COCOON CONVECTIVE WARMING SYSTEM

K140635 · Care Essentials Pty, Ltd. · DWJ · Jul 25, 2014 · Cardiovascular

Device Facts

• Record ID: K140635
• Device Name: COCOON CONVECTIVE WARMING SYSTEM
• Applicant: Care Essentials Pty, Ltd.
• Product Code: DWJ · Cardiovascular
• Decision Date: Jul 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Cocoon Convective Warming System is indicated for hyper or hypothermic patients or normothermic patients for whom induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.

Device Story

Convective warming system; consists of CWS4000 warming machine and disposable patient warming blankets. Machine delivers continuous flow of temperature-controlled air via flexible hose to blanket. User selects one of six temperature settings: Ambient, 34°C, 37°C, 40°C, 43°C, or 46°C. Safety feature: 46°C setting automatically drops to 43°C after 10 minutes. Mains-powered; microprocessor-controlled. Used in clinical settings to manage patient body temperature or provide thermal comfort. Benefits include prevention or treatment of hypo/hyperthermia.

Clinical Evidence

No clinical study conducted. Substantial equivalence supported by performance testing, design validation, and historical use (CE marked and included in Australian Register of Therapeutic Goods for >5 years).

Technological Characteristics

Mains-powered, microprocessor-controlled convective warming unit. Includes flexible hose and disposable blankets. Temperature settings: Ambient, 34-46°C. Safety: 46°C auto-stepdown to 43°C after 10 minutes. Standards: ANSI/AAMI/ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971.

Indications for Use

Indicated for adult and pediatric patients who are hyperthermic, hypothermic, or normothermic requiring induced temperature therapy or thermal comfort.

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

• Bair Hugger Temperature Management System Model 750 (K053645)
• Bair Hugger Temperature Management System Model 505 (K041686)

Submission Summary (Full Text)

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# 510(k) Summary

JUL 25 2014

#### Introduction

This summary is intended to comply with requirements of the SMDA and 21CFR \$807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.

## 510(k) Applicant

Abhay Sinha Care Essentials Pty Ltd 25-27 Slevin Street North Geelong Victoria 3215, Australia Tel: [phone]/ Fax: [phone]

# 510(k) Correspondent

Kea Imgraben KD&A Pty Ltd 36-38 Glen Osmond Road Parkside South Australia 5063, Australia Tel: [phone]

## Date Prepared

03 March 2014

#### Device Trade or Proprietary Name

Cocoon Convective Warming System

### Common Name

Hypothermia System

## Classification Name

Thermal Regulating System

#### Device Class

FDA Class II

#### Product Code

DWJ

#### Regulation Number

21 CFR 870.5900

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# Predicate Device(s)

The Cocoon Convective Warming System is substantially equivalent to the following predicate device(s):

- K053645 Bair Hugger Temperature Management System Model 750. .
- K041686 Bair Hugger Temperature Management System Model 505. .

### Device Description

The Cocoon Convective Warming system incorporates the Convective Warming Machine CWS4000, and the Cocoon Disposable Patient Warming Blankets. The Convective Warming Machine is a mains-powered, microprocessor-controlled device that delivers a continuous flow of temperature-controlled air through a flexible hose to the warming blanket. The temperature of the air delivered to the blanket can be set to one of six settings: Ambient, 34℃, 37℃, 40℃, 43ºC, or 46ºC. When a temperature of 46ºC is selected, the setting automatically drops to 43ºC after 10 minutes.

### Intended Use

The Cocoon Convective Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.

# Clinical Testing

Care Essentials Pty Ltd did not conduct a clinical study as defined in the guidance for Industry Financial Disclosures by Clinical Investigators to determine substantial equivalence. Care Essentials Pty Ltd conducted performance testing with satisfactory results. In addition the device have been CE Marked and included in the Australian Register of Therapeutic Goods for more than 5 vears.

# Non-Clinical Testing

Non-clinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary standards:

- ANSI/AAMI/ES60601-1(2005 + C1 + A2) Medical electrical equipment Part 1: . General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). (General).
- ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation � and testing within a risk management process. (Biocompatibility).

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- . ISO 14971:2007 Medical devices - Application of risk management to medical devices. (General).
# Risk Management

This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program according to standard ISO 14971.

# Substantial Equivalence

Care Essentials Pty Ltd believes that the Cocoon Convective Warming System is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

July 25, 2014

Care Essentials Pty Ltd Abhay Sinha Managing Director 25 Slevin Street North Geelong Vic 3215 Australia

Re: K140635

Trade/Device Name: Cocoon Convective Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: June 23, 2014 Received: June 25, 2014

Dear Abhay Sinha:

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 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

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Page 2 - Abhay Sinha

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MA

for

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): | K140635 |
|---------------------------|----------------------------------|
| Device Name: | Cocoon Convective Warming System |

Indications for Use:

The Cocoon Convective Warming System is indicated for hyper or hypothermic patients or normothermic patients for whom induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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