The WElkins EMT Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated.

The WElkins ICU Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated and monitoring of patient temperature.

Device Description

The WElkins EMT/ICU Temperature Management System is a thermoregulatory device that reduces and/or maintains patient body temperature within a range of 30℃ (86°F) to 37°C (98.6°F). The System delivers temperature-controlled coolant ranging between 5°C (41°F) and 25°C (77°F) from one of two Conditioning Units (EMT or ICU) to a patientcontacting Cooling Pad, resulting in heat exchange between the coolant and the patient.

The EMT Conditioning Unit is a lightweight, battery-powered pack for use in the field; patient temperature is controlled manually, by modulating the temperature of coolant circulated to the Cooling Pad, and must be monitored regularly during treatment. The ICU Conditioning Unit is an enhanced, microprocessor-driven version of the EMT Conditioning Unit designed for use in the hospital setting: it features a touchscreen graphical user interface and automatic patient temperature control, in addition to the same core hydraulic and pneumatic cooling system used in the EMT Conditioning Unit. A patient temperature probe connected to the ICU Conditioning Unit provides biofeedback to an internal control algorithm, which automatically modulates coolant temperature to achieve a patient target temperature determined by the clinician.

The Cooling Pad comes in Universal and Head-Neck configurations. The safety and effectiveness of the Cooling Pad has not been demonstrated for treatment of stroke or head trauma, and is not indicated for use in their treatment.

AI/ML Overview

The provided text describes a 510(k) submission for the WElkins EMT/ICU Temperature Management System. This is a medical device for thermal regulation, not an AI/ML powered device, therefore most of the requested information (such as sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or not available in the provided document.

However, based on the available information, here's a breakdown of the testing and performance data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it lists the types of testing performed to demonstrate substantial equivalence. The overall "acceptance criterion" in this context is demonstrating substantial equivalence to predicate devices for the FDA's 510(k) clearance.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Biocompatibility	Testing performed to affirm safety
Electromagnetic Compatibility	Testing performed to affirm safety and functionality
Electrical Safety	Testing performed to affirm safety
Functional Performance	Testing performed to demonstrate intended operation and effectiveness for thermal regulation within specified temperature ranges (30℃ to 37°C patient temp; 5°C to 25°C coolant temp). Specific performance metrics are not detailed, but the device is stated to reduce and/or maintain patient body temperature.
Substantial Equivalence	Determined to be substantially equivalent to existing legally marketed devices based on intended use, design, materials, principle of operation, and overall technological characteristics.

2. Sample size used for the test set and the data provenance

Not applicable. The document describes a medical device, not an AI/ML algorithm that would use a test set in this manner. The "testing" refers to standard medical device verification and validation activities (biocompatibility, electrical safety, functional performance) rather than a dataset for evaluating an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" in the AI/ML sense is mentioned or relevant for this device's submission.

4. Adjudication method for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a thermal regulating system, not an imaging analysis or diagnostic AI tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical system, not an algorithm. The ICU Conditioning Unit features a "microprocessor-driven version... with an internal control algorithm," which automatically modulates coolant temperature based on a patient temperature probe. This algorithm operates in a "standalone" capacity within the device to regulate temperature, but it's not a standalone AI diagnostic tool evaluated in the context of the requested question.

7. The type of ground truth used

Not applicable in the context of AI/ML performance evaluation. For functional performance, the "ground truth" would be the actual patient temperature and coolant temperature measurements, and the device's ability to maintain or adjust these within specified ranges.

8. The sample size for the training set

Not applicable. The device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K121720

AUG 2002012

510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	WElkins, LLC
DATE PREPARED:	3 August 2012
CONTACT PERSON:	Christopher Blodgett1430 Blue Oaks Blvd., Suite 250Roseville, CA 95747Phone: 207.449.6398Fax: 866.663.2271Email: christopher@welkinsmed.com
TRADE NAME:	WElkins EMT/ICU Temperature ManagementSystem
CLASSIFICATION NAME:	Thermal Regulating System
DEVICE CLASSIFICATION:	Class II
REGULATION NUMBER:	870.5900
PRODUCT CODE:	DWJ
PREDICATE DEVICES:	Cincinnati SubZero Blanketrol II (K110104)Medivance Arctic Sun 5000 (K101092)MedCool RapidCool (K070112)EMCOOLS EMCOOLSpad (K100071)

Substantially Equivalent To:

The WElkins EMT/ICU Temperature Management System is substantially equivalent in intended use, Principle of operation and technological characteristics to the Cincinnati SubZero Blanketrol II (K110104), Medivance Arctic Sun 5000 (K101092), MedCool RapidCool (K070112), and the EMCOOLS EMCOOLSpad (K100071).

Description of the Device Subject to Premarket Notification:

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ICU Conditioning Unit is an enhanced, microprocessor-driven version of the EMT Conditioning Unit designed for use in the hospital setting: it features a touchscreen graphical user interface and automatic patient temperature control, in addition to the same core hydraulic and pneumatic cooling system used in the EMT Conditioning Unit. A patient temperature probe connected to the ICU Conditioning Unit provides biofeedback to an internal control algorithm, which automatically modulates coolant temperature to achieve a patient target temperature determined by the clinician.

Indication for Use:

The WElkins EMT Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated.

The WElkins ICU Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated and monitoring of patient temperature.

Technological Characteristics:

The WElkins EMT/ICU Temperature Management System has the same technological characteristics and is similar in overall design, materials and configuration compared to the predicate device. It is substantially equivalent to the predicate in terms of:

. Indications for Use
. Basic design/configuration
. Where used
. Target population
. Cooling method

Testing and Performance Data:

. Biocompatibility
. Electromagnetic Compatibility
. Electrical Safety
. Functional Performance

Basis for Determination of Substantial Equivalence:

Upon reviewing and comparing intended use, design, materials, principle of operation and overall technological characteristics, the WElkins EMT/ICU Temperature Management System is determined by WElkins, LLC to be substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 20 2012

Welkins, LLC. c/o Mr. Mark Job 1394 25th Street NW Buffalo MN 55313

Re: K121720

Trade/Device Name: Welkins EMT/ICU Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: June 11, 2012 Received: June 12, 2012

Dear Mr. Job:

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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Page 2 - Mr. Mark Job

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/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 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 vours.

M.A. Hiller

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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INDICATIONS FOR USE STATEMENT

510(k) Number: K121720 Device Name: WElkins EMT/ICU Temperature Management System The WElkins EMT Temperature Management System is a thermal Indications for Use: regulating system, indicated for temperature reduction in patients where clinically indicated.

The WElkins ICU Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated and monitoring of patient temperature.

OR

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.A. Hillen

(Division Sign-Off) Division of Cardiovascular Devices

K124720 510(k) Number

Page of

Regulation Number and Section

§ 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).