(90 days)
The Cool Line Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infaccerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The ZOLL ICY Catheter Model IC-3893A, connected to the ZOLL Thermal Regulation System, is indicated for use:
- In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:
- In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recoveryintensive care.
ZOLL IVTM Cool Line. ICY and Quattro catheters are multi lumen intravascular catheters with balloons as heat exchange units. Each of these three catheter models has two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The thermal regulation system chills/warms the saline and pumps it through the inflow lumen of the catheter. The chilled/warmed saline travels to the balloons, whose surface facilitates heat exchange between the patient's circulating blood and the saline returns to the system via the outflow lumen. The chilled/warmed saline is not infused into the patient. Two additional lumens provide infusion channels. The fifth lumen serves as a guide wire lumen which can also be used as an infusion lumen. The basic difference between these three models of catheters is size and number of balloons which provides different heat exchange capacity.
The catheters are supplied sterile for single-use only.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the device must meet for approval. Instead, it presents the results of a randomized controlled trial and uses this data to inform a warning to be included in the device labeling. The performance is reported in terms of mortality rates for different patient cohorts.
| Cohort (Diagnosis) | Cool Line n (count) | Cool Line N (total) | Cool Line % (mortality) | Control n (count) | Control N (total) | Control % (mortality) | p-value* |
|---|---|---|---|---|---|---|---|
| CI (Cerebral Infarction) | 3 | 16 | 18.8 | 3 | 14 | 21.4% | 0.74 |
| ICH (Intracerebral Hemorrhage) | 8 | 33 | 24.2 | 7 | 27 | 25.9% | 1.00 |
| PTBI (Primary Traumatic Brain Injury) | 10 | 44 | 22.7 | 4 | 38 | 10.5% | 0.24 |
| SAH (Subarachnoid Hemorrhage) | 13 | 61 | 21.3 | 7 | 63 | 11.1% | 0.15 |
Note: The p-value is from Fischer's exact test.
The conclusion drawn from this study is that "The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury." This indicates that for these specific conditions, the observed mortality rates were either higher in the Cool Line group or not statistically different enough to confirm safety, leading to a labeling warning rather than a clear "acceptance" for those indications. The device is indicated for fever reduction in adult patients with cerebral infarction and intracerebral hemorrhage, implying that its performance for these conditions was considered acceptable despite the lack of explicit "acceptance criteria" in this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 296 patients.
- Data Provenance: The document states "a randomized controlled trial." While the country of origin is not explicitly mentioned, FDA review documents typically pertain to devices intended for the US market, and the listed address for ZOLL Circulation, Inc. is Sunnyvale, California, USA. The trial type is prospective as it's a randomized controlled trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document describes a randomized controlled clinical trial measuring mortality. No information is provided about experts establishing a "ground truth" for the test set in the context of diagnostic performance. The "ground truth" in this context is the actual clinical outcome (mortality), which is a direct observation.
4. Adjudication Method for the Test Set
No information is provided about an adjudication method. The trial measured mortality, which is a definitive outcome and typically doesn't require adjudication in the way diagnostic interpretations might.
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
This document describes a clinical trial for a thermal regulating catheter, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study was done and the concept of "human readers improve with AI" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Again, this is a physical medical device (catheter) for thermal regulation, not an algorithm or AI. Therefore, no standalone performance study was done in the context of an algorithm.
7. The Type of Ground Truth Used
The ground truth used in the clinical trial was outcomes data, specifically mortality by diagnosis.
8. The Sample Size for the Training Set
No information is provided about a "training set." The study described is a clinical trial, which typically has a single patient cohort (divided into treatment and control groups) rather than separate training and test sets in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" described in the context of this device and study. The ground truth (mortality) for the clinical trial was established through direct observation of patient outcomes.
§ 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).