(41 days)
The Icy™ Catheter Model IC-3893A, connected to the COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, 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.
The ICY™ catheters are multi lumen intravascular catheters in various sizes. In common across the models, the catheters have two lumens that 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 or 8mm 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 Icy™ Catheter Model IC-3893A consist of a standard guide wire lumen that can be used as a primary infusion lumen, and two additional infusion lumens within the shaft.
The Icy™ Catheter Model IC-3893A is the same as the predicate device, the Icy™ Model IC-3585A except that it has two extra infusion lumens with a corresponding increase in shaft diameter. The heat exchange capability of the two catheters is the same.
The provided document is a 510(k) summary for a medical device called the Icy™ Catheter Model IC-3893A. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific, pre-defined acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for an AI/ML-based device. The original content describes a comparison to a predicate device for regulatory approval, focusing on technical characteristics and intended use.
However, I can extract the information that is present and explain why the other requested details are not available.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria or reported device performance in the context of an AI/ML device study. Instead, it compares the technical characteristics of the new device (Icy™ IC-3893A) to a predicate device (Icy™ IC-3585A) to demonstrate substantial equivalence.
| Feature | Predicate Device (Icy™ IC-3585A) | New Device (Icy™ IC-3893A) |
|---|---|---|
| Saline Circuit | Same | Same |
| Tip Infusion Lumen | Same | Same |
| Mid shaft Infusion Lumen | x | ✔ |
| Lower shaft Infusion Lumen | x | ✔ |
| Length | 35cm insertion length, 38cm tip to manifold | (Not explicitly stated if different, implied same unless specified) |
| Shaft Diameter | 8.5 Fr | 9.3 Fr |
| Cooling Balloons | 3 Balloons of same dimensions and locations | Same |
| Heat Exchange Capability | Same | Same |
Acceptance Criteria for Substantial Equivalence (implied by the 510(k) process): The device's characteristics do not raise new questions of safety and effectiveness compared to the predicate device. Performance data (not detailed in this summary) demonstrate equivalence where appropriate.
Reported Device Performance: The document states that the heat exchange capability of the two catheters is the same. The overall conclusion is that descriptive information and performance data (which are not extensively detailed in the summary but would have been part of the full 510(k) submission) demonstrate that the new catheter characteristics do not raise new questions of safety and effectiveness, and where appropriate, performance data demonstrate equivalence.
2. Sample size used for the test set and the data provenance
- Not applicable. This document is a 510(k) summary for a physical medical device (catheter) based on substantial equivalence, not an AI/ML study with a test set. There is no mention of a "test set" in the context of data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. See point 2.
4. Adjudication method for the test set
- Not applicable. See point 2.
5. 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 document is for a physical medical device and does not involve AI or human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used
- Not applicable. As this is a physical device submission focused on substantial equivalence to a predicate, "ground truth" in the AI/ML sense is not relevant. The "truth" for this submission is based on the established safety and effectiveness of the predicate device and the physical and functional characteristics of the new device.
8. The sample size for the training set
- Not applicable. See point 2.
9. How the ground truth for the training set was established
- Not applicable. See point 2.
In summary: The provided document is a regulatory submission (510(k) summary) for a conventional medical device (catheter) seeking market clearance based on substantial equivalence to a previously cleared predicate device. It focuses on comparing technical characteristics and intended use. The questions posed are highly specific to AI/ML device studies, which are not described or implied in this document.
§ 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).