The Rotaflow Centrifygal Pump is a device that uses a method other to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

· Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

· Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Device Description

The Jostra RotaFlow Centrifugal Pump with Safeline Coating is a sterile, nonpyrogenic device for single use only and is not to be re-sterilized by the user.

The RotaFlow Centrifugal Pump with Safeline Coating is indicated as a component of the extracorporeal circuit and is intended to be used exclusively in conjunction with the RotaFlow-Console, the RotaFlow Drive Unit and the RotaFlow Emergency Drive. The device is not designed or intended for use except as indicated. The centrifugal pump is indicated for single use as a pump for up to 6 hrs.

The RotaFlow is a blood pump that functions on the basis of the centrifugal principle, whereas the drive is based on a magnetic system. A sapphire ball and a PE calotte guarantee low friction bearing.

The centrifugal pump has a spinning rotor with flow channels which impart rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The Rotor is shrouded. It forms the flow channels with 4 fan-shaped members. The flow is guided from the center of the pump to the periphery of the pump, where it is then forced into the flow channel by means of a spiral flow channel the cross-section of which increases in the direction of flow. The RotaFlow Centrifugal Pump allows for pulsatile and non-pulsatile flow.

The RotaFlow Centrifugal Pump comes with an integrated flow probe connector.

The design principle minimizes blood traumatization and stress with optimum flow guidance. Additionally, the pump design results in no stagnant blood zones and a small priming volume of 32 ml which allows for minimal mean transit time (MTT).

AI/ML Overview

This document is a 510(k) premarket notification for the RotaFlow Centrifugal Pump System with Safeline Coating, seeking substantial equivalence to existing predicate devices. It describes the device, its indications for use, and the studies conducted to support its safety and effectiveness.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes areas of evaluation and general findings to demonstrate substantial equivalence to predicate devices. The "reported device performance" is descriptive rather than numerical against predefined criteria.

Acceptance Criteria Category (Inferred)	Reported Device Performance (Description)
Integrity of the RotaFlow	Tested and/or evaluated to ensure structural soundness.
Performance of the RotaFlow	Tested and/or evaluated to ensure functional characteristics comparable to predicate.
Stability of the Coating	Tested and/or evaluated to confirm the Safeline coating remains intact and effective.
Biocompatibility	Tested and/or evaluated to demonstrate safety for contact with blood, similar to the predicate Quadrox Safeline Oxygenator (K992559).
Sterility	Tested and/or evaluated, indicating the device is sterile and non-pyrogenic.
Indications for Use (Equivalence)	Demonstrated to be the same as the predicate devices.
Materials, Components, Design (Equivalence)	Stated to be the same as the predicate devices, with the exception of the Safeline coating.
Functional Characteristics (Equivalence)	Stated to be the same as the predicate devices.
Blood Traumatization and Stress	Minimized due to the design principle, with optimum flow guidance.
Stagnant Blood Zones	No stagnant blood zones due to pump design.
Priming Volume	Small priming volume of 32 ml, allowing for minimal mean transit time.

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

The document does not provide specific sample sizes for any of the tests conducted (e.g., integrity, performance, stability, biocompatibility, sterility). It simply states that these areas "have been tested and / or evaluated."

The "data provenance" is not explicitly mentioned regarding country of origin or whether the studies were retrospective or prospective. Given it's a premarket notification for a medical device manufactured by Maquet Cardiopulmonary AG in Germany, it's highly probable the testing was conducted in Germany or by its designated contract research organizations. The nature of the tests (integrity, performance, biocompatibility, sterility) suggests prospective laboratory testing.

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

This document does not describe studies that require expert-established ground truth in the way clinical diagnostic AI studies do. The tests performed are engineering and biological validations (e.g., device integrity, coating stability, biocompatibility, sterility). These typically rely on standardized test methods and laboratory measurements rather than expert consensus on diagnostic interpretations. Therefore, this information is not applicable to this document.

4. Adjudication Method for the Test Set

As the tests described are primarily objective engineering and biological assessments rather than diagnostic interpretations, an "adjudication method" in the context of expert review (e.g., 2+1, 3+1) is not applicable. The methods would involve analytical techniques and comparisons to engineering specifications or biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document describes a traditional medical device (a centrifugal blood pump), not an AI/CADe/CADx system that would typically involve human readers or MRMC studies. Therefore, this information is not applicable.

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

No. This device is a physical medical device (a blood pump), not an algorithm. Therefore, this information is not applicable.

7. The Type of Ground Truth Used

For the various tests conducted:

Integrity and Performance: Ground truth would likely be established based on engineering specifications, physical measurements, and functional testing against design requirements.
Stability of the Coating: Ground truth would be defined by pre-defined chemical and physical stability profiles of the Safeline coating.
Biocompatibility: Ground truth is established by recognized international standards for biocompatibility (e.g., ISO 10993 series) and comparison to the biocompatibility data of the predicate Quadrox Safeline Oxygenator.
Sterility: Ground truth is established by validation to comply with established sterility assurance levels (e.g., ISO 11135, ISO 11137).

8. The Sample Size for the Training Set

This document describes a physical medical device, not a machine learning algorithm. Therefore, the concept of a "training set" is not applicable.

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

As the concept of a "training set" does not apply to this physical device, this information is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2016

Maquet Cardiopulmonary AG c/o Katrin Schwenkglenks Hechinger Strasse 38 Hirrlingen, Germany 72145

Re: K061072

Trade/Device Name: RotaFlow Centrifugal Pump System with Safeline Coating Regulation Number: 21 CFR 870.4360 Regulation Name: Non-Roller Type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class II Product Code: KFM Dated: April 7, 2006 Received: April 17, 2006

Dear Ms. Schwenkglenks:

This letter corrects our substantially equivalent letter of May 23, 2006.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Ms. Katrin Schwenkglenks

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Eric E. Richardson -S

For 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) K061072

Device Name

Rotaflow Centrifugal Pump with Safeline

Indications for Use (Describe)

The Rotaflow Centrifygal Pump is a device that uses a method other to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

· Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

· Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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QUET

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

Submitter:	Maquet Cardiopulmonary AGHechinger Strasse 3872145 HirrlingenGermany
Contact Person:	Katrin SchwenkglenksPhone: +49 7478 921-151Fax: +49 7478 921-400E-mail: katrin.schwenkglenks@maquet-cp.com
Date Prepared:	April 07, 2006
Device Trade Name:	RotaFlow Centrifugal Pump with Safeline Coating
Common/Usuai Name:	Centrifugal pump, coated
Classification Names:	Pump, blood, non-roller-type, cardiopulmonary;(21 CFR 870.4360, product code: KFM)
Predicate Devices:	RotaFlow Centrifugal Pump (K991864)Quadrox Hollow Fiber Membrane OxgenatorSafeline (K992559, K030264)

Device Description

The Jostra RotaFlow Centrifugal Pump with Safeline Coating is a sterile, nonpyrogenic device for single use only and is not to be re-sterilized by the user.

The RotaFlow Centrifugal Pump comes with an integrated flow probe connector.

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MAQUET

Indications for Use:

The Jostra RotaFlow Centrifuqal Pump with Safeline Coating is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Statement of Technical Characteristics Comparison

The two devices differ in that the blood contacting surfaces of the Jostra RotaFlow Centrifugal Pump with Safeline Coating has been treated with the Safeline Coating. Otherwise, indications for use, materials, components, design, performance characteristics and sterilization for the two devices are the same. The safety of the Safeline Coating has been shown with the Quadrox Safeline Oxygenator (K992559). Due to equivalence of indications for use, materials, design and functional characteristics, the device raises no new safety or effectiveness issues.

Determination of Substantial Equivalence

Evaluation and testing on safety and effectiveness was executed to demonstrate that the Jostra RotaFlow Centrifugal Pump with Safeline Coating described in this submission is substantially equivalent to the Jostra RotaFlow Centrifugal Pump as a pump and to the Quadrox Safeline Hollow Fiber Membrane Oxygenator regarding the Safeline coating.

The following areas have been tested and / or evaluated:

Integrity of the RotaFlow ●
Performance of the RotaFlow .
Stability of the Coating ●
Biocompatibility .
. Sterility

Conclusion

The data given demonstrate that the Jostra RotaFlow Centrifugal Pump with Safeline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.