(187 days)
No
The description focuses on a forced-air warming system and its components, with no mention of AI or ML capabilities.
Yes
The device is used for patient warming, which restores or maintains normal body temperature in patients, providing a therapeutic effect by improving comfort and physiological well-being.
No.
The device is described as a "Convective Warming System" for patient warming, not for diagnosing medical conditions.
No
The device description explicitly states it comprises a "Cocoon Convective Warming Unit, Model CWS7000 unit" and "Cocoon™ Disposable Patient Warming Gown Blankets," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "patient warming." This is a therapeutic or supportive function performed directly on the patient's body.
- Device Description: The device is a "Convective Warming System" that uses forced air and blankets to warm the patient. This is a physical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic or other health-related information. This device's function is entirely focused on directly warming the patient.
N/A
Intended Use / 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.
Product codes
DWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children, adolescent, and adult patients.
Intended User / Care Setting
The Cocoon Convective warming system should be used by trained medical professionals only. Pre-op, intensive care unit, labor and delivery, recovery room, emergency rooms, long-term care facilities and other areas.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was conducted, but details on study type, sample size, AUC, MRMC, or standalone performance are not provided. The conclusion states that the Cocoon™ Convective Warming System, Model CWS7000, is substantially equivalent to the legally marketed Bair Paws Temperature Management System (K060865) based on the comparison of technological characteristics. Clinical testing is not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) | |
|---|---|
| ☑ 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 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
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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
| 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
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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/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).