ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32

K080470 · Maquet Cardiopulmonary, AG · KFM · Sep 12, 2008 · Cardiovascular

Device Facts

• Record ID: K080470
• Device Name: ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: KFM · Cardiovascular
• Decision Date: Sep 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

Centrifugal blood pump for extracorporeal circulation; non-roller type. Operates by pumping blood through circuit during cardiac/vascular surgery. Features Bioline coating to improve surface properties. Used in clinical settings (OR) by trained medical professionals. Provides circulatory support during planned flow disruption or bypass. Benefits patient by maintaining perfusion during complex surgical procedures. Device design, operation, and components identical to predicate RotaFlow pump, differing only by the addition of Bioline coating.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing including integrity, performance, biocompatibility, and sterility evaluations.

Technological Characteristics

Non-roller centrifugal blood pump. Features Bioline surface coating. Identical design and fundamental scientific technology to predicate RotaFlow pump. Sterilized device for extracorporeal use.

Indications for Use

Indicated for patients undergoing open surgical procedures on the heart, great vessels, aorta, or vena cava requiring full or partial cardiopulmonary bypass or temporary circulatory bypass for periods < 6 hours.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• RotaFlow Centrifugal Pump with Safeline Coating
• Quadrox D Diffusion Membrane Oxygenator with Bioline Coating

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 AG<br>Hechinger Strasse 38<br>72145 Hirrlingen, Germany |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Katrin Schwenkglenks<br>Phone: [phone]<br>Fax: [phone] |
| 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 LEGALLY<br>MARKETED DEVICES | RotaFlow Centrifugal Pump with Safeline<br>Coating<br>Quadrox D Diffusion Membrane Oxygenator with<br>Bioline Coating |

## DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT

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.

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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.