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 RotaFlow Centrifugal Pump is 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.

The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

AI/ML Overview

This document is a 510(k) premarket notification summary for the RotaFlow Centrifugal Pump with Bioline Coating. It focuses on demonstrating substantial equivalence to pre-existing devices. This type of regulatory submission does not contain the detailed study results and acceptance criteria typically used to prove a device meets specific performance metrics in the way a clinical study for a novel diagnostic or treatment would.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the manner you've requested for a device that involved clinical performance testing with metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here are based on demonstrating that the new device (with Bioline coating) performs similarly to the predicate devices and meets relevant safety standards (integrity, performance, biocompatibility, sterility) for a medical device of its class.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations:

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

As explained above, this document describes a special 510(k) for a coating modification. The "acceptance criteria" are implied to be substantial equivalence to predicate devices regarding safety and effectiveness, demonstrated through evaluation of integrity, performance, biocompatibility, and sterility. The document does not provide quantitative performance metrics or a detailed acceptance criteria table as might be found in a clinical trial report.

Performance Area	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Integrity	Similar to predicate devices (RotaFlow with Safeline Coating).	Evaluated. Conclusion: Substantially equivalent. (Specific data not provided in summary.)
Performance	Similar to predicate devices (RotaFlow with Safeline Coating).	Evaluated. Conclusion: Substantially equivalent. (Specific data not provided in summary.)
Biocompatibility	Appropriate for a device with Bioline coating, similar to Quadrox D Diffusion Membrane Oxygenator with Bioline Coating.	Evaluated. Conclusion: Substantially equivalent. (Specific data not provided in summary.)
Sterility	Achieves sterility similar to predicate devices.	Evaluated. Conclusion: Substantially equivalent. (Specific data not provided in summary.)
Functional Equivalence	Shares the same design, intended use, method of operation, components, packaging, and fundamental scientific technology as the RotaFlow Centrifugal Pump with Safeline Coating, except for the coating.	The RotaFlow Centrifugal Pump with Bioline Coating is identical to the RotaFlow Centrifugal Pump with Safeline Coating with the only exception that it has been coated with Bioline Coating. This coating is the same as with the Quadrox D Diffusion Membrane Oxygenator with Bioline.

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

The document does not specify a "test set" sample size in the context of clinical or diagnostic performance. The evaluations mentioned (integrity, performance, biocompatibility, sterility) would typically involve laboratory testing. The provenance of this data (e.g., country of origin, retrospective/prospective) is not provided in this summary.

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

This type of information is not relevant to a 510(k) submission for a device change related to a coating, particularly when the submission focuses on substantial equivalence through non-clinical testing (integrity, performance, biocompatibility, sterility). There isn't a "ground truth" established by human experts in the context of a diagnostic test set described here.

4. Adjudication method for the test set

Not applicable for this type of submission.

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

Not applicable. This device is a medical pump, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a mechanical pump, not an algorithm.

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

For the evaluations of integrity, performance, biocompatibility, and sterility, the "ground truth" would be established by validated scientific methodologies and standards relevant to each of these areas (e.g., ISO standards for biocompatibility, engineering specifications for integrity and performance, validated sterilization methods). It does not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would.

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.

Summary

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

June 17, 2016

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

Re: K080470

Trade/Device Name: RotaFlow Centrifugal Pump System with Bioline Coating Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller Type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class II Product Code: KFM Dated: August 29, 2008 Received: September 4, 2008

Dear Ms. Schwenkglenks:

This letter corrects our substantially equivalent letter of September 12, 2008.

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.

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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 ); 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/dcfault.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) K080470

Device Name

ROTAFLOW Centrifugal Pump with BIOLINE Coating

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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Special 510(k): Device Modification: RotaFlow Centrifugal Pump with Bioline Coating

510(k) SUMMARY

SUBMITTER:	Maquet Cardiopulmonary AGHechinger Strasse 3872145 Hirrlingen, Germany
CONTACT PERSON:	Katrin SchwenkglenksPhone: (011) 49 7478 921-151Fax: (011) 49 7478 921-400
DATE PREPARED:	February 08, 2008
DEVICE TRADE NAME:	RotaFlow Centrifugal Pump with Bioline Coating
COMMON/USUAL NAME	Centrifugal Pump
CLASSIFICATION NAME	Pump, Blood, Non-roller type, Cardiopulmonary
PREDICATE DEVICES OR LEGALLYMARKETED DEVICES	RotaFlow Centrifugal Pump with SafelineCoatingQuadrox D Diffusion Membrane Oxygenator withBioline Coating

DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT

(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.

The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

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STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The RotaFlow Centrifugal Pump with Bioline Coating is identical to the RotaFlow Centrifugal Pump with Safeline Coating with the only exceception that the RotaFlow Centrifugal Pump with Bioline Coating has been coated with Bioline Coating is the same as with the Quadrox D Diffusion Membrane Oxygenator with Bioline. Besides this difference the both RotaFlow Centrifugal Pumps are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Evaluation on safety and effectiveness was executed to demonstrate that the RotaFlow Centrifugal Pump with Bioline Coating described in this submission is substantially equivalent to the RotaFlow Centrifugal Pump with Safeline Coating as a centrifugal pump and to the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the Bioline Coating.

The following areas have been evaluated:

Integrity -
-Performance
Biocompatibility -
-Sterilitv

Conclusion

The data given demonstrate that the RotaFlow Centrifugal Pump with Bioline 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.