(87 days)
Not Found
No
The description mentions an "internal control algorithm" which is a standard term for a deterministic control system, not necessarily AI/ML. There are no mentions of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML models.
Yes
The device is indicated for monitoring and controlling patient temperature, which directly contributes to patient therapy by helping to maintain physiological stability.
No
The device is described as a thermal regulating system that monitors and controls patient temperature. It does not identify or diagnose a disease or condition; rather, it provides therapy by managing temperature.
No
The device description explicitly states that the system consists of a Control Module and disposable ArcticGel Pads, which are hardware components. The description also details the physical process of circulating temperature-controlled water through the pads for heat exchange.
Based on the provided information, the Arctic Sun Temperature Management System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "monitor and control patient temperature." This is a physiological function performed directly on the patient's body, not on a sample taken from the body.
- Device Description: The device works by circulating temperature-controlled water through pads placed on the patient's skin to regulate their body temperature. This is a physical intervention, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Arctic Sun System does not fit this definition.
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.
Product codes
DWJ
Device Description
The Arctic Sun Temperature Management System is a thermoregulatory 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 Arctic Sun System consists of the Arctic Sun Control Module and disposable ArcticGel Pads.
A patient temperature probe connected to the Control Module 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 pulls temperature-controlled water ranging between 4°C and 42°C (39.2°F and 107.6°F) through the ArcticGel Pads, resulting in heat exchange between the water and the patient.
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
Not Found
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)
Full system software, performance, functional, and inspection verifications were performed on the Arctic Sun Model 5000.
Design verification of the system requirements and software validation of the control and monitor processors software requirements involved repeating the same or similar testing conducted on the predicate Arctic Sun Model 2000. Additionally, design verification and software validation of the new control panel software requirements was performed that confirmed functionality of the new control panel graphic user interface and the associated software, as well as communications with the internal control and monitor processors.
The verification and validation test results demonstrate that the new control panel graphic user interface functions as designed and the Arctic Sun Model 5000 is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION Premarket Notification [510(K)] Summary (per 21 CFR 807.92)
Company Name
Medivance, Inc. 321 South Taylor Avenue, Suite 200 Louisville, Colorado 80027
JUL 1 32010
| Contact Person: | Lynne Aronson |
|---|---|
| Director, Regulatory Affairs and Quality Assurance | |
| Telephone: | 303-926-1917 |
| Facsimile: | 303-926-1924 |
Device Name
Trade/Proprietary Name: Arctic Sun™ Temperature Management System, Model 2000 Common/Usual Name: Hypo/Hyperthermia System Classification Name: System, Thermal Regulating (per 21 CFR 870.5900)
Predicate Devices
The Arctic Sun™ Temperature Management System, Model 5000, is substantially equivalent to the following predicate devices:
| Arctic Sun Temperature Management System | Medivance, Inc. | K010338 |
|---|---|---|
| - Model 2000 | K071341 |
Intended use of the device
The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Description of the Device
The Arctic Sun Temperature Management System is a thermoregulatory 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 Arctic Sun System consists of the Arctic Sun Control Module and disposable ArcticGel Pads.
A patient temperature probe connected to the Control Module 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 pulls temperature-controlled water ranging between 4°C and 42°C (39.2°F and 107.6°F) through the ArcticGel Pads, resulting in heat exchange between the water and the patient.
1
Summary of the technological characteristics of the device compared to the predicate device.
The Arctic Sun Temperature Management System Model 5000 includes the following modifications:
- . Changed user interface from a LCD with membrane switch to an integrated PC with color graphical user interface (GUI) and touch screen, which also provides for the following new device features:
- . New streamlined industrial design of the console:
- Associated software modifications required to implement the new graphical user I interface and console configuration.
Testing
Full system software, performance, functional, and inspection verifications were performed on the Arctic Sun Model 5000.
Design verification of the system requirements and software validation of the control and monitor processors software requirements involved repeating the same or similar testing conducted on the predicate Arctic Sun Model 2000. Additionally, design verification and software validation of the new control panel software requirements was performed that confirmed functionality of the new control panel graphic user interface and the associated software, as well as communications with the internal control and monitor processors.
The verification and validation test results demonstrate that the new control panel graphic user interface functions as designed and the Arctic Sun Model 5000 is safe and effective for its intended use.
Conclusions
Based upon the testing and comparison to the predicate device, the Arctic Sun Temperature Management System performs as intended and raises no new safety or effectiveness issues.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 6 2010
Medivance c/o Ms. Lynne Aronson Director, Regulatory Affairs and Quality Assurance 321 South Taylor Avenue Suite 200 Louisville, CO 80027
Re: K101092
Arctic Sun® Temperature Management System - Model 5000 Control Unit Regulation Number: 21 CFR 870.5900 Regulation Name: System, Thermal Regulating Regulatory Class: Class II Product Code: DWJ Dated: June 1, 2010 Received: June 2, 2010
Dear Ms. Aronson:
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.
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
3
Page 2 - Ms. Lynne Aronson
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
R. vacher
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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STATEMENT: INDICATION FOR USE
510 (k) Number: K101092
Arctic Sun Temperature Management System Device Name:
Indications for Use:
The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Prescription Use Over the Counter Use X (Part 21 CFR 801 Subpart D) and/or (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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