LIFEBRIDGE

K103357 · Lifebridge Medizintechnik AG · KFM · Dec 27, 2010 · Cardiovascular

Device Facts

• Record ID: K103357
• Device Name: LIFEBRIDGE
• Applicant: Lifebridge Medizintechnik AG
• Product Code: KFM · Cardiovascular
• Decision Date: Dec 27, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LIFEBRIDGE 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.

Device Story

LIFEBRIDGE SYSTEM is a compact, modular cardiopulmonary support system. Input: extracorporeal blood flow. Components: patient module (rigid reservoir, centrifugal pump, oxygenator, arterial filter, active air management, tubing), sensors (flow, pressure, level, bubble), control module (electronics, UI), and base module (touch screen, power). Operation: system provides extracorporeal blood oxygenation for short-term cardiac/pulmonary support. Modification: replacement of BioCor 200 oxygenator with Medtronic Affinity NT oxygenator (with Carmeda BioActive or Trillium Biopassive surface coating). Used in clinical settings for temporary support. Healthcare providers monitor system parameters via the touch screen interface to manage patient support. Benefits: provides temporary life support for patients in acute cardiac or pulmonary distress.

Clinical Evidence

Bench testing only. Performance testing was conducted to validate mitigations for the oxygenator change and to ensure the modified patient module is safe and performs equivalently to the original.

Technological Characteristics

Modular system; hollow fiber membrane oxygenator; centrifugal pump; sensors for flow, pressure, level, and bubble detection. Surface coatings: Carmeda BioActive or Trillium Biopassive. System includes control module with electronics and touch screen interface. Designed for short-term (≤ 6 hours) use.

Indications for Use

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

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

• Lifebridge B2T System (K090006)
• Medtronic Affinity NT oxygenator with Carmeda Bioactive Surface (K000430)
• Avecor Affinity Hollow Fiber oxygenator with Trillium Biopassive Surface (K973760)

Submission Summary (Full Text)

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K10335.7

LIFEBRIDGF Special 5100k1 Additional Information

### Special 510(k) Summary

| SUBMITTER: | LIFEBRIDGE® Medizintechnik AG<br>Simon-Ohm-Str 1<br>84539 Ampfing Germany | DEC 27 2010 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Kathleen Johnson<br>Medical Device Approvals, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Mobile: [phone]. | |
| DATE PREPARED: | November 26, 2010 | |
| DEVICE TRADE NAME: | LIFEBRIDGE SYSTEM | |
| COMMON/USUAL NAME: | Cardiopulmonary Support System | |
| CLASSIFICATION: | Class III per 21 CFR 870.4360 | |
| PRODUCT CODE: | KFM | |

## 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:

Lifebridge B2T System K090006 Medtronic Affinity NT oxygenator with Carmeda Bioactive Surface K000430 Avecor Affinity Hollow Fiber oxygenator with Trillium Biopassive Surface K973760

# DEVICE DESCRIPTION:

The LIFE.BRIDGE 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 modification to the current Lifebridge System is to exchange the current oxygenator, BioCor 200, used in the patient module, for the Medtronic Affinity® NT oxygenator. The Affinity NTC Oxygenator is available with either a Carmeda® BioActive surface coating or a Trillium Biopassive surface coating.

#### INDICATIONS FOR USE:

The LIFEBRIDGE 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.

# STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:

This "Special 510(k)" is being submitted for a modification to the patient module of the Lifebridge System. The modification is to exchange one 510(k) cleared oxygenator for another. Both are hollow fiber membrane oxygenators cleared for short-term cardio-pulmonary support up to 6 hrs.

The major differences between the oxygenators are availability and a surface coating.

The Medtronic Affinity® NT oxygenator provides a surface coating to the large surface area of the oxygenator and the BioCor oxygenator does not. The coating can be nither Carmeda® Bioactive Surface coating or Trillium Biopassive Surface coating.

The modification has been implemented through adherence to Design Controls. Risks posed by the change have been identified and analyzed. Measures to reduce any possible risks hovod been identified. Performance testing has been carried out to validate the mitigations and to ensure that the change to the patient module is safe, does not create any new risks and that performance of the modified module is equivalent to that of the original.

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

DEC 2 7 2010

Lifebridge Medizintechnik AG c/o Ms. Kathleen Johnson Medical Device Approvals, Inc. 1282 Round Hill Rd. Bryn Mawr, PA 19010

K103357 Re:

LIFEBRIDGE System Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller type CPB Pump Regulatory Class: Class III (three) Product Code: KFM Dated: December 13, 2010 Received: December 14, 2010

Dear Ms. Kathleen 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. 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. Kathleen Johnson

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/CDRH0ffices/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 vours.

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

Enclosure

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# Indications for Use

K103357

DEC 2 7 2010

510(k) Number (if known): Device Name:

LIFEBRIDGE

.

Indications For Use: The LIFEBRIDGE is indicated for use as an extracorporcal blood ox ygenation system for patients needing short term, 6 hours or less, cardiac and / or pulmonary support.

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use X (Part 21 CFR 801 Subpart D) (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)

W.M.

rdiovascular Devices

510(k) Number K083557

Page I of I

11/26/2010

Confidential