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510(k) Data Aggregation
(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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(14 days)
The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures.
The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is a hardshell collection reservoir for venous blood and for blood recovered from Cardiotomy ouction room of for renease ices. The blood recovered by intracardiac suction ouslow and venthoular devices enters the reservoir through the top and passes through a filter media. The design of the reservoir is such that if, under normal operating a lume of less than 1000ml and if there is no foaming of the recovered blood, there is no blood contact with the open cell polyurethane defoamer. Venous there to ho blood comugh the top of the reservoir and is mixed with the filtered blood. As with the recovered Cardiotomy blood, under normal operating volume of less than 1000ml if there is no foaming of the venous blood entering the reservoir, there is no blood contact with the defoamer.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K021287 does not explicitly state specific acceptance criteria in terms of numerical performance thresholds (e.g., a certain percentage of accuracy, sensitivity, or specificity). Instead, it relies on a determination of "substantial equivalence" to a predicate device.
However, based on the determination of substantial equivalence, we can infer the implicit "acceptance criteria" are that the new device, Trillium™ AFFINITY NT CVR with Filter with Trillium BioPassive Surface, performs at least as safely and effectively as the predicate devices and does not raise new safety or effectiveness concerns.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: No significant adverse biological effects compared to predicate. | "The biocompatibility [...] demonstrated that when compared to the predicate devices, the Trillium™ AFFINITY NT CVR does not significantly affect safety and effectiveness." |
| In vitro Bench Testing: Performance (e.g., blood collection, filtration, defoaming) is comparable to predicate, with no new safety/effectiveness concerns. | "The [...] in vitro bench testing demonstrated that when compared to the predicate devices, the Trillium™ AFFINITY NT CVR does not significantly affect safety and effectiveness." |
| Substantial Equivalence: No new technological characteristics that raise new types of safety or effectiveness questions, and existing ones are assessed by acceptable scientific methods. | "The Trillium™ AFFINITY NT CVR has 'no new technological characteristics (e.g., materials and manufacturing processes)' from the currently marketed Cardiotomy/Venous Reservoir." |
| "This technological characteristic 'could affect the safety and effectiveness of the device'. However, these 'technological characteristics do not raise new types of safety or effectiveness questions'. In addition, 'there are acceptable scientific methods which exist for assessing effects of these new technological characteristics'." | |
| "Performance data [...] demonstrate that the Trillium™ AFFINITY NT CVR is substantially equivalent to other marketed extracorporeal cardiopulmonary bypass devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify a sample size for a test set in clinical trials or performance studies involving human subjects. The evaluation appears to be based on biocompatibility and in vitro bench testing.
- Sample Size: Not specified for any "test set" in the context of clinical performance. The testing mentioned is "biocompatibility and in vitro bench testing."
- Data Provenance: Not explicitly stated, but the submission is for a US FDA 510(k) clearance, implying the testing was conducted to US regulatory standards. It's likely a combination of preclinical lab studies. The text does not indicate retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or provided in the context of this 510(k) submission. The device is a physical medical device (venous reservoir), not an AI/diagnostic software. Therefore, there's no "ground truth" establishment by experts in the typical diagnostic sense. The "ground truth" for material compatibility and functional performance would be established through established scientific and engineering testing protocols.
4. Adjudication Method for the Test Set
This is not applicable or provided. As stated above, this is a physical medical device, and the evaluation relies on biocompatibility and bench testing, not expert adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI systems where human readers interpret medical images or data. The device in question is a component of an extracorporeal perfusion circuit.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI system was not done. This device is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Established scientific and engineering metrics: For biocompatibility (e.g., cytotoxicity, hemocompatibility, sensitization testing) and in vitro bench testing (e.g., flow rates, filtration efficiency, defoaming effectiveness, structural integrity).
- Comparison to predicate device performance: The "ground truth" for safety and effectiveness is largely anchored to the established performance profile of the predicate devices. If the new device performs equivalently or better in these established tests, it meets the "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is a physical product, not a machine learning model, so there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As there is no training set for a machine learning model, there is no ground truth established for one.
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