(286 days)
The LIFEBRIDGE B2T 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 B2T 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. 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 following LIFEBRIDGE ByT SYSTEM components have been previously 510(k)-cleared for use in cardiopulmonary bypass: oxygenator, arterial filter, centrifugal pump, level sensors, and bubble detector.
The provided document is a 510(k) summary for the LIFEBRIDGE B2T System, a cardiopulmonary support system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way one might expect for novel technology or a software algorithm.
Here's an analysis based on the provided text, addressing your points where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" or present a table of reported device performance in the context of a formal study demonstrating compliance with such criteria. Instead, it states:
| Acceptance Criteria (Implied) | Reported Device Performance / Claim |
|---|---|
| Safety and Effectiveness | Non-clinical tests performed on the LIFEBRIDGE B2T SYSTEM provide evidence of the safety and effectiveness of the device for its intended use. |
| Substantial Equivalence to Predicate Devices | The LIFEBRIDGE B-T SYSTEM is comprised of standard cardiopulmonary bypass components packaged into a modular, user-friendly system. The technological characteristics of the device are equivalent to traditional cardiopulmonary circulatory support systems. The LIFEBRIDGE B2T SYSTEM is substantially equivalent to the Bard (CPS) Cardiopulmonary Support System (K892664), Medtronic Performer CPB and Resting Heart System (K031700, K052555), and Jostra MECC System (K023132), in that all are indicated for use as cardiopulmonary support systems for periods up to six hours, and share equivalent technological characteristics. All of the devices incorporate previously 510(k)-cleared cardiopulmonary bypass components into a preassembled, optimally-sized system. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" with a specific sample size or data provenance. The assessment for this device appears to be based on:
- Non-clinical tests: The document mentions "Non-clinical tests performed on the LIFEBRIDGE B2T SYSTEM provide evidence of the safety and effectiveness of the device for its intended use." Details of these tests (e.g., number of runs, specific parameters) are not provided.
- Comparison to predicate devices: The primary argument for approval is based on substantial equivalence to existing, legally marketed cardiopulmonary bypass systems. This implies that the safety and effectiveness of the components and overall system are inferred from the established performance of the predicate devices.
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 to this 510(k) submission. There is no mention of an expert-adjudicated test set or ground truth establishment in the context of human expert review. The submission relies on non-clinical testing and comparison to predicate device characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described because there is no expert-adjudicated test set in the provided document.
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
Not applicable. This document describes a medical device (a cardiopulmonary support system), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied in AI/diagnostic device studies (e.g., expert consensus, pathology, clinical outcomes) is not explicitly detailed in this 510(k) summary. The "ground truth" for demonstrating safety and effectiveness of a cardiopulmonary support system in this type of submission is typically derived from:
- Engineering specifications and performance standards: Non-clinical tests verify the device meets these standards (e.g., flow rates, pressure limits, oxygenation efficiency, material biocompatibility).
- Established performance of predicate devices: The "truth" of what constitutes a safe and effective cardiopulmonary bypass system is based on the long history and regulatory clearance of the predicate devices.
8. The sample size for the training set
Not applicable. This pertains to an AI/machine learning model, which is not what the LIFEBRIDGE B2T System is.
9. How the ground truth for the training set was established
Not applicable. This pertains to an AI/machine learning model, which is not what the LIFEBRIDGE B2T System is.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).