(236 days)
Temperature reduction for adult patients where clinically indicated, e.g. in hyperthermic patients.
The IQool™ System is a surface cooling device that sustains and 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 refrigerator unit with an integrated control system operated via a touch screen monitor. BC COOL- BC COOL is a cooling liquid consisting of diluted monopropylene glycol (MPG5). The dilution is made by BrainCool AB to optimally serve the IQool™ System. Five liters of BC COOL are delivered with the system. Cooling Pads – the single use cooling pads are the only skin contacting component and can be fitted to the head/neck, torso, and thigh. Liquid coolant is circulated from the tank 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.
The provided text describes a medical device, "The IQool System," and its claim of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC).
Instead, the document focuses on regulatory submission (510(k)) for a thermal regulating system and its comparison to a predicate device. The performance data section broadly states that "Testing was completed for the IQool™ System which demonstrated intended, labeled device performance," and lists various functional, temperature, software, and safety tests, as well as adherence to standards.
Therefore, I cannot populate the table or answer most of your specific questions based on the provided text, as this document type typically doesn't contain that level of detail for performance metrics, study design, or ground truth establishment relevant to AI/ML device evaluations.
Here's what can be inferred or stated about the device based on the provided text, recognizing its limitations regarding your specific questions:
Device: The IQool System (Thermal Regulating System)
Intended Use: Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cooling mechanism: Automated, controlled temperature | "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." |
| Patient Temperature Range: 33°C to 37°C (91.4°F to 98.6°F) | "The IQool System is a surface cooling device that sustains and monitors patient temperature within a range of 33°C to 37°C." |
| Patient Temperature Measurement Accuracy: $\pm$ 0.4°C (10°C to 32°C), $\pm$ 0.2°C (32°C to 38°C), $\pm$ 0.4°C (38°C to 44°C) (Includes $\pm$ 0.1C external probe) | The IQool System reports this as its capability, directly matching the predicate device. |
| Cooling Rates: (Not explicitly stated as an "acceptance criterion" but reported) | 1.38 to 1.61 °C/hour |
| Electrical Safety: Conformance to IEC/EN 60601-1 | "All testing confirmed that the IQool™ System operates as described and is substantially equivalent to the predicate device." |
| Electromagnetic Compatibility: Conformance to IEC/EN 60601-1-2 | "All testing confirmed that the IQool™ System operates as described and is substantially equivalent to the predicate device." |
| Usability: Conformance to IEC/EN 60601-1-6 | "All testing confirmed that the IQool™ System operates as described and is substantially equivalent to the predicate device." |
| Alarm Systems: Conformance to IEC/EN 60601-1-8 | "All testing confirmed that the IQool™ System operates as described and is substantially equivalent to the predicate device." |
| Software Life-Cycle Processes: Conformance to IEC/EN 62304 | "All testing confirmed that the IQool™ System operates as described and is substantially equivalent to the predicate device." |
| Biocompatibility: Testing for patient contacting parts | "biocompatibility testing for patient contacting parts" was performed, and "All testing confirmed that the IQool™ System operates as described..." |
| Functional Testing: (General) | "Performance testing included functional testing... All testing confirmed that the IQool™ System operates as described..." |
| Temperature Control Testing: (General) | "Performance testing included... temperature testing, temperature control… All testing confirmed that the IQool™ System operates as described..." |
Note: The document broadly states "All testing confirmed that the IQool™ System operates as described and is substantially equivalent to the predicate device" in lieu of specific numerical performance outcomes for many criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes general performance testing and standards compliance, not a clinical trial or specific test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The device is a thermal regulating system, not an AI diagnostic tool requiring expert ground truth for interpretation of outputs like images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Not applicable for this type of device and testing described.
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
This information is not provided in the document. This is not an AI/ML diagnostic device with human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical thermal regulating system. Its "performance" is based on its ability to control temperature as per its design. The document states it was functionally tested and meets standards, implying a standalone performance assessment of the device's physical and software functions. The "algorithm" in this context refers to its internal control system for temperature regulation, not an AI for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a thermal regulating system, "ground truth" would typically refer to:
- Reference temperature measurements: Calibrated temperature probes would act as the ground truth for measuring the patient's core temperature.
- System set points: The desired temperature set by the clinician would be the target "ground truth" for the device to achieve and maintain.
- Engineering specifications: Conformance to design specifications for cooling rates, fluid parameters, and safety elements.
The document states "Patient temperature is monitored by one or two commercially available third-party temperature probes." These probes would serve as the reference for patient temperature.
8. The sample size for the training set
This information is not provided in the document. This concept (training set) is typically relevant to AI/ML models, not purely electro-mechanical medical devices with control system software.
9. How the ground truth for the training set was established
This information is not provided in the document. Not applicable given the type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with no facial features.
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
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: +46 733 93 70 76
Contact Person: Adam Harris, MM, RAC Associate Director, Regulatory Affairs Target Health Inc. 261 Madison Avenue, 24th Floor New York, NY 10016 Tel: (646) 218-2009 Fax: (212) 682-2105 aharris@targethealth.com
April 28, 2017 Date of Summary:
| Device ProprietaryName | The IQool™ System | ||
|---|---|---|---|
| Common/Usual Name | Thermal Regulating System | ||
| Classification Names /Numbers and Code | 21 CFR870.5900 | Classification NameThermal Regulating System | CodeNZE |
| 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 andmonitors 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 arefrigerator unit with an integrated control system operatedvia a touch screen monitor. | |||
| • BC COOL- BC COOL is a cooling liquid consisting ofdiluted monopropylene glycol (MPG5). The dilution is madeby BrainCool AB to optimally serve the IQool™ System.Five liters of BC COOL are delivered with the system. | |||
| • Cooling Pads – the single use cooling pads are the only skincontacting component and can be fitted to the head/neck,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® TemperatureManagement System - Reference |
|---|---|---|---|
| Manufacturer | BrainCool AB | Emergency Medical Cooling SystemsAG | 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 forUse | Temperature reduction for adultpatients where clinically indicated, e.g.in hyperthermic patients. | Temperature reduction for adultpatients where clinically indicated, e.g.in hyperthermic patients. | Thermal regulating system, indicatedfor monitoring and controlling patienttemperature. |
| Description | The IQool System is a surface coolingdevice that sustains and monitorspatient temperature within a range of33°C to 37°C.The IQool™ System consists of:ECU 100 – refrigeration andcontrol unit – The ECU 100 is arefrigerator unit with anintegrated control systemoperated via a touch screenmonitor.BC COOL- BC COOL is acooling liquid consisting ofdiluted monopropylene glycol(MPG5). The dilution is madeby BrainCool AB to optimally | The EMCOOLSpad is a single usesurface (skin) cooling device, which isadherent to the patient's skin and sohighly adjustable during the coolingprocedure.An EMCOOLSpad consists of multiplecooling-cells made of thermoplasticpolyurethane, filled with high thermalconductivity material, stored frozen at0 to -10°C.Physics and Mechanism SummaryIn nature, there is always anautomatically started balancing-processamong interacting Subjects, thisprocess stops automatically when aperfectly balanced energy level isreached. | The Arctic Sun TemperatureManagement System is athermoregulatory device that monitorsand controls patient temperature withina range of 32.0° C to 38.5° C (89.60° Fto 101.3° F).The Arctic Sun System consists of theArctic Sun Control Module anddisposable ArcticGel Pads.A patient temperature probe connectedto the Control Module provides patienttemperature feedback to an internalcontrol algorithm which automaticallyincreases or decreases the circulatingwater temperature to achieve a pre-setpatient target temperature determinedby the clinician. |
| liters of BC COOL aredelivered with the system.Cooling Pads – the single usecooling pads are the only skincontacting component and canbe fitted to the head/neck,torso, and thigh. Liquidcoolant is circulated from thetank through the pads to coolpatients. The cooling pads aredesigned and molded to give agood fit during treatment andare intended for single patientuse. Stabilization insulation – Thepatented stabilization insulationis made of insulating andmoisture-absorbent neoprene.The stabilization insulationsupports the cooling pads andinsulates against the ambientenvironment condensation. Theelasticity of the stabilizationinsulation keeps the CoolingPads in place during treatmentand ensures maximum coolingbetween the skin and thesurface of the Cooling Pad. Thestabilizing insulation isintended for single use only. Accessories: | this interaction process is startedautomatically when the pads areadhered to the skin (see sketch below)and ends automatically with a balancedenergy level between cold pad andwarm skin.If you remove EMCOOLSpad from thepatient's body, another balancing-process commences automatically,leading to a slow and mild re-warming,again to a certain “balanced level”.Image: Heat Exchange Mechanism of the EMCOOLSpadsBetween start-point and end-point ofthis balancing process, the cold goesinto the skin vertically and locally first,but immediately is "transported" awayinto the complete human body andcools it down. Seen from the patient'sperspective the warmth of the body andskin is "transported" into the pad andmelts it.User and Patient InterfaceThe patient's core temperature isregulated within in a certaintemperature range by manually | The Arctic Sun pulls temperature-controlled water ranging between 40°and 420C (39.20F and 1 07.60F)through the ArcticGel Pads, resultingin heat exchange between the waterand 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.Device InterfaceA 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 treatmentsettings 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, RewarmPatient | |
| 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 |
| Coolingmedium | Diluted monopropylene glycol | HypoCarbon® - described as a highthermal conductivity material | Water |
| ReservoirCapacity | 4.0 liters | N/A | 3.5 liters |
| Water FlowRate | 1.5 – 6 liters per minute | N/A | 5 liters per minute |
| Patient ProbeType | YSI 400 Series compatible (rectal) | YSI 400 Series compatible | YSI 400 Series compatible |
| PatientTemperatureInputs | Patient Temp 1: control, monitor,alarmPatient Temp 2: monitor, alarm | N/A | Patient Temp 1: control, monitor,alarmPatient Temp 2: monitor, alarm |
| PatientTemperatureMeasurementAccuracy | $\pm$ 0.4°C (10°C to 32°C)$\pm$ 0.2°C (32°C to 38°C)$\pm$ 0.4°C (38°C to 44°C)Includes $\pm$ 0.1C external probe | N/A | $\pm$ 0.4°C (10°C to 32°C)$\pm$ 0.2°C (32°C to 38°C)$\pm$ 0.4°C (38°C to 44°C)Includes $\pm$ 0.1C external probe |
| PatientTemperatureRange | 33°C to 37°C91.4°F to 98.6°F0.1 °C/°F increments | N/A | 32°C to 38.5°C89.6°F to 101.3°F0.1 °C/°F increments |
| Water/FluidTemperatureDisplay Range | -50°C to 99°C / -58°F to 210.2°F0.1 °C/°F increments-12°C to 27°C / 10.4°F to 80.6°F0.1 °C/°F increments | N/A | -50°C to 99°C / -58°F to 210.2°F0.1 °C/°F increments4°C to 42°C / 39.2°F to 107.6°F0.1 °C/°F increments |
| WaterTemperatureControl Range(Manual) | N/A | ||
| Mains Input | 115 VAC, 60 Hz, 10.0 Amp (nominal)230 VAC, 50 Hz, 6.3 Amp | N/A | 115 VAC, 60 Hz, 11.0 Amp (nominal)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)Width: 20 inches (50.5cm)Depth: 24 inches (61 cm) | Not listed in labeling | Height: 35 inches (89 cm)Width: 14 inches (36 cm)Depth: 18.5 inches (47 cm) |
| Weight | Empty: 71 kg / 157 lbs.Filled: 75 kg / 165 lbs. | Not listed in labeling | Empty: 43 kg / 95 lbs.Filled: 47 kg / 103 lbs. |
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| Characteristics | IQool™ ThermalRegulation SystemK16 | EMCoolspadK100071 | Arctic Sun®TemperatureManagementSystem K101092 |
|---|---|---|---|
| Thermal regulatingsystem | Yes | Yes | Yes |
| Non-invasive system | Yes | Yes | Yes |
| Patient surface cooling | Yes | Yes | Yes |
| Contact to the patient'sskin during cooling | Yes | Yes | Yes |
| Single use device | Yes | Yes | Yes |
| Temperature gradientbetweenpatient and cooling pad | Yes | Yes | Yes |
| Removal of thermalenergyfrom the patient | Yes | Yes | Yes |
| Rapid cooling function | No | Yes | No |
| Temperature monitoringwith 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.
§ 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).