(87 days)
Not Found
No
The description mentions a "control algorithm" but provides no details suggesting it utilizes AI or ML. The focus is on a feedback loop based on temperature sensing and water temperature adjustment.
Yes
The device is indicated for "monitoring and controlling patient temperature," and its mechanism of action involves actively adjusting water temperature to achieve a desired patient temperature, which directly influences the patient's physiological state to provide a therapeutic benefit.
No
The device is a thermal regulating system designed to control patient temperature, not to diagnose a condition or disease.
No
The device description clearly outlines hardware components including a control module, disposable pads, and temperature probes, indicating it is not software-only.
Based on the provided text, 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 function of the patient's body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device works by circulating temperature-controlled water through pads applied to the patient's skin to directly influence their body temperature. It uses a temperature probe to measure core body temperature. This is a physical intervention and measurement, not an in vitro test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Arctic Sun Temperature Management System is a therapeutic and monitoring device that acts directly on the patient's body, not an IVD device that analyzes samples outside the body.
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
DWJ
Device Description
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.
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)
Biocompatibility testing performed in accordance with ISO 10993-1, 10993-05 and 10993-10 demonstrated the fabric material used on Small Universal ArcticGel Pad and Neonatal ArcticGel Pad to be non-cytotoxic, non-irritating and nonsensitizing.
Comparative performance testing demonstrated that the performance of the Small Universal ArcticGel Pad and Neonatal ArcticGel Pad is substantially equivalent to that of the predicate devices.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple, clean, and easily recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Medivance, Inc. % Stacci Cronk Senior Regulatory Specialist 321 South Taylor Avenue Suite 200 Louisville, Colorado 80027
Re: K142702
Trade/Device Name: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System
Regulatory Class: Class II Product Code: DWJ Dated: November 26, 2014 Received: November 28, 2014
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.
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 (reporting of medical devicerelated 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 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
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number: | K142702 | |||
|---|---|---|---|---|
| Device Name: | Arctic Sun® Temperature Management System | |||
| (including the ArcticGel™ pads) | ||||
| 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. | |||
| Prescription Use: ☑ | or | Over the Counter Use ☐ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
) | MEDICAL
Image /page/3/Picture/1 description: The image shows the logo for Medivance. The logo consists of a blue, curved line on the left side and the word "Medivance" in orange on the right side. The logo is simple and modern.
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR §807.92 for the Arctic Sun® Temperature Management System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
| Sponsor: | Medivance, Inc.
A wholly owned subsidiary of C. R. BARD, Inc.
321 South Taylor Avenue, Suite 200
Louisville, CO 80027 USA | | | | |
|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact: | Stacci Cronk, RAC
Senior Regulatory Affairs Specialist
Ph: 303-327-5151
Fax: 720-880-5400
E-mail: stacci.cronk@crbard.com | | | | |
| Date Prepared: | September 19, 2014 | | | | |
| Trade Name:
Common/Usual Name:
Classification Name:
Requlation:
Classification:
Product Code: | Sun® Temperature
Management
Arctic
System
(including the ArcticGel™ pads)
patient temperature management system
system, thermal regulating
21 CFR §870.5900
DWJ | | | | |
Predicate Device(s):
| Arctic Sun® Temperature Management System
(including the ArcticGel™ pads) | Medivance, Inc. | K101092
K002577 |
|--------------------------------------------------------------------------------------------------|------------------------|--------------------|
| Medi-Therm® Hyper/Hypothermia System
(including Hyper/Hypothermia blanket(s)/body
wrap(s)) | Gaymar Industries Inc. | K100585 |
Device Description: 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.
4
I MEDICAL
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.
Indications for Use: The Arctic Sun Temperature Management System is a thermal requlating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.
Substantial Equivalence: The Arctic Sun Temperature Management System (Arctic Sun 5000 Control Module and ArcticGel Pads) was shown to be substantially equivalent in indications for use, design, technological characteristics, materials and system features and functions to the predicate devices.
The Arctic Sun Temperature Management System (Arctic Sun 5000 Control Module and ArcticGel Pads) proposed Indications for Use is the same as the predicate Arctic Sun Temperature Management System with the addition of a defined patient population. The predicate Medi-Therm Hypothermia System Indications for Use contains the proposed "adult and pediatric patients" verbiage.
The Small Universal ArcticGel Pad, Neonatal ArcticGel Pad and the predicate ArcticGel Pads and Gaymar Blankets are noninvasive surface temperature management devices. Additionally, the Small Universal and Neonatal ArcticGel Pads and the predicate ArcticGel Pads may be used in with the Arctic Sun Temperature Management System for use in continuous patient temperature monitoring and control.
The Small Universal ArcticGel Pad, Neonatal ArcticGel Pad and the predicate devices are manufactured from common biocompatible materials that are common to many disposable medical devices.
The Small Universal ArcticGel Pad, Neonatal ArcticGel Pad and the predicate devices are of similar sizes and weights, and provide similar cooling capacities and durations.
Biocompatibility and Performance Testing:
Biocompatibility testing performed in accordance with ISO 10993-1, 10993-05 and 10993-10 demonstrated the fabric material used on Small Universal ArcticGel Pad and Neonatal ArcticGel Pad to be non-cytotoxic, non-irritating and nonsensitizing.
Comparative performance testing demonstrated that the performance of the Small Universal ArcticGel Pad and Neonatal ArcticGel Pad is substantially equivalent to that of the predicate devices.
Conclusions: Based on the testing and comparison to the predicate devices, the Arctic Sun Temperature Management System (Arctic Sun 5000 Console and ArcticGel Pads) performs as intended, raises no new safety or effectiveness issues and is substantially equivalent to the predicate devices.