(47 days)
Not Found
No
The description focuses on a hardware-based system for temperature control using circulating water and a temperature probe, with no mention of AI or ML algorithms for control or analysis.
Yes
The device is used to regulate patient temperature for therapeutic purposes, such as addressing hypothermia, which is a medical condition requiring treatment.
No
Explanation: The device is intended for monitoring and controlling patient temperature, which is a therapeutic function rather than a diagnostic one. While it senses patient temperature, this is for feedback in the control process, not for diagnosing a condition.
No
The device description explicitly states it consists of single-use heat transfer pads, a control module, flexible tubing, and a commercially available probe, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "monitoring and controlling patient temperature." This is a therapeutic and monitoring function performed directly on the patient's body.
- Device Description: The device works by circulating temperature-controlled water through pads adhered to the patient's skin and uses a probe to sense core temperature. This is a physical intervention and measurement on the patient.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not involve the analysis of such specimens.
The device is clearly designed for direct patient care and temperature management, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
DWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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Section 14
Premarket Notification [510(k)] Summary
| 1. | Submitted by: | Kimberly-Clark Corporation
1400 Holcomb Bridge Road
Roswell, GA 30076 |
|----|-------------------------------------|-----------------------------------------------------------------------------|
| | Contact Person: | Richard V. Wolfe
Manager, Regulatory Affairs |
| | Telephone:
Facsimile:
e-mail: | (770) 587-8208
(770) 587-7761
richard.wolfe@kcc.com |
| | Date Prepared: | September 25, 2003 |
2. Device Name
| Trade / Proprietary Name: | Kimberly-Clark Patient Warming System - Model 100
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.
1
K033021
p 2/2
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.
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
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.
3
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
4
Section 15
Indications For Use
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K033021 |
| Device Name: | Kimberly-Clark Patient Warming System - Model 100 |
| Control Unit and Energy Transfer Pads | |
| Indications for 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. |
(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_