EMCOOLSPAD

K100071 · Emcools Emergency Medical Cooling Systems AG · NZE · Oct 12, 2010 · Cardiovascular

Device Facts

• Record ID: K100071
• Device Name: EMCOOLSPAD
• Applicant: Emcools Emergency Medical Cooling Systems AG
• Product Code: NZE · Cardiovascular
• Decision Date: Oct 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Temperature reduction in adult patients where clinically indicated, e.g. in hyperthermic patients.

Device Story

EMCOOLSpad is a single-use, non-invasive surface cooling device. It consists of thermoplastic polyurethane cooling cells filled with high thermal conductivity material, stored frozen at 0 to -10°C. Pads adhere to patient skin; cooling occurs via passive heat exchange (balancing process) where body heat melts the pad contents. Clinicians manually apply or remove pads to regulate core temperature, monitored via third-party temperature probes and monitors. Device is intended for adult patients requiring temperature reduction. Benefits include controlled, non-invasive cooling without active power sources.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and animal studies. Bench testing compared cooling rates against predicate devices. Animal testing (pigs) assessed skin safety over 24 hours and 1 week, reporting no skin damage.

Technological Characteristics

Non-invasive surface cooling pad. Materials: Thermoplastic polyurethane cells with high thermal conductivity filler. Dimensions/form factor: Adherent pads. Energy source: Passive (stored frozen at 0 to -10°C). Connectivity: None (standalone). Sterilization: Not specified. Biocompatibility: Tested per ISO 10993-1, -5, -10, -12.

Indications for Use

Indicated for temperature reduction in adult patients where clinically indicated, such as hyperthermic 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

• Arctic Sun® Model 2000 Temperature Management System (K010338)
• Thermosuit™ Hypothermia System (K061023)

Submission Summary (Full Text)

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www.emcools.com

K100092
EMCO

# 510k Summary per 21 CFR 807.92 (c)

# Submitted by / Contact Data

| Submitter: | EMCOOLS - Emergency Medical Cooling Systems AG | | |
|-----------------|------------------------------------------------|--|--|
| | Brucknerstrasse 6/7a | | |
| | 1040 Wien (Vienna) | | |
| | Österreich (Austria) | | |
| Contact Person: | Michael Kühling | | |
| Title: | CEO | | |
| Tel.: | [phone] - 185 | | |
| Fax: | + 43 2252 890 152 - 119 | | |
| Email: | [e-mail] | | |

October 2009 - August 2010

Date prepared:

## Device Name

| Trade Name: | EMCOOLSpad |
|----------------------|-------------------------------------------------|
| Common/Usual Name: | Hypothermia System |
| Classification Name: | System/Thermal Regulating (per 21 CFR 870.5900) |
| Product Code | NZE |

# Predicate Devices

| No | Model | Producer | 510(k) |
|----|---------------------------------------------------------|-----------------------------------------------------------------------------|---------|
| 1 | Arctic Sun® Model 2000<br>Temperature Management System | Medivance, Inc.<br>321 South Taylor Ave., Suite 200<br>Louisville, Colorado | K010338 |
| 2 | Thermosuit™<br>Hypothermia System | Life Recovery Systems HD<br>150 Hopper Avenue,<br>Waldwick, New Jersey | K061023 |

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1

Brucknerstrasse 6/7a * A-1040 Vienna, Austria * Tel: [phone] * Fax: [phone] 119 E-Mail: [e-mail]

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Image /page/1/Picture/1 description: The image is completely white and contains no discernible content. There are no objects, shapes, or patterns visible. The image appears to be a blank canvas.

Image /page/1/Picture/2 description: The image is a logo for EMCOOLS. The logo features the text "EMCOOLS" in a bold, sans-serif font. Above the text is a graphic that resembles a stylized waveform or heartbeat line, suggesting a connection to technology or medical fields. The overall design is simple and modern, with a focus on readability and brand recognition.

Device Description

www.emcools.com

The EMCOOLSpad is a single use surface (skin) cooling device, which is adherent to the patien's skin and so highly adjustable during the cooling procedure.

An EMCOOLSpad consists of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material, stored frozen at 0 to -10°C.

### Physics and Mechanism Summary

In nature there is always an automatically started balancing-process among interacting subjects, this process stops automatically when a perfectly balanced energy level is reached.

For the EMCOOLSpad and the patient this interaction process is started automatically when the pads are adhered to the skin (see sketch below) and ends automatically with a balanced energy level between cold pad and warm skin.

If you remove EMCOOLSpads from the patient 's body, another balancing-process commences automatically, leading to a slow and mild re-warming, again to a certain "balanced level".

Image /page/1/Figure/10 description: This image shows the heat exchange mechanism of the EMCOOLSpads. The diagram shows the skin and body with arrows indicating the flow of cold and warm energy. The legend indicates that the white space represents pad cells, and the white lines represent cell covers. The arrows show the direction of heat transfer between the skin and body.

Between start-point and end-point of this balancing process, the cold goes into the skin vertically and locally first, but immediately is "transported" away into the complete human body and cools it down. Seen from the patient 's perspective the warmth of the body and skin is "transported" into the pad and melts it.

### User and Patient Interface

The patient's core temperature is regulated within in a certain temperature range by manually removing (= warming) or applying (=cooling) the EMCOOLSpads.

## Device Interface

A commercially available third-party temperature probe connected to a commercially available third-party monitor senses the patient's core temperature.

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Image /page/2/Picture/1 description: The image shows a logo with the text "EMCOOLS" in bold, block letters. Above the text, there is a stylized graphic that resembles a waveform or a mountain range. The logo is black and white, with the text and graphic appearing in black against a white background.

www.emcools.com

# Intended Use of the Device

Temperature reduction for adult patients where clinically indicated, e.g. in hyperthermic patients.

# Summary of the technological characteristics of the device compared to the predicate device

| Device →<br>Criteria ↓ | Arctic Sun®<br>K010338 | EMCOOLSpad | Thermosuit™<br>K061023 |
|--------------------------------------------------------------------------------|------------------------|------------|------------------------|
| Thermal regulating system | Yes | Yes | Yes |
| Non-invasive system | Yes | Yes | Yes |
| Patient surface cooling | Yes | Yes | Yes |
| Permanent contact to the<br>patient's skin during cooling | Yes | Yes | Yes |
| Temperature gradient between<br>patient and cooling pad/blanket | Yes | Yes | Yes |
| Removal of thermal energy<br>from the patient | Yes | Yes | Yes |
| Rapid cooling function | Yes | Yes | Yes |
| temperature monitoring with<br>a temperature probe<br>(own brand or 3rd party) | Yes | Yes | Yes |
| Rewarming function | Yes | No | No |

The EMCOOLSpad and the identified predicate devices are all non-invasive, thermal regulating systems for patient surface cooling under permanent contact to the patients skin during cooling targeting the removal of thermal energy from the patient.

The technical realization how to cool down a patient might be differently solved, but the features and functional criteria above make all devices substantially equivalent.

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Image /page/3/Picture/1 description: The image shows a logo for "EMCOOLS". The logo features the text "EMCOOLS" in a rectangular box on the bottom left. Above the text, there is a stylized graphic that resembles a waveform or a mountain range. The logo is in black and white.

#### www.emcools.com

### Testing

Biocompatibility Testing was performed according to these standards:

ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing; 2003

ISO 10993-5: 1999-11; Biological evaluation of medical devices - Part 5: Tests for cytotoxicity; in vitro methods.

prEN ISO 10993-5: 2007, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10; Biological evaluation of medical devices - Part 10 Test for irritation and delayed hypersensitivity (components).

ISO 10993 -12: 2008 -02, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

The tests were conducted by Medical Device Services - Dr. Rossberger GmbH, Lilienthalstraße 4, 82205 Gilching, Germany (www.mdservices.de) acc. to Directive 93/43/EEC, 90/385/EEC, EN ISO/IEC 17025 (ZLG-P-870.96.08 accredited) and Good Laboratory Practices (GLP).

### Performance Testing - Bench

Lab testing was done internally by Research & Development to benchmark the EMCOOLSpad and the predicate devices.

No difference between the EMCOOLSpad and the ArcticSun could be detected in terms of the cooling-rate. The EMCOOLSpad does cool down not as aggressively as seen for the very fast cooling-rate of the ThermoSuit, so we conclude it is physiologically even better tolerated.

#### Performance Testing - Animal

Animal testing was done by qualified and trained physicians and nurses to demonstrate the "under-the-pad" skin safety of the EMCOOLSpad on pigs after 24h and 1 week. Both for the immediate assessment of potential damages (24h) and for the assessment of potential damages developing over time (1 week), not any skin damage could be detected on the large amount of pig skin photos recorded. So we conclude it is safe to use it in terms of skin safety.

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Image /page/4/Picture/1 description: The image shows a logo for EMCOOLS. The logo features the text "EMCOOLS" in a rectangular box. Above the text, there is a graphic that resembles a waveform or a mountain range, adding a dynamic element to the design.

www.emcools.com

### Conclusion

The comparison of the EMCOOLSpad and the predicate devices resulted -based on functional criteria- in the conclusion that the EMCOOLSpad is substantially equivalent to the predicate devices.

Based upon the biocompatibility- and performance-testing we conclude that the EMCOOLSpad temperature reduction system performs as intended and raises no new safety or effectiveness issues.

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring; MD 20993-0002

OCT 1 2 2010

EMCOOLS - Emergency Medical Cooling Systems AG c/o Ms. Kristen Langen MHS- Foreign Affairs TUV SUD America, Inc 1775 Old Highway 8 NW New Brighton, MN 55112-1891

Re: K100071

Trade/Device Name: EMCOOLSpad Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: NZE Dated: September 3, 2010 Received: September 9, 2010

Dear Ms. Langen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Ms. Kristen Langen

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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# 4. Indication for Use

# K100071 510(k) Number (if known):

EMCOOLSpad

Device Name:

Indication For Use:

Temperature reduction in adult patients where clinically indicated, e.g. in hyperthermic patients.

Prescription Use YES (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use NO (21 CFR Part 801 Subpart C)

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

(Division Sign-Off)
Division of Cardiovascular Devices
Number K100071

EMCOOLS- Emergency Medical Cooling Systems AG

510(k) Submission EMCOOLSpad