(29 days)
The Levitronix 2nd Generation CentriMag Primary Console and Levitronix Monitor are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
The 2nd Generation CentriMag Primary Console is a microprocessor based device. The microprocessor generates the primary motor control signal, monitors system sensors, generates display outputs, interprets the inputs through the front keypad, provides alarm functions and handles the Levitronix Monitor interface. The Console is intended to be operated on single phase AC power; however, it also has a built-in rechargeable battery with a battery charger. The rechargeable battery is field replaceable. In addition, an optional external modular battery (UPS) can be used to power the CentriMag Primary Console. The human interface of the CentriMag Primary Console consists of a graphical screen to display data and system options and touch pads to change the system status. The 2nd Generation CentriMag Primary Console is intended to be used together with the Levitronix Monitor; however it can be also operated as a stand-alone unit.
The Levitronix Monitor provides a redundant user interface containing a display and touch pads. The Primary and Back-Up Consoles also provide a fullyfunctional user interface containing a display and touch pads. The Levitronix Monitor is a non-sterile, reusable device that is designed to work only with the 2nd Generation CentriMag Primary Console; therefore, it does not support the 1st Generation CentriMag Primary Console or the CentriMag Back-Up Console. The Levitronix Monitor is a 12V DC-powered device and receives its power directly from 2nd Generation CentriMag Primary Console via a power connector that mates with a connector on the back-panel of 2nd Generation CentriMag Primary Console. Based on the design of its power connector, the Levitronix Monitor cannot be plugged into a hospital AC power outlet. The Levitronix Monitor's core function is to provide multi-color alpha-numerical and graphical displays of information it receives from the 2nd Generation CentriMag Primary Console. The Levitronix Monitor is intended for use as a hospital-based unit (OR and bed-side) and is not intended for use during patient transport from one hospital to another.
The Levitronix Monitor is a processor based device, with a flat color screen (e.g. LCD). In addition, it is equipped with touch pad to allow the user to enter commands. In the hospital-setting configuration, the user is able to operate and monitor the performance of the CentriMag System through the Levitronix Monitor. The Levitronix Monitor can control the functions of the 2nd Generation CentriMag Primary Console, and therefore, of the CentriMag System. The Levitronix Monitor only displays data and stores user commands without interacting directly with the primary motor control which is managed by the 2nd Generation CentriMag Primary Console. The Levitronix Monitor is connected to the 2nd Generation Primary Console through one cable, which includes data and power lines. Power is provided by the 2nd Generation CentriMag Primary Console.
Here's an analysis of the provided text regarding device acceptance criteria and study information:
Device Acceptance Criteria and Study Analysis for Levitronix 2nd Generation CentriMag Primary Console and Levitronix Monitor
Based on the provided 510(k) summary, the Levitronix 2nd Generation CentriMag Primary Console and Levitronix Monitor did not undergo a clinical study with specific acceptance criteria and performance metrics in the traditional sense for this submission. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through functional testing and risk management.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from 510(k)) | Reported Device Performance (from 510(k)) |
|---|---|
| Not explicitly defined as quantitative performance criteria for an independent study. The overarching "acceptance criterion" for this 510(k) is: Demonstration of Substantial Equivalence to Predicate Devices | "The Levitronix 2nd Generation CentriMag Primary Console and the Levitronix Monitor have successfully undergone functional testing demonstrating substantial equivalence to the predicate devices." |
| Risk Management: Assess operational integrity through Risk Analysis and FMEA. | "The risk management methods used to assess the operational integrity of the 2nd Generation CentriMag Primary Console and the Levitronix Monitor were a Risk Analysis and a Failure Modes and Effects Analysis (FMEA)." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set with human subjects. The "test set" here refers to the functional tests performed on the physical devices.
- Data Provenance: The document does not specify the exact location or details of where the functional testing was conducted. It mentions that the devices were CE Mark approved on February 5, 2010, and have been successfully used clinically in Europe in the commercial market, implying that some performance data may have been gathered during that commercial use, but this is not presented as formal clinical study data for this 510(k) submission. The functional testing would have been conducted by the manufacturer, Levitronix LLC.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As no clinical study with a "test set" requiring expert ground truth was performed for this 510(k) submission, this information is not provided.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical study requiring subject-level adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The submission states: "Clinical testing was not performed."
- There is no information regarding the effect size of human readers improving with or without AI assistance, as AI is not mentioned as a component of this device, and no human reader study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This concept is not directly applicable to this device. The Levitronix 2nd Generation CentriMag Primary Console and Monitor are hardware devices for managing a cardiopulmonary bypass system. There isn't an "algorithm-only" performance to evaluate separately from the device's integrated function. The "functional testing" mentioned is essentially the standalone performance of the physical device.
7. Type of Ground Truth Used:
- For the functional testing, the "ground truth" would be the engineering specifications and established performance parameters of the predicate devices. The new devices were tested to ensure their performance matched or exceeded these established benchmarks, thereby demonstrating substantial equivalence. There's no mention of pathology, outcomes data, or expert consensus in this context.
8. Sample Size for the Training Set:
- Not applicable. This submission does not describe a machine learning algorithm or AI model that would require a training set. The device is a hardware system.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set was used.
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).