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.

Device Description

The Arctic Sun™ Stat Temperature Management System is a non-invasive, thermal regulating device that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The system consists of a console, non-sterile single patient use ArcticGel™ Pads, and associated accessories.

The Arctic Sun™ Stat Temperature Management System circulates temperature-controlled water ranging between 4°C and 40°C (39.2°F and 104°F) through the ArcticGel™ Pads, resulting in heat exchange between the water and the patient. A commercially available Yellow Springs Instrument (YSI) 400 series compatible patient temperature probe connected to the console provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun™ Stat console has the option to provide secure data output of device monitoring values; there is no patient-identifiable information. The data output functions, including USB, RS-232, and Wi-Fi, do not allow the user to write to the device and are intended for user convenience only.

AI/ML Overview

The provided FDA 510(k) clearance letter for the Arctic Sun Stat Temperature Management System does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, or ground truth establishment for a clinical or performance study that would typically be associated with an AI/ML device clearance.

This document describes a regulatory submission for a device that has undergone software modifications and other minor changes, primarily relating to alarms, Wi-Fi support, and software anomaly corrections. The clearance is based on substantial equivalence to an existing predicate device (which is, in fact, the same device but an earlier version, K200225).

The submission emphasizes non-clinical testing and states that "No clinical testing was required to evaluate substantial equivalence." This is a key point: detailed human reader studies or extensive clinical data would generally NOT be required for a 510(k) based on substantial equivalence for this type of device (a thermal regulating system), especially when the changes are software-based and don't alter the fundamental mechanism of action or indications for use.

Therefore, many of the requested points in your prompt are not applicable (N/A) based on the information provided in this 510(k) summary. The acceptance criteria and "studies" are focused on engineering verification and validation rather than clinical performance with human-in-the-loop or standalone AI performance against a ground truth.

Here's how to address your prompt based on the provided text:

Description of Acceptance Criteria and Proving Device Meets Them

The "acceptance criteria" and "study" in this context refer to the non-clinical performance testing and verification/validation activities conducted to demonstrate that the modified Arctic Sun Stat Temperature Management System remains safe and effective, and is substantially equivalent to its predicate device. Since this is a hardware device with software modifications, the focus is on maintaining previously established performance, reliability, and safety characteristics.

The overarching acceptance criterion is demonstrating substantial equivalence to the predicate device (K200225) without raising new questions of safety or effectiveness. This is achieved through a suite of non-clinical tests.

Summary of Device Performance: The document states, "The results from this testing demonstrate that the technological characteristics and performance criteria of the subject device are substantially equivalent to the predicate device and performs in a manner equivalent to devices currently on the market for the same intended use."

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for software and minor hardware modifications to an existing device, the "acceptance criteria" are more akin to successful completion of verification and validation against specified design requirements and FDA-recognized standards, rather than clinical performance metrics in humans.

Acceptance Criterion (Test Category)	Reported Device Performance (Outcome)
System Mechanical Verification	Met requirements; functionally equivalent to predicate.
System Electrical Safety	Met requirements; functionally equivalent to predicate.
Electrical Reliability	Met requirements; functionally equivalent to predicate.
Software Verification	All new system and software requirements verified successfully. Function of device modifications confirmed. Equivalent to predicate with enhancements.
Control Accuracy and Precision	Met requirements; equivalent to predicate.
Electromagnetic Compatibility	Met requirements.
Radio Frequency	Met requirements.
Alarm Functionality	Verified new alarm conditions, prioritization, and user explanatory text. Met requirements and improved safety profiles. Equivalent to predicate with enhancements.
Artificial Patient Testing	Met requirements; equivalent to predicate's control capabilities.
Cybersecurity	Met relevant cybersecurity standards and requirements; secure data output confirmed.
Packaging Integrity	Met requirements.
Human Factors and Validation	Conducted to ensure user interface changes (e.g., new notification banner, alarm text) are suitable and safe. Met requirements.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of patient numbers. For non-clinical testing, "samples" would refer to the number of devices or components tested. The document lists "Artificial patient testing," which would imply a simulated environment, not human subjects. Therefore, the "sample size" for patient data is N/A (not applicable, as no clinical patient data was used for testing equivalence).
Data Provenance: N/A (no clinical patient data used). The testing was conducted internally by Medivance, Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A: No ground truth in the context of expert consensus on medical images or diagnoses was established as this was not an AI diagnostic device or clinical study. The "ground truth" for non-clinical testing is adherence to engineering specifications, safety standards, and performance benchmarks established during the device's original development (and maintained through these modifications).

4. Adjudication Method for the Test Set

N/A: No clinical adjudication process was performed for patient data, as no clinical patient data was used. Adjudication in this context would refer to internal quality assurance and design control processes.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, N/A: An MRMC comparative effectiveness study was not performed. This type of study is typical for AI-powered diagnostic imaging devices to assess the impact of AI on human reader performance. As a thermal regulating system, this is not relevant to its regulatory pathway or the type of changes involved.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, in spirit (but not as a diagnostic AI model): The "Software verification," "Control accuracy and precision," and "Alarm functionality" tests represent the standalone performance of the device's algorithms and internal logic. These tests ensure the automated control and monitoring processes (the 'brains' of the device) function correctly as programmed, without direct human intervention during the measurement/control cycle itself. However, this is not an "AI diagnostic algorithm" in the typical sense of a standalone output for diagnosis.

7. The Type of Ground Truth Used

Engineered Specifications and Standards: The "ground truth" for this device's performance validation is its design specifications, pre-established performance benchmarks, and compliance with applicable FDA-recognized consensus standards (e.g., for electrical safety, EMC, software validation, cybersecurity). For specific functionalities like temperature control, the "ground truth" is the accurate and precise maintenance of temperature within the specified range (32°C to 38.5°C), verified using calibrated equipment (e.g., in artificial patient testing).

8. The Sample Size for the Training Set

N/A: As this device is not an AI/ML device that requires a "training set" in the common sense of machine learning, this concept does not apply. The control algorithm is likely rule-based or uses traditional control theory, not a learned model from data.

9. How the Ground Truth for the Training Set was Established

N/A: See point 8.

Summary

FDA 510(k) Clearance Letter - Arctic Sun Stat Temperature Management System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 30, 2025

Medivance, Inc.
Lauren Valdes
Regulatory Affairs Manager
321 South Taylor Avenue
Suite 200
Louisville, Colorado 80027

Re: K243942
Trade/Device Name: Arctic Sun Stat Temperature Management System
Regulation Number: 21 CFR 870.5900
Regulation Name: Thermal regulating system
Regulatory Class: Class II
Product Code: DWJ
Dated: December 20, 2024
Received: April 10, 2025

Dear Lauren Valdes:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K243942 - Lauren Valdes Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K243942 - Lauren Valdes Page 3

Sincerely,

Nicole M. Gillette -S

Nicole Gillette
Assistant Director
DHT2B: Division of Circulatory Support,
Structural, and Vascular Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K243942

Device Name
Arctic Sun Stat Temperature Management System

Indications for Use (Describe)
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.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Arctic Sun™ Stat Temperature Management System

510(k) Owner: Medivance, Inc.
321 South Taylor Avenue, Suite 200
Louisville, CO 80027 USA

Contact Person: Lauren Valdes
Regulatory Affairs Manager
Telephone: 678-231-1627
E-mail: Lauren.Valdes@bd.com

Date of Submission: December 20, 2024

Subject Device Name: Arctic Sun™ Stat Temperature Management System

Subject Device

Device Trade Names: Arctic Sun™ Stat Temperature Management System
Common Name: Patient Temperature Management System
Regulation Name: Thermal Regulating System
Regulation Number: 21 CFR 870.5900
Product Code: DWJ
Regulatory Class: II
Classification Panel: Cardiovascular
Prior Correspondence: None

Predicate Device

510(k) Number: K200225
Device Trade Name: Arctic Sun™ Stat Temperature Management System
Common Name: Patient Temperature Management System
Regulation Name: Thermal Regulating System
Regulation Number: 21 CFR 870.5900
Product Code: DWJ
Regulatory Class: II
Classification Panel: Cardiovascular

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Device Description

Substantial Equivalence

Indications for Use

The Arctic Sun™ Stat 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™ Stat Temperature Management System and the predicate device have the same indications for use.

Intended Use

The Arctic Sun™ Stat Temperature Management System is a non-invasive, 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™ Stat Temperature Management System and the predicate device have the same intended use.

Technological Comparison to Predicate Device

The Arctic Sun™ Stat Temperature Management System is the same as the predicate device in the following manner:

Intended Use
Indications for Use
Target user and patient population
Control and monitoring processes
Principle of operation
Control algorithm
Patient temperature control range
Hypothermia and Normothermia therapy modes
Fundamental technology to monitor and control patient temperature

The subject Arctic Sun™ Stat Temperature Management System has the following modifications for one of the water temperature alarms when compared to the predicate device:

Software modifications for alarm conditions, prioritization, and user explanatory text
Labeling modifications to reflect changes made to alarm prioritization and explanatory text

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The subject Arctic Sun™ Stat Temperature Management System has the following other minor modifications when compared to the predicate device:

Software modifications
- New notification banner when Manual Mode is employed
- WPA2 Enterprise and hidden Wi-Fi network support
- Software anomaly corrections
Other changes made to the predicate device since the last clearance
- Labeling (temperature simulator caution moved to warnings section, clarifications for readability)
- Software modifications to improve Wi-Fi data output clarity, branding, and anomaly corrections
- New/modified components

Performance Data

Performance testing was developed and executed according to internal design control and risk assessment procedures, software FDA Guidance documents, and applicable FDA recognized consensus standards. Software validation of the Arctic Sun™ Stat Temperature Management System was performed to verify all new system and software requirements, the result of which confirmed the function of the device modifications. No clinical testing was required to evaluate substantial equivalence. The following table lists the relevant nonclinical tests performed on the Arctic Sun™ Stat Temperature Management System.

Arctic Sun™ Stat Temperature Management System – Nonclinical Tests Performed
System mechanical verification
System electrical safety
Electrical reliability
Software verification
Control accuracy and precision
Electromagnetic compatibility
Radio frequency
Alarm functionality
Artificial patient testing
Cybersecurity
Packaging integrity
Human factors and validation

The results from this testing demonstrate that the technological characteristics and performance criteria of the subject device are substantially equivalent to the predicate device and performs in a manner equivalent to devices currently on the market for the same intended use.

Conclusions

The purpose of this 510(k) notification is to obtain market clearance for safety enhancements made to the software of the Arctic Sun Stat console and related labeling. These enhancements maintain the substantial equivalence of the device to the legally marketed predicate device. The Arctic Sun™ Stat Temperature Management System, as designed and manufactured, does not raise new questions regarding safety and effectiveness as compared to the predicate device.

Regulation Number and Section

§ 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).