The IQool System

K162523 · Braincool AB · NZE · May 3, 2017 · Cardiovascular

Device Facts

• Record ID: K162523
• Device Name: The IQool System
• Applicant: Braincool AB
• Product Code: NZE · Cardiovascular
• Decision Date: May 3, 2017
• 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

The IQool System is a surface cooling device used in clinical settings to maintain and monitor adult patient temperature between 33°C and 37°C. It consists of an ECU 100 refrigeration/control unit, a monopropylene glycol-based coolant (BC COOL), and single-use cooling pads applied to the head/neck, torso, or thigh. The system circulates coolant (4°C to 30°C) through the pads to facilitate heat exchange. A physician or clinician operates the system via a touchscreen monitor, setting target temperatures and durations. The device uses third-party temperature probes for patient feedback; an internal control system automatically adjusts coolant flow via solenoid valves to maintain the target temperature. Alarms notify the user of errors or deviations. By automating the cooling process, the device provides controlled thermal regulation, potentially improving patient tolerance and reducing the risk of over-cooling compared to manual cooling methods.

Clinical Evidence

Bench testing only. Performance evaluation included functional testing, temperature control accuracy, cooling pad performance, software validation, shipping/handling, climate testing, biocompatibility of patient-contacting parts, and standards testing (electrical safety, EMC, usability, alarm systems, and coolant microbiology).

Technological Characteristics

Surface cooling system; refrigeration unit (ECU 100) with touchscreen; monopropylene glycol coolant; single-use neoprene-backed cooling pads. Sensing: YSI 400 Series compatible temperature probes. Connectivity: USB (BC STICK) for configuration/logs. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, ISO 14971, ISO 13485.

Indications for Use

Indicated for temperature reduction in adult patients, including 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)

Reference Devices

• Arctic Sun® Temperature Management System (K101092)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2017

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

Re: K162523

Trade/Device Name: The IQool System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NZE Dated: March 31, 2017 Received: April 3, 2017

Dear Adam Harris:

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 (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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando Aguel-S
Fernando Agnel

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) K162523

Device Name The IQool 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510(k) SUMMARY

#### 510(k) Applicant

BrainCool 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 Tel: [phone] Fax: [phone] [e-mail]

April 28, 2017 Date of Summary:

| Device Proprietary<br>Name | The IQool™ System | | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------|
| Common/Usual Name | Thermal Regulating System | | |
| Classification Names /<br>Numbers and Code | 21 CFR<br>870.5900 | Classification Name<br>Thermal Regulating System | Code<br>NZE |
| Regulatory Class | II | | |
| Prescription Status | Prescription Device | | |
| Classification Panel | Cardiovascular | | |
| Predicate Device | K100071 | EMCoolspad | |
| Reference Device | K101092 | Arctic Sun® Temperature Management System | |
| Description of Device | The IQool™ System is a surface cooling device that sustains and<br>monitors patient temperature within a range of 33°C to 37°C. | | |
| | The IQool™ System consists of: | | |
| | • ECU 100 – refrigeration and control unit – The ECU 100 is a<br>refrigerator unit with an integrated control system operated<br>via a touch screen monitor. | | |
| | • BC COOL- BC COOL is a cooling liquid consisting of<br>diluted monopropylene glycol (MPG5). The dilution is made<br>by BrainCool AB to optimally serve the IQool™ System.<br>Five liters of BC COOL are delivered with the system. | | |
| | • Cooling Pads – the single use cooling 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 | | |

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| | through the pads to cool patients. The cooling pads are designed and molded to give a good fit during treatment and are intended for single patient use. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Stabilization insulation – The patented stabilization insulation is made of insulating and moisture-absorbent neoprene. The stabilization insulation supports the cooling pads and insulates against the ambient environment condensation. The elasticity of the stabilization insulation keeps the Cooling Pads in place during treatment and ensures maximum cooling between the skin and the surface of the Cooling Pad. The stabilizing insulation is intended for single use only. |
| | Accessories: |
| | BC STICK — The BC STICK is a USB flash drive used to save system configurations, specifically prepared to communicate with the program of the IQool™ System. The BC stick does not store or capture any user identifying information. It can also be used to save a log file for system troubleshooting or to update the software. Filling pitcher – The filling pitcher is for refilling the tank with BC COOL (coolant). Fill the tank with coolant before or directly after start to avoid damage to the system. |
| | The ECU 100 pushes temperature-controlled BC COOL ranging between 4°C and 30°C through the Cooling Pads at approximately 1.2 liter per minute per pad. This results in heat exchange between the BC COOL and the patient. Patient temperature is monitored by one or two commercially available third-party temperature probes. The IQool™ System maintains a controlled patient temperature during the entire treatment period. Any deviations from the default temperature are automatically adjusted by the system. The default treatment settings for temperature and time can be changed through the touchscreen monitor. Alarms and notifications are activated if any errors are detected. Temperature graphs for each treatment are shown on the touchscreen display for visual monitoring. |
| Indications for Use | Temperature reduction in adult patients where clinically indicated, e.g. in hyperthermic patients. |

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### Table: Substantial Equivalence Comparison Table

| Name | IQool™ Thermal Regulation System | EMCoolspad – Predicate | Arctic Sun® Temperature<br>Management System - Reference |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BrainCool AB | Emergency Medical Cooling Systems<br>AG | Medivance, Inc |
| 510(K) Number | K162523 | K100071 | K101092 |
| Product Code | NZE | NZE | DWJ |
| Regulation | 21 CFR 870.5900 | 21 CFR 870.5900 | 21 CFR 870.5900 |
| Indications for<br>Use | Temperature reduction for adult<br>patients where clinically indicated, e.g.<br>in hyperthermic patients. | Temperature reduction for adult<br>patients where clinically indicated, e.g.<br>in hyperthermic patients. | Thermal regulating system, indicated<br>for monitoring and controlling patient<br>temperature. |
| Description | The IQool System is a surface cooling<br>device that sustains and monitors<br>patient temperature within a range of<br>33°C to 37°C.<br><br>The IQool™ System consists of:<br>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 | 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.<br><br>An EMCOOLSpad consists of multiple<br>cooling-cells made of thermoplastic<br>polyurethane, filled with high thermal<br>conductivity material, stored frozen at<br>0 to -10°C.<br><br>Physics and Mechanism Summary<br>In nature, there is always an<br>automatically started balancing-process<br>among interacting Subjects, this<br>process stops automatically when a<br>perfectly balanced energy level is<br>reached. | The Arctic Sun Temperature<br>Management System is a<br>thermoregulatory device that monitors<br>and controls patient temperature within<br>a range of 32.0° C to 38.5° C (89.60° F<br>to 101.3° F).<br><br>The Arctic Sun System consists of the<br>Arctic Sun Control Module and<br>disposable ArcticGel Pads.<br><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. |
| | | | |
| liters of BC COOL are<br>delivered with the system.<br><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<br>stabilizing insulation is<br>intended for single use only. Accessories: | this interaction process is started<br>automatically when the pads are<br>adhered to the skin (see sketch below)<br>and ends automatically with a balanced<br>energy level between cold pad and<br>warm skin.<br><br>If you remove EMCOOLSpad from the<br>patient's body, another balancing-<br>process commences automatically,<br>leading to a slow and mild re-warming,<br>again to a certain “balanced level”.<br><br>Image: Heat Exchange Mechanism of the EMCOOLSpads<br><br>Between start-point and end-point of<br>this balancing process, the cold goes<br>into the skin vertically and locally first,<br>but immediately is "transported" away<br>into the complete human body and<br>cools it down. Seen from the patient's<br>perspective the warmth of the body and<br>skin is "transported" into the pad and<br>melts it.<br><br>User and Patient Interface<br>The patient's core temperature is<br>regulated within in a certain<br>temperature range by manually | The Arctic Sun pulls temperature-<br>controlled water ranging between 40°<br>and 420C (39.20F and 1 07.60F)<br>through the ArcticGel Pads, resulting<br>in heat exchange between the water<br>and the patient. | |

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| BC STICK — The BC STICK is a USB flash drive used to save system configurations, specifically prepared to communicate with the program of the IQool™ System. The BC stick does not store or capture any user identifying information. It can also be used to save a log file for system troubleshooting or to update the software. Filling pitcher – The filling pitcher is for refilling the tank with BC COOL (coolant). Fill the tank with coolant before or directly after start to avoid damage to the system. The ECU 100 pushes temperature-controlled BC COOL ranging between 4°C and 30°C through the Cooling Pads at approximately 1.2 liter per minute per pad. This results in heat exchange between the BC COOL and the patient. Patient temperature is monitored by one or two commercially available third-party temperature probes. The IQool™ System maintains a controlled patient temperature during the entire treatment period. Any deviations from the default temperature are automatically adjusted | removing (= warming) or applying (=cooling) the EMCOOLSpad.<br><br>Device Interface<br>A commercially available third-party temperature probe connected to a commercially available third-party monitor senses the patient's core temperature. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| | by the system. The default treatment<br>settings for temperature and time can | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | be changed through the touchscreen | | |
| | monitor. Alarms and notifications are | | |
| | activated if any errors are detected. | | |
| | Temperature graphs for each treatment | | |
| | are shown on the touchscreen display | | |
| | for visual monitoring. | | |
| Technological | Achieves cooling with patient | Achieves cooling through patient | Achieves cooling and heating through |
| Characteristics | contacting Cooling Pads through which | contacting Cooling Pads which are | patient contacting Cooling Pads |
| | coolant is circulated. Cooling is | filled with a high thermal conductivity | through which water is circulated. |
| | controlled by the settings on the | material. Pads must be pre-cooled | |
| | device. Consistent temperature | before use. To control cooling, pads | |
| | reduction is maintained and controlled | are removed from the patient's skin to | |
| | by the system pushing more or less | slow cooling or to stop cooling. The | |
| | coolant through the pads as needed | pads are re-applied to the patient's skin | |
| | achieve or maintain desired cooling. | to recommence the cooling process. | |
| Therapy Modes | Hypothermia: Cool Patient | Cooling patients to desired temperature | Normothermia: Control Patient |
| | Normothermia: Control Patient | through manually removing and | Hypothermia: Cool Patient, Rewarm<br>Patient |
| | | reapplying the pads | |
| Cooling | Employs a single tank which employs | Cooling Pads are filled with a high | Employs two separate tanks, one for |
| Mechanism | three solenoid valves (ON/OFF) to | thermal conductivity material and pre- | cooling and another for heating. To |
| | push coolant to the pads intermittently | frozen at 0 to -10°C. | obtain a certain temperature liquid |
| | to achieve and maintain desired | | from the two tanks is mixed passes |
| | temperature automatically. | | continuously into the cooling pads on |
| | | | the patient. |
| Heating | None | None | Yes |
| Mechanism | | | |
| Cooling Rates | 1.38 to 1.61 °C/hour | 0.6 °C/hour to 3.3 °C/hour | 1.2 to 2.0 per hour °C/hour |
| | | | |
| Cooling<br>medium | Diluted monopropylene glycol | HypoCarbon® - described as a high<br>thermal conductivity material | Water |
| Reservoir<br>Capacity | 4.0 liters | N/A | 3.5 liters |
| Water Flow<br>Rate | 1.5 – 6 liters per minute | N/A | 5 liters per minute |
| Patient Probe<br>Type | YSI 400 Series compatible (rectal) | YSI 400 Series compatible | YSI 400 Series compatible |
| Patient<br>Temperature<br>Inputs | Patient Temp 1: control, monitor,<br>alarm<br>Patient Temp 2: monitor, alarm | N/A | Patient Temp 1: control, monitor,<br>alarm<br>Patient Temp 2: monitor, alarm |
| Patient<br>Temperature<br>Measurement<br>Accuracy | $\pm$ 0.4°C (10°C to 32°C)<br>$\pm$ 0.2°C (32°C to 38°C)<br>$\pm$ 0.4°C (38°C to 44°C)<br>Includes $\pm$ 0.1C external probe | N/A | $\pm$ 0.4°C (10°C to 32°C)<br>$\pm$ 0.2°C (32°C to 38°C)<br>$\pm$ 0.4°C (38°C to 44°C)<br>Includes $\pm$ 0.1C external probe |
| Patient<br>Temperature<br>Range | 33°C to 37°C<br>91.4°F to 98.6°F<br>0.1 °C/°F increments | N/A | 32°C to 38.5°C<br>89.6°F to 101.3°F<br>0.1 °C/°F increments |
| Water/Fluid<br>Temperature<br>Display Range | -50°C to 99°C / -58°F to 210.2°F<br>0.1 °C/°F increments<br>-12°C to 27°C / 10.4°F to 80.6°F<br>0.1 °C/°F increments | N/A | -50°C to 99°C / -58°F to 210.2°F<br>0.1 °C/°F increments<br>4°C to 42°C / 39.2°F to 107.6°F<br>0.1 °C/°F increments |
| Water<br>Temperature<br>Control Range<br>(Manual) | | N/A | |
| Mains Input | 115 VAC, 60 Hz, 10.0 Amp (nominal)<br>230 VAC, 50 Hz, 6.3 Amp | N/A | 115 VAC, 60 Hz, 11.0 Amp (nominal)<br>230 VAC, 50 Hz, 5.5 Amp |
| Alarms | Monitoring and safety alarms | None | Monitoring and safety alarms |

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### Other Specifications

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| Pad Placement | Image: Pad Placement | Image: Pad Placement | Image: Pad Placement |
|---------------|---------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------|
| Dimensions | Height: 41 inches (105.2 cm)<br>Width: 20 inches (50.5cm)<br>Depth: 24 inches (61 cm) | Not listed in labeling | Height: 35 inches (89 cm)<br>Width: 14 inches (36 cm)<br>Depth: 18.5 inches (47 cm) |
| Weight | Empty: 71 kg / 157 lbs.<br>Filled: 75 kg / 165 lbs. | Not listed in labeling | Empty: 43 kg / 95 lbs.<br>Filled: 47 kg / 103 lbs. |

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| Characteristics | IQool™ Thermal<br>Regulation System<br>K16 | EMCoolspad<br>K100071 | Arctic Sun®<br>Temperature<br>Management<br>System K101092 |
|------------------------------------------------------------|--------------------------------------------|-----------------------|------------------------------------------------------------|
| Thermal regulating<br>system | Yes | Yes | Yes |
| Non-invasive system | Yes | Yes | Yes |
| Patient surface cooling | Yes | Yes | Yes |
| Contact to the patient's<br>skin during cooling | Yes | Yes | Yes |
| Single use device | Yes | Yes | Yes |
| Temperature gradient<br>between<br>patient and cooling pad | Yes | Yes | Yes |
| Removal of thermal<br>energy<br>from the patient | Yes | Yes | Yes |
| Rapid cooling function | No | Yes | No |
| Temperature monitoring<br>with a temperature probe | Yes | Yes | Yes |
| Heating mechanism | No | No | Yes |

#### Summary of Technological Characteristics compared to the predicate device

#### Comparison of Significant Features

- With the Predicate and Subject devices, cooling pads are single use and placed on the patient's chest arms and legs.
- The cooling pads on both devices transfer cooling to the patient and are monitored by 3rd ● party temperature probes.
- The Predicate device manages patient temperature (by manually removing the cooling pads or applying the cooling pads), whereas the Subject device manages the patient temperature and the cooling process automatically according to settings.
- Cooling rates are comparable but not exactly the same for the Predicate and Subject devices

#### Discussion

The IQool System is not a new device from a standpoint of intended use or of technological characteristics. The intended use and indications for use for the Subject and Predicate devices are the same. Both devices are applying cooling to the patient at the same location on the body. The main differences are the energy source for the Subject device is electrical and clinicians can manage cooling with the touch screen settings of the device, whereas with the Predicate device, the user must manage cooling manually by applying and removing the pads to achieve the desired level of cooling. The Predicate cooling pads are stored frozen at 0 to -10°C which is

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considerably colder than the coolant in the IOool, which ranges in temperature from +4 to 30°C. This difference in temperature and approach to the cooling process may mean that the Predicate can cool at a faster rate than the Subject device. but that the Subject device may be better tolerated, and with the Subject device there may be a lower risk of over cooling a patient.

### Performance Data

Testing was completed for the IQool™ System which demonstrated intended, labeled device performance. Performance testing included functional testing, temperature testing, temperature control, cooling pads, full software testing, shipping and handling, and climate testing, biocompatibility testing for patient contacting parts, and standards testing including electrical safety, electromagnetic compatibility, usability, alarm systems, and microbiological testing for the coolant. All testing confirmed that the IQool™ System operates as described and is substantially equivalent to the predicate device.

The IQool™ System was tested to conform to the following standards:

- . IEC/EN 60601-1:2005 ed 3.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC/EN 60601-1-2:2007 ed. 3 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC/EN 60601-1-6:2010 ed. 3 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC/EN 60601-1-8:2006 ed. 2 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC/EN 62304:2007 ed. 1 Medical device software - Software life-cycle processes
- . IEC/EN 50581:2014 ed. 1 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
- ASTM-D4169 Standard Practice for Performance Testing of Shipping Containers and ● Systems
- IEC-TR 60721-4-7 Classification of environmental conditions Part 4-7: Guidance for the ● correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
- ISO 14971:2012 ed. 4 Medical devices Application of risk management to medical devices ●
- ISO 13485:2012 ed. 3 Medical devices ●

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### Conclusion

It is the opinion of the Sponsor that the IQool™ System does not raise new questions of safety and effectiveness in comparison to the Predicate. The differences in technological characteristics between the IQool™ System and the Predicate are not critical and thus meet the requirements of 21 CFR 807.87(f). Therefore, the sponsor has determined that the IQool™ System is substantially equivalent to its Predicate EMCoolspad K100071.