Search Results

The ROCSafe™ Hybrid Perfusion System is a pre-connected extra-corporeal circuit that is designed to offer circulatory support, blood gas maintenance and blood filtration during cardiopulmonary bypass procedures lasting not more than 6-hours in duration. The ROCSafe may only be used with Terumo's System 1 Heart/Lung Pump Platform. The System includes the following:

The Capiox RX Hollow Fiber Oxygenators are intended to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The Capiox RX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. The Capiox RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min. The Oxygenators are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

The Centrifugal Pump is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures and is a component of the ROCSafe Hybrid Perfusion System. It is intended to propel blood through the cardiopulmonary bypass circuit. The centrifingal pump is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

The Capiox AF125X Arterial Line Blood Filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit for up to 6 hours. The Arterial Filter is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

The Capiox Venous Bubble Trap is intended to facilitate the removal of air and bubbles from incoming venous blood as it flows into the extra-corporeal bypass circuit. The Bubble Trap is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

The CDI Cuvette is intended for use with the CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit, hemoglobin and oxygen saturation is desired. The Cuvettes are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

The components included in the Terumo ROCSafe™ Hybrid Perfusion System are medical devices that have been previously cleared by the United States Food and Drug Administration in prior 510(k) applications. This particular system is a collection of those "cleared" devices that are herein being presented in a pre-assembled configuration to satisfy the needs of clinical perfusionists. As such, there has been no change in the operation or technology employed by the individual devices.

The blood contacting surfaces of the ROCSafe™ circuit are coated with Terumo's exclusive X-Coating surfactant that is designed to reduce the adhesion of platelets to the foreign surfaccs of the circuit.

The materials that are used in the construction of the Terumo ROCSafe™ Hybrid Perfusion System includes, but not limited to, polycarbonate, steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™. These materials are the same materials that are used in the construction of the individual components that were previously cleared by FDA.

The provided text describes a 510(k) premarket notification for the Terumo ROCSafe™ Hybrid Perfusion System. This system is a pre-connected extra-corporeal circuit designed to offer circulatory support, blood gas maintenance, and blood filtration during cardiopulmonary bypass procedures. The submission argues for substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study used to prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The submission does not explicitly state acceptance criteria in a quantitative format (e.g., minimum performance thresholds for specific metrics). Instead, the performance evaluations focus on demonstrating substantial equivalence to predicate devices. The "performance evaluations" section lists various aspects that were considered. Since the device is a collection of previously cleared components, the "performance" here refers to confirming that the assembled system retains the performance characteristics of its individual, already-approved parts and that the combination does not introduce new safety or effectiveness concerns.

Therefore, the "acceptance criteria" are implicitly meeting the performance characteristics already established and accepted for the predicate devices across various parameters, and the "reported device performance" is that it achieves this substantial equivalence.

Study Details

The submission explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject Terumo ROCSafe™ Hybrid Perfusion System to the individual predicate devices."

The "studies" that support the substantial equivalence claim are primarily comparative assessments and analyses of the combined system against its individual predicate components, relying on prior data.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a traditional "test set" for performance evaluation of a novel device. The evaluations rely on prior in-vitro clinically simulated studies of the individual components and comparative assessments of the assembled system. No specific sample sizes for these re-evaluations are provided, as they are not new, standalone performance studies but rather a review of existing data.
   • Data Provenance: The data primarily comes from retrospective reviews of prior 510(k) submissions for the individual predicate devices. The submission does not specify a country of origin for these past studies, but given the US FDA submission, it's implied they were conducted in a manner acceptable for US regulatory purposes.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This was not a study requiring expert readers to establish ground truth for a test set. The validation of the individual predicate device performance came from various engineering and biological tests.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable, as there was no test set or expert adjudication process for this type of submission.

4. 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:

   • No MRMC or AI-assisted study was conducted. This device is a medical apparatus, not an AI or imaging diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithmic device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the performance of the individual components, the "ground truth" would have come from established engineering and biological benchmarks (e.g., specific gas transfer rates, hemolysis limits, pressure drop specifications, material integrity tests, sterility protocols, biocompatibility standards). For the current submission, the "ground truth" is that the assembled system aligns with the established characteristics and safety profiles of its predicate components.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

Ask a specific question about this device