(20 days)
The IQool System is a thermal regulating system indicated for monitoring and controlling patient temperature.
The IQool™ System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 33°C to 38.5°C (91.4°F to101.3°F).
The IOooL™ System consists of:
- ECU 100 Refrigeration and Control Unit an integrated control system operated via a . touch screen monitor.
- BC COOL a cooling liquid consisting of diluted monopropylene glycol (MPG5). The ● dilution is made by BrainCool AB to optimally serve the IQool™ System. Five liters of BC COOL are delivered with the system.
- Cooling Pads The Cooling Pads are made of non-sterile, biocompatible material and do ● not contain latex. The Cooling Pads are intended for single use only.
- . Stabilization Insulation - The patented stabilization is made of insulating and moisture-absorbent neoprene. It insulates against the ambient environment while counteracting condensation. The elasticity of the stabilization keeps the Cooling Pad in place during treatment and ensures maximum contact between the skin and the surface of the Cooling Pad. The stabilizing insulation is intended for single use only.
Accessories:
- BC Stick a USB flash drive used to save system configurations, specifically prepared to ● communicate with the program of the IQool™ System. The BC stick does not store or capture any user identifying information. It can also be used to save a log file for system troubleshooting or to update the software.
- Filling Pitcher - The filling pitcher should be used to fill or refill the coolant tank. Fill the tank with coolant before or directly after starting to enable start of the system.
The IQool™ System is a thermoregulatory device that monitors and controls patient temperature within a range of 33°C to 38.5°C. The IQool System refrigeration and control unit (ECU 100) pushes a temperature-controlled cooling agent (BC COOL), ranging between 4°C and 40°C, through the Cooling Pads applied to the patient. This results in heat exchange between the BC COOL and the patient. Patient core temperature is monitored and controlled based on the temperature probe (PT1) attached to the system. The IQool™ System maintains a controlled patient temperature during the entire treatment period. The default treatment settings for temperature and time can be changed via the touchscreen monitor. Alarms and notifications are activated if any errors are detected. Temperature graphs for each treatment are shown on the touchscreen display for visual monitoring. After a treatment, a detailed log file can be collected with the memory stick (BC STICK).
This is a 510(k) premarket notification for a medical device called The IQool System, which is a thermal regulating system. The document states that a special 510(k) was submitted for "software changes," implying that the device itself has not fundamentally changed but its software has been updated. The submission aims to demonstrate substantial equivalence to a predicate device (K180375 IQool Warm System).
The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily focuses on the regulatory submission process, device description, and a claim of substantial equivalence based on "testing summaries" for software changes.
Therefore, I cannot provide a table of acceptance criteria or details regarding a study as requested, because this information is not present in the provided document. The document only mentions that "testing summaries provided document that the changes were verified and that the subject device provides the same temperature management performance and safety as the predicate device," but it does not elaborate on what these tests entailed, their results, or the acceptance criteria used.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).