(78 days)
The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM 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.
The Alsius CoolGard® 3000 and Cool Line™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The 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 provided document is a 510(k) Summary and an FDA 510(k) clearance letter for the Alsius CoolGard 3000 and Catheter Thermal Regulation System. This submission is for modifications to the software of an existing device, and the device acts as its own predicate.
As such, acceptance criteria and device performance in the traditional sense of a new medical device showing clinical efficacy or diagnostic accuracy are not explicitly outlined as a pass/fail threshold. Instead, the study aims to demonstrate that the software modifications do not raise new questions of safety or effectiveness and that the updated system is substantially equivalent to its existing predicate (itself).
The document details a randomized controlled trial that was previously conducted, which is relevant to a specific warning for the device, rather than being the primary study proving the current software modification meets acceptance criteria.
Let's break down the information based on your request, focusing on what is available and noting where details are not provided due to the nature of this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for a software modification to an existing device, the "acceptance criteria" are not reported as specific performance metrics against a threshold for new clinical efficacy. Instead, the acceptance criteria are implicitly that the software modifications do not negatively impact the device's safety or effectiveness as established by its previous clearances. The reported device performance relates to a clinical trial mentioned in a warning on its labeling.
| Acceptance Criteria (Implicit for Software Modification) | Reported Device Performance (from cited clinical trial relevant to a warning) |
|---|---|
| No new questions of safety or effectiveness | Trial results for mortality by diagnosis are provided. The "device performance" in this context is the observed mortality rates in different cohorts with and without the device (Cool Line) for fever reduction, to inform a warning about specific uses. The p-values indicate no statistically significant difference in mortality across the groups for the specified conditions (CI, ICH, PTBI, SAH) in this particular study. This study is not proving efficacy for the current software modification, but providing data for a device warning. |
| Substantial equivalence to predicate device (itself) | "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 specific technical performance data supporting this claim for the software modification are summarized but not detailed in this 510(k) summary. |
2. Sample Size Used for the Test Set and Data Provenance
The primary "test set" discussed in relation to clinical outcomes is from a randomized controlled trial of 296 patients. This study's data informs a warning related to fever reduction with the Cool Line Catheter.
- Sample Size (for the referenced clinical trial): 296 patients
- Cool Line group: (16 CI + 33 ICH + 44 PTBI + 61 SAH) = 154 patients
- Control group: (14 CI + 27 ICH + 38 PTBI + 63 SAH) = 142 patients
- Data Provenance: The document does not specify the country of origin. It is a retrospective analysis of previously collected data, forming the basis of a clinical trial used to establish a warning rather than being a prospective trial for the current software modification. The trial itself would have been prospective to collect the data, but the analysis presented here is of already completed data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The clinical trial generated patient outcomes (mortality), which served as the "ground truth" for evaluating the safety concern, rather than requiring expert consensus on a subjective measure.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given that the outcome measured was mortality, which is an objective endpoint, a formal adjudication method for interpretation might not have been
explicitly required in the same way it would be for subjective diagnostic evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers, sometimes with and without AI assistance, especially in diagnostic imaging. The device in question is a thermal regulation system, not an imaging or diagnostic AI device. The study cited is a randomized controlled trial assessing mortality outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone algorithm-only study was not done in the context of diagnostic performance. The device is a physical thermal regulation system with software control. The "algorithm" here refers to the software controlling the device's function. The 510(k) submission for the software modification indicates that software revisions were made and "supportive evidence is provided to establish that there are no new questions of safety or efficacy." The details of this "supportive evidence" are not fully elaborated in the summary but would likely involve verification and validation testing of the software changes to ensure it performs as intended and does not introduce hazards (e.g., in a standalone testing environment for the software, but not in the sense of a standalone clinical performance study).
7. The Type of Ground Truth Used (for the described clinical trial)
The ground truth for the clinical trial was outcomes data, specifically mortality. Mortality is an objective and directly observable outcome.
8. The Sample Size for the Training Set
The document is for a 510(k) submission for a software modification to an existing medical device. It does not describe a machine learning algorithm or an AI model that would require a "training set" in the conventional sense. The "software revisions" mentioned would have been developed and tested, but the term "training set" doesn't apply here.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the context of this 510(k) submission. The software modifications would have undergone software validation and verification according to established engineering and regulatory practices, rather than being "trained" on data.
§ 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).