KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS

K033021 · Kimberly-Clark Corp. · DWJ · Nov 12, 2003 · Cardiovascular

Device Facts

• Record ID: K033021
• Device Name: KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
• Applicant: Kimberly-Clark Corp.
• Product Code: DWJ · Cardiovascular
• Decision Date: Nov 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

System monitors and controls patient core temperature; consists of control unit and single-use energy transfer pads. Pads adhere to patient skin; control unit circulates temperature-controlled water through pads via flexible tubing. External probe senses patient core temperature; system adjusts water temperature to achieve target patient temperature. Used in clinical settings; operated by healthcare professionals. Output provides thermal regulation to manage patient temperature; aids clinical decision-making by maintaining normothermia or inducing mild hypothermia.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-1/USP), electrical safety (IEC601), and functional safety performance testing.

Technological Characteristics

Thermal regulating system; consists of control unit and single-use energy transfer pads. Circulates temperature-controlled water. Biocompatibility per ISO 10993-1/USP; electrical safety per IEC601.

Indications for Use

Indicated for patients requiring temperature control within the range of mild hypothermia to normothermia, including medical, surgical, febrile, accidental hypothermia, or heat stroke patients.

Regulatory Classification

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.

Predicate Devices

• MediVance Inc. ARTIC SUN™ Temperature Management System - Model 100 Control Unit and Energy Transfer Pads (K002577)

Submission Summary (Full Text)

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# Section 14

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

| 1. | Submitted by: | Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 |
|----|-------------------------------------|-----------------------------------------------------------------------------|
| | Contact Person: | Richard V. Wolfe<br>Manager, Regulatory Affairs |
| | Telephone:<br>Facsimile:<br>e-mail: | [phone]<br>[phone]<br>[e-mail] |
| | Date Prepared: | September 25, 2003 |

### 2. Device Name

| Trade / Proprietary Name: | Kimberly-Clark Patient Warming System - Model 100<br>Control 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

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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 100<br>Control Unit and Energy Transfer Pads |
| Indications for Use: | The KIMBERLY-CLARK* Patient Warming System is<br>intended for monitoring and controlling patient<br>temperature. The indications for use of the device include<br>any condition where patient temperature control within<br>the range covering mild hypothermia to normothermia is<br>required. |

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Concurrence of CDRH Office of Device Evaluation (ODE)

Q.M.Ollie

**(Division Sign-Off)**
**Division of Cardiovascular Devices**

K03302 | 510(k) Number_