The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 Vmin. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and requiates blood temperature.

The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm.

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 Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating is a blood-gas exchanger with integrated heat exchanger and optional integrated arterial blood filter.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating." It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the document details a substantial equivalence determination study, which is a regulatory pathway for medical devices in the US. This type of study demonstrates that a new device is as safe and effective as a legally marketed predicate device.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is absent:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., "sensitivity must be >X%"). The acceptance criteria are implicitly that the device performs equivalently to the predicate devices across certain aspects.
Reported Device Performance: No specific numerical performance results (e.g., actual oxygenation rates, CO2 elimination rates, or filtering efficiencies) are reported in a granular manner. The study concludes that the device is "substantially equivalent" in key areas described below.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for test sets in terms of individual patients, images, or data points.
It refers to "evaluation and testing" but does not detail the methodology or scale of this testing.
Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable to this type of regulatory submission. The "ground truth" here is not an expert-derived clinical diagnosis or measurement, but rather a comparison against established performance benchmarks of predicate devices.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication mentioned for performance comparison.

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

No. This is not an AI-enabled device, nor is it a diagnostic device where human reader performance would be a primary metric. Therefore, an MRMC study is not relevant here. The device is a physical medical device (oxygenator) used during surgery.

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

Not applicable. This is not a software algorithm or an AI device. The "performance" relates to the physical and biological function of the oxygenator itself.

7. The type of ground truth used

The "ground truth" in this context is the established safety and effectiveness profile of the legally marketed predicate devices. The new device aims to demonstrate it is "substantially equivalent" to these known and accepted devices. The evaluation included:
- Integrity
- Performance (general, not specific metrics detailed)
- Biocompatibility
- Sterility

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Study Description (What was done, based on the document):

The study was a substantial equivalence determination study. The objective was to demonstrate that the new device, the "QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating," is as safe and effective as its predicate devices.

Predicate Devices:

QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (K090689)
QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating (K000511)

Methodology (as inferred from the summary):

The sponsor conducted "evaluation and testing" in the following categories:

Integrity: Likely assessed the structural soundness and leak protection of the device.
Performance: This would involve testing the device's ability to oxygenate blood, eliminate carbon dioxide, regulate blood temperature, and for the filtered version, filter out air bubbles and particles >40 µm. No specific metrics or results are provided, but the conclusion states it's substantially equivalent.
Biocompatibility: Likely involved tests to ensure the materials used in the device, particularly the BIOLINE coating, are compatible with blood and human tissue and do not cause adverse reactions. (This is the key difference from the primary predicate, which uses Softline coating).
Sterility: Tests to ensure the device is sterile when provided for use.

Conclusion of the Study:

The data demonstrated that the new device is substantially equivalent to the named predicate devices. The primary change was the coating (BIOLINE vs. Softline), and the new device was shown to be equivalent to an existing device that also uses the BIOLINE coating (K000511), as well as being equivalent in its oxygenator function to a similar small adult device (K090689) with the Softline coating.

Summary

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093527 AQUET GETINGE GROUP

510(k) Summary

יי

{as required by 21 CFR 807.92(c)]

Submitter	MAQUET Cardiopulmonary AGHechinger Strasse 3872145 HirrlingenGermany	DEC - 7 2009
Contact Person	Frank MoehrkePhone: 011 49 7478 921 229Fax: 011 49 7478 921 8667
Date Prepared	November 10, 2009
Device Trade Name	QUADROX-i Small Adult MicroporousMembrane Oxygenator with and withoutIntegrated Arterial Filter with BIOLINE Coating
Common/Usual Name	Oxygenator with integrated heat exchanger andoptional integrated arterial filter
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 Small Adult Microporous MembraneOxygenator with and without Integrated ArterialFilter with Softline Coating (K090689),
	QUADROX-i Adult Microporous MembraneOxygenator with and without Integrated ArterialFilter with BIOLINE Coating (K000511)

Device Description

014

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GETINGE GROUP

Indications for Use

The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm.

Statement of Technical Comparison

The QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating is identical to the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating with the only exception that the QUADROX-i Small Adult Oxygenators with BIOLINE Coating have been coated with BIOLINE Coating instead of Softline Coating. However, the BIOLINE Coating is the same as with the QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating. Besides this difference the QUADROX-i Small 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 Small 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 Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating as oxygenator and to the QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating regarding the BIOLINE Coating.

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MAQU GETINGE GROUP

The following areas have been tested and / or evaluated:

Integrity -
Performance -
Biocompatibility -
Sterility -

Conclusion

The data given demonstrate that the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filler with BIOLINE Coating is substantially equivalent to the named predicate devices which hold currently market clearance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

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

DEC - 7 2009

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

Re: K093522

QUADROX-i Small Adult Microporous Membrane Oxygenator With and without Integrated Arterial Filter with BIOLINE Coating Regulation Number: 21 CFR 870.4350 Regulation Name: Oxygenator Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTZ, DTR, DTM Dated: November 10, 2009 Received: November 13, 2009

Dear Mr. Moehrke:

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 - Mr. Frank Moehrke

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Dina R. Vahner

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): Ko93522

Device Name:

QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating

Indications for Use:

The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature.

The QUADROX - i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.

AND/OR Prescription Use (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)

bune R. Ladner

(Division Sign-Off) (Division Sign-Sil, vascular Devices

510(k) Number K093522

Page 1 of 1

013

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.”