(28 days)
The Sorin C5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the C5 System.
The C5 System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified, through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.
The Sorin C5 System modification consists of the addition of the mast pumps and the Electrical Venous Occluder (EVO) to the Sorin C5 System. The function of the modified Sorin C5 System is identical to that of the parent C5 system. Masts pumps expand the number of pumps available to the perfusionist. The Electrical Venous Occluder allows the perfusionist to respond more quickly to detections of air in the extracorporeal circuit. This Special 510(k) was submitted for the addition of optional components and accessories that are provided to assist the perfusionist in their conduct of cardiopulmonary bypass. The mast pumps allow for additional pumping for such activities as left ventricular venting, cardiotomy suction, and administration of cardioplegia solution. The EVO replaces a maximum of two manual tubing clamps and interfaces perfusionist-selected roller pumps to clamp the venous line when a pump alarm condition occurs.
This 510(k) summary (K103762) for the Sorin C5 System is a Special 510(k) submission for modifications to an existing device rather than a new device with a comprehensive clinical or standalone performance study. Therefore, much of the requested information regarding acceptance criteria and detailed study designs for AI-powered devices is not directly applicable or available in this document.
The submission focuses on demonstrating substantial equivalence to a predicate device (Stöckert S5 System and the parent Sorin C5 System) for the modifications introduced, which are the addition of mast pumps and an Electrical Venous Occluder (EVO).
Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable:
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 metrics for the modified device in the way one would expect for an AI/algorithm-driven device. The "performance" assessment here is focused on demonstrating that the added components function as intended and do not negatively impact the overall system's safety and effectiveness compared to the predicate.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functionality of Mast Pumps: Ability to provide additional pumping for left ventricular venting, cardiotomy suction, and cardioplegia solution administration. | "The mast pumps allow for additional pumping for such activities as left ventricular venting, cardiotomy suction, and administration of cardioplegia solution." (Implied successful functionality through verification and validation testing). |
| Functionality of Electrical Venous Occluder (EVO): Ability to replace manual tubing clamps (max two) and interface with selected roller pumps to clamp the venous line upon pump alarm condition, allowing quicker response to air detection. | "The Electrical Venous Occluder allows the perfusionist to respond more quickly to detections of air in the extracorporeal circuit." (Implied successful functionality through verification and validation testing). |
| Overall System Safety (Electrical/Mechanical): Compliance with relevant safety standards (IEC 60601-1). | "safety testing (per IEC60601-1)" was conducted. (Implied compliance). |
| Overall System Electromagnetic Compatibility: Compliance with relevant EMC standards (IEC 60601-1-2). | "electromagnetic immunity and compatibility (per IEC 60601-1-2)" was conducted. (Implied compliance). |
| Integrated System Performance (Simulated/In Use): The modified system performs as expected in a simulated or "in-use" environment. | "simulated use/in use testing of the integrated system" was conducted. (Implied successful performance). |
| Substantial Equivalence: The modified Sorin C5 System performs according to specifications and is substantially equivalent to the predicate device. | "Based on the descriptive information and verification/validation /V testing provided... the modified Sorin C5 System performs according to specifications, demonstrating that there are no significant differences and that the devices are substantially equivalent." |
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 provide details on specific "test set" sample sizes in the context of clinical data or AI model evaluation. The testing described is verification and validation (V&V) testing of hardware and integrated system functionality, not a clinical study with patient data.
- Sample Size: Not applicable in the context of a "test set" for performance evaluation via clinical data. The V&V testing would involve a sufficient number of tests to confirm functionality and safety, but these are typically engineering tests, not patient data samples.
- Data Provenance: Not applicable. No patient data or clinical data is mentioned as being used for performance evaluation of the modifications.
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)
Not applicable. "Ground truth" in the context of expert consensus on diagnostic or prognostic outcomes is not relevant here as this is a hardware modification submission, not an AI or diagnostics device. The "ground truth" for the V&V testing would be engineering specifications and functional requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions on clinical cases.
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. No MRMC study was conducted, as this device is a hardware modification to a heart-lung machine, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a console with added components, not a standalone algorithm. The EVO component has an automated function (clamping the venous line upon pump alarm), but its performance is verified through engineering tests, not an "algorithm only" study in the sense of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission refers to:
- Engineering Specifications: Functional requirements for the mast pumps and EVO.
- Safety Standards: Compliance with IEC 60601-1 and IEC 60601-1-2.
- Predicate Device Performance: The established safety and effectiveness of the existing Sorin C5 System and the predicate Stöckert S5 System.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned.
§ 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).