(170 days)
The Terumo® HX2™ Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
The Terumo® HX2™ Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of patient blood and cardioplegia solution during cardiovascular bypass surgery.
The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).
The system will have the capacity to circulate water at least 6.5 gal/min (25 L/min) with no load connected.
The system is capable of heating and cooling for a single channel or for both channels.
Channels are configurable such that different waterlice mixture ratios can be obtained. Manually added ice is the only means of obtaining the cool water supply. If a channel should fail during use, the user may switch the water hose connections to the other channel allowing the user to be operational in less than or equal to a minute.
Software is used to adjust and display channel set temperatures, acquire and display actual temperatures, automatically regulate temperatures to the entered setpoint, perform system diagnostics, and present visual and audible indications of faults that may occur.
The provided text describes a 510(k) premarket notification for the Terumo® HX2™ Temperature Management System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria, sample sizes, and expert ground truth establishment for AI/Machine Learning performance.
Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (like MRMC or standalone performance, training data, etc.) is not applicable to this traditional 510(k) submission as it is not an AI/ML device.
The document states that the device's performance was "exhaustively tested and compared with the performance characteristics of the currently marketed Sarns™ Dual Cooler/Heater and the Sarns™ Temperature Control and Monitor System (TCM II)." It also concludes that "The Terumo® HX2 ™ Temperature Management System performed as intended according to its performance specifications." However, the specific acceptance criteria and the detailed results of these tests (e.g., in a table format) are not provided in this summary.
General Summary of the Device and its Testing as per the Document:
- Device: Terumo® HX2™ Temperature Management System
- Indication for Use: To supply temperature regulated water to heat exchangers during open heart surgery.
- Legal Basis: 510(k) premarket notification, demonstrating substantial equivalence to predicate devices (Sarns™ Dual Cooler/Heater and Sarns™ Temperature Control and Monitor System (TCM II)).
- Performance Evaluation: Non-clinical performance testing was conducted where the HX2™ system's characteristics were compared to its predicate devices.
- Conclusion: The device performed as intended based on its performance specifications and was found to be substantially equivalent to its predicate devices.
Specific answers to the requested points, based only on the provided text:
- Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a quantitative table. The general acceptance criterion is that the device "performed as intended according to its performance specifications" and its characteristics were successfully "compared with the performance characteristics" of the predicate devices.
- Reported Device Performance:
- Circulate water at least 6.5 gal/min (25 L/min) with no load.
- Capable of heating and cooling for a single channel or both channels.
- User can switch water hose connections to the other channel allowing operation in ≤ 1 minute if a channel fails.
- Automated control for both heating and cooling.
- Improvements to priming and draining.
- Range of user temperature setpoints for both channels (compared to 4 hardware-limited setpoints of predicate).
- New system diagnostics display error codes.
- Temperature display accuracy "better than analog temperature display on Dual Cooler Heater."
- Operation within 10° to 40°C,
§ 870.4250 Cardiopulmonary bypass temperature controller.
(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).