The IQoolTM Warm System

K180375 · Braincool AB · DWJ · May 18, 2018 · Cardiovascular

Device Facts

• Record ID: K180375
• Device Name: The IQoolTM Warm System
• Applicant: Braincool AB
• Product Code: DWJ · Cardiovascular
• Decision Date: May 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IQoolTM Warm System is a temperature regulating system indicated for monitoring and controlling patient temperature.

Device Story

Non-invasive thermal regulating system; monitors and controls patient temperature (32°C to 38.5°C). System comprises ECU 100 refrigeration/control unit, BC COOL (monopropylene glycol coolant), single-use cooling pads (head/neck, torso, thigh), and moisture-absorbing neoprene stabilization insulation. Operated via touchscreen monitor; uses third-party temperature probes for feedback. ECU 100 circulates coolant through pads to remove/add thermal energy. Supports hypothermia (cool/maintain) and normothermia (active rewarming) modes. Includes USB-based BC Stick for configuration/logs/updates. Used in clinical settings (not OR) by healthcare providers. Provides visual temperature graphs and safety alarms, including rapid-warming detection. Benefits patient by maintaining target temperature during treatment.

Clinical Evidence

Bench testing only. Simulated testing demonstrated the device's ability to cool patients to hypothermia, maintain temperature, and rewarm to normothermia, showing performance comparable to the predicate device and published research. No new clinical data provided.

Technological Characteristics

Thermal regulating system; non-invasive surface cooling/heating. Materials: monopropylene glycol coolant, neoprene stabilization insulation. Energy: 115/230 VAC. Dimensions: 105.2 x 50.5 x 61 cm. Connectivity: USB port for configuration/logs. Software-controlled fluid circulation via solenoid valves. Not sterilized. Patient contact materials identical to K162523.

Indications for Use

Indicated for monitoring and controlling patient temperature in patients requiring thermal regulation.

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

• Arctic Sun® Temperature Management System (K101092)

Reference Devices

• IQool™ System (K162523)

Submission Summary (Full Text)

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May 18, 2018

Brain Cool AB % Adam Harris Associate Director, Regulatory Affairs Target Health Inc 261 Madison Ave New York, New York 10016

Re: K180375

Trade/Device Name: The IQoolTM Warm System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: March 28, 2018 Received: March 30, 2018

Dear Adam Harris:

We have reviewed vour 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 (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. 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.

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 803); good

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manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K180375

Device Name The IQoolTM Warm System

Indications for Use (Describe)

The IQoolTM Warm System is a temperature regulating system indicated for monitoring and controlling patient temperature.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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### 5. 510(k) Summary

### 510(k) Applicant

Brain Cool AB

Scheelevägen 2, Medicon Village Lund, Sweden SE-223 81

Phone: [phone]

#### Contact Person: Adam Harris, MM, RAC Associate Director, Regulatory Affairs Target Health Inc. 261 Madison Avenue, 24th Floor New York, NY 10016 Telephone: [phone]

Fax: [phone] [e-mail]

Date of Summary: March 28, 2018

| Device Proprietary<br>Name | The IQool™ Warm System | | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------|
| Common/Usual Name | Thermal Regulating System | | |
| Classification Names /<br>Numbers and Code | 21 CFR | Classification Name | Code |
| | 870.5900 | Thermal Regulating<br>System | DWJ |
| Regulatory Class | II | | |
| Prescription Status | Prescription Device | | |
| Classification Panel | Cardiovascular | | |
| Predicate Device | K101092 | Arctic Sun® Temperature Management System | |
| Description of Device | The IQool™ Warm System is a non-invasive, thermal<br>regulating system that monitors and controls patient<br>temperature within a range of 32°C to 38.5°C (89.6°F to<br>101.3°F). | | |
| | The IQooL™ Warm System consists of: | | |
| | • ECU 100 – refrigeration and control unit – an integrated<br>control system operated via a touch screen monitor. | | |
| | • BC COOL– a cooling liquid consisting of diluted<br>monopropylene glycol (MPG5). The dilution is made by | | |
| | BrainCool AB to optimally serve the IQool TM Warm<br>System. Five liters of BC COOL are delivered with the<br>system. | | |
| | • Cooling Pads – the single use pads are the only skin<br>contacting component and can be fitted to the head/neck,<br>torso, and thigh. Liquid coolant is circulated from the tank<br>through the pads to control patient temperature. The pads<br>are designed and molded to give a good fit during<br>treatment and are intended for single patient use. | | |
| | • Stabilization insulation – the patented stabilization<br>insulation is made of insulating and moisture-absorbing<br>neoprene which supports the cooling pads and insulates<br>against the ambient environment condensation. The<br>elasticity of the stabilization insulation keeps the cooling<br>pads in place during treatment and ensures maximum<br>contact between the skin and the surface of the cooling<br>pad. The stabilizing insulation is intended for single use<br>only. | | |
| | Accessories: | | |
| | • BC Stick – a USB flash drive used to save system<br>configurations, specifically prepared to communicate with<br>the program of the IQoolTM Warm System. The BC stick<br>does not store or capture any user identifying information.<br>It can also be used to save a log file for system<br>troubleshooting or to update the software. | | |
| | • Filling pitcher – for refilling the tank with BC COOL<br>(coolant). Fill the tank with coolant before or directly after<br>start to avoid damage to the system. | | |
| Indications for Use | The IQoolTM Warm System is a temperature regulating system<br>indicated for monitoring and controlling patient temperature. | | |

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| Name | IQool™ Warm System | Arctic Sun® Temperature<br>Management System – Predicate | IQool™ System – Reference |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BrainCool AB | Medivance, Inc | BrainCool AB |
| 510(K) Number | K180375 | K101092 | K162523 |
| Product Code | DWJ | DWJ | NZE |
| Regulation | 21 CFR 870.5900 | 21 CFR 870.5900 | 21 CFR 870.5900 |
| Indications for<br>Use | The IQool™ Warm System is a<br>temperature regulating system<br>indicated for monitoring and<br>controlling patient temperature. | Thermal regulating system, indicated<br>for monitoring and controlling patient<br>temperature. | Temperature reduction for adult<br>patients where clinically indicated, e.g.<br>in hyperthermic patients. |
| Description | The IQool™ Warm System is a non-<br>invasive, thermal regulating system that<br>monitors and controls patient<br>temperature within a range of 32°C to<br>38.5°C (89.6°F to 101.3°F). | The Arctic Sun Temperature<br>Management System is a<br>thermoregulatory device that monitors<br>and controls patient temperature<br>within a range of 32.0° C to 38.5° C<br>(89.60° F to 101.3° F). | The IQool™ System is a surface<br>cooling device that sustains and<br>monitors patient temperature within a<br>range of 33°C to 37°C.<br>The IQool™ System consists of: |
| | The IQool™ Warm System consists of:<br>• ECU 100 refrigeration and<br>control unit – an integrated<br>control system operated via a<br>touch screen monitor.<br>• BC COOL – a cooling liquid<br>consisting of diluted<br>monopropylene glycol<br>(MPG5). The dilution is made<br>by BrainCool AB to optimally<br>serve the IQool™ Warm<br>System. Five liters of BC | The Arctic Sun System consists of the<br>Arctic Sun Control Module and<br>disposable ArcticGel Pads.<br>A patient temperature probe connected<br>to the Control Module provides patient<br>temperature feedback to an internal<br>control algorithm which automatically<br>increases or decreases the circulating<br>water temperature to achieve a pre-set<br>patient target temperature determined<br>by the clinician.<br>The Arctic Sun pulls temperature- | • ECU 100 – refrigeration and<br>control unit – The ECU 100 is a<br>refrigerator unit with an<br>integrated control system<br>operated via a touch screen<br>monitor.<br>• BC COOL- BC COOL is a<br>cooling liquid consisting of<br>diluted monopropylene glycol<br>(MPG5). The dilution is made<br>by BrainCool AB to optimally<br>serve the IQool™ |
| Name | IQool™ Warm System | Arctic Sun® Temperature<br>Management System – Predicate | IQool™ System- Reference |
| | COOL are delivered with the<br>system.<br>Cooling Pads – the single use<br>pads are the only skin<br>contacting component and can<br>be fitted to the head/neck,<br>torso, and thigh. Liquid coolant<br>is circulated from the tank<br>through the pads to control<br>patient temperature. The pads<br>are designed and molded to give<br>a good fit during treatment and<br>are intended for single patient<br>use. Stabilization insulation – The<br>patented stabilization<br>insulation is made of<br>insulating and moisture-<br>absorbing neoprene which<br>supports the cooling pads and<br>insulates against the ambient<br>environment condensation.<br>The elasticity of the<br>stabilization insulation keeps<br>the cooling pads in place<br>during treatment and ensures<br>maximum contact between the<br>skin and the surface of the<br>cooling pad. The stabilizing<br>insulation is intended for<br>single use only. | controlled water ranging between 4° C<br>and 42 ° C (39.2° F and 107.6° F)<br>through the ArcticGel Pads, resulting<br>in heat exchange between the water<br>and the patient. | System.<br>Five liters of BC COOL are<br>delivered with the system.<br>Cooling Pads – the single use<br>cooling pads are the only skin<br>contacting component and can<br>be fitted to the head/neck,<br>torso, and thigh. Liquid<br>coolant is circulated from the<br>tank through the pads to cool<br>patients. The cooling pads are<br>designed and molded to give a<br>good fit during treatment and<br>are intended for single patient<br>use. Stabilization insulation – The<br>patented stabilization insulation<br>is made of insulating and<br>moisture-absorbent neoprene.<br>The stabilization insulation<br>supports the cooling pads and<br>insulates against the ambient<br>environment condensation. The<br>elasticity of the stabilization<br>insulation keeps the Cooling<br>Pads in place during treatment<br>and ensures maximum cooling<br>between the skin and the<br>surface of the Cooling Pad. The |
| Name | IQool™ Warm System | Arctic Sun® Temperature<br>Management System – Predicate | IQool™ System – Reference |
| | Accessories:<br>BC Stick – a USB flash drive<br>used to save system<br>configurations, specifically<br>prepared to communicate with<br>the program of the IQool™<br>Warm System. The BC Stick<br>does not store or capture any<br>user identifying information.<br>It can also be used to save a<br>log file for system<br>troubleshooting or to update<br>the software. Filling pitcher – for refilling<br>the tank with coolant. Fill the<br>tank with coolant before or<br>directly after start to avoid<br>damage to the system. The ECU 100 pushes temperature-<br>controlled BC COOL ranging<br>between 4°C and 40°C through the<br>Cooling Pads at approximately 1.2<br>liter per minute per pad. This results<br>in heat exchange between the BC<br>COOL and the patient. Patient<br>temperature is monitored by one or | | stabilizing insulation is<br>intended for single use only.<br>Accessories:<br>BC STICK — The BC STICK<br>is a USB flash drive used to<br>save system configurations,<br>specifically prepared to<br>communicate with the program<br>of the IQool™ System. The BC<br>stick does not store or capture<br>any user identifying<br>information. It can also be used<br>to save a log file for system<br>troubleshooting or to update the<br>software. Filling pitcher - The filling<br>pitcher is for refilling the tank<br>with BC COOL (coolant). Fill<br>the tank with coolant before or<br>directly after start to avoid<br>damage to the system. The ECU 100 pushes temperature-<br>controlled BC COOL ranging between<br>4°C and 30°C through the Cooling<br>Pads at approximately 1.2 liter per<br>minute per pad. This results in heat |
| | two commercially available third-<br>party temperature probes. The<br>IQool™ Warm System maintains a<br>controlled patient temperature during | | exchange between the BC COOL and<br>the patient. Patient temperature is<br>monitored by one or two commercially<br>available third-party temperature |
| Name | IQool™ Warm System | Arctic Sun® Temperature<br>Management System – Predicate | IQool™ System- Reference |
| | | | |
| | the entire treatment period. Any<br>deviations from the set temperature<br>are automatically re-adjusted by the<br>system. The treatment settings for<br>temperature and time can be changed<br>through the touchscreen monitor.<br>Alarms and notifications are<br>activated if any errors are detected.<br>Temperature graphs for each<br>treatment are shown on the<br>touchscreen display for visual<br>monitoring. | | probes. The IQool™ System maintains<br>a controlled patient temperature during<br>the entire treatment period. Any<br>deviations from the default temperature<br>are automatically adjusted by the<br>system. The default treatment settings<br>for temperature and time can be<br>changed through the touchscreen<br>monitor. Alarms and notifications are<br>activated if any errors are detected.<br>Temperature graphs for each treatment<br>are shown on the touchscreen display<br>for visual monitoring. |
| Technological<br>Characteristics | Achieves thermal regulation (cooling<br>and rewarming) by circulating liquid<br>coolant through patient contacting<br>cooling pads. Temperature is<br>controlled by the settings on the<br>device. | Achieves cooling and heating through<br>patient contacting gel pads<br>through which water is circulated.<br>Temperature is controlled by the<br>settings on the device. | Achieves cooling with patient<br>contacting Cooling Pads through which<br>coolant is circulated. Cooling is<br>controlled by the settings on the<br>device. Consistent temperature<br>reduction is maintained and controlled<br>by the system pushing more or less<br>coolant through the pads as needed<br>achieve or maintain desired cooling. |
| Therapy Modes | Hypothermia: cool, maintain<br>Normothermia: actively rewarm | Hypothermia: cool, maintain<br>Normothermia: actively rewarm | Hypothermia: cool, maintain<br>Normothermia: monitor and control<br>rewarming |
| Cooling<br>Mechanism | Employs a single tank which employs<br>three solenoid valves (ON/OFF) to<br>push coolant to the pads intermittently<br>to achieve and maintain desired<br>temperature automatically | Employs two separate tanks, one for<br>cooling and another for heating. To<br>obtain a certain temperature liquid<br>from the two tanks is mixed passes<br>continuously into the cooling pads on | Employs a single tank which employs<br>three solenoid valves (ON/OFF) to<br>push coolant to the pads intermittently<br>to achieve and maintain desired<br>temperature automatically. |
| Name | IQool™ Warm System | Arctic Sun® Temperature Management System – Predicate | IQool™ System- Reference |
| | | the patient. | |
| Heating Capability | Yes | Yes | No |
| Heating Capacity | 2500 BTU/hr 750 Watts | 2500 BTU/hr / 750 Watts | N/A |
| Cooling Rates | 1.38 to 1.61 °C/hour | 1.2 to 2.0 per hour °C/hour | 1.38 to 1.61 °C/hour |

## Table 1: Substantial Equivalence Comparison Table

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## Other Specifications

| Cooling<br>medium | Diluted monopropylene glycol | Water | Diluted monopropylene glycol |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reservoir<br>Capacity | 4.0 liters | 3.5 liters | 4.0 liters |
| Water Flow<br>Rate | 1.5 – 6 liters per minute | 5 liters per minute | 1.5 – 6 liters per minute |
| Patient Probe<br>Type | YSI 400 Series compatible (rectal) | YSI 400 Series compatible | YSI 400 Series compatible (rectal) |
| Patient<br>Temperature<br>Inputs | Patient Temp 1: control, monitor, alarm<br>Patient Temp 2: monitor, alarm | Patient Temp 1: control, monitor, alarm<br>Patient Temp 2: monitor, alarm | Patient Temp 1: control, monitor, alarm<br>Patient Temp 2: monitor, alarm |
| Patient<br>Temperature<br>Measurement | ±0.4°C (10°C to 32°C)<br>±0.2°C (32°C to 38°C)<br>±0.4°C (38°C to 44°C) | ±0.4°C (10°C to 32°C)<br>±0.2°C (32°C to 38°C)<br>±0.4°C (38°C to 44°C) | ±0.4°C (10°C to 32°C)<br>±0.2°C (32°C to 38°C)<br>±0.4°C (38°C to 44°C) |
| Accuracy | Includes ±0.1°C external probe | Includes ±0.1°C external probe | Includes ±0.1°C external probe |
| Patient<br>Temperature<br>Range | 32°C to 38.5°C<br>89.6°F to 101.3°F<br>0.1 °C/°F increments | 32°C to 38.5°C<br>89.6°F to 101.3°F<br>0.1 °C/°F increments | 33°C to 37°C<br>91.4°F to 98.6°F<br>0.1 °C/°F increments |
| Water/Fluid<br>Temperature | -50°C to 99°C / -58°F to 210.2°F<br>0.1 °C/°F increments | -50°C to 99°C / -58°F to 210.2°F<br>0.1 °C/°F increments | -50°C to 99°C / -58°F to 210.2°F<br>0.1 °C/°F increments |
| Display Range | 4°C to 40°C / 39.2°F to 105.8°F | 4°C to 42°C / 39.2…