(347 days)
Not Found
No
The device description focuses on passive cooling technology and material properties, with no mention of AI or ML. The performance studies are related to biocompatibility, packaging, and bench testing of cooling performance, not algorithmic performance.
Yes
The device is intended for "temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients," which describes a therapeutic action.
No
The device is described as a body cooling solution for temperature reduction in hyperthermic patients, which is a therapeutic function, not a diagnostic one. It does not analyze or interpret medical data to identify a condition.
No
The device description explicitly states it is a "portable, non-invasive body cooling solution" and describes physical components like "multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material." This indicates a hardware-based device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients." This describes a therapeutic or physiological intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "portable, non-invasive body cooling solution" that utilizes "cooling-cells" applied to the "Patient skin surface." This is a physical cooling method applied externally to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.
Product codes
NZE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient skin surface
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Used by trained user. It is non-professional use only device.
Hospital/ clinic/ Home use
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
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 .
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.
Key Metrics
Not Found
Predicate Device(s)
EMCoolspad (K100071)
Reference Device(s)
Not Found
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 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.
1
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
2
assistance/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,
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
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: +65 9135 7048 | |
| E-mail Id: geetha@medraplus.com | |
| 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, | |
| Malaysia | |
| Phone: +65 9725 9715 | |
| E-mail Id: jacksiow@globalhealthcare.sg | |
| 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.
5
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.
6
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
7
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
8
| Comparable
Properties | Subject Device | EMCoolspad (K100071) – Predicate
Device | Comparison Results |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | CarbonCool® Systems | EMCoolspad - Predicate | NA |
| Manufacturer | Global Healthcare SG Sdn. Bhd. | Emergency Medical Cooling Systems
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
patients where clinically indicated,
e.g. in hyperthermic patients | Temperature reduction for adult
patients where clinically indicated,
e.g. in hyperthermic patient | Identical |
| Description | The CarbonCool® System is a
single use passive body cooling
solution designed for medical and
comfort cooling purposes. The
CarbonCool® System utilizes the
MPad™ which consist of multiple
cooling-cells made of thermoplastic
polyurethane, filled with high thermal
conductivity material. | The EMCOOLSpad is a single use
surface (skin) cooling device, which is
adherent to the patient's skin and so
highly adjustable during the cooling
procedure. An EMCOOLSpad
consists of multiple cooling-cells made
of thermoplastic polyurethane, filled
with high thermal conductivity
material, stored frozen at 0 to -10°C. | Is almost identical, as MPad™ and
EMCOOLSpad used the same technology, the
only difference is the method of apply on patient's
skin.
CarbonCool® System's MPad™ recommended
to store at -15 to -18°C and and EMCOOLS store
at 0 to -10°C. |
| Comparable
Properties | Subject Device | EMCoolspad (K100071) – Predicate
Device | Comparison Results |
| User and patient
interface | The patient's core temperature is
regulated within in a certain
temperature range by manually
removing (= warming) or applying
(=cooling) the Pad Holder that
contain MPadTM | The patient's core temperature is
regulated within in a certain
temperature range by manually
removing (= warming) or applying
(=cooling) the EMCOOLSpads. | Almost identical as both is apply on patient skin.
The only differences is EMCOOLSpads apply
directly on the skin with an adhesive layer and
CarbonCool® Systems is the MPadTM slot into
the Pad Holder and apply on the skin. |
| Device interface | A commercially available third-party
temperature probe connected to a
commercially available third-party
monitor senses the patient's core
temperature. | A commercially available third-party
temperature probe connected to a
commercially available third-party
monitor senses the patient's core
temperature. | Identical. |
| Implantable device | Non-implantable device | Non-implantable device | Identical. |
| Intended patient
Population | adult patients | adult patients | Identical.
Both systems are designed for medical
applications and are used to provide temperature
reduction in patients for specific medical
conditions. |
| Intended use | Used by trained user. It is non-
professional use only device. | Used by trained user. It is non-
professional use only device. | Identical. |
| Comparable
Properties | Subject Device | EMCoolspad (K100071) – Predicate
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
requires no power supply during cooling, making
it more portable and suitable for immediate
application in emergencies. |
| | | | Identical. |
| | | | CarbonCool® System offers better cooling
duration with CarbonCool® Pad Holder as
insulation and depending on the application and
use of CarbonCool® XTend™ for extending
cooling duration. EMCOOLS Flex.Pad is direc
applied on skin, and one side of the pad is
contact with the ambient temperature. |
| Feature | Non-sterile.
Prescription use device.
The product is free of latex, PVC,
and phthalates. | Non-sterile.
Prescription use device.
The product is free of latex, PVC, and
phthalates. | Identical. |
| Comparable
Properties | Subject Device | EMCoolspad (K100071) – Predicate
Device | Comparison Results |
| Single use/Re use | Single use | Single use | Identical. |
| Disposable/Non-
Disposable | Non-Disposable | Non-Disposable | Identical. |
| Sterilization | Non-sterile | Non-sterile | Identical. |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Identical. |
| Materials | MPad is made of HypoCarbon®,
Pad holder is made ofT PU, Velcro is
made of PVC. | Flex pad is made of HypoCarbon®,
Pad holder is made of TPU, Velcro is
made of PVC. | Both systems utilize advanced cooling mediums
to achieve effective temperature reduction in
patients. CarbonCool® System uses a
proprietary carbon-based cooling medium
(HypoCarbon®), while EMCOOLS Flex.Pad
contains HypoCarbon® as well. |
| Biocompatibility | • ISO 10993-1: Biological
evaluation of medical devices -
Part 1: Evaluation and testing;
2003 | • ISO 10993-1: Biological evaluation
of medical devices - Part 1:
Evaluation and testing; 2003
• ISO 10993-5: 1999-11; Biological
evaluation of medical devices - | |
| Comparable
Properties | Subject Device | EMCoolspad (K100071) – Predicate
Device | Comparison Results |
| | 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). | 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). ISO 10993 -12: 2008 -02,
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials. | |
| Technological characteristics | | | |
| Thermal regulating
system | Yes | Yes | Identical. |
| Comparable
Properties | Subject Device | EMCoolspad (K100071) – Predicate
Device | Comparison Results |
| Non-invasive system | Yes | Yes | Identical.
Both CarbonCool® System and EMCOOLS
Flex.Pad are non-invasive cooling solutions
allowing temperature reduction without the need
for invasive procedures. |
| Patient surface
cooling | Yes | Yes | Identical. |
| Permanent contact
to the patient's skin
during cooling | Yes | Yes | Identical. |
| Permanent contact
to the patient's skin
during cooling | Yes | Yes | Identical. |
| Removal of thermal
energy from the
patient | Yes | Yes | Identical. |
| Removal of thermal
energy from the
patient | Yes | Yes | Identical. |
| Comparable
Properties | Subject Device | EMCoolspad (K100071) – Predicate
Device | Comparison Results |
| temperature
monitoring with a
temperature probe
(own brand or 3rd
party) | Yes | Yes | Identical. |
| Rewarming function | Yes | Yes | Identical. |
| Compatible freezer
details | Yes | Yes | Both systems require pre-cooling in a freezer
before use. |
| Imaging
Compatibility | Yes | Yes | Identical. |
| | | | Both systems are compatible with medical
imaging techniques like X-ray, CT, and MRI
enabling medical professionals to perform scans
without removing the cooling pads. |
| Shelf life | 36 months | 36 months | Identical |
Table 1: Predicate Device Comparison
9
CarbonCool® System
510(K) Summary
Traditional 510(k): PremarketNotification
10
11
12
510(K) Summary
Traditional 510(k): PremarketNotification
13
CarbonCool® System 510(K) Summary Traditional 510(k): PremarketNotification
14
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.
15
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.
16
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.