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 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.

AI/ML Overview

The provided text describes the regulatory clearance for the Cocoon Convective Warming System, Model CWS7000. It includes a summary of nonclinical testing but explicitly states that clinical testing is not applicable. Therefore, I can provide information based on the nonclinical testing, but there is no study described that proves the device meets acceptance criteria through clinical performance.

Here's an analysis based on the provided text, focusing on what's available and noting what is not applicable:

Acceptance Criteria and Reported Device Performance (Nonclinical)

The acceptance criteria for the Cocoon Convective Warming System, Model CWS7000 are based on compliance with various international standards for medical electrical equipment, electromagnetic compatibility, software life cycle processes, heating devices, biological evaluation, and risk management. The reported performance is simply "Pass" or "Meets requirements" for each of these standards.

Acceptance Criteria Category	Standard/Requirement	Reported Device Performance
Basic Safety & Performance	AAMI/ANSI ES60601-1: Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Edition 3.1; FDA rec. # 19-46)	Pass
EMC	IEC 60601-1-2: Medical electrical equipment - Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and tests (Edition 4.1; FDA rec. # 19-36)	Pass
Software Life Cycle	IEC 62304: Medical Device Software - Software Life Cycle Processes (Edition 1.1; FDA rec. # 13-79)	Pass
Heating Devices	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)	Pass
Biocompatibility	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)	Pass
Risk Management	ISO 14971: Medical devices - Application of risk management to medical devices (Edition 3.0; FDA rec. # 5-125)	Meets requirements

Study Details (for nonclinical testing as clinical testing was not applicable)

Sample size used for the test set and the data provenance: Not specified in terms of patient data, as clinical testing was deemed not applicable. The sample size for nonclinical engineering and safety tests would refer to the number of units or components tested, which is not detailed but assumed to be sufficient for compliance with the listed standards. Data provenance is not applicable as it's not a study involving human or animal data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For nonclinical standards compliance, "ground truth" is established by the specifications and requirements of the standards themselves. The testing would be conducted by qualified engineers and technicians.
Adjudication method for the test set: Not applicable for nonclinical standards testing. Compliance is determined by whether the device meets the specified parameters and requirements of each standard.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating observer performance with medical images or clinical judgment, which is not relevant to a convective warming system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The provided information refers to the device itself (hardware and embedded software), not a standalone algorithm. The device's performance was evaluated independently against the standards.
The type of ground truth used: For this device, the "ground truth" for demonstrating performance is derived from the requirements and specifications of the referenced international technical and safety standards (e.g., IEC 60601-1, IEC 60601-2-35, ISO 10993-1). These standards define acceptable levels for electrical safety, electromagnetic compatibility, temperature control accuracy, biocompatibility, and risk management.
The sample size for the training set: Not applicable, as this is not an AI/ML-based device that undergoes a training phase with a dataset.
How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

In summary, the provided document focuses on the regulatory clearance of a medical device based on its compliance with established nonclinical safety and performance standards, rather than clinical efficacy studies or AI performance metrics.

Summary

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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).

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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

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Indications for Use

510(k) Number (if known) K232502

Device Name

Cocoon Convective Warming System, Model CWS7000

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 SinhaCare Essentials Pty. Ltd.103 Mornington StreetNorth GeelongVictoria, Australia 3215Phone: +61-3-5277-1455Email: queries@careessentials.com.au
510(k) Correspondent:	Abhay SinhaCare Essentials Pty. Ltd.103 Mornington StreetNorth GeelongVictoria, Australia 3215Phone: +61-3-5277-1455Email: 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, ModelCWS7000Hypothermia SystemThermal Regulating SystemDWJCardiovascularFDA Class II21 CFR §870.5900
Primary Predicate Device:Reference Device:	Bair Paws Temperature Management SystemK060865Cocoon Convective Warming System,K140635

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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 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

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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.

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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

DeviceCharacteristic	Proposed Device	Reference DeviceCocoon™ Convective WarmingSystemK140635	Primary Predicate DeviceBair Paws Temperature ManagementSystemK060865	ComparisonAnalysis
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 ManagementSystem	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 WarmingSystem, Model CWS7000, is indicated forpatient warming. The Cocoon™ ConvectiveWarming Unit, Model CWS7000 has beendesigned for use with Cocoon™ DisposablePatient Warming Gown Blankets. It isintended for use with children, adolescent,and adult patients.	The Cocoon Convective Warming Systemis indicated for hyper or hypothermicpatients or normothermic patients for whominduced hyper or hypothermia or localizedtemperature therapy is clinically indicated.In addition, the Cocoon ConvectiveWarming System can be used to providepatient thermal comfort when conditionsexist that may cause patients to becometoo cold or too warm. The CocoonConvective Warming System can be usedwith adult and pediatric patients.	The Bair Hugger temperature managementsystem is indicated for hyper - orhypothermic patients or normothermicpatients for whom induced hyper - orhypothermia or localized temperaturetherapy is clinically indicated. In Addition,the Bair Hugger temperature managementsystem can be used to provide patientthermal comfort when conditions exist thatmay cause patients to become too warm ortoo cold.	Similar
Areas for deviceuse	Pre-op, intensive care unit, labor anddelivery, 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 anddelivery, recovery room, emergency rooms,ships, aircraft, EMT vehicles, accident	Similar

Section 5 – 510(k) Summar

Page 5 of 7

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CARE ESSENTIAL
----------------

TABLE 1:
COMPARISON OF PROPOSED AND PREDICATE DEVICES

DeviceCharacteristic	Proposed Device	Reference DeviceCocoon™ Convective WarmingSystemK140635	Primary Predicate DeviceBair Paws Temperature ManagementSystemK060865	ComparisonAnalysis
	where medical professionals can warm andpatients.	and other areas whereprofessionals can warm patients.	medical sites, long-term care facilities, home healthcare and other areas where medicalprofessionals can warm patients.
Intended patientpopulation	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 hardsurface; clamped on an I.V pole; or hung ona bed rail.	Can be set on table, shelf, or other hardsurface; clamped on an I.V pole; or hung ona bed rail.	Can be set on table, shelf, or other hardsurface; clamped on an I.V pole; or hung ona bed rail; or attached to the wall using awall 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 WarmingSystem, Model CWS7000 has a blowermotor and a heating element. The warmingunit delivers warmed air through a hose thatis connected to a port in the Cocoon ™warming blanket	The Cocoon ™Convective WarmingSystem has a blower motor and a heatingelement. The warming unit delivers warmedair through a hose that is connected to aport in the Cocoon ™ warming blanket	The Bair Paws Temperature Managementsystem has a blower motor and a heatingelement. The warming unit delivers warmedair through a hose that is connected to aport in the Bair Paws warming gown.	Same
Alarm system	Over-temperature detection, color indicatorlight illuminates, heater and blower shutsdown.	Over-temperature detection, color indicatorlight illuminates, heater and blower shutsdown.	Over-temperature detection, color indicatorlight illuminates, heater and blower shutsdown.	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

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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/ANSIES60601-1	Medical electrical equipment - Part 1: GeneralRequirements for Basic Safety and EssentialPerformance(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: ElectromagneticCompatibility - Requirements and tests(Edition 4.1; FDA rec. # 19-36)	2014/A1:2021	Pass
IEC 62304	Medical Device Software - Software Life CycleProcesses(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 safetyand essential performance of heating devicesusing blankets, pads and mattresses andintended for heating in medical use.(Edition 2.0; FDA rec. # 6-483)	2020	Pass
ISO 10993-1	Biological Evaluation of Medical Devices - Part1: Evaluation and Testing Within a RiskManagement Process(Edition 5.0; FDA rec. # 2-258)	2018	Pass
ISO 14971	Medical devices - Application of riskmanagement to medical devices(Edition 3.0; FDA rec. # 5-125)	2019	Meetsrequirements

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).

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
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.(b)
Classification. Class II (performance standards).