The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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.

Device Description

The Quadrox D Safeline 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 heartlung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Safeline 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 Safeline Diffusion Membrane Oxygenator is a model of the Quadrox Safeline Hollow Fiber Membrane Oxygenator. In contrast to the Quadrox, a tight diffusive membrane instead of a microporous membrane is used for the gas exchange.

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 diffusive membrane has the same outer diameter as the open-pored membrane. The outer diameters are 1.8 m² gas exchange surface and 0.6 m² heat exchanger surface available.

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

The complete construction, priming volume and the connections are the same for the Quadrox D Safeline as well as for the Quadrox Safeline Oxygenator.

It may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to Jostra Quadrox Safeline Oxygenator (K992559). The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator will be provided with a Jostra Manifold Sampling Line.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Integrity	Met requirements via testing
Performance	Met requirements via testing; comparable to predicate device performance (Quadrox Safeline Oxygenator)
Stability of the Coating	Met requirements via testing
Biocompatibility	Met requirements via testing, specifically ISO 10993-1
Sterility	Met requirements via testing
Regulatory Standards Compliance	Met requirements of ISO 7199: 1996 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators)"
Substantial Equivalence	Concluded to be substantially equivalent to the predicate device, Jostra Quadrox Safeline Membrane Oxygenator

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

The document does not specify a distinct "test set" sample size in terms of patient data or clinical trials. The testing appears to be primarily engineering and bench testing, focused on verifying the device's physical and functional properties. The data provenance is internal testing performed by Maquet Cardiopulmonary AG ("Non-clinical Testing"). There is no mention of country of origin for specific data or whether it was retrospective or prospective.

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

There is no information provided about experts establishing ground truth for a test set. This type of device evaluation relies on objective measurements against established engineering and biological standards (e.g., ISO standards), rather than expert consensus on a "ground truth" derived from clinical cases.

4. Adjudication Method for the Test Set

Not applicable. The evaluation is based on meeting pre-defined standards and specifications through testing, not on adjudicated clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative medical devices where human readers play a critical role in diagnosis or assessment (e.g., radiology AI). The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is a life-support device, and its performance is evaluated through engineering and biocompatibility testing.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the testing described appears to be for the standalone device's performance. The "Non-clinical Testing" section states that the device was tested to meet specific ISO standards and for various performance aspects (integrity, performance, stability, biocompatibility, sterility). This refers to the device's inherent functional characteristics, not its performance in conjunction with a human operator.

7. Type of Ground Truth Used

The "ground truth" for this device evaluation is established by international consensus standards (ISO 10993-1 and ISO 7199:1996) and the performance characteristics of the legally marketed predicate device (Jostra Quadrox Safeline Oxygenator). The goal of the testing was to demonstrate that the new device meets these established benchmarks and is "substantially equivalent" to an existing, approved device.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The device's design and manufacturing process would involve extensive engineering development and testing, but these are not described as "training sets" for an AI model.

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

Not applicable, as there is no "training set" for an AI/ML algorithm.

Summary

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K061628
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AUG 2 2 2006

MAQUET

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

Submitter:	Maquet Cardiopulmonary AGHechinger Strasse 3872145 HirrlingenGermany
Contact Person:	James ColliePhone: 215-491-5245Fax: 215-491-5942E-mail: jrcollie@msn.com
Date Prepared:	June 09, 2006
Device Trade Name:	Jostra Quadrox D Safeline Diffusion MembraneOxygenator
Common/Usual name:	Quadrox D
Classification names:	Oxygenator, cardiopulmonary bypassHeat Exchanger, cardiopulmonary bypass
Predicate Devices:	Jostra Quadrox Safeline Hollow Fiber MembraneOxygenator (K992559, K030264)

Device Description:

The Quadrox D Safeline 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 diffusive membrane has the same outer diameter as the open-pored membrane. The outer diameters are 1.8 m² gas exchange surface and 0.6 m² heat exchanger surface available.

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

The complete construction, priming volume and the connections are the same for the Quadrox D Safeline as well as for the Quadrox Safeline Oxygenator.

Indications for Use:

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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.

Statement of Technical Comparison:

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator has the same intended use, design, principals of operation, and performance as the Jostra Quadrox Safeline Oxygenator. The only difference is that the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator uses a tight diffusive membrane instead of a microporous membrane for the gas exchange.

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KC61628
Page 3 of 3

MAQUET

Non-clinical Testing:

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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).

Determination of Substantial Equivalence

Testing and evaluation on safety and effectiveness was executed to demonstrate that the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator described in this submission is substantially equivalent to the Jostra Quadrox Safeline 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 Safeline Diffusion Membrane Oxygenator is substantially equivalent to the named predicate device which holds currently market clearance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2006

Maquet Cardiopulmonary AG c/o Mr. James R. Collie J.R. Collie Associates, Inc. 414 Maryjoe Way Warrington, PA 18976

Re: K061628

Quadrox D Safeline Diffusion Membrane Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: August 7, 2006 Received: August 8, 2006

Dear Mr. Collie:

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 haft or bin 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. James R. Collie

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I DTC issuazes or our device complies with other requirements of the Act that I DA has made a detel masulations administered by other Federal agencies. You must of any I catal stutures and registments, including, but not limited to: registration and listing (21 comply with an the 10t 3 requirements)01); good manufacturing practice requirements as set CITY art 607); laboring (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This letter will anow you to begin mailioning of substantial equivalence of your device to a legally promatics notification: "The PDF interessification 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 If you desire specific at not 10. Jose (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Comphance as (21 transmit (21CFR Part 807.97). You may obtain Milsolalling of Yelerone to premainsnibilities under the Act from the Division of Small other general information on your response in its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zudkerman M

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Jostra Quadrox D Safeline Diffusion Membrane Oxygenator_

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)

(Division Sign-Off)
Division of card

510(k) Number K061625

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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.”