Who is the manufacturer of Cocoon Convective Warming System, Model CWS7000?

Care Essentials Pty, Ltd. filed the 510(k) submission for Cocoon Convective Warming System, Model CWS7000 (K232502).

What is the FDA product code for Cocoon Convective Warming System, Model CWS7000?

DWJ. It is classified under 21 CFR 870.5900 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Cocoon Convective Warming System, Model CWS7000?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Cocoon Convective Warming System, Model CWS7000?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cocoon Convective Warming System, Model CWS7000

K232502 · Care Essentials Pty, Ltd. · DWJ · Feb 21, 2024 · Cardiovascular

Device Facts

Record ID	K232502
Device Name	Cocoon Convective Warming System, Model CWS7000
Applicant	Care Essentials Pty, Ltd.
Product Code	DWJ · Cardiovascular
Decision Date	Feb 21, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5900
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The Cocoon Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon Convective Warming Unit, Model CWS7000 has been designed for use with Cocoon Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients.

Device Story

The Cocoon Convective Warming System (Model CWS7000) is a portable forced-air temperature management unit used for prewarming and postoperative comfort warming. It consists of a warming unit (blower, heating element, LCD screen, controls) and disposable warming gown blankets. The device draws ambient air through a filter, heats it, and delivers it via an insulated hose to the blanket, which distributes air through small perforations. It is operated by trained medical professionals in settings such as pre-op, ICU, labor and delivery, recovery, and emergency rooms. The system continuously monitors performance; in fault conditions (e.g., over-temperature), it triggers audible alarms and automatically shuts down the heater and blower. It does not deliver air below ambient room temperature. The device helps maintain patient thermal comfort.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (AAMI/ANSI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), software life cycle (IEC 62304), and performance testing for heating devices (IEC 60601-2-35).

Technological Characteristics

Materials: Plastic/Metal. Principle: Forced-air convection via blower and heating element. Dimensions: 33.5 cm x 24.5 cm x 10.4 cm. Connectivity: Standalone. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-2-35, ISO 10993-1, ISO 14971.

Indications for Use

Indicated for patient warming in children, adolescent, and adult patients. Designed for use with Cocoon Disposable Patient Warming Gown Blankets.

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 Paws Temperature Management System (K060865)

Reference Devices

Cocoon Convective Warming System (K140635)

Related Devices

K181671 — Cocoon Convective Warming System · Care Essentials Pty, Ltd. · May 2, 2019
K181699 — Level 1 Convective Warmer · Smiths Medical Asd, Inc. · Jul 26, 2018
K060865 — BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 · Arizant Healthcare, Inc. · Apr 24, 2006
K231211 — Medline ComfortTemp Patient Warming System · Medline Industries, LP · Dec 1, 2023
K140635 — COCOON CONVECTIVE WARMING SYSTEM · Care Essentials Pty, Ltd. · Jul 25, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. February 21, 2024 Care Essentials Pty Ltd Abhay Sinha Managing Director 103 Mornington Street North Geelong, Victoria 3215 Australia Re: K232502 Trade/Device Name: Cocoon Convective Warming System, Model CWS7000 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: September 14, 2023 Received: September 15, 2023 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 (the 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 available 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 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Eric E. Richardson -S for Nicole Gillette Assistant 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232502 ### Device Name Cocoon Convective Warming System, Model CWS7000 Indications for Use (Describe) The Cocoon Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon Convective Warming Unit, Model CWS7000 has been designed for use with Cocoon Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------|---------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo for Care Essentials. The logo features a stylized letter "e" in gold and blue. The word "CARE" is written in blue, block letters above the word "ESSENTIALS", which is also written in blue, block letters. The logo is simple and professional. # Cocoon™ Convective Warming System, Model CWS7000 Traditional 510(k) SUMMARY - K232502 # Introduction This summary is intended to comply with the requirements of 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. 103 Mornington Street North Geelong Victoria, Australia 3215 Phone: +61-3-5277-1455 Email: queries@careessentials.com.au | |-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Correspondent: | Abhay Sinha Care Essentials Pty. Ltd. 103 Mornington Street North Geelong Victoria, Australia 3215 Phone: +61-3-5277-1455 Email: queries@careessentials.com.au | | Date of Summary: | 21 February 2024 | | Type of 510(k) Submission: | Traditional | | Device Trade or Proprietary Name: Common name: Classification Name: Product Code: Classification Panel: Regulatory Class: Regulation #: | Cocoon™ Convective Warming System, Model CWS7000 Hypothermia System Thermal Regulating System DWJ Cardiovascular FDA Class II 21 CFR §870.5900 | | Primary Predicate Device: Reference Device: | Bair Paws Temperature Management System K060865 Cocoon Convective Warming System, K140635 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo for Care Essentials. The logo features a stylized letter 'e' in a golden color, outlined with a blue border. Below the 'e', the words 'CARE ESSENTIALS' are written in blue, with 'CARE' on the top line and 'ESSENTIALS' on the bottom line. The logo is simple and professional, suggesting a focus on essential care services. # Device Description The Cocoon Convective Warming System, Model CWS7000 is part of the Cocoon family of temperature management systems that consists of portable forced-air temperature management units, Cocoon™ Disposable Patient Warming Gown Blanket. The Cocoon Convective Warming System, Model CWS7000 comprises of the Cocoon Convective Warming Unit, Model CWS7000 unit and the Cocoon™ Disposable Patient Warming Gown Blankets. The Cocoon Convective Warming System, Model CWS7000 can be used in preoperative and postoperative settings. In a preoperative setting, the warming system provides prewarming and comfort warming. In a postoperative setting, the warming system provides comfort warming only. The Cocoon Convective warming system should be used by trained medical professionals only. The Cocoon™ Convective Warming System, Model CWS7000 is not intended for use in the operating room. Image /page/4/Picture/5 description: The image shows a person lying in a hospital bed with a medical device attached. The person is lying on their back with a pillow behind their head. A medical device is attached to the side of the bed with a tube connected to the person's leg. The bed has wheels and is positioned at an angle. Figure 1. Cocoon™ Convective Warming System, Model CWS7000 Cocoon™ Convective Warming Unit, Model CWS7000 & Cocoon™ Disposable Patient Warming Gown Blanket {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for Care Essentials. The logo features a stylized letter 'e' in two colors: gold on the inside and blue on the outside. Below the 'e', the words 'CARE ESSENTIALS' are written in a blue sans-serif font, with 'CARE' on the top line and 'ESSENTIALS' on the bottom line. ### Cocoon™ Convective Warming Unit. Model CWS7000 The Cocoon Convective Warming Unit, Model CWS7000 is constituted of the following main components: a blower, a heating element, LCD screen and buttons for power and temperature controls. Warm air is delivered to the port of the Cocoon™ Disposable Patient Warming Gown Blanket through an insulated hose that is connected to the warming unit. The patient can adjust the air temperature and airflow using the temperature controller buttons located under the LCD screen of the warming unit. There is a power button also located under the LCD screen of the warming unit to turn the power ON/OFF. The CWS7000 will not deliver air to the blanket below the ambient temperature of the room. Air is drawn into the rear of the CWS7000 and passes through a filter. There are multiple overtemperature prevention systems in place. In any specified temperature fault condition, the blower and heating element automatically shuts down and signals with audible tones or complete disconnect of power. The Cocoon Convective Warming Unit. Model CWS7000 continuously monitors system integrity and performance from the time of start-up. ### Cocoon™ Warming Blanket The Cocoon™ Disposable Patient Warming Gown Blanket has channels that deliver ambient or warm air through small perforations to warm the patient. The blankets enable pre-warming or post-warming comfort with a Cocoon CWS7000 warming unit or other Cocoon temperature manaqement units. The Cocoon™ Disposable Patient Warming Gown Blanket is not made with natural rubber latex and are sized for children, adolescent, and adult patients. ### Indications for Use The Cocoon™ Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon™ Convective Warming Unit. Model CWS7000 has been designed for use with Cocoon™ Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Care Essentials. The logo features a stylized, abstract design resembling a flower or a swirling shape, with a combination of blue and yellow colors. The text "CARE ESSENTIALS" is vertically aligned to the right of the graphic. # Summary of Technological Characteristic # TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES | Device Characteristic | Proposed Device | Reference Device Cocoon™ Convective Warming System K140635 | Primary Predicate Device Bair Paws Temperature Management System K060865 | Comparison Analysis | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Manufacturer | Care Essentials Pty Ltd | Care Essentials Pty Ltd | 3M Company | N/A | | 510(k) Reference | K232502 | K140635 | K060865 | N/A | | Trade Name | Cocoon ™ Convective Warming System, Model CWS7000 | Cocoon ™ Convective Warming System | Bair Paws Temperature Management System | N/A | | Common name | Hypothermia System | Hypothermia System | Hypothermia System | Same | | Regulation Number | 21 CFR §870.5900 | 21 CFR §870.5900 | 21 CFR §870.5900 | Same | | Class | FDA Class II | FDA Class II | FDA Class II | Same | | Product Code | DWJ | DWJ | DWJ | Same | | Indications for Use | The Cocoon™ Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon™ Convective Warming Unit, Model CWS7000 has been designed for use with Cocoon™ Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients. | 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. | The Bair Hugger temperature management 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 Bair Hugger temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. | Similar | | Areas for device use | Pre-op, intensive care unit, labor and delivery, recovery room, emergency rooms, long-term care facilities and other areas | Pre-op, intensive care unit, operating room, labor and delivery, recovery room, emergency rooms, long-term care facilities | Pre-op, intensive care unit, labor and delivery, recovery room, emergency rooms, ships, aircraft, EMT vehicles, accident | Similar | Section 5 – 510(k) Summar Page 5 of 7 {7}------------------------------------------------ | CARE ESSENTIAL | |----------------| |----------------| | TABLE 1: | |----------------------------------------------| | COMPARISON OF PROPOSED AND PREDICATE DEVICES | | Device Characteristic | Proposed Device | Reference Device Cocoon™ Convective Warming System K140635 | Primary Predicate Device Bair Paws Temperature Management System K060865 | Comparison Analysis | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | | where medical professionals can warm and patients. | and other areas where professionals can warm patients. | medical sites, long-term care facilities, home health care and other areas where medical professionals can warm patients. | | | Intended patient population | Children, adolescent and adult patients | Adult and pediatric patients | Adult and pediatric patients | Similar | | Patient position | Stationary | Stationary | Stationary | Same | | Device positioning | Can be set on table, shelf, or other hard surface; clamped on an I.V pole; or hung on a bed rail. | Can be set on table, shelf, or other hard surface; clamped on an I.V pole; or hung on a bed rail. | Can be set on table, shelf, or other hard surface; clamped on an I.V pole; or hung on a bed rail; or attached to the wall using a wall mount bracket. | Similar | | Dimensions | 33.5 cm x 24.5 cm x 10.4 cm (Height * Width * Depth) | 40 cm x 29 cm x 22 cm (Height * Width * Depth) | 27.9 cm x 19.6 cm x 6.4 cm (Height * Width * Depth) | Similar | | Weight | Max.: 3 kg | Max.: 6 kg | Max.: 3 kg | Similar | | Method of operation | The Cocoon ™ Convective Warming System, Model CWS7000 has a blower motor and a heating element. The warming unit delivers warmed air through a hose that is connected to a port in the Cocoon ™ warming blanket | The Cocoon ™ Convective Warming System has a blower motor and a heating element. The warming unit delivers warmed air through a hose that is connected to a port in the Cocoon ™ warming blanket | The Bair Paws Temperature Management system has a blower motor and a heating element. The warming unit delivers warmed air through a hose that is connected to a port in the Bair Paws warming gown. | Same | | Alarm system | Over-temperature detection, color indicator light illuminates, heater and blower shuts down. | Over-temperature detection, color indicator light illuminates, heater and blower shuts down. | Over-temperature detection, color indicator light illuminates, heater and blower shuts down. | Same | | Materials | Plastic/Metal | Plastic/Metal | Plastic/Metal | Same | | Warming Unit hose | Detachable, flexible, fixed length (2m), washable, 2.0" diameter | Detachable, flexible, fixed length (1.8m), washable, 2.5" diameter | Detachable, flexible, fixed length, washable, 1.5" diameter | Similar | Section 5 — 510(k) Summary {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo for Care Essentials. The logo features a stylized letter 'e' in gold and blue, with the words 'CARE ESSENTIALS' written in blue below it. The 'e' is designed with a swirling, dynamic shape, giving the logo a modern and professional look. | Number/Code | Title | Version | Pass/Fail | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------| | AAMI/ANSI ES60601-1 | Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Edition 3.1; FDA rec. # 19-46) | 2005/(R)2012 & A1:2012, C1:2009/ (R)2012 & A2:2010/(R)2012/ A2:2021 | Pass | | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and tests (Edition 4.1; FDA rec. # 19-36) | 2014/A1:2021 | Pass | | IEC 62304 | Medical Device Software - Software Life Cycle Processes (Edition 1.1; FDA rec. # 13-79) | 2006/A1:2016 | Pass | | IEC 60601-2- 35 | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use. (Edition 2.0; FDA rec. # 6-483) | 2020 | Pass | | ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process (Edition 5.0; FDA rec. # 2-258) | 2018 | Pass | | ISO 14971 | Medical devices - Application of risk management to medical devices (Edition 3.0; FDA rec. # 5-125) | 2019 | Meets requirements | ### TABLE 2: SUMMARY OF NONCLINICAL TESTING ### Summary of Clinical Testing Clinical testing is not applicable to the Cocoon™ Convective Warming System, Model CWS7000. ### Conclusion The conclusions drawn from the comparison of technological characteristics demonstrate that the Cocoon™ Convective Warming System, Model CWS7000, is substantially equivalent to the legally marketed Bair Paws Temperature Management System (K060865).