ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)

K090515 · Maquet Cardiopulmonary, AG · KFM · Dec 18, 2009 · Cardiovascular

Device Facts

• Record ID: K090515
• Device Name: ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: KFM · Cardiovascular
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RotaFlow Centrifugal Pump is indicated as a component of the extracorporeal circuit for pumping liquid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.

Device Story

RotaFlow Centrifugal Pump is a non-occlusive blood pump for extracorporeal circuits. Device features a spinning rotor with flow channels that imparts rotary motion to blood, directing it through a spiral housing to an outflow port. Used in conjunction with RotaFlow Console. Operates for a maximum duration of six hours. Intended for clinical use by healthcare professionals. Softline coating applied to internal surfaces to improve biocompatibility. Device functions as a mechanical pump to maintain blood flow during extracorporeal circulation.

Clinical Evidence

Bench testing only. Evaluation included integrity, performance, biocompatibility, and sterility testing to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Non-occlusive centrifugal blood pump; spinning rotor with flow channels; spiral housing; Softline biocompatible coating; non-roller type; intended for short-term use (up to 6 hours).

Indications for Use

Indicated for use as a component of an extracorporeal circuit for pumping blood in conjunction with the RotaFlow Console for a duration restricted to six 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 BIOLINE Coating (K080470)
• QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117)

Submission Summary (Full Text)

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K090515

MAQUET

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

DEC 1 8 2009

| Submitter | MAQUET Cardiopulmonary AG<br>Hechinger Strasse 38<br>72145 Hirrlingen<br>Germany |
|----------------|----------------------------------------------------------------------------------|
| Contact Person | Frank Moehrke |
| | Phone: [phone] |
| | Fax: [phone] |

Date Prepared February 24, 2009

Device Trade Name

C

Centrifugal Pump

Common/Usual Name

Classification Names

Nonroller-type cardiopulmonary bypass blood pump (21 CFR 870.4360 - Product Code: KFM)

Legally Marketed Devices .

- RotaFlow Centrifugal Pump with BIOLINE Coating (K080470),
RotaFlow Centrifugal Pump

with Softline Coating

- QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117)
#### Device Description

The RotaFlow Centrifugal Pump is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to incoming liquid, directing it through a spiral housing to the outflow port.

#### Indications for Use

The RotaFlow Centrifugal Pump is indicated as a.component of the extracorporeal circuit for pumping liguid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.

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# MAQUET

#### Statement of Technical Comparison

The RotaFlow Centrifugal Pump with Softline Coating is identical to the RotaFlow Centrifugal Pump with BIOLINE Coating with the only exception that the RotaFlow Centrifugal Pump with Softline Coating has been coated with Softline Coating instead of BIOLINE Coating. However, the Softline Coating is the same as with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating. Besides this difference the RotaFlow Centrifygal Pump with Softline Coating is the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the RotaFlow Centrifugal Pump with BIOLINE Coating.

#### Determination of Substantial Equivalence

Evaluation on safety and effectiveness was executed to demonstrate that the RotaFlow Centrifugal Pump with Softline Coating described in this submission is substantially equivalent to the RotaFlow Centrifugal Pump with BIOLINE Coating as pump and to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating regarding the Softline Coating.

The following areas have been evaluated:

- Integrity .
- Performance
- Biocompatibility .
- Sterility -

#### Conclusion

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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal 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 Room W-066-0609 Silver Spring, MD 20993-0002

Maquet Cardiopulmonary AG c/o Mr. Frank Moehrke Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirringen Germany

### DEC 1 8 2009

Re: K090515

> Maquet RotaFlow Centrifugal Pump with Softline Coating Model BO-RF-32 Regulation Number: 21 CFR 870.4360 Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Regulatory Class: Class III (three) Product Code: KFM Dated: November 23, 2009 Received: November 25, 2009

Dear Mr. Moehrke:

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 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 – Mr. Frank Moehrke

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 (OS) 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 go to http://www.fda.gov/AboutiFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ram D/Zuckerman, M.D. Directo 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): كاركار 09 0510

Device Name:

#### RotaFlow Centrifugal Pump with Softline Coating

Indications for Use:

The RotaFlow Centrifugal Pump is indicated as a component of the extracorporeal circuit for pumping liquid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign/Off)
Division of Cardiovascular Devices
510(k) Number K090513