(106 days)
The CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature.
The CritiCool system consists of the following elements:
- Temperature controlled garment .
- . Body sensors
- Connecting flexible water pipes .
- Heating/Cooling Unit .
The system is operated by circulating water by a pump in a closed loop between the device and a disposable garment - CureWrap, worn by the patient. The water circulates through the thermoregulating unit. Temperature (body) sensors are placed on the patient's skin to measure surface temperature and in the rectum, nasopharynx or esophagus to measure core temperature. The operator selects the desired patient core temperature (between 30-40°C) and the unit automatically controls it via a feedback loop. The heating / cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump
The provided document is a 510(k) premarket notification for the CritiCool System, a thermal regulating device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data proving efficacy or meeting specific acceptance criteria in the way a new drug or novel medical device might.
Therefore, the document does not contain a detailed study proving the device meets acceptance criteria in the format requested. Instead, it relies on demonstrating that the CritiCool device has similar specifications and indications for use as previously cleared predicate devices (ArcticSun and Allon 2001 Version 5).
However, I can extract the relevant information regarding performance specifications and any implied "acceptance criteria" through comparison with the predicate devices.
Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not explicitly stated in the context of a "study":
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the specifications of the predicate devices. The CritiCool device is considered "substantially equivalent" if its performance matches or is within acceptable limits of these predicate devices.
| Specification (Implied Acceptance Criteria) | Predicate Device (Allon 2001 Version 5) Performance | CritiCool Reported Performance |
|---|---|---|
| Control Modes | Automatic | Automatic |
| Heater Capability | 500W | 500W |
| Circulating Fluid | Tap Water | Tap Water |
| Reservoir Capacity | 6 liters (1.6 gal) | 6 liters (1.6 gal) |
| Heat Exchanger | Garment | Garment |
| Water Flow Rate (total) | 1-1.2 Liter/min | 1-1.2 Liter/min |
| Patient Probe Type | YSI 400 Series compatible | YSI 400 Series compatible |
| Patient Temperature Inputs | 2 – Core and Surface temperature | 2 – Core and Surface temperature |
| Patient Temperature Display Range | 18.5°C to 43.9°C (65.3°F to 111.0°F) in 0.1°C/°F steps | 18.5°C to 43.9°C (65.3°F to 111.0°F) in 0.1°C/°F steps |
| Patient Temperature Measurement Accuracy | ±0.3°C (0.4°F) | ±0.3°C (0.4°F) |
| Patient Temperature Control Range - Automatic Mode | 30°C to 40°C (86°F to 104°F) in 0.1°C/F increments | 30°C to 40°C (86°F to 104°F) in 0.1°C/F increments |
| Water Temperature Display Range | 9°C to 44°C (48.2°F to 111.2°F) in 0.1°C/F | 9°C to 44°C (48.2°F to 111.2°F) in 0.1°C/F |
| Maximum Water Temperature (Automatic Mode) | 40.8°C (105.4°F) | 40.8°C (105.4°F) |
| Minimum Water Temperature (Automatic Mode) | 13°C (55.4°F) | 13°C (55.4°F) |
| Mains Input | 230/115 VAC, 500W, 50/60 Hz, 6.3 amp | 230/115 VAC, 500W, 50/60 Hz, 6.3 amp |
| Current Leakage |
§ 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).