(255 days)
The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ model catheter, is indicated for use:
- . in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and,
- . to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.
"he CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
The technical characteristics of the Catheter are essentially identical to those of widely used multi-lumen central venous catheters except for the dedicated closed loop fluid path through the heat exchange balloons. The Alsius Catheter materials are all biocompatible polyurethanes.
Likewise, the CoolGard™ 3000 heater/cooler has the same technical features as the medical heater/cooler unit Identified as the predicate device. These common technical features include connections for recirculating coolant to and intravascular catheter and all or combinations of the following: redundant safety controls and alarms, patient monitoring and control and temperature displays for the clinician users.
Two Models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System:
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- ICY™ Catheter Kit Model IC-3585A
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- Fortius™ Catheter Kit Model FR-5093A
The ICY™ and Fortius™ catheters are multi lumen intravascular catheters in various sizes. Two of the catheter's lumens are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm where the heating/cooling membranes interface with the patient's circulating blood. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The chilled saline is not infused into the patient.
Additional lumens of the Alsius Catheters consist of a standard guide wire lumen that can be used as a primary infusion lumen, and a second infusion lumen within the shaft, depending on the catheter model selected by the clinician.
The Catheter blood contact surfaces are coated with Duraflo® Treatment, a heparin coating manufactured by Edwards Lifesciences Corporation.
The Alsius Catheters are supplied sterile for single-use only.
Principles of Operation:
The CoolGard™ 3000 system automatically adjusts the temperature of the heater/chiller saline bath to achieve the patient target temperature that has previously een set by the attending physician. This is done via data from a temperature probe in the patient that interfaces with the temperature controller. This principle of operation is identical to currently marketed devices.
The provided 510(k) summary for the Alsius CoolGard and Catheter Thermal Regulation System states that performance data demonstrate equivalence to the predicate device, but it does not specify detailed acceptance criteria or present a study proving the device met those criteria. The 510(k) summary focuses on demonstrating substantial equivalence based on identical indications for use, principle of operation, and similar technical characteristics and materials compared to the predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The submission relies on equivalence to predicate devices rather than a new set of performance metrics.
- Sample size used for the test set and the data provenance: No specific test set or associated data is described for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment is detailed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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. This device is a thermal regulation system, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Basis for Substantial Equivalence (as described in the document):
The 510(k) submission's core argument for substantial equivalence is based on the following:
- Identical Indications for Use: The CoolGard and Catheter Thermal Regulation System's indications for use are identical to the predicate device.
- Identical Principle of Operation: The principle of operation, which involves automatically adjusting saline bath temperature based on a patient temperature probe to achieve a set target temperature, is identical to currently marketed devices (including the predicate).
- Similar Technical Characteristics and Materials: The technical characteristics of the catheter (biocompatible polyurethanes, heat exchange balloons, multiple lumens, heparin coating) and the CoolGard™ 3000 heater/cooler (integrated electro-mechanical heater/cooler, temperature monitor/controller, heat exchanger, roller pump, redundant safety controls, alarms, patient monitoring, temperature displays) are described as "very similar" or "essentially identical" to the predicate devices.
Conclusion stated by the submitter:
"In summary, descriptive information and performance data demonstrate that the Alsius CoolGard and Catheter Thermal Regulation System characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence. The CoolGard and Catheter Thermal Regulation System is substantially equivalent to the predicate device."
In essence, the "study" demonstrating the device meets "acceptance criteria" is the comprehensive comparison of its design, function, and intended use against already legally marketed predicate devices, concluding that there are no new questions of safety or effectiveness. Specific quantitative performance metrics or studies beyond this comparative analysis are not detailed in the provided summary.
§ 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).