(95 days)
The IQoolTM Warm System is a temperature regulating system indicated for monitoring and controlling patient temperature.
The IQool™ Warm System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQooL™ Warm System consists of: ECU 100 – refrigeration and control unit – an integrated control system operated via a touch screen monitor. BC COOL– a cooling liquid consisting of diluted monopropylene glycol (MPG5). The dilution is made by BrainCool AB to optimally serve the IQool TM Warm System. Five liters of BC COOL are delivered with the system. Cooling Pads – the single use 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 control patient temperature. The 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-absorbing neoprene which 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 contact between the skin and the surface of the cooling pad. The stabilizing insulation is intended for single use only. Accessories: BC Stick – a USB flash drive used to save system configurations, specifically prepared to communicate with the program of the IQoolTM Warm 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 – for refilling the tank with BC COOL (coolant). Fill the tank with coolant before or directly after start to avoid damage to the system.
This document is a 510(k) Premarket Notification from Brain Cool AB for their IQool™ Warm System (K180375), seeking to demonstrate substantial equivalence to a predicate device, the Arctic Sun® Temperature Management System (K101092). The information provided focuses on the device's characteristics and a comparison to the predicate, rather than a clinical study establishing acceptance criteria through human performance or expert consensus.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device submission. This is a medical device regulation document, not a clinical study report for an AI-powered diagnostic tool.
The "study" referenced in this document is primarily bench testing and a comparison of technical specifications to a predicate device to demonstrate substantial equivalence under regulatory guidelines. The acceptance criteria are therefore focused on the device's ability to perform its core function (temperature regulation) within specified ranges, as well as adherence to safety and design standards already established by the predicate device.
Here's an breakdown based on the provided document, addressing the applicable points:
Device Name: The IQool™ Warm System
Regulatory Submission: 510(k) Premarket Notification (K180375)
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a thermal regulating system, the acceptance criteria are based on demonstrating comparable performance to a legally marketed predicate device (Arctic Sun® Temperature Management System, K101092) and adhering to established engineering and safety standards. The "reported device performance" is framed in terms of its technical characteristics matching or being similar to the predicate.
| Characteristic / Acceptance Criteria (Implied by equivalence to predicate) | Reported IQool™ Warm System Performance (K180375) |
|---|---|
| Intended Use | Temperature regulating system indicated for monitoring and controlling patient temperature. (Identical to predicate) |
| Temperature Range | Control patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). (Identical to predicate) |
| Cooling Rate | 1.38 to 1.61 °C/hour. (Comparable to predicate's 1.2 to 2.0 °C/hour) |
| Heating Capability | Yes (Identical to predicate) |
| Heating Capacity | 2500 BTU/hr / 750 Watts (Identical to predicate) |
| Cooling Medium | Diluted monopropylene glycol. (Predicate uses water; considered a minor difference and acceptable through testing) |
| Reservoir Capacity | 4.0 liters. (Predicate: 3.5 liters; Reference IQool™ System: 4.0 liters) |
| Water Flow Rate | 1.5 – 6 liters per minute. (Predicate: 5 liters per minute) |
| Patient Temperature Measurement Accuracy | ±0.4°C (10°C to 32°C), ±0.2°C (32°C to 38°C), ±0.4°C (38°C to 44°C), includes ±0.1°C external probe. (Identical to predicate) |
| Temperature Control & Monitoring | Automates temperature control based on set point, uses third-party temperature probes, provides monitoring and safety alarms. Simulated testing demonstrated cooling patients to hypothermia, maintaining patient temperature, and rewarming patients to normothermia comparably to the Predicate device and according to general therapeutic hypothermia practice. (Demonstrated through bench testing and comparison to predicate/literature) |
| Safety Alarms | Monitoring and safety alarms present. Includes an additional alarm if the patient begins warming too quickly. (Comparable to predicate, with an additional safety feature) |
| Patient Contacting Materials/Pads | Single-use pads for head/neck, torso, thigh. Identical in design and material to previously cleared IQool system (K162523), ensuring biocompatibility. |
| Sterilization | Not Sterilized. (Consistent with predicate and reference device) |
| Software Validation | New software testing and package provided appropriate to the identified level of concern. (Validated according to FDA's Guidance for Software Contained in Medical Devices) |
2. Sample size used for the test set and the data provenance:
- This submission relies primarily on bench testing (simulated testing) rather than a clinical human subject test set for proving device performance. The specific "sample size" is not quantitated as it would be for a clinical trial with human subjects.
- Data Provenance: The testing is laboratory-based ("simulated testing"). No information on geographical origin (country) or retrospective/prospective nature of a human data set is provided, as it's not a clinical study involving patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this device's performance is its ability to accurately control temperature, which is verified through engineering principles, bench testing, and comparison to the known performance of the predicate device and established medical literature on therapeutic hypothermia. This does not involve expert readers establishing ground truth on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to expert review and potential disagreement resolution in studies involving subjective assessment (e.g., image interpretation). The evaluation here is based on objective physical measurements and comparisons.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a thermal regulating system, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the context of an AI algorithm. However, the device's automated temperature control function can be thought of as "standalone" in that it performs its function without continuous human intervention to manually control temperature once set. Its performance was assessed through engineering and bench testing.
7. The type of ground truth used:
- The "ground truth" for this device's effectiveness is its ability to accurately and reliably regulate temperature within specified ranges, as determined by physical measurements, engineering specifications, and comparison to the established performance characteristics of the legally marketed predicate device (Arctic Sun® Temperature Management System) and general therapeutic hypothermia practice.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):
The IQool™ Warm System's acceptance criteria are met by demonstrating substantial equivalence to the predicate device (Arctic Sun® Temperature Management System, K101092). The "study" proving this involved:
- Comparative analysis: Detailed comparison of the IQool™ Warm System's indications for use, technological characteristics, and performance specifications against the predicate device.
- Bench Testing / Simulated Testing: The sponsor submitted "simulated testing" for the new rewarming features. This testing demonstrated the device's ability to cool patients to hypothermia, maintain patient temperature, and rewarm patients to normothermia comparably to the predicate device, based on published cooling times for the predicate and general therapeutic hypothermia practice.
- Cross-referencing to a previously cleared device (K162523): Information regarding cooling pads, accessories, shelf-life, sterilization, and biocompatibility was referenced from a prior 510(k) submission for a related IQool system, as these components were identical.
- Software Validation: New software testing was conducted and submitted, adhering to FDA guidance for software in medical devices, to ensure appropriate level of concern was addressed for the added rewarming capability.
The conclusion is that the differences between the IQool™ Warm System and the predicate are minor and do not raise new questions of safety and effectiveness, thus meeting the requirements for 510(k) clearance by demonstrating substantial equivalence.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line. The logo is clean and professional, reflecting the FDA's role in regulating food and drugs in the United States.
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
5. 510(k) Summary
510(k) Applicant
Brain Cool 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 Telephone: (646) 218-2009
Fax: (212) 682-2105 aharris@targethealth.com
Date of Summary: March 28, 2018
| Device ProprietaryName | The IQool™ Warm System | ||
|---|---|---|---|
| Common/Usual Name | Thermal Regulating System | ||
| Classification Names /Numbers and Code | 21 CFR | Classification Name | Code |
| 870.5900 | Thermal RegulatingSystem | 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, thermalregulating system that monitors and controls patienttemperature within a range of 32°C to 38.5°C (89.6°F to101.3°F). | ||
| The IQooL™ Warm System consists of: | |||
| • ECU 100 – refrigeration and control unit – an integratedcontrol system operated via a touch screen monitor. | |||
| • BC COOL– a cooling liquid consisting of dilutedmonopropylene glycol (MPG5). The dilution is made by | |||
| BrainCool AB to optimally serve the IQool TM WarmSystem. Five liters of BC COOL are delivered with thesystem. | |||
| • Cooling Pads – the single use pads are the only skincontacting component and can be fitted to the head/neck,torso, and thigh. Liquid coolant is circulated from the tankthrough the pads to control patient temperature. The padsare designed and molded to give a good fit duringtreatment and are intended for single patient use. | |||
| • Stabilization insulation – the patented stabilizationinsulation is made of insulating and moisture-absorbingneoprene which supports the cooling pads and insulatesagainst the ambient environment condensation. Theelasticity of the stabilization insulation keeps the coolingpads in place during treatment and ensures maximumcontact between the skin and the surface of the coolingpad. The stabilizing insulation is intended for single useonly. | |||
| Accessories: | |||
| • BC Stick – a USB flash drive used to save systemconfigurations, specifically prepared to communicate withthe program of the IQoolTM Warm System. The BC stickdoes not store or capture any user identifying information.It can also be used to save a log file for systemtroubleshooting or to update the software. | |||
| • Filling pitcher – for refilling the tank with BC COOL(coolant). Fill the tank with coolant before or directly afterstart to avoid damage to the system. | |||
| Indications for Use | The IQoolTM Warm System is a temperature regulating systemindicated for monitoring and controlling patient temperature. |
{4}------------------------------------------------
{5}------------------------------------------------
| Name | IQool™ Warm System | Arctic Sun® TemperatureManagement 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 forUse | The IQool™ Warm System is atemperature regulating systemindicated for monitoring andcontrolling patient temperature. | Thermal regulating system, indicatedfor monitoring and controlling patienttemperature. | Temperature reduction for adultpatients where clinically indicated, e.g.in hyperthermic patients. |
| Description | The IQool™ Warm System is a non-invasive, thermal regulating system thatmonitors and controls patienttemperature within a range of 32°C to38.5°C (89.6°F to 101.3°F). | The Arctic Sun TemperatureManagement System is athermoregulatory device that monitorsand controls patient temperaturewithin a range of 32.0° C to 38.5° C(89.60° F to 101.3° F). | The IQool™ System is a surfacecooling device that sustains andmonitors patient temperature within arange of 33°C to 37°C.The IQool™ System consists of: |
| The IQool™ Warm System consists of:• ECU 100 refrigeration andcontrol unit – an integratedcontrol system operated via atouch screen monitor.• BC COOL – a cooling liquidconsisting of dilutedmonopropylene glycol(MPG5). The dilution is madeby BrainCool AB to optimallyserve the IQool™ WarmSystem. Five liters of BC | 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.The Arctic Sun pulls temperature- | • 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 optimallyserve the IQool™ | |
| Name | IQool™ Warm System | Arctic Sun® TemperatureManagement System – Predicate | IQool™ System- Reference |
| COOL are delivered with thesystem.Cooling Pads – the single usepads are the only skincontacting component and canbe fitted to the head/neck,torso, and thigh. Liquid coolantis circulated from the tankthrough the pads to controlpatient temperature. The padsare designed and molded to givea good fit during treatment andare intended for single patientuse. Stabilization insulation – Thepatented stabilizationinsulation is made ofinsulating and moisture-absorbing neoprene whichsupports the cooling pads andinsulates against the ambientenvironment condensation.The elasticity of thestabilization insulation keepsthe cooling pads in placeduring treatment and ensuresmaximum contact between theskin and the surface of thecooling pad. The stabilizinginsulation is intended forsingle use only. | controlled water ranging between 4° Cand 42 ° C (39.2° F and 107.6° F)through the ArcticGel Pads, resultingin heat exchange between the waterand the patient. | System.Five 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. The | |
| Name | IQool™ Warm System | Arctic Sun® TemperatureManagement System – Predicate | IQool™ System – Reference |
| Accessories:BC Stick – a USB flash driveused to save systemconfigurations, specificallyprepared to communicate withthe program of the IQool™Warm System. The BC Stickdoes not store or capture anyuser identifying information.It can also be used to save alog file for systemtroubleshooting or to updatethe software. Filling pitcher – for refillingthe tank with coolant. Fill thetank with coolant before ordirectly after start to avoiddamage to the system. The ECU 100 pushes temperature-controlled BC COOL rangingbetween 4°C and 40°C through theCooling Pads at approximately 1.2liter per minute per pad. This resultsin heat exchange between the BCCOOL and the patient. Patienttemperature is monitored by one or | stabilizing insulation isintended for single use only.Accessories:BC STICK — The BC STICKis a USB flash drive used tosave system configurations,specifically prepared tocommunicate with the programof the IQool™ System. The BCstick does not store or captureany user identifyinginformation. It can also be usedto save a log file for systemtroubleshooting or to update thesoftware. Filling pitcher - The fillingpitcher is for refilling the tankwith BC COOL (coolant). Fillthe tank with coolant before ordirectly after start to avoiddamage to the system. The ECU 100 pushes temperature-controlled BC COOL ranging between4°C and 30°C through the CoolingPads at approximately 1.2 liter perminute per pad. This results in heat | ||
| two commercially available third-party temperature probes. TheIQool™ Warm System maintains acontrolled patient temperature during | exchange between the BC COOL andthe patient. Patient temperature ismonitored by one or two commerciallyavailable third-party temperature | ||
| Name | IQool™ Warm System | Arctic Sun® TemperatureManagement System – Predicate | IQool™ System- Reference |
| the entire treatment period. Anydeviations from the set temperatureare automatically re-adjusted by thesystem. The treatment settings fortemperature and time can be changedthrough the touchscreen monitor.Alarms and notifications areactivated if any errors are detected.Temperature graphs for eachtreatment are shown on thetouchscreen display for visualmonitoring. | probes. The IQool™ System maintainsa controlled patient temperature duringthe entire treatment period. Anydeviations from the default temperatureare automatically adjusted by thesystem. The default treatment settingsfor temperature and time can bechanged through the touchscreenmonitor. Alarms and notifications areactivated if any errors are detected.Temperature graphs for each treatmentare shown on the touchscreen displayfor visual monitoring. | ||
| TechnologicalCharacteristics | Achieves thermal regulation (coolingand rewarming) by circulating liquidcoolant through patient contactingcooling pads. Temperature iscontrolled by the settings on thedevice. | Achieves cooling and heating throughpatient contacting gel padsthrough which water is circulated.Temperature is controlled by thesettings on the device. | Achieves cooling with patientcontacting Cooling Pads through whichcoolant is circulated. Cooling iscontrolled by the settings on thedevice. Consistent temperaturereduction is maintained and controlledby the system pushing more or lesscoolant through the pads as neededachieve or maintain desired cooling. |
| Therapy Modes | Hypothermia: cool, maintainNormothermia: actively rewarm | Hypothermia: cool, maintainNormothermia: actively rewarm | Hypothermia: cool, maintainNormothermia: monitor and controlrewarming |
| CoolingMechanism | Employs a single tank which employsthree solenoid valves (ON/OFF) topush coolant to the pads intermittentlyto achieve and maintain desiredtemperature automatically | Employs two separate tanks, one forcooling and another for heating. Toobtain a certain temperature liquidfrom the two tanks is mixed passescontinuously into the cooling pads on | Employs a single tank which employsthree solenoid valves (ON/OFF) topush coolant to the pads intermittentlyto achieve and maintain desiredtemperature 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
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
Other Specifications
| Coolingmedium | Diluted monopropylene glycol | Water | Diluted monopropylene glycol |
|---|---|---|---|
| ReservoirCapacity | 4.0 liters | 3.5 liters | 4.0 liters |
| Water FlowRate | 1.5 – 6 liters per minute | 5 liters per minute | 1.5 – 6 liters per minute |
| Patient ProbeType | YSI 400 Series compatible (rectal) | YSI 400 Series compatible | YSI 400 Series compatible (rectal) |
| PatientTemperatureInputs | Patient Temp 1: control, monitor, alarmPatient Temp 2: monitor, alarm | Patient Temp 1: control, monitor, alarmPatient Temp 2: monitor, alarm | Patient Temp 1: control, monitor, alarmPatient Temp 2: monitor, alarm |
| PatientTemperatureMeasurement | ±0.4°C (10°C to 32°C)±0.2°C (32°C to 38°C)±0.4°C (38°C to 44°C) | ±0.4°C (10°C to 32°C)±0.2°C (32°C to 38°C)±0.4°C (38°C to 44°C) | ±0.4°C (10°C to 32°C)±0.2°C (32°C to 38°C)±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 |
| PatientTemperatureRange | 32°C to 38.5°C89.6°F to 101.3°F0.1 °C/°F increments | 32°C to 38.5°C89.6°F to 101.3°F0.1 °C/°F increments | 33°C to 37°C91.4°F to 98.6°F0.1 °C/°F increments |
| Water/FluidTemperature | -50°C to 99°C / -58°F to 210.2°F0.1 °C/°F increments | -50°C to 99°C / -58°F to 210.2°F0.1 °C/°F increments | -50°C to 99°C / -58°F to 210.2°F0.1 °C/°F increments |
| Display Range | 4°C to 40°C / 39.2°F to 105.8°F | 4°C to 42°C / 39.2°F to 107.6°F | 4°C to 30°C / 39.2°F to 86°F |
| TemperatureControl Range(Manual) | 0.1 °C/0.1 °F increments | 0.1 °C/°F increments | 0.1 °C/°F increments |
| Mains Input | 115 VAC, 60 Hz, 10.0 Amp (nominal)230 VAC, 50 Hz, 6.3 Amp | 115 VAC, 60 Hz, 11.0 Amp (nominal)230 VAC, 50 Hz, 5.5 Amp | 115 VAC, 60 Hz, 10.0 Amp (nominal)230 VAC, 50 Hz, 6.3 Amp |
| Alarms | Monitoring and safety alarms | Monitoring and safety alarms | Monitoring and safety alarms |
| Alarm if patientwarms too quickly | Yes | No | N/A |
| Pad Placement | Image: Pad Placement | Image: Pad Placement | Image: Pad Placement |
| Total of 4 pads, 2 pads for the thighs, 2for the torso, plus 2 optional pads tocover the head and neck for additionalcooling area coverage. | Total of 4 pads, 2 pads for the thighs, 2for the torso, plus 2 optional pads tocover the head and neck for additionalcooling area coverage. | ||
| Dimensions | Height: 41 inches (105.2 cm)Width: 20 inches (50.5cm)Depth: 24 inches (61 cm) | Height: 35 inches (89 cm)Width: 14 inches (36 cm)Depth: 18.5 inches (47 cm) | Height: 41 inches (105.2 cm)Width: 20 inches (50.5cm)Depth: 24 inches (61 cm) |
| Weight | Empty: 73 kg / 161 lbs.Filled: 77 kg / 169 lbs. | Empty: 43 kg / 95 lbs.Filled: 47 kg / 103 lbs. | Empty: 71 kg / 157 lbs.Filled: 75 kg / 165 lbs. |
| Usage in OR | Not intended to be used in OR | N/A | Not intended to be used in OR |
| Componentsterilization | Not Sterilized | N/A | Not Sterilized |
| Cooling pads shelf-life (Torso, Neckand Thighs) | 2 Years | N/A | 2 Years |
{10}------------------------------------------------
{11}------------------------------------------------
| Characteristics | IQoolTM WarmSystem K180375 | Arctic Sun®TMTemperatureManagementSystem K101092 | IQoolTM SystemK162523 |
|---|---|---|---|
| Thermal regulating system | Yes | Yes | Yes |
| Non-invasive system | Yes | Yes | Yes |
| Patient surface cooling | Yes | Yes | Yes |
| Contact to the patient'sskin during treatment | Yes | Yes | Yes |
| Single use device | Yes | Yes | Yes |
| Temperature gradientbetween patient and pads | Yes | Yes | Yes |
| Removal of thermal energyfrom the patient | Yes | Yes | Yes |
| Temperature monitoringwith a temperature probe | Yes | Yes | Yes |
| Heating mechanism | Yes | Yes | No |
| Table 2: Summary of Technological Characteristics Compared to the Predicate Device | ||
|---|---|---|
Comparison of Significant Features
- . The Predicate and the Subject devices are identical in intended use and technological characteristics.
- . Cooling and rewarming rates for both the Predicate and Subject devices are comparable and are according to standard practice in therapeutic hypothermia treatment.
- . For both 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.
- Minor differences include dimensions, number of cooling tanks, flow rate, cooling ● and warming rates and the Subject device includes an additional alarm in case the patient begins warming too quickly.
Discussion
Both Subject and Predicate devices have the same intended use and there are no significant differences in technological characteristics between the Subject and Predicate devices. For this submission, the sponsor submitted bench testing for the new rewarming features and cross-referenced information from the reference device (K162523) which have not change as a result of adding rewarming capability. For both Subject and Predicate, temperature is managed by circulating fluid through surface-contacting pads, and for both, temperature is monitored
{12}------------------------------------------------
through one or two 3rd-party temperature probes. Both systems provide monitoring and safety alarms. The Subject device includes an additional alarm in case the patient begins warming too quickly.
The simulated testing submitted for the Subject device demonstrated cooling patients to hypothermia, maintaining patient temperature and rewarming patients to normothermia comparably to the Predicate device based on published cooling times for the Predicate and according to general therapeutic hypothermia practice as represented in published research. This testing supported substantial equivalence in that the Subject device accomplished the same intended use as the Predicate with the same or similar technological characteristics.
In addition, the cooling pads and all accessories identified in this device will be identical in terms of design, material, etc. to those of the previously cleared IQool system K162523 and both devices are not intended to be used in the operating room (OR). Thus, the previously provided shelf-life and sterilization information presented in K162523 will be applicable for the IQool Warm System K180375. Additionally, the Sponsor submitted no new Biocompatibility testing for K180375, as the patient contacting materials are identical to those cleared in K162523. A new software testing and package were provided in this submission for the Subject device K180375 appropriate to the identified level of concern according to the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Conclusion
It is the opinion of the Sponsor that the IQool™ Warm System does not raise new questions of safety and effectiveness in comparison to the Predicate. This is supported by the comparison table above and the cited Reference device. The differences between the IQool Warm System and the Predicate are minor and thus meet the requirements of 21 CFR 807.87(f). Therefore, the sponsor has determined that the IQool™ Warm System is substantially equivalent to the Predicate, Arctic Sun Temperature Management System K101092.
§ 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).