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. 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.

AI/ML Overview

The provided text describes the CarbonCool System, a thermal regulating system, and compares it to a predicate device (EMCoolspad, K100071) to demonstrate substantial equivalence. However, it does not contain detailed acceptance criteria for specific device performance metrics or a study that rigorously proves the device meets those criteria with statistical data.

Instead, the document focuses on:

Indications for Use: Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.
Device Description: Portable, non-invasive body cooling solution using MPad™ (thermoplastic polyurethane filled with high thermal conductivity material) and pad holders.
Mechanism: Optimizes heat exchange by minimizing ambient temperature interference and ensuring snug fit.
Comparison to Predicate: Highlights similarities in regulation, product code, class, indications, materials (HypoCarbon®), technological characteristics (thermal regulating, non-invasive, patient surface cooling, permanent skin contact, thermal energy removal, temperature monitoring, rewarming function, compatible freezer details, imaging compatibility, shelf life), and general safety/effectiveness claims.
Non-Clinical Testing: Biocompatibility and packaging integrity according to ISO and ASTM standards.
General Performance Claims (Bench): "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."

Limitations in the provided text for answering the request:

No specific numerical acceptance criteria are listed for performance (e.g., target temperature reduction, rate of cooling, duration of cooling effectiveness).
No detailed study results or data are presented to quantify "high performance," "surpassing traditional methods," or "withstanding pressure and maintaining durability."
No information on sample size for test or training sets, data provenance, expert involvement for ground truth, or adjudication methods.
No mention of MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, based only on the provided text, I cannot complete the table or provide the requested study details. The document claims equivalence based on technical characteristics and general performance statements rather than specific, quantified performance acceptance criteria and a detailed study demonstrating their fulfillment.

If this were a real submission, a full demonstration of substantial equivalence would typically include:

Specific performance goals/acceptance criteria (e.g., "device must reduce core body temperature by X degrees Celsius within Y minutes").
Detailed protocols and results of performance testing against these criteria.
Validation data where the new device's performance is quantitatively compared to the predicate device or established clinical benchmarks.

Given the information available, I can only create a table that summarizes the claims and types of testing mentioned, rather than specific acceptance criteria and detailed performance data.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Performance Metric	Acceptance Criteria (as implied/claimed)	Reported Device Performance (as implied/claimed)
Indications for Use	Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.	Identical to predicate device.
Cooling Mechanism	Effective heat exchange from skin to cooling pad, minimizing ambient temperature interference, ensuring snug fit to maximize heat exchange.	"Ensures optimal cooling performance and temperature regulation." "Optimized heat exchange efficiency and maintain consistent skin contact." "Minimizes ambient temperature interference." "Maximizes the effectiveness of heat exchange."
Material/Technology	Utilizes high thermal conductivity material (HypoCarbon®) in flexible pads.	"MPad™ which consist of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material." "Proprietary carbon-based cooling medium (HypoCarbon®)."
Safety - Biocompatibility	Meets ISO 10993 standards for biological evaluation, cytotoxicity, irritation, and delayed hypersensitivity.	"Passed all the testing in accordance with internal requirements, national standards, and international standards." "Biocompatibility testing per ISO 10993-1: Passed."
Safety - Packaging Integrity	Meets ASTM standards for packaging.	"Primary packaging testing as per ASTM F1980-21, ASTM F1886/F1886M-16, ASTM F3039-15, ASTM F2096-11, and ASTM F88/F88M-21: Passed."
Shelf Life	36 months.	"36 months" (identical to predicate).
Cooling Efficacy (General)	Provides safe and efficient cooling; surpasses traditional cooling methods (ice/water); withstands pressure and maintains durability over extended periods.	"High performance of the MPad™." "Surpassing traditional cooling methods like ice and water." "Withstands pressure and maintains durability over extended periods." "Reliability in critical situations."
Rewarming Function	Capable of rewarming.	Identical to predicate (implied "Yes").
Imaging Compatibility	Compatible with medical imaging techniques (X-ray, CT, MRI).	Identical to predicate (implied "Yes").
Sterility	Non-sterile.	Non-sterile.
Pyrogenicity	Non-pyrogenic.	Non-pyrogenic.

2. Sample size used for the test set and the data provenance:

Not provided. The document refers to "in-house testing" but gives no details about sample sizes, whether it was prospective or retrospective, or the country of origin of any data used for performance validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. The document describes a physical medical device for temperature regulation, not an AI or diagnostic device that would typically involve experts establishing ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. As above, this type of detail is typically relevant for diagnostic or AI-driven systems where expert consensus is needed to establish ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical thermal regulating system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device, not an algorithm. However, its "standalone" performance implies the performance of the device itself without human intervention defining its core function (beyond application and monitoring). The document claims "in-house testing confirms the high performance of the MPad™" in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / Performance-based. For a thermal regulating system, "ground truth" generally refers to quantitative measurements against engineering specifications and relevant physiological outcomes (e.g., actual temperature reduction in a controlled environment or in a simulated body). The document mentions "in-house testing" and "compliance with recognized standards" for biocompatibility and packaging, but does not detail the "ground truth" for its core cooling performance.

8. The sample size for the training set:

Not applicable/Not provided. This is a physical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above.

Summary

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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 (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

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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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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: +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:

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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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ComparableProperties	Subject Device	EMCoolspad (K100071) – PredicateDevice	Comparison Results
Product Name	CarbonCool® Systems	EMCoolspad - Predicate	NA
Manufacturer	Global Healthcare SG Sdn. Bhd.	Emergency Medical Cooling SystemsAG	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 adultpatients where clinically indicated,e.g. in hyperthermic patients	Temperature reduction for adultpatients where clinically indicated,e.g. in hyperthermic patient	Identical
Description	The CarbonCool® System is asingle use passive body coolingsolution designed for medical andcomfort cooling purposes. TheCarbonCool® System utilizes theMPad™ which consist of multiplecooling-cells made of thermoplasticpolyurethane, filled with high thermalconductivity material.	The EMCOOLSpad is a single usesurface (skin) cooling device, which isadherent to the patient's skin and sohighly adjustable during the coolingprocedure. An EMCOOLSpadconsists of multiple cooling-cells madeof thermoplastic polyurethane, filledwith high thermal conductivitymaterial, stored frozen at 0 to -10°C.	Is almost identical, as MPad™ andEMCOOLSpad used the same technology, theonly difference is the method of apply on patient'sskin.CarbonCool® System's MPad™ recommendedto store at -15 to -18°C and and EMCOOLS storeat 0 to -10°C.
ComparableProperties	Subject Device	EMCoolspad (K100071) – PredicateDevice	Comparison Results
User and patientinterface	The patient's core temperature isregulated within in a certaintemperature range by manuallyremoving (= warming) or applying(=cooling) the Pad Holder thatcontain MPadTM	The patient's core temperature isregulated within in a certaintemperature range by manuallyremoving (= warming) or applying(=cooling) the EMCOOLSpads.	Almost identical as both is apply on patient skin.The only differences is EMCOOLSpads applydirectly on the skin with an adhesive layer andCarbonCool® Systems is the MPadTM slot intothe Pad Holder and apply on the skin.
Device interface	A commercially available third-partytemperature probe connected to acommercially available third-partymonitor senses the patient's coretemperature.	A commercially available third-partytemperature probe connected to acommercially available third-partymonitor senses the patient's coretemperature.	Identical.
Implantable device	Non-implantable device	Non-implantable device	Identical.
Intended patientPopulation	adult patients	adult patients	Identical.Both systems are designed for medicalapplications and are used to provide temperaturereduction in patients for specific medicalconditions.
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.
ComparableProperties	Subject Device	EMCoolspad (K100071) – PredicateDevice	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 andrequires no power supply during cooling, makingit more portable and suitable for immediateapplication in emergencies.
			Identical.
			CarbonCool® System offers better coolingduration with CarbonCool® Pad Holder asinsulation and depending on the application anduse of CarbonCool® XTend™ for extendingcooling duration. EMCOOLS Flex.Pad is direcapplied on skin, and one side of the pad iscontact 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, andphthalates.	Identical.
ComparableProperties	Subject Device	EMCoolspad (K100071) – PredicateDevice	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 ismade of PVC.	Flex pad is made of HypoCarbon®,Pad holder is made of TPU, Velcro ismade of PVC.	Both systems utilize advanced cooling mediumsto achieve effective temperature reduction inpatients. CarbonCool® System uses aproprietary carbon-based cooling medium(HypoCarbon®), while EMCOOLS Flex.Padcontains HypoCarbon® as well.
Biocompatibility	• ISO 10993-1: Biologicalevaluation of medical devices -Part 1: Evaluation and testing;2003	• ISO 10993-1: Biological evaluationof medical devices - Part 1:Evaluation and testing; 2003• ISO 10993-5: 1999-11; Biologicalevaluation of medical devices -
ComparableProperties	Subject Device	EMCoolspad (K100071) – PredicateDevice	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 vitrocytotoxicity 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 regulatingsystem	Yes	Yes	Identical.
ComparableProperties	Subject Device	EMCoolspad (K100071) – PredicateDevice	Comparison Results
Non-invasive system	Yes	Yes	Identical.Both CarbonCool® System and EMCOOLSFlex.Pad are non-invasive cooling solutionsallowing temperature reduction without the needfor invasive procedures.
Patient surfacecooling	Yes	Yes	Identical.
Permanent contactto the patient's skinduring cooling	Yes	Yes	Identical.
Permanent contactto the patient's skinduring cooling	Yes	Yes	Identical.
Removal of thermalenergy from thepatient	Yes	Yes	Identical.
Removal of thermalenergy from thepatient	Yes	Yes	Identical.
ComparableProperties	Subject Device	EMCoolspad (K100071) – PredicateDevice	Comparison Results
temperaturemonitoring with atemperature probe(own brand or 3rdparty)	Yes	Yes	Identical.
Rewarming function	Yes	Yes	Identical.
Compatible freezerdetails	Yes	Yes	Both systems require pre-cooling in a freezerbefore use.
ImagingCompatibility	Yes	Yes	Identical.
			Both systems are compatible with medicalimaging techniques like X-ray, CT, and MRIenabling medical professionals to perform scanswithout 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.

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).