The system is operated by circulating water by a pump in a closed loop between the device and a disposable garment - CureWrap, worn by the patient. The water circulates through the thermoregulating unit. Temperature (body) sensors are placed on the patient's skin to measure surface temperature and in the rectum, nasopharynx or esophagus to measure core temperature. The operator selects the desired patient core temperature (between 30-40°C) and the unit automatically controls it via a feedback loop. The heating / cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump

AI/ML Overview

The provided document is a 510(k) premarket notification for the CritiCool System, a thermal regulating device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data proving efficacy or meeting specific acceptance criteria in the way a new drug or novel medical device might.

Therefore, the document does not contain a detailed study proving the device meets acceptance criteria in the format requested. Instead, it relies on demonstrating that the CritiCool device has similar specifications and indications for use as previously cleared predicate devices (ArcticSun and Allon 2001 Version 5).

However, I can extract the relevant information regarding performance specifications and any implied "acceptance criteria" through comparison with the predicate devices.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not explicitly stated in the context of a "study":

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the specifications of the predicate devices. The CritiCool device is considered "substantially equivalent" if its performance matches or is within acceptable limits of these predicate devices.

Specification (Implied Acceptance Criteria)	Predicate Device (Allon 2001 Version 5) Performance	CritiCool Reported Performance
Control Modes	Automatic	Automatic
Heater Capability	500W	500W
Circulating Fluid	Tap Water	Tap Water
Reservoir Capacity	6 liters (1.6 gal)	6 liters (1.6 gal)
Heat Exchanger	Garment	Garment
Water Flow Rate (total)	1-1.2 Liter/min	1-1.2 Liter/min
Patient Probe Type	YSI 400 Series compatible	YSI 400 Series compatible
Patient Temperature Inputs	2 – Core and Surface temperature	2 – Core and Surface temperature
Patient Temperature Display Range	18.5°C to 43.9°C (65.3°F to 111.0°F) in 0.1°C/°F steps	18.5°C to 43.9°C (65.3°F to 111.0°F) in 0.1°C/°F steps
Patient Temperature Measurement Accuracy	±0.3°C (0.4°F)	±0.3°C (0.4°F)
Patient Temperature Control Range - Automatic Mode	30°C to 40°C (86°F to 104°F) in 0.1°C/F increments	30°C to 40°C (86°F to 104°F) in 0.1°C/F increments
Water Temperature Display Range	9°C to 44°C (48.2°F to 111.2°F) in 0.1°C/F	9°C to 44°C (48.2°F to 111.2°F) in 0.1°C/F
Maximum Water Temperature (Automatic Mode)	40.8°C (105.4°F)	40.8°C (105.4°F)
Minimum Water Temperature (Automatic Mode)	13°C (55.4°F)	13°C (55.4°F)
Mains Input	230/115 VAC, 500W, 50/60 Hz, 6.3 amp	230/115 VAC, 500W, 50/60 Hz, 6.3 amp
Current Leakage	< 150uA	< 150uA
Circuit Breaker	2 X 6.3 Amp fuse	2 X 6.3 Amp fuse
Data Output	Yes	Yes
Operating Relative Humidity Range	10%-100%	10%-100%
Storage Relative Humidity Range	10%-100%	10%-100%
Operating Temperature Range	30°C to 40°C (50-104°F)	30°C to 40°C (50-104°F)
Storage Temperature Range	-40°C to 70°C (-40°F to 158°F)	-40°C to 70°C (-40°F to 158°F)
Weight when filled	86 lbs (39 Kg)	86 lbs (39 Kg)
Water Temperature High Alarm	42°C	42°C
Water Temperature Low Alarm	10°C	10°C
System Patient Temperature High Alarm	38.5°C (101.3°F) or 2°C above set point	38.5°C (101.3°F) or 2°C above set point
System Patient Temperature Low Alarm	35.5°C (95.9°F) or 0.5°C below set point	35.5°C (95.9°F) or 0.5°C below set point
Patient Probe Fault Alarm Short or Open	Yes	Yes
Water Flow Alert 50% of case maximum	Yes	Yes
System Water Temperature High Alarm	42°C	42°C
System Water Temperature Low Alarm	10°C	10°C
Reservoir level Alert then Alarm Low then Empty	Yes	Yes
System Self Test Alarm At power up	Yes	Yes

The document states that the CritiCool system's specifications are "compares to the predicate, ArcticSun and Allon 2001version 5." The table above focuses on direct comparisons to the primary predicate, Allon 2001 Version 5, where the values for CritiCool match exactly, indicating that these specifications are the "reported performance" and are accepted because they are equivalent to the cleared predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This 510(k) submission primarily relies on design specifications and functional comparisons to predicate devices. It does not describe a clinical study with a "test set" of patient data in the typical sense.

The document mentions "Materials were tested and proven for biocompatibility (see part 15)," which refers to a separate section not provided here. Such testing would involve laboratory samples, not human patient data in a "test set."

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)

Not applicable. The submission does not describe a study involving expert-established ground truth for a test set of patient data, as it is not a diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no described test set requiring adjudication.

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 a diagnostic imaging device that would involve human "readers" or AI assistance for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device's automatic control system. The "standalone" performance is described by its specifications (e.g., patient temperature control range and accuracy, alarm thresholds) which are directly compared and found equivalent to the predicate device. The claim of "automatic" control mode performance for CritiCool (matching Allon 2001) implies that the algorithm controlling the heating/cooling unit functions autonomously to maintain the set temperature within specified ranges.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this type of device's performance is typically established through:

Engineering verification and validation testing: Confirming that the device meets its design specifications (e.g., temperature accuracy, flow rates, alarm functionality) under various simulated and real-world conditions. This would involve calibrated instruments as the "ground truth" reference.
Comparison to predicate device specifications: The fundamental "ground truth" for FDA clearance via 510(k) is demonstrating that the new device's specifications and performance are substantially equivalent to a legally marketed predicate device.

The document does not detail specific "ground truth" for a patient study, as that is not the primary mechanism for demonstrating substantial equivalence for this type of device.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that would require a "training set" of data in the common sense.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set."

Summary

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K083662

MAR 2 6 2009

Food and Drug Administration Traditional 510(k) for CritiCool System

Image /page/0/Picture/3 description: The image shows the logo for MTRE. The logo consists of a geometric shape on the left and the letters "MTRE" on the right. The geometric shape is made up of six triangles arranged in a hexagon shape. The letters "MTRE" are in a simple, sans-serif font.

Topic: 510K for CritiCool system . . .

Establishment Name, Registration Number and Address:

Name: Registration Number: Operator Number: Address: Postal Address: Tel: Fax: Contact person:

MTRE Advanced Technology Ltd. 9616800 9038416 4 Hayarden Street, Yavne, 81228, Israel PO Box 102, Rehovot, 76100, Israel +972-8-9323333 +972-8-9328510 Ifat Oren, Regulatory Affairs

To: Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville MD, 20850
Attn .: Document Control Clerk From: Ifat Oren, Regulatory Affairs

Additional electronic copy (which is an exact duplicate of the paper copy) of the submission is attached on CD

The following information is being submitted in conformance with 21 CFR 807.87:

1. Classification Name 2. Classification Number: 3. Common/Usual Name 4. Trade/Proprietary Name CritiCool 5. Part Number of CritiCool 100-00003 6. Establishment Registration Number 9616800 7. FDA Classification Class II 8. Product Code DWJ 9. Reviewing Panel 10. 510 (k) marketing clearance of Medivance ArcticSun system 510(k) Marketing clearance for Allon system
  System Thermal regulating 21 CFR 870.5900 Thermal regulating systems Cardiovascular

K071341 August 3, 2007 K024128 - February 10, 2003 K003349 - November 13, 2000

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K001546 - June 8, 2000 K992386 - March 7, 2000

Terminology

CritiCool = subiect of this 510(k) submission. The CritiCool is a thermoregulation system based on water circulating via disposable Garment .

Arctic Sun Temperature Management System = the predicate device. was approved for marketing by the FDA - K071341 August 3, 2007

Allon 2001 Ver 5 = the predicate device was approved for marketing by the FDA - K024128 February 10, 2003

Device Description:

The CritiCool system consists of the following elements:

Temperature controlled garment .
. Body sensors
Connecting flexible water pipes .
Heating/Cooling Unit .

The system is essentially portable, vibration free and quiet. It is designed to be connected to a standard 120 /230 VAC supply. The device is placed near the patient. Tubing is connected to both the unit and the garment (worn by the patient) and the unit is switched on. The operator selects the desired body temperature, which the unit then automatically and autonomously regulate.

CritiCool is used with CureWrap Gaments with sizes equivalent to the sizes of the gaments of the Allon 2001 Version 5, predicated device K024128.

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Body Sensors:

The body sensors are the same sensors as those of the already cleared device with its former label of Allon 2001 Version 5. Therefore, there are no new issues of safety and effectiveness associated with these sensors

Indications for Use:

The CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Intended Use

The Intended Use of the CritiCool monitor as indicated above is the same as the Indications for use

The following table shows all the existing CureWrap garments:

No.	ModelNo.	Maximum GarmentHeight, m	Maximum GarmentWidth, m	GarmentArea, sq. m.
1	3521	0.698	0.602	0.347
2	3525	0.981	0.628	0.425
3	3531	1.118	0.740	0.637
4	3536	1.225	0.841	0.763
5	3541	1.390	1.054	1.089
6	3548	1.582	1.193	1.399
7	3500	2.030	1.354	2.324

Product Specifications *****

Listed below are the major attributes of the CritiCool compares to the predicate, ArcticSun and Allon 2001version 5.

Specifications	ArcticSun	Allon 2001Version 5	CritiCool
FDA approval	K071341	K024128	This application
Specifications	ArcticSun	Allon 2001Version 5	CritiCool
Control Modes	Automatic, Manual,Purge, Stop	Automatic	Automatic
Heater Capability	750 W	500W	500W
Circulating Fluid	Distilled or SterileWater	Tap Water	Tap Water
Reservoir Capacity	5 liters	6 liters ( 1.6 gal)	6 liters (1.6 gal)
Heat exchanger	Jell Pads	Garment	Garment
Water flow rate (total)	0.5 - 8.0 Liter/min	1-1.2 Liter/min	1-1.2 Liter/min
Patient Probe Type	YSI 400 Seriescompatible	YSI 400 Seriescompatible	YSI 400 Seriescompatible
Patient Temperature Inputs	2	2 – CoretemperatureSurfacetemperature	2 – CoretemperatureSurfacetemperature
Patient Temperature DisplayRange	10°C to 44°C,(50°F to 111.2°F)in 0.1°C/°F steps	18.5°C to 43.9°C(65.3°F to111.0°F)in 0.1°C/°F steps	18.5°C to43.9°C(65.3°F to111.0°F)in 0.1°C/°Fsteps
Patient TemperatureMeasurementAccuracy	±0.4°C 10 to 32°C±0.2°C 32 to 38°C±0.4°C 38 to 44°C	±0.3°C (0.4°F)	±0.3°C (0.4°F)
Patient Temperature ControlRange - Automatic Mode	32°C to 38.5°C(89.6° F to 101.3°F)in 0.1°C/Fincrements	30°C to 40°C(86°F to 104°F)in 0.1°C/Fincrements	30°C to 40°C(86°F to 104°F)in 0.1°C/Fincrements
Water Temperature DisplayRange	3°C to 45°C(37.4°F to 113.0°F )in 0.1°C/F	9°C to 44°C(48.2°F to111.2°F)in 0.1°C/F	9°C to 44°C(48.2°F to111.2°F)in 0.1°C/F
Water Temperature ControlRange Manual Mode	4°C to 42°C	N/A	N/A
Specifications	ArcticSun	Allon 2001Version 5	CritiCool
	(39.2°F to 107.6°F)in 0.1°C/Fincrements
Maximum WaterTemperature (AutomaticMode)	36°C to 42°C96.8°F to 107.6°Fin 1°C/F increments	40.8°C (105.4°F)	40.8°C(105.4°F)
Minimum WaterTemperature (AutomaticMode)	4°C to 25°C39.2°F to 77°Fin 1°C/F increments	13°C (55.4°F)	13°C (55.4°F)
Mains Input*	115VAC, 60 Hz,11.0 A (nominal)230VAC, 50 Hz,5.5 A	230/115 VAC500W 50/60 Hz6.3 amp	230/115 VAC500W 50/60 Hz6.3 amp
Current Leakage	< 300uA	< 150uA	< 150uA
Circuit Breaker	12.0 Amp	2 X 6.3 Amp fuse	2 X 6.3 Ampfuse
Data output	Yes	Yes	Yes
Operating relative humidityrange	5 - 70%	10%-100%	10%-100%
Storage relative humidityrange	5 - 95% non-condensing	10%-100%	10%-100%
Operating temperature range	10°C to 27°C(50°F to 80°F)	30°C to 40°C (50-104°F)	30°C to 40°C(50-104°F)
Storage temperature range	-30°C to - 50°C(20°F to 120°F)	-40°C to 70°C( 40°F to 158°F)	-40°C to 70°C( 40°F to158°F)
Height (handle down)	30" (76cm)	24.4" (62 cm)	24.4" (62 cm)
Length	22" (56cm)	24.6" (62.5 cm)	24.6" (62.5 cm)
Width	12.5" (32cm)	10.23" (26 cm)	10.23" (26 cm)
Weight when filled	116 lbs (53kg.)	86 lbs (39 Kg)	86 lbs (39 Kg)
Alarm Limits
Water Temperature High	42.5°C / 44°C	42°C	42°C
Specifications	ArcticSun	Allon 2001Version 5	CritiCool
Alarm	(108.5° F / 111.2°F)
Water Temperature LowAlarm	3.5°C (38.3°F)	10°C	10°C
System Patient TemperatureHigh Alarm	39.5°C (103.1°F)	38.5°C (101.3°F) or 2°C above set point	38.5°C (101.3°F) or2°C above setpoint
System Patient TemperatureLow Alarm	31.0°C (87.8°F)	35.5°C (95.9°F) or0.5°C below setpoint	35.5°C (95.9°F) or 0.5°C below set point
Adjustable PatientTemperature High Alert	10.1°C to 44°C(50.1°F to 111.2°F)	N/A	N/A
Adjustable PatientTemperature Low Alert	10.0°C to41.9°C to107.5°F	N/A	N/A
Patient Probe Fault AlarmShort or Open	Yes	Yes	Yes
Water flow Alert 50% ofcase maximum	Yes	Yes	Yes
System Water TemperatureHigh Alarm	43.0°C/ 44°C	42°C	42°C
	(109.4°F/ 111.2°F)
System Water TemperatureLow Alarm	3.0°C (37.4°F)	10°C	10°C
Reservoir level Alert thenAlarm Low then Empty	Yes	Yes	Yes
System Self Test AlarmAt power up	Yes	Yes	Yes

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Food and Drug Administration
Traditional 510(k) for CritiCool System

、

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Food and Drug Administration
Traditional 510(k) for CritiCool System

ﻳ

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Food and Drug Administration Traditional 510(k) for CritiCool System

Materials Materials James Bron

The material used for the CureWrap garments are :

Water Barrier Film -- Appelton MPE Grade #S6606 .
Non-Woven PP (Avgol Ltd.) .
Frontal Tape FT 600 .

{6}------------------------------------------------

Materials were tested and proven for biocompatibility. (see part 15)

Indications for Use:

The CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature. Intended Use

*The Intended Use of the CritiCool monitor as indicated above is the same as the Indications For Use

Over-The-Counter Use _ NO AND/OR Prescription Use YES (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

Confidentiality

MTRE Advanced Technology Ltd. considers its intent to market the CritiCool System to be confidential commercial information.

The Company, therefore, requests the FDA not disclose the existence of this application until such time as final action on the submission is taken.

In addition, some of the material in this application may be trade secret or confidential commercial or financial information within the meaning of 21 CFR § 20.61 and therefore not disclosable under the Freedom of Information Act, even after the existence of the application becomes public. We ask that FDA consult with the Company as provided in 21 CFR § 20.45 before making any part of this submission publicly available.

Signature:

Stat. Oren.

Ifat Oren OA & Regulatory Affairs MTRE Advanced Technology Ltd. +972-8-9323333 ext. 213 Tel: +972-8-9328510 Fax: E-mail: Ifat oren@mmi.co.il

{7}------------------------------------------------

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2009

MTRE Advanced Technology Ltd. c/o Ms. Ifat Oren QA & Regulatory Affairs 4 Havarden Street Yavne, 81228, Isracl

Re: K083662

CritiCool Regulation Number: 21 CFR 870.5900 Regulation Name: System, Thermal Regulating Regulatory Class: Class II Product Code: DWJ Dated: March 9, 2009 Received: March 11, 2009

Dear Ms. Oren:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{8}------------------------------------------------

Page 2 - Ms. Ifat Oren

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); good manufacturing practice requirements as set forth in 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

uma D. Wachner

^ Bram D. Zuckerman, M.D. Division 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): Ko83662

Device Name: CritiCool

Indications For Use:

The CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature.

. ... . . . . . . . . . . . . . . . . . . . . . . .

*The Intended Use of the CritiCool monitor as indicated above is the same as the Indications For Use

Prescription Use _YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quna R. Vochmes

Page 1 of 1

Ivision Sign-Off Division of Cardiovascular Devices

510(k) Number Ko8366

Regulation Number and Section

§ 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).