KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS

K011859 · Klimamed Technologie Medizingerate GmbH · DWJ · May 1, 2002 · Cardiovascular

Device Facts

• Record ID: K011859
• Device Name: KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
• Applicant: Klimamed Technologie Medizingerate GmbH
• Product Code: DWJ · Cardiovascular
• Decision Date: May 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The device is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors

Device Story

External thermal regulating system; consists of carbon-technology heating mat and temperature controller. Mat sizes: 95W (adult) and 55W (pediatric). Heating element and sensor embedded in mat. Regulates patient temperature between 30-37.7°C (86-100°F). Used in clinical settings (hospitals, OR, recovery, burn units) by physicians/clinical staff. Controller maintains physician-set temperature; supports normothermia during surgery. Benefits patient by preventing hypothermia/maintaining thermal stability.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Thermal regulating system using carbon-based heating technology. Includes controller and mat (95W adult, 55W pediatric). Embedded heating element and sensor. Dimensions: 0.950x0.495m (adult) or 0.550x0.495m (pediatric), 9mm height. Class II device (21 CFR 870.5900).

Indications for Use

Indicated for maintaining pre-set body temperature in adult and pediatric patients. Used in hospital invasive/coronary care units, operating, recovery, and emergency rooms, burn units, and medical/surgical floors. Prescription use only.

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

• Allon 2001 by M.T.R.E Advanced Technology, Ltd (K001546)

Submission Summary (Full Text)

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MAY 0-1 2002

K011859

# 510(k) Summary As Required by 21 section 807.92 ( c )

1-Submitter Name: Klimamed® Technologie Medizingeräte GmbH

- 2-Address: Oderstr 3 D-71083
Herrenberg GERMANY

- (011) 49-7032-83190 3-Phone:
- 4-Fax: [phone]

Thomas Schneider, quality inspector 5-Contact Person:

6-Date summarv prepared: May 30tt, 2001

7- Official Correspondent: Mansour Consulting

- 8- Address: 1308 Morningside Park Dr
Alpharetta, GA 30022 USA

- 9- Phone: [phone]
- 10- Fax [phone]

11- Contact person: Jay Mansour, president

12-Device Trade or Proprietary Name: Klimamed® Thermal Mat & Controller 95 & 55 Watts

13-Device Common or usual name: Thermal mat and controller

14-Device Classification Name: System, Thermal regulating

15-Substantial Equivalency is claimed against the following device:

- Allon 2001 by M.T.R.E Advanced Technology, Ltd (refer to appendix 2) .
- 16-Description of the Device:

# DESCRIPTION/INDICATION FOR USE by physicians in clinics and hospitals

This device is an external thermal regulating system consisting of a mat that is placed in contact with the patient and a temperature controller and is to regulate the patient's temperature between 30 and 37.7 ℃ (86 and 100ºF), using carbon technology

The heating element and sensor are both embedded inside the mat. Two mat sizes are available:

- 1- 95 Watts, Standard 0.950 by 0.495 meters (3.1 by 1.6 ft) and 9mm high (0.35 inches) weighing 5 kg (11 lbs) (Product code 75/95/12M) for adult patients
- 2- 55 Watts, Pediatric 0.550 by 0.495 meters (1.8 by 1.6 ft) and 9mm high (0.35 inches) weighing 3.5 kg (7.7 lbs) (Product code 55/95/12M) for pediatric patients

75/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 75/95/12M 55/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 55/95/12M

The device is intended to maintain pre-set body temperature as determined by the physician. It can also be utlized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors

# 17-Intended use of the device:

The device is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors

# 18-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above.

This is better expressed in the tabulated comparison (Paragraph 19 below)

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19-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that Klimamed® mat & controller is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency detailed chart path is attached.

| FDA file reference number | 510k K001546 |
|--------------------------------------------------|------------------------|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Similar |
| Thermal safety | Similar |
| Radiation safety | Similar |

# REFER TO PAGES 9 AND 10 FOR DETAILED INFORMATION

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines emanating from its head, representing health, services, and people.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Klimamed® Technologie Medizingeräte GmbH c/o Mr. Jav Mansour President Mansour Consulting 1308 Morningside Park Drive Alpharetta, GA 30022

Re: K011859

Trade Name: Klimamed® Thermal Mat & Controller 95 & 55 Watts Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: January 21, 2002 Received: January 31, 2002

### Dear Mr. Mansour:

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. Jay Mansour

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Donna-Bea Tillman, Ph.D.

nna-Bea Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): K011859

Device Name: THER HAL HAT & Contreautes ( REF. 75/95/12 PRM & S Indications For Usc:

THIS DEVICE IS INDICATED TO MAINTAIN PRESET BODY TEMPERATURE AS DETERMINED By THE PHYSICIAN.

IT CAN ALSO BE UTILIZED TO MAINTAIN NORMAL BODY TEMPERATURE DURING SURCICAL PROCEDURES .

IT IS INDICATED FOR USE IN HOSPITAL INVASIVE AND CORONARY CARD UNITS, IN OPERATING, RECOVERY AND EMERGENCY IN BURN UNITS, Rock's AND ON MEDICAL | SURGICAL floors

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011859

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1.2.96)