MECC SET WITH BIOLINE COATING

K083794 · Maquet Cardiopulmonary, AG · KFM · Apr 21, 2009 · Cardiovascular

Device Facts

• Record ID: K083794
• Device Name: MECC SET WITH BIOLINE COATING
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: KFM · Cardiovascular
• Decision Date: Apr 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MECC Set with Bioline 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 necessary for open surgical procedures on the aorta or vena cava.

Device Story

MECC Set with Bioline Coating is a minimized extracorporeal circulation system; utilizes non-roller pump technology to circulate blood through extracorporeal circuit; includes oxygenator for cardiopulmonary bypass; intended for use during open heart, great vessel, aorta, or vena cava surgeries; operated by clinical staff in surgical settings; provides temporary circulatory support; Bioline coating applied to components to improve biocompatibility; device customizable for specific clinical needs; benefits include minimized circuit volume compared to traditional bypass systems.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparisons to predicate devices.

Technological Characteristics

Minimized extracorporeal circuit; non-roller blood pump; Bioline coating on components; customizable configuration; intended for <6 hours 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 <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

• HLM Tubing Sets with Bioline Coating (K080592)
• Jostra MECC System (K023132)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

March 11, 2016

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

Re: K083794

Trade/Device Name: MECC Set with Bioline Coating Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-Type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class II Product Code: KFM Dated: April 3, 2009 Received: April 7, 2009

Dear Ms. Schwenkglenks:

This letter corrects our substantially equivalent letter of April 21, 2009.

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.

{1}------------------------------------------------

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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Eric E. Richardson -S

Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K083794

Device Name

MECC Set with Bioline Coating

Indications for Use (Describe)

The MECC Set with Bioline 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 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# Special 510(k): Device Modification MECC SET 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: | December 18, 2008 |
| DEVICE TRADE NAME: | MECC SET with Bioline·Coating |
| COMMON/USUAL NAME | Minimized Extracorporeal Circulation<br>System |
| CLASSIFICATION NAMES | Cardiopulmonary<br>Bypass<br>Vascular<br>Catheter, Cannula, or Tubing;<br>Cardiopulmonary Bypass Adaptor,<br>Stopcock, Manifold, or Fitting;<br>Pump, Blood, Cardiopulmonary Bypass,<br>Non-Roller Type. |

Maquet Cardiopulmonary AG, Hirrlingen, Germany

510(k) Summary – Page 1 of 3

{4}------------------------------------------------

# PREDICATE DEVICES OR LEGALLY MARKETED DEVICES

HLM Tubing Sets with Bioline Coating (K080592) Jostra MECC System (K023132)

### INDICATONS FOR USE STATEMENT

The MECC SET with Bioline 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 modified MECC SET with Bioline Coating follows. the same concept of a minimized extracorporeal circuit as the Jostra MECC System (K023132) that is, the same operational principles and clinical application, benefits for the patient and risks during clinical application are comparable.

Maquet Cardiopulmonary AG, Hirrlingen, Germany

510(k) Summary - Page 2 of 3

{5}------------------------------------------------

The MECC SET with Bioline Coating corresponds to the HLM Tubing Set with Bioline Coating (K080592) with regards to the Bioline Coating of the components and with regards to the aspect that the MECC SET may be customized for the convenience of the customer.

# DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Evaluation on safety and effectiveness was executed to demonstrate that the MECC SET with Bioline Coating described in this submission is substantially equivalent to the HLM-Tubing Set with Bioline Coating with regards to the Bioline Coating and customization and to the Jostra MECC System with regards to the principles of a minimal extracorporeal circuit and its application.

### CONCLUSION

The data given demonstrate that the MECC Set with Bioline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.

Maquet Cardiopulmonary AG, Hirrlingen, Germany

510(k) Summary - Page 3 of 3