HYBRID ARCTICGEL PAD

K120849 · Medivance, Inc. · DWJ · Jul 20, 2012 · Cardiovascular

Device Facts

• Record ID: K120849
• Device Name: HYBRID ARCTICGEL PAD
• Applicant: Medivance, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Jul 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hybrid ArcticGel™ Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia). Additionally, the Hybrid ActicGel™ Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System. The Hybrid ArcticGel™ Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in- hospital as well as EMS/transport settings.

Device Story

Hybrid ArcticGel Pad functions as a dual-mode thermal regulation device. In Ice Gel Mode, pre-frozen pads (stored at -3°C to -20°C) are applied directly to patient skin; heat transfer occurs via conduction through hydrogel adhesive into the ice gel compartment, providing cooling for 60-90 minutes. In Water Flow Mode, pads connect to the Arctic Sun Temperature Management System; temperature-controlled water circulates through the pad to maintain target patient temperature. Used by healthcare professionals in hospitals or EMS/transport settings. Output is patient core temperature modulation. Benefits include early initiation of cooling in pre-hospital settings and continuous temperature management in clinical environments.

Clinical Evidence

Bench testing and porcine skin model testing performed. Biocompatibility testing (ISO 10993-05/10) confirmed hydrogel adhesive is non-cytotoxic, non-irritating, and non-sensitizing. Porcine model demonstrated that minimum mean skin temperature remains above freezing, reaching minimum values within 15 minutes and rising over 90 minutes; placement was well-tolerated. Comparative performance testing confirmed cooling and temperature control performance equivalent to predicates.

Technological Characteristics

Noninvasive surface thermal regulation pad. Materials: polymer construction with biocompatible medical adhesive. Sensing/Actuation: conductive heat transfer via hydrogel layer. Energy Source: passive (pre-frozen ice) or active (circulating water via Arctic Sun system). Connectivity: fluid line connection to Arctic Sun control module. Sterilization: not specified. Software: none.

Indications for Use

Indicated for adult patients requiring core temperature reduction (e.g., heat stroke, hyperthermia) or temperature control via the Arctic Sun Temperature Management System. Intended for use by healthcare professionals in hospital and EMS/transport settings.

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 Arctic Sun ArcticGel Pad (K010338)
• EMCOOLS Pad (K100071)

Submission Summary (Full Text)

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JUL 20 2012

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### Device Name

Arctic Sun Hybrid ArcticGel Pad

# Manufacturer Name , Address and Contact Information

Medivance. Inc. 321 South Taylor Avenue, Suite 200 Louisville, CO 80027 Lynne Aronson, Director Regulatory Affaris Contact: 303-926-1917 Phone: [phone] Fax:

# Common, Classification & Proprietary Names

Common Name: Classification Name: Proprietary Name: Classification: Classification Panel: Classification Regulation: Product Code:

# patient temperature management system system, thermal regulating Arctic Sun Hybrid ArcticGel Pad Class II Cardiovascular Devices 870.5900 DWJ

K010338 K100071

### Predicate Devices

- Medivance Arctic Sun ArcticGel Pad
- 페 EMCOOLS Pad

# Device Description

The Arctic Sun Hybrid ArcticGel Pads are a modified version of the Arctic Sun ArcticGel Pads.

The Hybrid ArcticGel Pad is designed to operate in two different modes, Ice Gel Mode in which is the pre-frozen pads are used as standalone devices to initiate patient cooling, and Water Flow Mode in which the pads are connected to the Arctic Sun Temperature Management System which is used to control the patient at a target temperature.

These dual modes provide the opportunity for early initiation of cooling in the pre-hospital setting or the hospital emergency department followed by continued temperature management with the Arctic Sun once the ice gel is thawed.

The Hybrid ArcticGel Pads are pre-frozen in a freezer operating between -3°C and -20°C (27°F and -4°F). The release liners are removed from the hydrogel adhesive, and the frozen Hybrid ArcticGel Pads are applied to the patient's skin. Between 4 and 8 pads are applied to the patient, depending on the patient's size and patient temperature reduction required. Heat from the patient is conducted through the hydrogel and pad layers into the ice gel compartment. The heat from the skin melts the ice gel. The duration of Ice Gel Mode is approximately 60 to 90 minutes from the time of application to complete melting of the Ice Gel.

Medivance, Inc.

510(k) K120849 Hybid ArcticGel Pad

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To convert to Water Flow Mode, pad lines are irreversibly snapped onto the inlet and outlet water ports of the Hybrid ArcticGel Pads. The pad line connectors are connected to the Arctic Sun fluid delivery line. Up to 6 Hybrid ArcticGel Pads may be connected to the Arctic Sun. Temperature controlled water from the Arctic Sun control module can then be circulated through the pad. The water passes through the water flow compartment, allowing heat to be transferred from the patient's skin across the hydrogel adhesive and into the circulating water.

#### Indications for Use

The Hybrid ArcticGe!™ Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia).

Additionally, the Hybrid ActicGel™ Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System.

The Hybrid ArcticGel™ Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in- hospital as well as EMS/transport settings.

### Substantial Equivalence

The Arctic Sun Hybrid ArcticGel Pad was shown to be substantially equivalent in intended use, design, technological characteristics, materials and system features and functions to the predicate devices.

The Hybrid ArcticGel Pad and the predicated ArcticGel Pads and EMCOOLS Pads are noninvasive surface temperature management devices. The Hybrid ArcticGel Pads and the EMCOOLS Pads may be pre-frozen and used as standalone devices for use in patient temperature reduction. Additionally, the Hybrid ArcticGel Pads and the predicate ArcticGel Pads may be used in with the Artic Sun Temperature Management System for use in continuous patient temperature monitoring and control.

The Hybrid ArcticGel Pads and the predicate devices are manufactured from polymer materials that are common to many disposable medical devices, and utilize a biocompatible medical adhesive material to adhere the pads to the patient's skin. The Hybrid ArcticGel Pads and the predicate devices are of similar sizes and weights, and provide similar cooling capacities and durations.

#### Testing

Biocompatibility testing performed in accordance with ISO 10993-05 and 10993-10 demonstrated the hydrogel patient adhesive to be non-cytotoxic, non-irritating and nonsensitizing.

Comparative performance testing demonstrated that the cooling and temperature control performance of the Hybrid ArcticGel Pads is substantially equivalent to that of the predicate devices.

Medivance, Inc.

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Safety tests performed in the porcine skin model demonstrated that the minimum mean skin temperature remains above freezing, reaches its minimum value within the first 15 minutes after pad application, and gradually rises over the course of the 90 minute cooling treatment. The placement of the frozen Hybrid ArcticGel Pads on the pigs' skin of pigs was welltolerated.

#### Conclusions

Based upon the testing and comparison to the predicate devices, the Arctic Sun Hybrid Arctic Gel Pad performs as intended and raises no new safety or effectiveness issues.

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Medivance, Inc.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL 2002012

Medivance, Inc. c/o Ms. Lynne Aronson Director, Regulatory Affairs 321 South Taylor Avenue, Suite 200 Louisville, CO 80027

Re: K120849

Hybrid ArcticGel Pad Regulation Number: 21 CFR 870.5900 Regulation Name: System, Thermal Regulating Regulatory Class: Class II Product Code: DWJ Dated: May 21, 2012 Received: May 22, 2012

Dear Ms. Aronson:

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. Lynne Aronson

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/CDRH/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M.S. Hilliam

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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# STATEMENT OF INDICATIONS FOR USE (FDA FORM)

Statement of Indications for Use (FDA Form)

510(k):

K120849

Device:

Hybrid ArcticGel Pad

Indications for Use:

The Hybrid ArcticGel™ Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia).

Additionally, the Hybrid ActicGel™ Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System.

The Hybrid ArcticGel™ Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in- hospital as well as EMS/transport settings.

Prescription Use X Use (Per 21 CFR 801.109)

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ym. Yillebe

Division of Cardiovascular Devices

510(k) Number k120849

(Optional Format 1-2-96)

Over-the-Counter

Medivance, Inc.

510(k) K120849 Hybid ArcticGel Pad

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