(41 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 LIFE.BRIDGE 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 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.
This document refers to a Special 510(k) submission for a modification to a cardiopulmonary support system (LIFEBRIDGE SYSTEM). The modification involves exchanging one 510(k)-cleared oxygenator (BioCor 200) for another (Medtronic Affinity NT oxygenator). The document focuses on demonstrating that the modified system is substantially equivalent to the original and that potential risks have been mitigated.
Let's break down the requested information based on the provided text.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in a quantitative manner typical for algorithm performance. Instead, it refers to a process of demonstrating safety and equivalency.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adherence to Design Controls | "The modification has been implemented through adherence to Design Controls." |
| Identification and analysis of risks | "Risks posed by the change have been identified and analyzed." |
| Mitigation of identified risks | "Measures to reduce any possible risks have been identified." |
| Validation of mitigations through performance testing | "Performance testing has been carried out to validate the mitigations..." |
| Equivalence of performance of the modified module to the original | "...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." (This is a high-level statement of the outcome of the testing, rather than specific performance metrics.) |
| Device remains safe | "...does not create any new risks..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI/algorithm evaluation with a defined sample size of cases or patients. The performance testing mentioned is for the physical device components (oxygenator) rather than a diagnostic algorithm. Therefore, information about data provenance and retrospective/prospective nature is not applicable in the context of an imaging AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a cardiopulmonary support system, not an imaging AI device requiring expert-established ground truth on a test set of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no mention of a test set requiring adjudication in the context of an algorithm or diagnostic performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The document describes a physical medical device (cardiopulmonary support system), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and human reader improvement with AI are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical cardiopulmonary support system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of an AI/algorithm. For this device, the "ground truth" would be related to established engineering and physiological performance standards for oxygenators and overall cardiopulmonary support systems, demonstrated through a combination of in vitro testing, animal studies, and potentially human clinical data if significant changes were made (though for a 510(k) modification, focusing on equivalence to a cleared device, extensive new clinical ground truth may not be required). The document indicates performance testing was done to validate mitigations and ensure safety and equivalence.
8. The sample size for the training set
This information is not applicable. The device is not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is not an AI/machine learning algorithm that requires a training set with established ground truth.
§ 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.