(7 days)
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.
The LIFEBRIDGE SYSTEM is a compact, pre-assembled, modular system consisting of:
- 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.
- Sensors, including flow, pressure, level and bubble to read system parameters.
- Control module that contains the electronics and user interface.
- Base module that contains a touch screen, the main power connection and acts as a stable frame for the svstem.
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 with Trillium Biopassive surface coating.
This document describes a Special 510(k) submission for the LIFEBRIDGE SYSTEM, specifically concerning a modification to exchange one 510(k) cleared oxygenator (BioCor 200) for another (Medtronic Affinity NT oxygenator with Trillium Biopassive surface coating). As such, the study described is a performance validation to demonstrate equivalence and safety of the modified device rather than a study to establish primary efficacy or diagnostic accuracy.
Therefore, many of the requested categories related to diagnostic AI (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device modification submission.
1. Table of Acceptance Criteria and Reported Device Performance
The submission details that "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." While specific numeric acceptance criteria and detailed performance results are not provided in this summary document, the FDA's clearance indicates that these criteria were met and the performance was found acceptable for substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance (Modified LIFEBRIDGE System) |
|---|---|
| Safety | Demonstrated to be safe; no new risks identified. |
| Equivalence | Performance equivalent to the original LIFEBRIDGE System. |
| Functionality | Maintained intended functionality of an extracorporeal blood oxygenation system. |
| Biocompatibility | Medtronic Affinity NT oxygenator with Trillium Biopassive surface coating is already cleared and accepted for short-term cardiopulmonary support. |
| Indication for Use | Continues to meet the indication for use: extracorporeal blood oxygenation for short-term (6 hours or less) cardiac and/or pulmonary support. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a device modification for a cardiopulmonary support system, not an AI diagnostic device. The "test set" in this context refers to the samples used in performance validation testing (e.g., in-vitro or in-vivo testing of the oxygenator's function), not a diagnostic image dataset. The document does not specify the number of units or test conditions used in this performance testing. The data provenance would be from laboratory or animal testing specific to the device modification, not human retrospective/prospective data from specific countries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for a cardiopulmonary support system's performance typically involves established engineering and medical standards for oxygenation efficiency, blood parameter maintenance, pressure limits, flow rates, and biocompatibility, verified through laboratory testing against benchmarks, rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert labeling of diagnostic data. Performance testing of a medical device like an oxygenator would rely on validated measurement techniques and adherence to pre-defined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not applicable. MRMC studies are designed to assess the performance of diagnostic devices or AI algorithms when interpreted by multiple human readers, often comparing AI-assisted vs. unassisted reading. This submission is for a physical medical device (an oxygenator) and does not involve human readers interpreting diagnostic cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device modification is based on established performance specifications for oxygenators in cardiopulmonary bypass, including oxygen transfer efficiency, CO2 removal, blood compatibility, pressure drop, and absence of hemolysis. These are verified through bench testing and potentially in-vivo animal models (though not specified in this summary). The fact that the Medtronic Affinity NT oxygenator itself was "previously 510k-cleared" implies that its performance capabilities are already well-established and accepted. The current testing would focus on ensuring these capabilities are maintained when integrated into the LIFEBRIDGE SYSTEM.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI algorithm.
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LIFEBRIDGE®
K11384
LIFEBRIDGE Affinity Special 510(k)
MAY 2 4 2011
Special 510(k) Summary
SUBMITTER:
LIFEBRIDGE® Medizintechnik AG Simon-Ohm-Str 1 84539 Ampfing Germany
CONTACT PERSON:
Kathleen Johnson Medical Device Approvals, Inc. Phone: (641)472-0775 Fax: (641)472-0241 Mobile: (302) 521-9496
Class III per 21 CFR 870.4360
DATE PREPARED: May 3, 2011
DEVICE TRADE NAME: LIFEBRIDGE SYSTEM
COMMON/USUAL NAME: Cardiopulmonary Support System
CLASSIFICATION:
PRODUCT CODE:
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)
KFM
PREDICATE DEVICES:
LIFEBRIDGE B2T System K090006
Avecor Affinity Hollow Fiber oxygenator with Trillium Biopassive Surface K973760
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Image /page/1/Picture/0 description: The image shows the word "LIFEBRIDGE" in bold, black letters. Above the word is a curved line that resembles a bridge. The word is in all caps and has a registered trademark symbol on the upper right.
DEVICE DESCRIPTION:
The LIFEBRIDGE SYSTEM is a compact, pre-assembled, modular system consisting of:
-
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.
-
Sensors, including flow, pressure, level and bubble to read system parameters.
-
Control module that contains the electronics and user interface.
-
Base module that contains a touch screen, the main power connection and acts as a stable frame for the svstem.
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 with 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 isTrillium 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 have 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. 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
Lifebridge Medizintechnik AG c/o Ms. Kathleen Johnson Medical Device Approvals, Inc. 1282 Round Hill Rd. Bryn Mawr, PA 19010
2 4 2011 NAY
Re: K111384 LIFEBRIDGE System Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller type CPB Pump Regulatory Class: Class III (three) Product Code: KFM Dated: May 3, 2011 Received: May 17, 2011
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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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):
Device Name: Lifebridge System
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.
X 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
(Division Sign-Off) Divis Irdiovascular Devices 510(lk) Number
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)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.
(2)
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.