The KIMBERLY-CLARK* Patient Warming System is intended for monitoring and controlling patient temperature. The indications for use of the device include any condition where patient temperature control within the range covering mild hypothermia to normothermia is required.

Device Description

The Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads is a device used to monitor and control patient temperature. It consists of single-use heat transfer pads, which are adhered to areas of the patient's skin, and a control module that circulates temperature-controlled water. The control module is connected to the pads by flexible tubing. A commercially available probe connected to the control module senses the patient's core temperature. The system can control the patient's core temperature by altering the temperature of the circulating water.

AI/ML Overview

This submission is for a 510(k) premarket notification for the Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads. The submission claims substantial equivalence to a predicate device, the MediVance Inc. ARTIC SUN™ Temperature Management System - Model 100, which was cleared under 510(k) # K002577. The core argument for substantial equivalence is that the Kimberly-Clark device is "identical in design" to the previously cleared MediVance device, and Kimberly-Clark acquired all product rights related to it.

Therefore, the study proving the device meets acceptance criteria relies on the prior clearance of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Since the submission states the device is "identical in design" to the predicate, and was previously cleared based on that predicate, the acceptance criteria and performance are implicitly met by virtue of the predicate device's clearance. There are no new performance metrics or acceptance criteria presented specifically for the Kimberly-Clark device.

Acceptance Criteria (Implied from Predicate)	Reported Device Performance (Implied from Predicate)
Biocompatibility in accordance with ISO 10993-1 and/or USP	Met (as evidenced by predicate clearance)
Electrical safety in accordance with IEC601	Met (as evidenced by predicate clearance)
Functional safety and safety performance	Met (as evidenced by predicate clearance)
Ability to monitor and control patient temperature within range of mild hypothermia to normothermia	Met (as evidenced by predicate clearance and identical design claim)

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

Not applicable. This 510(k) submission does not involve a new clinical study with a test set of data for the Kimberly-Clark device. The claim is based on the identical design to a previously cleared device. The "testing" mentioned refers to tests conducted for the original MediVance device.

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

Not applicable. No new ground truth for a test set was established for this submission.

4. Adjudication method for the test set:

Not applicable. No new test set requiring adjudication was performed.

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 AI-based diagnostic tool, so MRMC studies are not relevant.

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

Not applicable. This device is a thermal regulating system, not an algorithm, and intrinsically involves human interaction for setup and monitoring.

7. The type of ground truth used:

Not applicable for this submission. The "ground truth" for proving the device meets its intended use was established during previous testing of the predicate device, likely through:

Engineering verification and validation (e.g., temperature accuracy, control algorithms).
Biocompatibility testing against standards.
Electrical safety testing against standards.
Functional performance testing to demonstrate the ability to achieve and maintain target temperatures in vitro or in animal models (though details are not provided in this summary).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary of the Study Proving Acceptance Criteria:

The study proving the Kimberly-Clark Patient Warming System - Model 100 meets acceptance criteria is essentially the prior 510(k) clearance (K002577) of the MediVance Inc. ARTIC SUN™ Temperature Management System - Model 100.

According to the provided text:

"The Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads is the exact same medical device as MediVance's Artic Sun™ Temperature Management System which obtained FDA clearance on October 26, 2000." (Section 14, Pg 2, Item 8. Conclusions)
Kimberly-Clark "acquired all product rights related to the patient warming business from MediVance, Inc. on May 27, 2003." (Section 14, Pg 2, Item 6. Summary of technological characteristics)
"Testing of the Kimberly-Clark Patient Warming System -- Model 100 Control Unit and Energy Transfer Pads [under MediVance's 510(k) # K002577], included: biocompatibility testing in accordance with ISO 10993-1 and / or USP, electrical testing in accordance with IEC601 and functional safety and safety performance testing." (Section 14, Pg 2, Item 7. Testing)

Therefore, the Kimberly-Clark device meets its acceptance criteria because it is a re-submission of a device that has already undergone and passed the required testing for safety and effectiveness, leading to its original clearance by the FDA. The identical design and acquisition of product rights mean no new testing was deemed necessary for this specific 510(k) submission (K033021) to demonstrate substantial equivalence to the predicate.

Summary

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Section 14

Premarket Notification [510(k)] Summary

1.	Submitted by:	Kimberly-Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30076
	Contact Person:	Richard V. WolfeManager, Regulatory Affairs
	Telephone:Facsimile:e-mail:	(770) 587-8208(770) 587-7761richard.wolfe@kcc.com
	Date Prepared:	September 25, 2003

2. Device Name

Trade / Proprietary Name:	Kimberly-Clark Patient Warming System - Model 100Control Unit and Energy Transfer Pads
Common / Usual name:	Hypo / Hyperthermia System
Classification Name:	System, Thermal Regulating (per 21CFR 870.5900)

3. Predicate Device

The Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads is substantially equivalent to the MediVance Inc. ARTIC SUN™ Temperature Management System - Model 100 Control Unit and Energy Transfer Pads cleared under 510(k) # K002577.

4. Intended Use of the Device

The Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Clinical applications of this device include any condition where patient temperature control within a range covering mild hypothermia to normothermia is required. This would include, but not be limited to, medical, surgical, febrile, accidental hypothermia, or heat stroke patients.

5. Description of the Device

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K033021
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Section 14

Premarket Notification [510(k)] Summary (Continued)

6. Summary of the technological characteristics of the device compared to the predicate device

The Kimberly-Clark Patient Warming System -- Model 100 Control Unit and Energy Transfer Pads is identical in design to MediVance's Artic Sun™ Temperature Management System which obtained FDA clearance on October 26, 2000 under 510(k) number K002577 Kimberly-Clark acquired all product rights related to the patient warming business from MediVance, Inc. on May 27, 2003

7. Testing

Testing of the Kimberly-Clark Patient Warming System -- Model 100 Control Unit and Energy Transfer Pads [under MediVance's 510(k) # K002577], included: biocompatibility testing in accordance with ISO 10993-1 and / or USP, electrical testing in accordance with IEC601 and functional safety and safety performance testing.

8. Conclusions

The Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads is the exact same medical device as MediVance's Artic Sun™ Temperature Management System which obtained FDA clearance on October 26, 2000. Therefore, no new safety or effectiveness issues exist.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2003

Kimberly-Clark Corporation c/o Mr. Richard V. Wolfe 1400 Holcomb Bridge Road Roswell, GA 30076

Re: K033021

Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: September 25, 2003 Received: September 26, 2003

Dear Mr. Wolfe:

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 such 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. Richard V. Wolfe

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

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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Section 15

Indications For Use

Applicant:	Kimberly-Clark Corporation
510(k) Number:	K033021
Device Name:	Kimberly-Clark Patient Warming System - Model 100Control Unit and Energy Transfer Pads
Indications for Use:	The KIMBERLY-CLARK* Patient Warming System isintended for monitoring and controlling patienttemperature. The indications for use of the device includeany condition where patient temperature control withinthe range covering mild hypothermia to normothermia isrequired.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Q.M.Ollie

(Division Sign-Off)
Division of Cardiovascular Devices

K03302 | 510(k) Number_

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).