CarbonCool® System

K240933 · Global Healthcare SG Sdn. Bhd · NZE · Mar 18, 2025 · Cardiovascular

Device Facts

• Record ID: K240933
• Device Name: CarbonCool® System
• Applicant: Global Healthcare SG Sdn. Bhd
• Product Code: NZE · Cardiovascular
• Decision Date: Mar 18, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.

Device Story

CarbonCool System is a non-invasive, passive body cooling solution for adult patients. It consists of MPad cooling cells made of thermoplastic polyurethane (TPU) filled with a proprietary carbon-based cooling medium (HypoCarbon). The system uses a Pad Holder design to minimize ambient temperature interference and ensure snug skin contact, facilitating heat transfer from the patient's skin to the cooling pad. The device is pre-cooled in a freezer (-15 to -18°C) before use and requires no external power supply. It is used in hospital, clinic, or home settings by trained users. Patient core temperature is monitored via third-party probes and monitors. The system is compatible with medical imaging (X-ray, CT, MRI). By providing consistent, portable cooling, it assists in temperature regulation for hyperthermic patients.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and biocompatibility evaluation. Bench testing demonstrated the device's cooling performance, durability, and pressure resistance. Biocompatibility testing was conducted per ISO 10993-1, ISO 10993-5, and ISO 10993-10. Packaging integrity was validated per ASTM F1980-21, ASTM F1886/F1886M-16, ASTM F3039-15, ASTM F2096-11, and ASTM F88/F88M-21.

Technological Characteristics

Passive thermal regulating system; non-powered. Components: TPU Pad Holder, MPad (HypoCarbon cooling medium), PVC Velcro. Dimensions/form factor: various pads/suits. Connectivity: None (standalone). Sterilization: Non-sterile. Biocompatibility: ISO 10993-1, 5, 10. Packaging standards: ASTM F1980-21, F1886/F1886M-16, F3039-15, F2096-11, F88/F88M-21.

Indications for Use

Indicated for temperature reduction in adult patients where clinically indicated, such as hyperthermic patients.

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

• EMCoolspad (K100071)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 18, 2025

Global Healthcare SG Sdn. Bhd Keng Liang Cheng Managing Director Lot 43824, Jln Tech Valley 2/1, Bandar Sri Sendayan Seremban Negeri Sembilan, 71950 Malaysia

Re: K240933

Trade/Device Name: CarbonCool System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NZE Dated: February 21, 2024 Received: November 20, 2024

Dear Keng Liang Cheng:

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.

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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).

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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Nicole M. Gillette -S

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

Enclosure

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240933

Device Name

CarbonCool® System

Indications for Use (Describe)

Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic 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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510(k) summary of Safety and Effectiveness for CarbonCool® is provided in accordance with 21 CFR 807.92.

| Date: | 19 Mar 2024 |
|------------------------|--------------------------------------------------------|
| Submitter (Owner): | Ms. Geetha Ganesh |
| | Medra+ Pte. Ltd., |
| | 6 Kitchener Link, 05 - 11, |
| | Singapore - 207227 |
| | Phone: [phone] |
| | E-mail Id: [e-mail] |
| 510(k) Contact Person: | Mr. Siow Ming Qian |
| | Global Healthcare SG Sdn. Bhd |
| | Lot 43824, Jln Tech Valley 2/1, Bandar Sri |
| | Sendayan, 71950 Seremban, Negeri Sembilan,<br>Malaysia |
| | Phone: [phone] |
| | E-mail Id: [e-mail] |
| Device Trade Name: | CarbonCool® System |
| Regulation Number: | 21 CFR 870.5900 |
| Regulation Name: | Thermal regulating system |
| Classification Panel: | Cardiovascular |
| Device Class: | Class II |
| Product Code: | NZE |
| Predicate Device: | EMCoolspad (K100071) |
| | Regulation number: 21 CFR 870.5900 |
| | Regulation Name: Thermal regulating system |
| | Device class: II |
| | Product code: NZE |
| | Review panel: Cardiovascular |

### 1. Indications for Use:

Temperature reduction for adult patients where clinically indicated, e.g. in hyperthermic patients.

### 2. Description of the Device:

Global Healthcare SG has developed the CarbonCool® products as a portable, non-invasive body cooling solution designed to enhance temperature reduction for adult patients. The CarbonCool® also enables more widespread applications by reducing treatment cost and increasing treatment flexibility and accessibility.

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The model numbers included in the submission are indicated below:

| MODEL NAME | MODEL NO |
|--------------------------------|----------------|
| MPadTM | MP-FPS729-001 |
| MPadTM Large | MPL-FPS123-001 |
| CarbonCool® XTendTM | XT-FPS001-001 |
| CarbonCool® XTendTM Large | XTL-FPS001-001 |
| Detachable TPU (non-sterile) | DT-FPS1-002 |
| CarbonCool® OmniPadTM | OP-FPS3-002 |
| CarbonCool® Full Body SuitTM | FB-FPS20-002 |
| CarbonCool® Abdomen Pad Holder | AB-FPS6-002 |
| CarbonCool® Chest Pad Holder | CH-FPS8-002 |
| CarbonCool® Thigh Pad Holder | TH-FPS3-002 |
| CarbonCool® Comfort SuitTM | CS-FPS14-002 |
| CarbonCool® Vest | CV-FPS6-003 |
| CarbonCool® Vest Set | CVS-FPS6-003 |
| CarbonCool® Comfort Suit VTM | CSV-FPS14-003 |
| CarbonCool® Military Vest | CMV-FPS14-003 |
| CarbonCool® Wrap ITM | CCWI-FPS20-003 |

### 3. Physics and Mechanism Summary:

#### 3.1 Cooling Duration and Skin Temperature:

CarbonCool employs a Pad Holder design to optimize heat exchange efficiency and maintain consistent skin contact.

#### 3.2 Heat Exchange Mechanism:

The Pad Holder minimizes ambient temperature interference, allowing for effective transfer of heat from the skin to the cooling pad.

#### 3.3 Enhanced Efficiency:

By reducing air gaps and ensuring a snug fit against the patient's skin, CarbonCool maximizes the effectiveness of heat exchange.

#### 3.4 Device Performance:

CarbonCool offering enhanced comfort and efficacy for medical cooling applications and confirms that this device is as safe and effective as the predicate device.

In summary, CarbonCool's innovative Pad Holder design and efficient heat transfer mechanism ensures optimal cooling performance and temperature regulation.

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Image /page/6/Figure/2 description: The image shows the heat exchange mechanism of CarbonCool. The diagram shows the different layers of the CarbonCool system, including the pad holder, MPad, skin, and body. The diagram also shows the direction of heat flow, with arrows indicating heat moving from the body to the skin, from the skin to the MPad, and from the MPad to the pad holder and ambient air.

Figure 1: Heat Exchange Mechanism of CarbonCool

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## 4. Comparison to Predicate Devices:

One predicate device is selected in this submission for the substantial equivalence discussion of CarbonCool® Systems. Please refer to Table 1 for detailed substantial equivalence discussion.

Predicate device: EMCoolspad – Predicate device

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| Comparable<br>Properties | Subject Device | EMCoolspad (K100071) – Predicate<br>Device | Comparison Results |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | CarbonCool® Systems | EMCoolspad - Predicate | NA |
| Manufacturer | Global Healthcare SG Sdn. Bhd. | Emergency Medical Cooling Systems<br>AG | NA |
| Regulation Number | 21 CFR 870.5900 | 21 CFR 870.5900 | Identical |
| Product Code | NZE | NZE | Identical |
| Product Class | 2 | 2 | Identical |
| Indications for Use | Temperature reduction for adult<br>patients where clinically indicated,<br>e.g. in hyperthermic patients | Temperature reduction for adult<br>patients where clinically indicated,<br>e.g. in hyperthermic patient | Identical |
| Description | The CarbonCool® System is a<br>single use passive body cooling<br>solution designed for medical and<br>comfort cooling purposes. The<br>CarbonCool® System utilizes the<br>MPad™ which consist of multiple<br>cooling-cells made of thermoplastic<br>polyurethane, filled with high thermal<br>conductivity material. | The EMCOOLSpad is a single use<br>surface (skin) cooling device, which is<br>adherent to the patient's skin and so<br>highly adjustable during the cooling<br>procedure. An EMCOOLSpad<br>consists of multiple cooling-cells made<br>of thermoplastic polyurethane, filled<br>with high thermal conductivity<br>material, stored frozen at 0 to -10°C. | Is almost identical, as MPad™ and<br>EMCOOLSpad used the same technology, the<br>only difference is the method of apply on patient's<br>skin.<br>CarbonCool® System's MPad™ recommended<br>to store at -15 to -18°C and and EMCOOLS store<br>at 0 to -10°C. |
| Comparable<br>Properties | Subject Device | EMCoolspad (K100071) – Predicate<br>Device | Comparison Results |
| User and patient<br>interface | The patient's core temperature is<br>regulated within in a certain<br>temperature range by manually<br>removing (= warming) or applying<br>(=cooling) the Pad Holder that<br>contain MPadTM | The patient's core temperature is<br>regulated within in a certain<br>temperature range by manually<br>removing (= warming) or applying<br>(=cooling) the EMCOOLSpads. | Almost identical as both is apply on patient skin.<br>The only differences is EMCOOLSpads apply<br>directly on the skin with an adhesive layer and<br>CarbonCool® Systems is the MPadTM slot into<br>the Pad Holder and apply on the skin. |
| Device interface | A commercially available third-party<br>temperature probe connected to a<br>commercially available third-party<br>monitor senses the patient's core<br>temperature. | A commercially available third-party<br>temperature probe connected to a<br>commercially available third-party<br>monitor senses the patient's core<br>temperature. | Identical. |
| Implantable device | Non-implantable device | Non-implantable device | Identical. |
| Intended patient<br>Population | adult patients | adult patients | Identical.<br><br>Both systems are designed for medical<br>applications and are used to provide temperature<br>reduction in patients for specific medical<br>conditions. |
| Intended use | Used by trained user. It is non-<br>professional use only device. | Used by trained user. It is non-<br>professional use only device. | Identical. |
| Comparable<br>Properties | Subject Device | EMCoolspad (K100071) – Predicate<br>Device | Comparison Results |
| Anatomical sites | Patient skin surface | Patient skin surface | Identical. |
| Use environment | Hospital/ clinic/ Home use | Hospital/ clinic/ Home use | Identical. |
| Device components | Pad holder, Detachable TPU, MPad | Detachable TPU, Flex Pad | Both is designed for pre-hospital use and<br>requires no power supply during cooling, making<br>it more portable and suitable for immediate<br>application in emergencies. |
| | | | Identical. |
| | | | CarbonCool® System offers better cooling<br>duration with CarbonCool® Pad Holder as<br>insulation and depending on the application and<br>use of CarbonCool® XTend™ for extending<br>cooling duration. EMCOOLS Flex.Pad is direc<br>applied on skin, and one side of the pad is<br>contact with the ambient temperature. |
| Feature | Non-sterile.<br>Prescription use device.<br>The product is free of latex, PVC,<br>and phthalates. | Non-sterile.<br>Prescription use device.<br>The product is free of latex, PVC, and<br>phthalates. | Identical. |
| Comparable<br>Properties | Subject Device | EMCoolspad (K100071) – Predicate<br>Device | Comparison Results |
| Single use/Re use | Single use | Single use | Identical. |
| Disposable/Non-<br>Disposable | Non-Disposable | Non-Disposable | Identical. |
| Sterilization | Non-sterile | Non-sterile | Identical. |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Identical. |
| Materials | MPad is made of HypoCarbon®,<br>Pad holder is made ofT PU, Velcro is<br>made of PVC. | Flex pad is made of HypoCarbon®,<br>Pad holder is made of TPU, Velcro is<br>made of PVC. | Both systems utilize advanced cooling mediums<br>to achieve effective temperature reduction in<br>patients. CarbonCool® System uses a<br>proprietary carbon-based cooling medium<br>(HypoCarbon®), while EMCOOLS Flex.Pad<br>contains HypoCarbon® as well. |
| Biocompatibility | • ISO 10993-1: Biological<br>evaluation of medical devices -<br>Part 1: Evaluation and testing;<br>2003 | • ISO 10993-1: Biological evaluation<br>of medical devices - Part 1:<br>Evaluation and testing; 2003<br>• ISO 10993-5: 1999-11; Biological<br>evaluation of medical devices - | |
| Comparable<br>Properties | Subject Device | EMCoolspad (K100071) – Predicate<br>Device | Comparison Results |
| | ISO 10993-5: 1999-11;Biological evaluation of medical devices -<br>Part 5: Tests for cytotoxicity; in vitro methods. EN ISO 10993-5: 2007,<br>Biological evaluation of medical devices - PartS5: Tests for in vitro<br>cytotoxicity ISO 10993-10; Biological evaluation of medical devices -<br>Part 10 Test for irritation and delayed hypersensitivity<br>(components). | Part 5: Tests for cytotoxicity; in vitro methods. EN ISO 10993-5: 2007, Biological evaluation of medical devices -<br>PartS5: Tests for in vitro cytotoxicity ISO 10993-10; Biological evaluation of medical devices -<br>Part 10 Test for irritation and delayed hypersensitivity<br>(components). ISO 10993 -12: 2008 -02,<br>Biological evaluation of medical devices - Part 12: Sample preparation and reference materials. | |
| Technological characteristics | | | |
| Thermal regulating<br>system | Yes | Yes | Identical. |
| Comparable<br>Properties | Subject Device | EMCoolspad (K100071) – Predicate<br>Device | Comparison Results |
| Non-invasive system | Yes | Yes | Identical.<br><br>Both CarbonCool® System and EMCOOLS<br>Flex.Pad are non-invasive cooling solutions<br>allowing temperature reduction without the need<br>for invasive procedures. |
| Patient surface<br>cooling | Yes | Yes | Identical. |
| Permanent contact<br>to the patient's skin<br>during cooling | Yes | Yes | Identical. |
| Permanent contact<br>to the patient's skin<br>during cooling | Yes | Yes | Identical. |
| Removal of thermal<br>energy from the<br>patient | Yes | Yes | Identical. |
| Removal of thermal<br>energy from the<br>patient | Yes | Yes | Identical. |
| Comparable<br>Properties | Subject Device | EMCoolspad (K100071) – Predicate<br>Device | Comparison Results |
| temperature<br>monitoring with a<br>temperature probe<br>(own brand or 3rd<br>party) | Yes | Yes | Identical. |
| Rewarming function | Yes | Yes | Identical. |
| Compatible freezer<br>details | Yes | Yes | Both systems require pre-cooling in a freezer<br>before use. |
| Imaging<br>Compatibility | Yes | Yes | Identical. |
| | | | Both systems are compatible with medical<br>imaging techniques like X-ray, CT, and MRI<br>enabling medical professionals to perform scans<br>without removing the cooling pads. |
| Shelf life | 36 months | 36 months | Identical |

# Table 1: Predicate Device Comparison

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# CarbonCool® System

# 510(K) Summary

Traditional 510(k): PremarketNotification

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# 510(K) Summary

Traditional 510(k): PremarketNotification

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# CarbonCool® System 510(K) Summary Traditional 510(k): PremarketNotification

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Based on the results of risk assessments, biocompliance with recognized standards demonstrate that the Cabon Cool® system is as safe and effective as the predicate and therefore is substantially equivalent to the predicate.

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### 5. Summary of Non-Clinical Testing:

- ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing; . 2003
- . ISO 10993-5: 1999-11; Biological evaluation of medical devices - Part 5: Tests for cytotoxicity; in vitro methods.
- . EN ISO 10993-5: 2007, Biological evaluation of medical devices - PartS5: Tests for in vitro cytotoxicity
- ISO 10993-10; Biological evaluation of medical devices Part 10 Test for irritation and . delayed hypersensitivity (components).

The tests were conducted by NAMSA, 6750 Wales Road, Northwood, OH 43619. The CarbonCool® System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

- Biocompatibility testing per ISO 10993-1: Passed
- Primary packaging testing as per ASTM F1980-21, ASTM F1886/F1886M-16, ASTM . F3039-15, ASTM F2096-11, and ASTM F88/F88M-21: Passed
- Useable life of the device of three (3) years .

### 6. Performance Testing - Bench:

The CarbonCool® System utilizes the innovative MPad™ technology encased in a thermal enclosure, providing safe and efficient cooling for various applications. The MPad™, made from flexible yet durable TPU, houses a proprietary carbon-based cooling medium, ensuring rapid heat exchange with the skin. This unique design enables passive cooling after precooling in a freezer, resulting in a portable and cost-effective cooling solution.

In-house testing confirms the high performance of the MPad™, surpassing traditional cooling methods like ice and water. The MPad™ withstands pressure and maintains durability over extended periods, ensuring reliability in critical situations.

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# 7. Conclusion:

Based on the results of risk assessments, biocompatibility evaluation, and compliance with recognized standards demonstrate that the CabonCool® system is as safe and effective as the predicate and therefore is substantially equivalent to the predicate.