(37 days)
The Solex Catheter Model SL2593, connected to an Alsius External 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 SOLEX catheter is a multi lumen intravascular catheter. The catheter has 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 12.2 mm 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 Solex Catheter Model SL2593 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 provided document is a 510(k) summary for the Alsius Solex Catheter Model SL2593, which is a submission to the FDA for market clearance based on substantial equivalence to a predicate device. This type of submission generally does not include a detailed study proving the device meets acceptance criteria in the same way a clinical trial for a novel drug or a high-risk device might. Instead, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested categories (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable in this context, as this document is not a report of a new clinical study with acceptance criteria being met in a statistically powered trial.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of "acceptance criteria" with measured performance for the Solex Catheter in the way it would for a clinical trial endpoint. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device (Alsius Fortius Catheter Kit Model FR-5093, K030421) by comparing technical characteristics and intended use.
The "performance" is implicitly considered equivalent if the technical changes do not raise new questions of safety and effectiveness, and the basic operating principle and indications for use are the same.
| Characteristic/Comparison Point | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|---|
| Indications for Use | Identical to predicate device | Identical to predicate device |
| Principle of Operation | Same as predicate device | Same as predicate device |
| Technical Characteristics | Very similar to predicate device; differences should not raise new safety/effectiveness concerns | Differences noted (shorter balloon, shorter length, additional infusion lumens, different insertion site label, different PET construction OD). These differences were deemed not to raise new safety/effectiveness concerns. |
| Materials Used | Very similar to predicate device | Very similar (e.g., same heat exchange balloon material, Duraflo® Treatment heparin coating) |
| Clinical Performance (Cooling/Heating) | Not explicitly stated as a numerical criterion; assumed to be acceptable given similarity in principle and material. Shorter balloon results in reduced heat exchange power, but this is not presented as a failure to meet a criterion, but rather a characteristic. | The shorter length balloon "results in reduced heat exchange power." The document implies this is acceptable given the overall substantial equivalence determination. |
| Safety | No new questions of safety | No new questions of safety raised. |
| Effectiveness | No new questions of effectiveness | No new questions of effectiveness raised. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. This is not a study with a test set in the conventional sense. The submission relies on comparative analysis with a predicate device.
- Data Provenance: Not applicable. The data primarily consists of engineering and design specifications for the new device and a comparison to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. Ground truth as typically established by medical experts for clinical endpoints is not part of this 510(k) submission for substantial equivalence based on technical comparison.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There was no test set requiring expert adjudication.
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:
- MRMC Study: Not applicable. This device is a catheter for thermal regulation, not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical medical device (catheter) and associated system, not an algorithm. Its operation involves human medical professionals.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness of the predicate device. The new device is compared against the predicate's characteristics and performance to demonstrate that it is "substantially equivalent." There isn't a separate, independently established ground truth for the new device's performance in a clinical setting presented in this document.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is a medical device submission, not an AI/machine learning model submission that would require a "training set."
9. How the Ground Truth for the Training Set was Established:
- How Ground Truth for Training Set was Established: Not applicable. This is a medical device submission, not an AI/machine learning model submission.
§ 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).