KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET

K031728 · Klimamed Technologie Medizingerate GmbH · DWJ · Oct 12, 2004 · Cardiovascular

Device Facts

• Record ID: K031728
• Device Name: KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET
• Applicant: Klimamed Technologie Medizingerate GmbH
• Product Code: DWJ · Cardiovascular
• Decision Date: Oct 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The device is intended to warming pre-set body temperature as determined by the physician. It can also be utilized to warming 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. The device has heating capability, not cooling.

Device Story

External thermal regulating system; consists of carbon-technology heating blankets and temperature controller. Inputs: physician-determined temperature set-point. Operation: controller regulates embedded heating elements to maintain patient temperature between 30-40°C (86-104°F). Output: controlled thermal energy. Used in hospitals (OR, recovery, ICU, burn units) by physicians/nurses. Benefits: maintains normothermia during surgery or clinical care. Heating only; no cooling function.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Thermal regulation system using carbon-based heating elements. Includes controller and four blanket sizes (pediatric, adult, arm/shoulder, leg warmer) ranging from 40W to 140W. Embedded sensors for temperature monitoring. Heating range 30-40°C. Class II device (21 CFR 870.5900).

Indications for Use

Indicated for patients in hospital settings including invasive/coronary care, operating, recovery, emergency, and burn units, or medical/surgical floors requiring body temperature warming as determined by a physician.

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

• Klimamed® Thermal Mats (K011859)

Submission Summary (Full Text)

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#### 007 1 % 2004

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

| 1-Submitter Name: | Klimamed® Technologie Medizingeräte GmbH |
|--------------------------------------|------------------------------------------------------|
| 2-Address: | Oderstr 3 D-71083<br>Herrenberg GERMANY |
| 3-Phone: | (011) 49-7032-83190 |
| 4-Fax: | (011) 49-7032-83290 |
| 5-Contact Person: | Thomas Schneider, quality inspector |
| 6-Date summary prepared: | July 21st, 2004 |
| 7- Official Correspondent: | Mansour Consulting LLC |
| 8- Address: | 1308 Morningside Park Dr<br>Alpharetta, GA 30022 USA |
| 9- Phone: | [phone] |
| 10- Fax | [phone] |
| 11- Contact person: | Jay Mansour, president |
| 12-Device Trade or Proprietary Name: | Klimamed® Thermal Blankets, including Arm |

Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket

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

System, Thermal regulating 14-Device Classification Name:

15-Substantial Equivalency is claimed against the following device:

- Klimamed® Thermal Mats, 510k # K011859 (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 blankets that are placed in contact with the patient, and a temperature controller and is to warming the patient's temperature using carbon technology between 30 and 40 ℃ (86 and 104ºF). The function of the device is heating, not cooling.

- The heating element and sensor are both embedded inside the blankets. Four blanket sizes are available:
- 11- 100 Watts, Pediatric: 1.0 by 0.65 meters (3.3 by 2.17) and 3mm high (0.12 inches) weighing 0.9 kgs (Product code WD-01-100)
- 2 140 Watts, Adult: 2.0 by 1.35 meters (6.6 by 4.5 ft) and 3mm high (0.12 inches) weighing 2.0 kgs (Product code WD-01-200)
- 3- 40 Watts, Arm Shoulder: 1.5 meters (5.0 ft) and 3mm high (0.12 inches) weighing 1.0 kg (Product code 150-AW)
- 4- 50 Watts, Leg Warmer: 0.95 meters (3.17 ft) and 3mm high (0.12 inches) weighing 1.2 kgs (Product code 100-DB)

The device is intended to warming pre-set body temperature as determined by the physician. It can also be utilized to warming 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. The device has heating capability, not cooling.

#### 17-Intended use of the device:

The device is intended to warming pre-set body temperature as determined by the physician. It can also be utilized to warming 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. The device has heating capability, not cooling.

#### 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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K031728

p212

## 19-Summary comparing technological characteristics with other predicate device:

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

| FDA file reference number | 510k K011859 |
|--------------------------------------------------|----------------------------|
| 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 (not applicable) |
| Biocompatibility | Similar |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Identical |

REFER TO MAIN SUBMISSION FOR DETAILED INFORMATION

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The overall design is simple and conveys a sense of national identity and governmental authority.

OCT 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Klimamed® Technologie Medizingerate GmbH c/o Mr. Jay Mansour Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022

Re: K031728

K031728
Klimamed® Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulation System Regulatory Class: Class II (two) Product Code: DWJ Dated: July 21, 2004 Received: August 13, 2004

Dear Mr. Mansour:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(t) premaire is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have decemblied the devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chaculture auth the provisions of the Federal Food, Drug, devices that have been reculted in accordance was are approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements for annual management general controls provisions of the fret merade comments of the summer misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mist exist ease increase and more can and may be subject to such additional controller Entroling and to 898. In addition, FDA may be found in the Code of Federal Tregations, 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 Please be advised that FDA s issualled of a bacamate requirements of the Act that FDA has made a determination administered by other Federal agencies. You must of any Federal statutes and regulations daminders but not limited to: registration and listing (21 comply with an the Act 3 requirements, not 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 807), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declines on a sectibed in your Section 510(k) I his letter will anow you to ocgin manetally your and equivalence of your device to a legally premarket notification. The PDA maing of basification 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 If you desire speedine at 1301) 594-4646. Additionally, for questions on the comact the Office of Compitance an evice, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to (2017) 574-4057. Allso, production and obtain. Other general information on your premarks. Inomicallon - (2) Of ICP are also obtained from the Division of Small Manufacturers, Itsponsibilities ander the Are Hey so out its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blummenhof

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

510(k) Number (if known): K031728

Device Name: THERMAL BLANKETS AND CONTROLLER

Indications For Use:

THERMAL BLANKETS AND CONTROLLER

- 1- 40 Watts Arm Shoulder blanket and controller
- 2- 50 Watts Leg Warmer blanket and controller
- 3- 100 Watts Thermal pediatric blanket and controller

3- 140 Watts Adult Thermal blanket and controller

The device is intended to warming pre-set body temperature as determined by the physician. The device is intended to warming pro oct body temperature during surgical procedures. It is It can also be unitized to warming normal care units, in operating, recovery and thurcated for use in nosplan madical / surgical floors. The device has heating capability, not cooling.

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimmlama

(Division Sian-Off) Cordiovascular Devices 510(k) N

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