(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.
§ 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.