(29 days)
Not Found
No
The description mentions an "internal control algorithm" but provides no details suggesting it uses AI or ML. The performance studies focus on standard engineering and software testing, not AI/ML validation. There are no mentions of AI, DNN, or ML in the provided text.
Yes
The device is indicated for "monitoring and controlling patient temperature," which is a physiological parameter. By actively controlling temperature within a therapeutic range (32°C to 38.5°C), it functions as a therapeutic intervention for conditions where temperature management is critical.
No
Explanation: The device monitors and controls patient temperature; it does not diagnose medical conditions.
No
The device description explicitly states that the system consists of a "Control Module," "associated accessories," and "ArcticGel Pads," and describes the physical process of circulating temperature-controlled water. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the Arctic Sun™ Temperature Management System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "monitor and control patient temperature." This is a physiological measurement and intervention performed directly on the patient, not on a sample taken from the patient.
- Device Description: The device description details a system that circulates temperature-controlled water through pads applied to the patient's skin. It uses a patient temperature probe to get feedback directly from the patient. This is a physical interaction with the patient for therapeutic and monitoring purposes.
- Lack of Mention of Samples: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is a defining characteristic of IVD devices.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Arctic Sun system does not perform this function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
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 system consists of the Arctic Sun Stat Control Module, associated accessories, and is used with the ArcticGel Pads. The Arctic Sun Stat Control Module and associated accessories are the subject of this submission. The Arctic Sun Stat Control Module 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 YSI 400 series compatible patient temperature probe connected to the Arctic Sun Stat Control Module provides patient temperature feedback to an internal control algorithm, which automatically increases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun Stat Control Module 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients of all ages.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria of the subject device were evaluated. No clinical testing was required to evaluate the changes for substantial equivalence. Using internal risks assessment procedures as well as FDA Guidance Documents on software, radio frequency wireless technology in medical devices, and reprocessing, the following tests were performed on the subject device.
The performance tests used to evaluate the proposed changes are based on methods previously provided to FDA in a previous 510(k) submission for the predicate device (K161602), as well as FDA recognized consensus standards and FDA Guidance documents. The testing methods from previous 510(k) submissions include artificial patient testing, software and graphical user interface testing, mechanical testing, and electrical testing. The FDA recognized consensus standards for Medical Electrical Equipment (MEE) detail test methods and these were executed on the subject device. A summary of these tests is provided along with references to the specific standards and previous submission. An explanation of any differences in those methods is provided, when applicable. The predicate device was most recently cleared in K161602. No clinical data or testing was required to evaluate the proposed device modifications that are the subject of this submission. The results from these tests demonstrate that the technological characteristics and performance criteria of the Arctic Sun Stat Temperature Management System are substantially equivalent to the predicate device and performs in a manner equivalent to devices currently on the market for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 28, 2020
Medivance, Inc. Jacquelyn Borinski Regulatory Affairs Specialist 321 South Taylor Ave, Suite 200 Louisville, Colorado 80027
Re: K200225
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: January 29, 2020 Received: January 30, 2020
Dear Jacquelyn Borinski:
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. 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 located 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely.
Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
510(k) Number (if known)
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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3
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: Jacquelyn Borinski Regulatory Affairs Specialist Phone: 720-880-5343 E-mail: Jackie.Borinski@bd.com
- Date of Submission: January 29, 2020
- Arctic Sun™ Stat Temperature Management System Subject Device Name:
Subject Device
| Device Trade Name | : Arctic Sun Stat Temperature Management System |
|---|---|
| Common Name | : Patient Temperature Management System |
| Regulation Name | : Thermal Regulating System |
| Regulation Number | : 21 C.F.R. 870.5900 |
| Product Code | : DWJ |
| Regulatory Class | : II |
| Classification Panel | : Cardiovascular |
| Prior Correspondence | : none |
Predicate Device
| 510(k) Number | : K161602 |
|---|---|
| Device Trade Name | : Arctic Sun Temperature Management System |
| Common Name | : Patient Temperature Management System |
| Regulation Name | : Thermal Regulating System |
| Regulation Number | : 21 C.F.R. 870.5900 |
| Product Code | : DWJ |
| Regulatory Class | : II |
| Classification Panel | : Cardiovascular |
| Prior Correspondence | : none |
4
Device Description
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 system consists of the Arctic Sun Stat Control Module, associated accessories, and is used with the ArcticGel Pads. The Arctic Sun Stat Control Module and associated accessories are the subject of this submission. The Arctic Sun Stat Control Module 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 YSI 400 series compatible patient temperature probe connected to the Arctic Sun Stat Control Module provides patient temperature feedback to an internal control algorithm, which automatically increases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun Stat Control Module 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.
Indications for Use of the Subject Device
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.
Indications for Use of the Predicate Device
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.
Comparison of Indications for Use to the Predicate Device
The indications for use statement for the subject device, the Arctic Sun Stat Temperature Management System, are identical to the predicate device.
5
Technological Comparison to Predicate Device
The subject Arctic Sun Stat Temperature Management System has the following similarities to the predicate device (K161602 for Arctic Sun Temperature Management System):
- Identical intended use ●
- o Identical indications for use
- . ldentical target population
- o Equivalent operating principle
- Identical fundamental scientific technology ●
- Similar cleaning process
- o Similar packaging materials and configuration
The subject Arctic Sun Stat Temperature Management System has the following differences when compared to the predicate device:
- Software modifications ●
-
- Updated the graphical user interface (GUI)
-
- Pad size selection available during therapy initiation
-
- Added 2nd option for the heat transfer indicator (Work to Cool)
-
- Added optional upper and lower patient temperature limits (Monitor Mode)
-
- Added alarm for upper and lower patient temperature limits (Monitor Mode)
-
- Added another data output method (Wi-Fi)
-
- Updated operating system (OS) and code architecture
-
- Removed the option for the user to upload a ipq
-
- Updated the default upper limit for water temperature control
-
- Updated the alarm naming and prioritization
-
- Component changes ●
- 11. Industrial design was changed to differentiate next generation product
-
- Added Wi-Fi card
-
- Changed the control panel
-
- Updated packaging based on industrial design change
- Labeling changes .
- 15. Clarifications in the instructions for use
-
- Added warning for additional information on electromagnetic interference
-
- Added warning for additional information on protection against the effects of discharge of cardiac defibrillators
-
- Added caution for heat transfer indicator (Work to Cool)
-
- Updated caution for manual control
-
- Added complication statement for targeted temperature management
- Other changes made to the predicate device since the last clearance
- 21. Added warning against use in the operating room
-
- Clarified the type of circulating fluid to be used in the device
-
- Added information regarding preventative maintenance
6
Performance Data
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria of the subject device were evaluated. No clinical testing was required to evaluate the changes for substantial equivalence. Using internal risks assessment procedures as well as FDA Guidance Documents on software, radio frequency wireless technology in medical devices, and reprocessing, the following tests were performed on the subject device.
| Proposed Change Type | ||||
|---|---|---|---|---|
| Software | Hardware | Labeling | ||
| FDA' s Criteria for | ||||
| Well-Established Methods | FDA recognized | |||
| consensus | ||||
| standards | • ES 60601-1 | |||
| • IEC 60601-1-8 | ||||
| • IEC 62304 | ||||
| • IEC 80601-2-35 | ||||
| • IEC 62366-1 | • ES 60601-1 | |||
| • IEC 60601-1-2 | • Medical | |||
| Electrical | ||||
| Equipment | ||||
| (MEE) | ||||
| standards | ||||
| FDA guidance | ||||
| documents | • Radio frequency | |||
| • Cybersecurity | ||||
| • Software | • Radio frequency | |||
| • Reprocessing | ||||
| Medivance, | ||||
| Inc.'s methods | ||||
| used in | ||||
| previous | ||||
| submissions | • Graphical user | |||
| interface (GUI) | ||||
| • Artificial patient | ||||
| • Regression | ||||
| • Alarm conditions | • Dimensional analysis | |||
| • Chiller response time | ||||
| • Artificial patient | ||||
| • Warming capacity | ||||
| • Water temp stability | ||||
| • Packaging integrity | ||||
| • Corrosion resistance | • Labeling | |||
| verification |
Summary of Performance Testing Used to Establish Substantial Equivalence
The performance tests used to evaluate the proposed changes are based on methods previously provided to FDA in a previous 510(k) submission for the predicate device (K161602), as well as FDA recognized consensus standards and FDA Guidance documents. The testing methods from previous 510(k) submissions include artificial patient testing, software and graphical user interface testing, mechanical testing, and electrical testing. The FDA recognized consensus standards for Medical Electrical Equipment (MEE) detail test methods and these were executed on the subject device. A summary of these tests is provided along with references to the specific standards and previous submission. An explanation of any differences in those methods is provided, when applicable. The predicate device was most recently cleared in K161602. No clinical data or testing was required to evaluate the proposed device modifications that are the subject of this submission. The results from these tests demonstrate that the technological characteristics and performance criteria of the Arctic Sun Stat Temperature Management System 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 subject device, Arctic Sun Stat Temperature Management System (including the Arctic Sun Stat Control Module and associated accessories), is substantially equivalent to the predicate device, the Arctic Sun Temperature Management System.
Confidential: This document contains information that is the confidential and proprietary property of BD. Neither this document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of BD.