(87 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Arctic Sun Temperature Management System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than an efficacy study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in this document.
However, I can extract information related to the device description, biocompatibility, and performance testing, which are relevant to the device meeting certain criteria for substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on comparative testing to demonstrate substantial equivalence to predicate devices. The "performance" mentioned is that the device performs as intended and its performance is substantially equivalent to predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Non-cytotoxic | Fabric material found non-cytotoxic (ISO 10993-05) |
| Non-irritating | Fabric material found non-irritating (ISO 10993-10) |
| Non-sensitizing | Fabric material found non-sensitizing (ISO 10993-10) |
| Similar Cooling Capacities | Small Universal ArcticGel Pad and Neonatal ArcticGel Pad provide similar cooling capacities to predicate devices. |
| Similar Durations | Small Universal ArcticGel Pad and Neonatal ArcticGel Pad provide similar durations to predicate devices. |
| Performs as Intended | Arctic Sun Temperature Management System (Arctic Sun 5000 Console and ArcticGel Pads) performs as intended. |
| No New Safety/Effectiveness Issues | Raises no new safety or effectiveness issues. |
| Substantially Equivalent | Substantially equivalent to predicate devices (K101092, K002577, K100585) in indications for use, design, technological characteristics, materials, and system features/functions. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state a sample size for a "test set" in the context of an efficacy study. The testing performed was "Biocompatibility and Performance Testing" for the Small Universal ArcticGel Pad and Neonatal ArcticGel Pad.
- Sample Size: Not specified. Biocompatibility testing typically involves in-vitro and in-vivo tests with specific sample numbers for each test, but these are not detailed here. Performance testing would involve a set of pads, but the quantity is not given.
- Data Provenance: Not specified, but likely from internal Medivance, Inc. studies as part of their 510(k) submission. There is no mention of country of origin of data, or if it was retrospective or prospective clinical data. It appears to be bench/laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document describes biocompatibility and performance testing against industry standards (ISO 10993) and comparison to predicate devices, not an expert-driven ground truth for a clinical test set.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication of a test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned. This is a thermal regulating system, not an imaging or diagnostic device where human reader performance with or without AI assistance would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an automated system (Arctic Sun 5000 Control Module) that automatically adjusts water temperature based on a control algorithm and sensed patient core temperature. While the control algorithm operates "standalone" in automatic mode, the document does not describe "standalone performance" in the context of a diagnostic algorithm or AI system for interpretation that would typically require such studies. It details that the system's performance (including the algorithm's control) was "substantially equivalent" to predicate devices.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth was established by adherence to recognized international standards (ISO 10993-1, 10993-05, and 10993-10). These standards define the methods and acceptance criteria for cytotoxicity, irritation, and sensitization.
- Performance: Ground truth for comparative performance (cooling capacities and durations) was the performance of the predicate devices. The new pads were compared to these established devices.
8. The Sample Size for the Training Set
No training set is mentioned. This is not a machine learning device that would typically involve a "training set" for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned.
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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
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.
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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
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| 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)
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) | 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 200Louisville, CO 80027 USA | ||||
|---|---|---|---|---|---|
| Contact: | Stacci Cronk, RACSenior Regulatory Affairs SpecialistPh: 303-327-5151Fax: 720-880-5400E-mail: stacci.cronk@crbard.com | ||||
| Date Prepared: | September 19, 2014 | ||||
| Trade Name:Common/Usual Name:Classification Name:Requlation:Classification:Product Code: | Sun® TemperatureManagementArcticSystem(including the ArcticGel™ pads)patient temperature management systemsystem, thermal regulating21 CFR §870.5900DWJ |
Predicate Device(s):
| Arctic Sun® Temperature Management System(including the ArcticGel™ pads) | Medivance, Inc. | K101092K002577 |
|---|---|---|
| Medi-Therm® Hyper/Hypothermia System(including Hyper/Hypothermia blanket(s)/bodywrap(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.
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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.
§ 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).