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 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 Temperature Management System consists of the Arctic Sun 5000 Control Module and disposable non-sterile ArcticGel Pads. The control module recirculates 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Arctic Sun Temperature Management System. It's a submission for modifications to an existing device, rather than a completely new one. Therefore, the information provided focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving efficacy against specific acceptance criteria in the same way one might for a new AI diagnostic tool.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a typical "table" format with pass/fail metrics. This is common for 510(k) submissions of modified devices where the primary goal is demonstrating substantial equivalence to a predicate. The performance testing is geared towards verifying the functionality of the modifications and ensuring the device still performs as intended and complies with relevant standards.

The document states:

"Hardware design verification and software validation of the Arctic Sun Temperature Management System was performed to verify all new system and software requirements, the result of which confirmed the function of the device modifications."
"In addition to functional testing, the Arctic Sun Temperature Management System was retested, when applicable to confirm ongoing compliance with Electrical Safety and Electromagnetic Compatibility Standards."
"The Arctic Sun Temperature Management System performs as intended, raises no new or different safety or effectiveness issues and is substantially equivalent to the predicate device."

Therefore, the implied acceptance criteria are:

Successful verification of all new system and software requirements.
Confirmation of the function of the device modifications.
Ongoing compliance with Electrical Safety Standards.
Ongoing compliance with Electromagnetic Compatibility Standards.
No new or different safety or effectiveness issues compared to the predicate device.
Substantial equivalence to the predicate device in indications for use, design, technological characteristics, materials, and system features and functions.

Reported Device Performance:
The document states that these criteria were met, but it does not provide specific numerical results or raw data from the tests. It concludes that the device "performs as intended" and is "substantially equivalent."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not mention "sample size" in the context of a dataset for model evaluation, as this is not an AI diagnostic device. The testing described refers to "functional testing" and "retesting" for compliance. These tests would involve physical device testing, software testing, and hardware verification, not the processing of a dataset of patient information. Therefore, data provenance is not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The device is a "Thermal Regulating System" for monitoring and controlling patient temperature. Its performance is evaluated through engineering verification and validation against design specifications and relevant standards, not by comparing its outputs to expert-established ground truth on a test set (like an imaging AI might).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the reasons stated in point 3.

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 is not applicable. The Arctic Sun Temperature Management System is not an AI diagnostic tool used by human readers. It's a system to regulate patient temperature.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a "Thermal Regulating System" with a control algorithm. The software validation confirmed the "function of the device modifications," which includes changes to the alert/alarm system, customizable protocols, data output for EMR, system default changes, and user preference changes to the user interface. While functional testing of the software components was performed, this isn't strictly a "standalone algorithm performance" study in the sense of evaluating an AI model's diagnostic accuracy. It's about verifying that the system operates correctly according to its specifications.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this type of device, ground truth would be established by:

Design Specifications: The intended behavior and performance limits defined during the device's design.
Regulatory Standards: Compliance with electrical safety (e.g., IEC 60601-1) and electromagnetic compatibility (e.g., IEC 60601-1-2) standards.
Predicate Device Performance: The established safety and effectiveness of the previously cleared Arctic Sun Temperature Management System (K142702 and K002577 for pads).
The ground truth isn't in the form of clinical outcomes or expert consensus on patient data, but rather engineering and regulatory compliance.

8. The sample size for the training set

This is not applicable. The document describes a software and hardware modification verification and validation, not a machine learning model's training process.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated in point 8.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 02, 2016

Medivance, Inc. Stacci Cronk Regulatory Affairs Manager 321 South Taylor Ave, Suite 200 Louisville, Colorado 80027

Re: K161602

Trade/Device Name: Arctic Sun Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: August 2, 2016 Received: August 3, 2016

Dear Stacci Cronk:

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 (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. 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K161602

Device Name Arctic Sun® 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)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

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PSC Publishing Servi

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K101092

510(k) SUMMARY

Arctic Sun® Temperature Management System

510(k) Owner:	Medivance, Inc.A wholly owned subsidiary of C. R. BARD, Inc.321 South Taylor Avenue, Suite 200Louisville, CO 80027 USA
Contact Person:	Stacci Cronk, RACRegulatory Affairs ManagerPhone: 303-327-5151E-mail: stacci.cronk@crbard.com
Date Prepared:	June 2, 2016
Trade Name:	Arctic Sun® Temperature Management System (Model5000 Control Module)
Common/Usual Name:	Patient temperature management system
Classification Name:	Thermal regulating system
Regulation:	21 C.F.R. §870.5900
Classification:	II
Product Code:	DWJ
Predicate Device
Arctic Sun® Temperature Management SystemMedivance, Inc.	K142702

Indications for Use

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

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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.

Please note that this Special 510(k) Notice is specific to the Arctic Sun 5000 Control Module. The ArcticGel Pads are previously 510(k) cleared under K002577 and K142702 and are not the subject of the Special 510(k) Notice.

Purpose of Special 510(k) Notice

The purpose of this 510(k) is to modify the cleared Arctic Sun Temperature Management System by incorporating minor component, software and associated labeling changes.

Summary of Technical Characteristics Compared to the Predicate Device

The modifications to the Arctic Sun Temperature Management System do not change the intended use, indications for use, or fundamental scientific technology of the device. The Arctic Sun Temperature Management System (Model 5000) includes the following modifications:

New alert and alarm (software change)
Option to add two additional customizable protocols (software change) ●
. Data output capability for Electronic Medical Records (EMR) connectivity support (software change)
System default changes
User preference changes to the user interface (software change)
New/modified components ●
Labeling (new caution, new IFU for temperature simulator key, and various changes ● for clarifications and/or safer use of the device)

Performance Testing

The software for the Arctic Sun Temperature Management System was developed and is maintained in accordance with the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" (05/11/05) and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (1/11/02). Hardware design verification and software validation of the Arctic Sun Temperature Management System was performed to verify all new system and software requirements, the result of which confirmed the function of the device modifications.

In addition to functional testing, the Arctic Sun Temperature Management System was retested, when applicable to confirm ongoing compliance with Electrical Safety and Electromagnetic Compatibility Standards.

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Substantial Equivalence

The Arctic Sun Temperature Management System has the same Indications for Use, Intended Use and fundamental scientific technology as the predicate Arctic Sun Temperature Management System. The Arctic Sun Temperature Management System was shown to be substantially equivalent in indications for use, design, technological characteristics, materials, and system features and functions to the predicate device.

Conclusion

Based on the testing and comparison to the predicate device, the Arctic Sun Temperature Management System performs as intended, raises no new or different safety or effectiveness issues and is substantially equivalent 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).