context refer to demonstrating that the new device meets the same safety and performance profiles as its predicate devices, primarily through non-clinical testing.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly that the new device (with "BIOLINE Coating") performs equivalently to the predicate devices (with "Softline Coating" for the oxygenator and "BIOLINE Coating" for the arterial filter component). The submission states that testing was undertaken to demonstrate this equivalence. Specific numerical thresholds for performance are not explicitly detailed in this summary, but would be part of the full submission.

Acceptance Criteria Category	Reported Device Performance (as stated in the summary)
Integrity	Evaluated to demonstrate substantial equivalence.
Performance	Evaluated to demonstrate substantial equivalence.
Biocompatibility	Evaluated to demonstrate substantial equivalence.
Sterility	Evaluated to demonstrate substantial equivalence.

Study to Prove Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) is a non-clinical evaluation comparing the new device against its predicate devices. The submission states:

"Evaluation and testing on safety and effectiveness was executed to demonstrate that the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating as oxygenator and to the QUART Arterial Filter with BIOLINE Coating regarding the BIOLINE coating."

The areas tested included:

Integrity
Performance
Biocompatibility
Sterility

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the 510(k) summary. Given that this is a non-clinical submission, the "test set" would refer to the number of devices or components tested. The data provenance would likely be internal testing data from the manufacturer (MAQUET) in Germany. This is not a study involving patient data or clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This point is not applicable. "Ground truth" established by experts typically pertains to clinical diagnostic studies where human experts evaluate medical images or patient data. This 510(k) is for a physical medical device (oxygenator/filter) and relies on technical and performance testing, not expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

This point is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among expert readers in establishing ground truth. As explained above, this submission does not involve such expert-based ground truth establishment.

5. 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

This point is not applicable. MRMC studies are relevant for evaluating the impact of AI in diagnostic imaging or clinical decision support where "human readers" interpret information. This 510(k) is for a physical device used during cardiopulmonary bypass, not an AI-driven diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This point is not applicable. Standalone algorithm performance is relevant for AI or software as a medical device. This 510(k) concerns a physical, mechanical medical device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established through objective engineering and laboratory testing based on established standards and methods for medical device performance, integrity, biocompatibility, and sterility. For example, "performance" would likely be measured against accepted physiological parameters (e.g., oxygen transfer rate, CO2 removal rate, filtration efficiency) under simulated in-vitro conditions, with the predicate device's performance serving as the reference for equivalence.

8. The Sample Size for the Training Set

This point is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) is not for an AI/ML device.

9. How the Ground Truth for the Training Set was Established

This point is not applicable for the same reason as point 8.

Summary

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K090511

MAQUET

510(k) Summarv

[as required by 21 CFR 807.92(c)]

JUN 1 2 2009

Submitter

MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germanv

Contact Person

Frank Moehrke Phone: 011 49 7478 921 229 011 49 7478 921 400 Fax:

Filter with BIOLINE Coating

February 24, 2009

Date Prepared

Device Trade Name

Common/Usual Name

Oxygenator with integrated heat exchanger and optional integrated arterial filter

QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial

Classification Names

Cardiopulmonary bypass oxygenator (21 CFR 870.4350 - Product Code: DTZ) Cardiopulmonary bypass heat exchanger (21 CFR 870.4240 - Product Code: DTR) Cardiopulmonary bypass arterial line blood filter (21 CFR 870.4260 - Product Code: DTM)

Legally Marketed Devices QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117), QUART Arterial Filter with BIOLINE Coating (K082544)

Device Description

Indications for Use

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The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.

Statement of Technical Comparison

The QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is identical to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating with the only exception that the QUADROX-i Adult with BIOLINE Coating have been coated with BIOLINE Coating instead of Softline Coating. However, the BIOLINE Coating is the same as with the QUART Arterial Filter with BIOLINE Coating. Besides this difference the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating.

Determination of Substantial Equivalence

Evaluation and testing on safety and effectiveness was executed to demonstrate that the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating as oxygenator and to the QUART Arterial Filter with BIOLINE Coating regarding the BIOLINE coating.

The following areas have been tested and / or evaluated:

Integrity
Performance
- Biocompatibility
Sterilitv

Conclusion

The data given demonstrate that the QUADROX-i Adult microporous membrane Oxygenator with and without integrated 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2009

Maquet Cardiopulmonary AG c/o Mr. Frank Mohrke Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany

Re: K090511

Quadrox-i Adult Microporous Membrane Oxygenatotor with and without Integrated Arterial Filter with Bioline Coating Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II (two) Product Code: DTZ . Dated: May 13, 2009 Received: May 15, 2009

Dear Mr. Mohrke:

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.

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Page 2 - Mr. Frank Mohrke

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

suma R. Vohrer

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): K0905) |

Device Name:

QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating

Indications for Use:

The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Page 1 of 1

Duana R. Vachner

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K090511

012

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
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.(b)
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.”