(95 days)
No
The description focuses on a hardware-based temperature regulation system with a control unit and software for operation and logging. There is no mention of AI or ML algorithms for temperature control, prediction, or analysis.
Yes
The "Intended Use / Indications for Use" section states that the system is "indicated for monitoring and controlling patient temperature," and the "Summary of Performance Studies" mentions "cooling patients to hypothermia, maintaining patient temperature and rewarming patients to normothermia," which aligns with therapeutic actions to modify a patient's physiological state.
No
The device is indicated for "monitoring and controlling patient temperature," which is a therapeutic rather than a diagnostic function. While it monitors temperature, this monitoring is for the purpose of controlling temperature, not for diagnosing a condition.
No
The device description clearly lists multiple hardware components including a refrigeration and control unit (ECU 100), cooling liquid (BC COOL), cooling pads, stabilization insulation, a USB flash drive (BC Stick), and a filling pitcher.
Based on the provided information, the IQoolTM Warm System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "monitoring and controlling patient temperature." This is a physiological function performed directly on the patient's body, not on samples taken from the body.
- Device Description: The device description details a system that circulates a coolant through pads applied to the patient's skin to regulate temperature. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The IQoolTM Warm System does not fit this definition. It is a therapeutic and monitoring device that acts directly on the patient's body.
N/A
Intended Use / Indications for Use
The IQoolTM Warm System is a temperature regulating system indicated for monitoring and controlling patient temperature.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
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.
The ECU 100 pushes temperature-controlled BC COOL ranging between 4°C and 40°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™ Warm System maintains a controlled patient temperature during the entire treatment period. Any deviations from the set temperature are automatically re-adjusted by the system. The 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head/neck, torso, and thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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 Proprietary
| Name | The IQool™ Warm System | ||
|---|---|---|---|
| Common/Usual Name | Thermal Regulating System | ||
| Classification Names / | |||
| Numbers and Code | 21 CFR | Classification Name | Code |
| 870.5900 | Thermal Regulating | ||
| System | DWJ | ||
| Regulatory Class | II | ||
| Prescription Status | Prescription Device | ||
| Classification Panel | Cardiovascular | ||
| Predicate Device | K101092 | Arctic Sun® Temperature Management System | |
| Description of Device | The IQool™ Warm System is a non-invasive, thermal | ||
| 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. | |||
| Indications for Use | The IQoolTM Warm System is a temperature regulating system | ||
| indicated for monitoring and controlling patient temperature. |
4
5
| Name | IQool™ Warm System | Arctic Sun® Temperature
Management System – Predicate | IQool™ System – Reference |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BrainCool AB | Medivance, Inc | BrainCool AB |
| 510(K) Number | K180375 | K101092 | K162523 |
| Product Code | DWJ | DWJ | NZE |
| Regulation | 21 CFR 870.5900 | 21 CFR 870.5900 | 21 CFR 870.5900 |
| Indications for
Use | The IQool™ Warm System is a
temperature regulating system
indicated for monitoring and
controlling patient temperature. | Thermal regulating system, indicated
for monitoring and controlling patient
temperature. | Temperature reduction for adult
patients where clinically indicated, e.g.
in hyperthermic patients. |
| Description | 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 Arctic Sun Temperature
Management System is a
thermoregulatory device that monitors
and controls patient temperature
within a range of 32.0° C to 38.5° C
(89.60° F to 101.3° F). | 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: |
| | 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™ Warm
System. Five liters of BC | The Arctic Sun System consists of the
Arctic Sun Control Module and
disposable ArcticGel Pads.
A patient temperature probe connected
to the Control Module provides patient
temperature feedback to an internal
control algorithm which automatically
increases or decreases the circulating
water temperature to achieve a pre-set
patient target temperature determined
by the clinician.
The Arctic Sun pulls temperature- | • 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™ |
| Name | IQool™ Warm System | Arctic Sun® Temperature
Management System – Predicate | IQool™ System- Reference |
| | 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. | controlled water ranging between 4° C
and 42 ° C (39.2° F and 107.6° F)
through the ArcticGel Pads, resulting
in heat exchange between the water
and the patient. | 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 |
| Name | IQool™ Warm System | Arctic Sun® Temperature
Management System – Predicate | IQool™ System – Reference |
| | Accessories:
BC Stick – a USB flash drive
used to save system
configurations, specifically
prepared to communicate with
the program of the IQool™
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 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 40°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 | | 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 |
| | two commercially available third-
party temperature probes. The
IQool™ Warm System maintains a
controlled patient temperature during | | exchange between the BC COOL and
the patient. Patient temperature is
monitored by one or two commercially
available third-party temperature |
| Name | IQool™ Warm System | Arctic Sun® Temperature
Management System – Predicate | IQool™ System- Reference |
| | | | |
| | the entire treatment period. Any
deviations from the set temperature
are automatically re-adjusted by the
system. The 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. | | 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. |
| Technological
Characteristics | Achieves thermal regulation (cooling
and rewarming) by circulating liquid
coolant through patient contacting
cooling pads. Temperature is
controlled by the settings on the
device. | Achieves cooling and heating through
patient contacting gel pads
through which water is circulated.
Temperature is controlled by the
settings on the device. | Achieves cooling with patient
contacting Cooling Pads through which
coolant is circulated. Cooling is
controlled by the settings on the
device. Consistent temperature
reduction is maintained and controlled
by the system pushing more or less
coolant through the pads as needed
achieve or maintain desired cooling. |
| Therapy Modes | Hypothermia: cool, maintain
Normothermia: actively rewarm | Hypothermia: cool, maintain
Normothermia: actively rewarm | Hypothermia: cool, maintain
Normothermia: monitor and control
rewarming |
| Cooling
Mechanism | Employs a single tank which employs
three solenoid valves (ON/OFF) to
push coolant to the pads intermittently
to achieve and maintain desired
temperature automatically | Employs two separate tanks, one for
cooling and another for heating. To
obtain a certain temperature liquid
from the two tanks is mixed passes
continuously into the cooling pads on | Employs a single tank which employs
three solenoid valves (ON/OFF) to
push coolant to the pads intermittently
to achieve and maintain desired
temperature automatically. |
| Name | IQool™ Warm System | Arctic Sun® Temperature Management System – Predicate | IQool™ System- Reference |
| | | the patient. | |
| Heating Capability | Yes | Yes | No |
| Heating Capacity | 2500 BTU/hr 750 Watts | 2500 BTU/hr / 750 Watts | N/A |
| Cooling Rates | 1.38 to 1.61 °C/hour | 1.2 to 2.0 per hour °C/hour | 1.38 to 1.61 °C/hour |
Table 1: Substantial Equivalence Comparison Table
6
7
8
9
Other Specifications
| Cooling
| medium | Diluted monopropylene glycol | Water | Diluted monopropylene glycol |
|---|---|---|---|
| Reservoir | |||
| Capacity | 4.0 liters | 3.5 liters | 4.0 liters |
| Water Flow | |||
| Rate | 1.5 – 6 liters per minute | 5 liters per minute | 1.5 – 6 liters per minute |
| Patient Probe | |||
| Type | YSI 400 Series compatible (rectal) | YSI 400 Series compatible | YSI 400 Series compatible (rectal) |
| Patient | |||
| Temperature | |||
| Inputs | Patient Temp 1: control, monitor, alarm | ||
| Patient Temp 2: monitor, alarm | Patient Temp 1: control, monitor, alarm | ||
| Patient Temp 2: monitor, alarm | Patient Temp 1: control, monitor, alarm | ||
| Patient Temp 2: monitor, alarm | |||
| Patient | |||
| Temperature | |||
| Measurement | ±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 |
| Patient | |||
| Temperature | |||
| Range | 32°C to 38.5°C | ||
| 89.6°F to 101.3°F | |||
| 0.1 °C/°F increments | 32°C to 38.5°C | ||
| 89.6°F to 101.3°F | |||
| 0.1 °C/°F increments | 33°C to 37°C | ||
| 91.4°F to 98.6°F | |||
| 0.1 °C/°F increments | |||
| Water/Fluid | |||
| Temperature | -50°C to 99°C / -58°F to 210.2°F | ||
| 0.1 °C/°F increments | -50°C to 99°C / -58°F to 210.2°F | ||
| 0.1 °C/°F increments | -50°C to 99°C / -58°F to 210.2°F | ||
| 0.1 °C/°F increments | |||
| Display Range | 4°C to 40°C / 39.2°F to 105.8°F | 4°C to 42°C / 39.2°F to 107.6°F | 4°C to 30°C / 39.2°F to 86°F |
| Temperature | |||
| Control 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 patient | |||
| warms 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, 2 | |||
| for the torso, plus 2 optional pads to | |||
| cover the head and neck for additional | |||
| cooling area coverage. | Total of 4 pads, 2 pads for the thighs, 2 | ||
| for the torso, plus 2 optional pads to | |||
| cover the head and neck for additional | |||
| cooling 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 |
| Component | |||
| sterilization | Not Sterilized | N/A | Not Sterilized |
| Cooling pads shelf- | |||
| life (Torso, Neck | |||
| and Thighs) | 2 Years | N/A | 2 Years |
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| Characteristics | IQoolTM Warm
System K180375 | Arctic Sun®TM
Temperature
Management
System K101092 | IQoolTM System
K162523 |
|----------------------------------------------------|--------------------------------|--------------------------------------------------------------|---------------------------|
| Thermal regulating system | Yes | Yes | Yes |
| Non-invasive system | Yes | Yes | Yes |
| Patient surface cooling | Yes | Yes | Yes |
| Contact to the patient's
skin during treatment | Yes | Yes | Yes |
| Single use device | Yes | Yes | Yes |
| Temperature gradient
between patient and pads | Yes | Yes | Yes |
| Removal of thermal energy
from the patient | Yes | Yes | Yes |
| Temperature monitoring
with 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
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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.