(87 days)
The Arctic Sun® Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.
The Arctic Sun Temperature Management System is a noninvasive, thermal regulating system that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The Arctic Sun Temperature Management System consists of the Arctic Sun 5000 Control Module and disposable non-sterile ArcticGel Pads. The control module re-circulates temperature-controlled water to the ArcticGel Pads. A commercially-available medical temperature probe, such as naso-pharyngeal, bladder, rectal, or esophageal, connected to the control module senses the patient's core temperature. A control algorithm automatically adjusts the water temperature (automatic mode) or the clinician can adjust the water temperature (manual mode) to obtain the desired patient temperature.
The ArcticGel Pads come in various sizes to cover a broad range of patients and fit both males and females. Each pad has an inlet and an outlet connection that attaches to a fluid delivery line that is connected to the Arctic Sun 5000 Control Module. Up to six pads can be connected at one time. The pads adhere to the patient by the use of a biocompatible hydrogel adhesive
The Small Universal ArcticGel Pad and Neonatal ArcticGel Pad are modified versions of the current ArcticGel Pads and utilize an additional patient contacting fabric material.
The provided text describes a 510(k) premarket notification for the Arctic Sun Temperature Management System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than an efficacy study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in this document.
However, I can extract information related to the device description, biocompatibility, and performance testing, which are relevant to the device meeting certain criteria for substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on comparative testing to demonstrate substantial equivalence to predicate devices. The "performance" mentioned is that the device performs as intended and its performance is substantially equivalent to predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Non-cytotoxic | Fabric material found non-cytotoxic (ISO 10993-05) |
| Non-irritating | Fabric material found non-irritating (ISO 10993-10) |
| Non-sensitizing | Fabric material found non-sensitizing (ISO 10993-10) |
| Similar Cooling Capacities | Small Universal ArcticGel Pad and Neonatal ArcticGel Pad provide similar cooling capacities to predicate devices. |
| Similar Durations | Small Universal ArcticGel Pad and Neonatal ArcticGel Pad provide similar durations to predicate devices. |
| Performs as Intended | Arctic Sun Temperature Management System (Arctic Sun 5000 Console and ArcticGel Pads) performs as intended. |
| No New Safety/Effectiveness Issues | Raises no new safety or effectiveness issues. |
| Substantially Equivalent | Substantially equivalent to predicate devices (K101092, K002577, K100585) in indications for use, design, technological characteristics, materials, and system features/functions. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state a sample size for a "test set" in the context of an efficacy study. The testing performed was "Biocompatibility and Performance Testing" for the Small Universal ArcticGel Pad and Neonatal ArcticGel Pad.
- Sample Size: Not specified. Biocompatibility testing typically involves in-vitro and in-vivo tests with specific sample numbers for each test, but these are not detailed here. Performance testing would involve a set of pads, but the quantity is not given.
- Data Provenance: Not specified, but likely from internal Medivance, Inc. studies as part of their 510(k) submission. There is no mention of country of origin of data, or if it was retrospective or prospective clinical data. It appears to be bench/laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document describes biocompatibility and performance testing against industry standards (ISO 10993) and comparison to predicate devices, not an expert-driven ground truth for a clinical test set.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication of a test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned. This is a thermal regulating system, not an imaging or diagnostic device where human reader performance with or without AI assistance would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an automated system (Arctic Sun 5000 Control Module) that automatically adjusts water temperature based on a control algorithm and sensed patient core temperature. While the control algorithm operates "standalone" in automatic mode, the document does not describe "standalone performance" in the context of a diagnostic algorithm or AI system for interpretation that would typically require such studies. It details that the system's performance (including the algorithm's control) was "substantially equivalent" to predicate devices.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth was established by adherence to recognized international standards (ISO 10993-1, 10993-05, and 10993-10). These standards define the methods and acceptance criteria for cytotoxicity, irritation, and sensitization.
- Performance: Ground truth for comparative performance (cooling capacities and durations) was the performance of the predicate devices. The new pads were compared to these established devices.
8. The Sample Size for the Training Set
No training set is mentioned. This is not a machine learning device that would typically involve a "training set" for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned.
§ 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).