LIFEBRIDGE B2T, MODEL 7001

K090006 · Lifebridge Medizintechnik AG · DTQ · Oct 15, 2009 · Cardiovascular

Device Facts

• Record ID: K090006
• Device Name: LIFEBRIDGE B2T, MODEL 7001
• Applicant: Lifebridge Medizintechnik AG
• Product Code: DTQ · Cardiovascular
• Decision Date: Oct 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LIFEBRIDGE B2T System is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support. The device is to be operated by trained personnel under the supervision of a physician.

Device Story

LIFEBRIDGE B2T is a compact, modular cardiopulmonary support system. Input: extracorporeal blood flow. Components: patient module (reservoir, centrifugal pump, oxygenator, arterial filter, air management, tubing); sensors (flow, pressure, level, bubble); control module (electronics, UI); base module (touch screen, power). Operation: system monitors parameters via sensors; provides extracorporeal circulation/oxygenation. Used in clinical settings by trained personnel under physician supervision. Output: real-time system parameters on touch screen. Benefit: provides temporary cardiac/pulmonary support.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modular cardiopulmonary bypass system. Components: centrifugal pump, oxygenator, arterial filter, reservoir, tubing, and sensors (flow, pressure, level, bubble). Connectivity: integrated touch screen interface. Power: main power connection via base module. Sterilization: components are previously cleared devices. Software: embedded control electronics for system monitoring.

Indications for Use

Indicated for patients requiring short-term (≤6 hours) cardiac and/or pulmonary support via extracorporeal blood oxygenation.

Regulatory Classification

Identification

A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

Predicate Devices

• Bard (CPS) Cardiopulmonary Support System (K892664)
• Medtronic Performer CPB and Resting Heart System (K031700)
• Medtronic Performer CPB and Resting Heart System (K052555)
• Jostra MECC System (K023132)
• Jostra HL-20 Integrated Perfusion System (K943803)
• RotaFlow Centrifugal Pump system (K991864)

Submission Summary (Full Text)

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LifeBridge B2T 510(k)

KO900006

# OCT 1 5 2009

510(k) Summary

SUBMITTER:

LIFEBRIDGE® Medizintechnik AG Simon-Ohm-Str 1 84539 Ampfing Germany

CONTACT PERSON:

Kathleen Johnson Medical Device Approvals, Inc. Phone: [phone] Fax: [phone] Mobile: [phone]

May 5, 2009 DATE PREPARED:

DEVICE TRADE NAME: LIFEBRIDGE B2T® SYSTEM

COMMON/USUAL NAME: Cardiopulmonary Support System

CLASSIFICATION NAMES:

Cardiopulmonary bypass heart/lung machine console (21 CFR 870.4220) Non-roller type cardiopulmonary bypass blood pump (21 CFR 870.4360) Cardiopulmonary bypass vascular catheter, cannulae, or tubing (21 CFR 870.4210) Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting (21 CFR 870.4290) Cardiopulmonary bypass blood reservoir (21 CFR 870.4400) Cardiopulmonary bypass pump speed control (21 CFR 870.4380) Cardiopulmonary bypass oxygenator (21 CFR 870.4350) Cardiopulmonary bypass heat exchanger (21 CFR 870.4240) Cardiopulmonary bypass arterial line blood filter (21 CFR 870.4260) Cardiopulmonary bypass level sensing monitor and/or control (21 CFR 870.4340) Cardiopulmonary bypass bubble detector (21 CFR 870.4205)

## PREDICATE DEVICES:

Bard (CPS) Cardiopulmonary Support System (K892664) Medtronic Performer CPB and Resting Heart System (K031700, K05255) Jostra MECC System (K023132) Jostra HL-20 Integrated Perfusion System (K943803) RotaFlow Centrifugal Pump system (K991864)

DEVICE DESCRIPTION:

The LIFEBRIDGE B2T SYSTEM is a compact, pre-assembled, modular system consisting of:

1. Patient module housing an extracorporeal circuit comprised of several previously 510k-cleared devices. The circuit includes a rigid reservoir bag, a centrifugal pump, oxygenator, arterial filter, active air management system, tubing and connectors.

2. Sensors, including flow, pressure, level and bubble to read system parameters.

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3. Control module that contains the electronics and user interface.

4. Base module that contains a touch screen, the main power connection and acts as a stable frame for the system.

The following LIFEBRIDGE ByT SYSTEM components have been previously 510(k)-cleared for use in cardiopulmonary bypass: oxygenator, arterial filter, centrifugal pump, level sensors, and bubble detector.

#### INDICATIONS FOR USE:

The LIFEBRIDGE B>T SYSTEM is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support. The device is to be operated by trained personnel under the supervision of a physician.

#### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:

The LIFEBRIDGE B-T SYSTEM is comprised of standard cardiopulmonary bypass components packaged into a modular, user-friendly system. The technological characteristics of the device are equivalent to traditional cardiopulmonary circulatory support systems. The LIFEBRIDGE B2T SYSTEM is substantially equivalent to the Bard (CPS) Cardiopulmonary Support System (K892664), Medtronic Performer CPB and Resting Heart System (K031700, K052555), and Jostra MECC System (K023132), in that all are indicated for use as cardiopulmonary support systems for periods up to six hours, and share equivalent technological characteristics. All of the devices incorporate previously 510(k)-cleared cardiopulmonary bypass components into a preassembled, optimally-sized system.

Non-clinical tests performed on the LIFEBRIDGE B2T SYSTEM provide evidence of the safety and effectiveness of the device for its intended use.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

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

OCT 1 5 2009

LIFEBRIDGE Medizinetechnik AG c/o Medical Device Approvals, Inc. Ms. Kathlecn Johnson 1282 Round Hill Rd. Bryn Mawr, PA 19010

Re: K090006

Trade/Device Name: LIFEBRIDGE B2T System Regulation Number: 21 CFR 870.4220 Regulation Name: Console, Heart-Lung Machine, Cardiopulmonary bypass Regulatory Class: Class II Product Code: DTQ Dated: October 2, 2009 Received: October 5, 2009

Dear Ms Johnson:

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.

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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 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 go to http://www.fda.gov/AboutFDA/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Duma R. bacher

- 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): KO90000

Device Name: LIFEBRIDGE B2T System

Indications For Use:

The LIFEBRIDGE B2T System is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

unna D.V.chner

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0020

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K 09006

Confidential

12/30/2008