The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/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. The device's utilization period is limited to six hours. The oxygenator is suitable for the 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 is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter. The QUADROX-i Small Adult may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136).

AI/ML Overview

This document is a 510(k) summary for the MAQUET QUADROX-i Small Adult Microporous Membrane Oxygenator. It describes non-clinical testing performed to establish substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria in a way that aligns with the detailed requests of questions 1-9.

The submission focuses on comparing the new device to existing, legally marketed predicate devices, primarily in terms of design, principles of operation, biocompatibility, and performance, as well as meeting recognized standards like ISO 10993-1, ISO 7199, and ISO 15675.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

1. A table of acceptance criteria and the reported device performance

The document states that the device "has been tested to and met the requirements of ISO 10993-1, ISO 7199:1996, and ISO 15675:2001." However, the specific acceptance criteria within these standards and the reported device performance values against those criteria are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions general "testing and evaluation on safety and effectiveness" but does not detail sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the testing described is non-clinical (device performance and biocompatibility), not involving human expert assessment of a test set for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reason as point 3.

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

There is no mention of an MRMC study or AI assistance. This document describes a medical device (oxygenator), not an AI diagnostic tool.

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

This is not applicable as the device is an oxygenator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" would be the specifications and requirements defined by the ISO standards mentioned (ISO 10993-1, ISO 7199, ISO 15675). The device's performance was measured against these engineering and biological requirements. No human "expert consensus" or "pathology" ground truth is relevant for device performance.

8. The sample size for the training set

This is not applicable as there is no machine learning or AI component to this device, and thus no "training set."

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

This is not applicable as there is no training set.

Summary of available information:

The 510(k) summary indicates that the QUADROX-i Small Adult Microporous Membrane Oxygenator was subjected to non-clinical testing to demonstrate substantial equivalence to predicate devices and adherence to relevant ISO standards, specifically:

ISO 10993-1: Biologic Evaluation of Medical Devices
ISO 7199:1996: Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators)
ISO 15675:2001: Cardiovascular implants and artificial organs – Cardiopulmonary Bypass – Arterial line blood filters

The testing covered:

Integrity
Performance (general, no specific metrics provided)
Biocompatibility
Sterility

The document explicitly states that the device "met the requirements" of these standards. However, the specific values, acceptance criteria thresholds, or detailed study results are not elaborated upon in this 510(k) summary.

Summary

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K040 689

MAQUET

OCT 2 9 2009

510 (K) Summary [as required by 21 CFR 807.92(c) ]

Submitter:

MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germany

Contact Person:

�

Dr. Ingrid Richter Phone: +49 7478 921-337 Fax: +49 7478 921-400 E-mail: ingrid.richter@maquet-cp.com

Date Prepared:

March 10, 2009

Device Trade Name:

Common/Usual name:

Classification names:

Predicate Devices:

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

Oxygenator with integrated heat exchanger and optional integrated arterial filter

Oxygenator, cardiopulmonary bypass Heat Exchanger, cardiopulmonary bypass Filter, blood, cardiopulmonary bypass, arterial line

QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (art. code HMO 70000/71000), K082117, manufactured by MAQUET Cardiopulmonary AG Quart Arterial Filter (art.code HBF 140), K001787 by MAQUET Cardiopulmonary AG and Capiox Fiber RX15 Hollow Oxygenator with/without Hardshell Reservoir with X-Coating from Terumo Cardiovascular Systems Corp., K051997

Device Description:

The QUADROX-i Small Adult is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.

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MAQUET

The QUADROX-i Small Adult may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136).

Indications for Use:

The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/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 µm. The device's utilization period is limited to six hours. The oxygenator is suitable for the 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.

Statement of Technical Comparison:

The QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating is well comparable to the QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (art. code HMO 70000/71000), K082117, manufactured by MAQUET Cardiopulmonary AG regarding the design, principals of operation, biocompatibility and performance as well as regarding the Softline coating, the only difference is the size. It is also comparable to Capiox RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir with X-Coating from Terumo Cardiovascular Systems Corp., K051997, regarding intended use, as well as to the Quart Arterial Filter as related to the filter part.

Non-clinical Testing:

The QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating has been tested to and met the requirements of ISO 10993-1 Biologic Evaluation of Medical Devices as well as the requirements of ISO 7199: 1996 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators) as well as the requirements of ISO 15675: 2001 "Cardiovascular implants and artificial organs – Cardiopulmonary Bypass – Arterial line blood filters".

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MAQUET

Determination of Substantial Equivalence

Testing and evaluation on safety and effectiveness was executed to demonstrate that the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating described in this submission is substantially equivalent to Capiox RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir with X-Coating from Terumo Cardiovascular Systems Corp., K051997, as related to the intended use, as well as to the Quart Arterial Filter (HBF 140), K001787, as related to the filter part.

It is also comparable to the QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (art. code HMO 70000/71000), K082117 regarding the constructional principle as well as the coating.

The following areas have been tested:

Integrity
Performance
Biocompatibility
Sterility

Conclusion

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

OCT 2 9 2009

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

Re: K090689

QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating Regulation Number: 21 CFR 870.4350 Regulation Name: Oxygenator, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DTZ Dated: October 16, 2009 Received: October 19, 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/CDRH/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 vours,

$\kappa/\omega$

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): K090689

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

Indications for Use: .

The oxygenator is suitable for the 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.

Over-The-Counter Use Prescription 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)

tinyascular Devices

510(K) in.

09 0689

Page 1 of 1

(Posted November 13, 2003)

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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.”