The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is used for extracorporeal circulation during cardiopulmonary bypass in the field of openheart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

The application and use of the oxygenator is the sole responsibility of the attending physician.

Device Description

The Quadrox D Bioline is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.

In open heart surgery it is used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Bioline is therefore a component in the extracorporeal perfusion circulation system, for oxygenation of blood and removal of carbon dioxide. The utilization period of this device is restricted to six hours.

The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different. The new device comes with a Bioline coating, the already cleared device comes with the Safeline Coating.

With this diffusive membrane the gas exchange takes place by diffusion through the membrane wall. This membrane has no pores, therefore a passover of air bubbles or plasma leakage is not possible.

The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.

The Quadrox D Bioline may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to the Jostra Quadrox D Safeline (K061628).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device by demonstrating that the new device, with a different coating, performs comparably and meets relevant safety and performance standards. The acceptance criteria are implicit in the comparison to the predicate and adherence to specified international standards.

Acceptance Criteria Category	Specific Criteria (Implicit / Demonstrated)	Reported Device Performance
Design	Identical to predicate device (Jostra Quadrox D Safeline, K061628)	Device is "exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different."
Materials	Identical to predicate device (except for coating)	Device is "exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different."
Sterilization Process	Identical to predicate device	Device is "exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different."
Intended Use	Identical to predicate device	Device is "exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different."
Biological Safety	Meet requirements of ISO 10993-1 Biologic Evaluation of Medical Devices.	Device "has been tested to and met the requirements of ISO 10993-1 Biologic Evaluation of Medical Devices." Testing for "Biocompatibility" was conducted.
Performance	Meet requirements of ISO 7199: 1996 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators)". Comparable to predicate.	Device "has been tested to and met... the requirements of ISO 7199: 1996." "The performance data of the Quadrox D Safeline [predicate] are comparable with the performance data of the Quadrox Safeline Oxygenator." Testing for "Performance" was conducted.
Integrity	Device integrity maintained.	Testing for "Integrity" was conducted. (No specific quantifiable criteria provided in the text).
Coating Stability	The new Bioline coating demonstrates stability.	Testing for "Stability of the Coating" was conducted. (No specific quantifiable criteria provided in the text).
Sterility	Device is sterile.	Testing for "Sterility" was conducted. Device is described as "sterile and non-pyrogenic."

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

The document does not specify a distinct "test set" in terms of patient data or a specific number of devices. The evaluation appears to be based on laboratory testing of the device itself.

Sample Size: Not explicitly stated. The text refers to "testing and evaluation" of the device, likely involving multiple units to ensure reproducibility and statistical validity for the various integrity, performance, and biocompatibility tests.
Data Provenance: Not explicitly stated about country of origin. The study appears to be a non-clinical, benchtop, and laboratory-based evaluation conducted by the manufacturer (Maquet Cardiopulmonary AG, Germany). It is retrospective in the sense that it evaluates a final product against established standards.

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

This section is not applicable to this type of device submission. The "ground truth" for this device is not established by human experts interpreting data (like radiologists for imaging devices). Instead, the ground truth is defined by:

Established international performance standards (ISO 7199).
Established biological safety standards (ISO 10993-1).
The performance characteristics of the legally marketed predicate device.
The evaluation involves engineering and laboratory testing against these predefined objective standards.

4. Adjudication method for the test set

This is not applicable as there is no expert adjudication needed for this type of non-clinical, objective testing. The results of the tests are compared directly against the specified standards and the predicate device's performance.

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 is not applicable. This submission is for a medical device (oxygenator) used during open-heart surgery, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. This is not an algorithm or AI device.

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

The ground truth used for this device's evaluation is primarily:

International Standards: ISO 10993-1 (Biologic Evaluation of Medical Devices) and ISO 7199: 1996 ("Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators)").
Predicate Device Performance: The established and legally marketed performance data of the Jostra Quadrox D Safeline Hollow Fiber Membrane Oxygenator (K061628). The objective was to demonstrate comparable safety and effectiveness.

8. The sample size for the training set

This is not applicable. This type of device does not involve a "training set" in the context of machine learning or AI models.

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

This is not applicable. See point 8.

Summary

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K071774 MAQUET

JAN 2 3 2008

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

Submitter:	Maquet Cardiopulmonary AGHechinger Strasse 3872145 HirrlingenGermany
Contact Person:	Katrin Schwenkglenks
	Phone: +49 7478 921-151
	Fax: +49 7478 921-400
	E-mail: katrin.schwenkglenks@maquet-cp.com
Date Prepared:	June 22, 2007
Device Trade Name:	Jostra Quadrox D Diffusion MembraneOxygenator with Bioline Coating
Common/Usual name:	Quadrox D Bioline
Classification names:	Oxygenator, cardiopulmonary bypassHeat Exchanger, cardiopulmonary bypass
Predicate Device:	Jostra Quadrox D Safeline Hollow FiberMembrane Oxygenator (K061628)

Device Description:

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

The Quadrox D Bioline is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.

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MAQUET

With this diffusive membrane the gas exchange takes place by diffusion through the membrane wall. This membrane has no pores, therefore a passover of air bubbles or plasma leakage is not possible.

The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.

The Quadrox D Bioline may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to the Jostra Quadrox D Safeline (K061628).

Indications for Use:

The Membrane Oxygenator Jostra Quadrox D is used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours. The application and use of the oxygenator is the sole responsibility of the attending physician.

Statement of Technical Comparison:

The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating has the same intended use, design, principals of operation, and performance as the Jostra Quadrox D Safeline Oxygenator. Only difference is that the new device comes with a Bioline coating, the already cleared device comes with the Safeline Coating.

Non-clinical Testing:

The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline 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).

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MAQUET

Determination of Substantial Equivalence

Testing and evaluation on safety and effectiveness was executed to demonstrate that the Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating described in this submission is substantially equivalent to the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator.

The following areas have been tested:

Integrity
Performance
Stability of the Coating
Biocompatibility
Sterility

Conclusion

The data given demonstrate that the Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is substantially equivalent to the named predicate device which holds currently market clearance.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

JAN 2 3 2008

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany

Re: K071774

Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating Regulation Number: 21 CFR 870.43500 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: January 14, 2008 Received: January 18, 2008

Dear Ms. Schwenkglenks:

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 – Ms. Katrin Schwenkglenks

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 yours,

Dana R. bochner

ABram 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): ¸¼០ገ | 774

Device Name: Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating Coating ______________________________________________________________________________________________________________________________________________________________

Indications for Use:

The application and use of the oxygenator is the sole responsibility of the attending physician.

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. Vales

Page 1 of 1

Division of Cardiovascular Devices

(Division Sign-Off

510(k) Number_K02) 774

(Posted November 13, 2003)

Confidential

033

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.”