(87 days)
The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.
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.
Here's an analysis of the provided text regarding the Arctic Sun™ Temperature Management System, Model 5000, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific pass/fail acceptance criteria in a quantitative format (e.g., "accuracy ±X°C"). However, it broadly describes the testing performed and the conclusion drawn.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| New features functional as designed: New GUI, touch screen, streamlined industrial design, associated software modifications. | "The verification and validation test results demonstrate that the new control panel graphic user interface functions as designed." "The Arctic Sun Model 5000 is safe and effective for its intended use." |
| Performance equivalent to predicate device: Meeting and controlling patient temperature within 32°C to 38.5°C. Water temperature ranging between 4°C and 42°C. | "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." |
| No new safety or effectiveness issues. | "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. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test set. It mentions "Full system software, performance, functional, and inspection verifications" and "Design verification of the system requirements and software validation of the control and monitor processors software requirements."
The data provenance is for a medical device submitted to the US FDA for 510(k) clearance, implying the testing was prospective as part of the device's development and regulatory submission. The country of origin for the data is not explicitly stated but is implicitly related to Medivance, Inc. in Louisville, Colorado, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described appears to be primarily engineering and software verification/validation, not a clinical study involving human expert judgment for "ground truth."
4. Adjudication Method for the Test Set
This information is not provided as the type of testing described (engineering/software verification) does not typically involve an adjudication method in the way a clinical study would.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The submission is for a thermal regulating system, and the testing described focuses on the functionality and safety of the device itself, particularly changes to the user interface and software, rather than evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, effectively, a standalone performance evaluation was done. The "control algorithm" mentioned in the device description operates automatically based on patient temperature feedback. The "software validation of the control and monitor processors software requirements" would be an evaluation of this algorithm's performance in achieving and maintaining target temperatures without direct human intervention in the temperature regulation process itself.
7. Type of Ground Truth Used
For the performance aspects (monitoring and controlling temperature), the ground truth would be objective physical measurements (e.g., calibrated temperature sensors) rather than expert consensus, pathology, or outcomes data. For the software and user interface, the ground truth would be adherence to design specifications and functional requirements.
8. Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. While the device utilizes a "control algorithm," the documentation does not indicate that this algorithm was developed using machine learning with a distinct training set. It's more likely a rule-based or PID (Proportional-Integral-Derivative) control system that doesn't traditionally have a "training set" in the sense of supervised learning. Therefore, this information is not applicable/provided.
9. How the Ground Truth for the Training Set Was Established
As explained above, a "training set" with established ground truth is not mentioned or implied for this device's control algorithm. The ground truth for developing and validating such a system typically comes from engineering principles, mathematical modeling, and previous predicate device data.
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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.
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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.
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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
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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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ാന of Cardiovascular Devices
1:) Number_K101092
§ 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).