Cocoon Convective Warming System

K181671 · Care Essentials Pty, Ltd. · DWJ · May 2, 2019 · Cardiovascular

Device Facts

• Record ID: K181671
• Device Name: Cocoon Convective Warming System
• Applicant: Care Essentials Pty, Ltd.
• Product Code: DWJ · Cardiovascular
• Decision Date: May 2, 2019
• Decision: SESE
• Submission Type: Special
• 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 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

The Cocoon Convective Warming System is a thermal regulating device designed to manage patient body temperature. It functions by delivering warmed or cooled air to a patient via a convective warming blanket. The system is intended for use in clinical settings to treat hyperthermia or hypothermia, or to maintain patient thermal comfort. It is operated by healthcare professionals. The device helps prevent or treat temperature-related clinical complications, thereby supporting patient stability during or after medical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to predicate devices.

Technological Characteristics

Thermal regulating system (Product Code: DWJ). Operates via convective air delivery to a patient-contacting blanket. Designed for adult and pediatric use.

Indications for Use

Indicated for adult and pediatric patients experiencing hyperthermia or hypothermia requiring induced temperature therapy, or for patients requiring thermal comfort support.

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.

Submission Summary (Full Text)

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May 2, 2019

Care Essentials Pty Ltd Abhay Sinha Managing Director 25 Slevin St North Geelong, 3215 Au

Re: K181671

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: March 25, 2019 Received: April 1, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions 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

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801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, fi applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Fernando Aguel Fernando Aguel -S

for Nicole Ibrahim Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K181671

Device Name Cocoon Convective Warming System

## Indications for Use (Describe)

The Cocoon Convective Warming System is indicated for hyper or hypothermic 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.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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