CRITICOOL

K083662 · Mtre Advanced Technology , Ltd. · DWJ · Mar 26, 2009 · Cardiovascular

Device Facts

• Record ID: K083662
• Device Name: CRITICOOL
• Applicant: Mtre Advanced Technology , Ltd.
• Product Code: DWJ · Cardiovascular
• Decision Date: Mar 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

CritiCool is a portable, closed-loop thermal regulation system used in clinical settings to manage patient body temperature. The system comprises a heating/cooling unit, disposable CureWrap garments, and body temperature sensors (rectal, nasopharyngeal, or esophageal). The unit utilizes a solid-state thermo-electric heat pump to circulate tap water through the garment. Operators select a target core temperature (30-40°C); the device automatically regulates water temperature via a feedback loop based on real-time sensor input. The system provides continuous monitoring and automated control, allowing clinicians to maintain or adjust patient temperature as required for therapeutic purposes. The device includes safety alarms for water temperature, flow, and probe faults. By automating the thermal regulation process, the device assists in maintaining patient normothermia or achieving targeted temperature management, potentially benefiting patients requiring precise thermal control.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including biocompatibility testing of garment materials and comparison of technical specifications and performance parameters against predicate devices.

Technological Characteristics

Thermal regulating system; solid-state thermo-electric heat pump; closed-loop water circulation. Materials: Water Barrier Film (Appelton MPE Grade #S6606), Non-Woven PP, Frontal Tape FT 600. Connectivity: Data output available. Power: 120/230 VAC. Dimensions: 24.4" x 10.23" x 24.6". Weight: 86 lbs filled. Sensors: YSI 400 series compatible. Software: Automated feedback control loop for temperature regulation.

Indications for Use

Indicated for monitoring and controlling patient temperature in a clinical setting via prescription use.

Regulatory Classification

Identification

A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

Predicate Devices

• ArcticSun Temperature Management System (K071341)
• Allon 2001 Ver 5 (K024128)

Submission Summary (Full Text)

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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 [phone] [phone] 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 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

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. | Model<br>No. | Maximum Garment<br>Height, m | Maximum Garment<br>Width, m | Garment<br>Area, 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 2001<br>Version 5 | CritiCool |
|-------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------|
| FDA approval | K071341 | K024128 | This application |
| Specifications | ArcticSun | Allon 2001<br>Version 5 | CritiCool |
| Control Modes | Automatic, Manual,<br>Purge, Stop | Automatic | Automatic |
| Heater Capability | 750 W | 500W | 500W |
| Circulating Fluid | Distilled or Sterile<br>Water | 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 Series<br>compatible | YSI 400 Series<br>compatible | YSI 400 Series<br>compatible |
| Patient Temperature Inputs | 2 | 2 – Core<br>temperature<br>Surface<br>temperature | 2 – Core<br>temperature<br>Surface<br>temperature |
| Patient Temperature Display<br>Range | 10°C to 44°C,<br>(50°F to 111.2°F)<br>in 0.1°C/°F steps | 18.5°C to 43.9°C<br>(65.3°F to<br>111.0°F)<br>in 0.1°C/°F steps | 18.5°C to<br>43.9°C<br>(65.3°F to<br>111.0°F)<br>in 0.1°C/°F<br>steps |
| Patient Temperature<br>Measurement<br>Accuracy | ±0.4°C 10 to 32°C<br>±0.2°C 32 to 38°C<br>±0.4°C 38 to 44°C | ±0.3°C (0.4°F) | ±0.3°C (0.4°F) |
| Patient Temperature Control<br>Range - Automatic Mode | 32°C to 38.5°C<br>(89.6° F to 101.3°F)<br>in 0.1°C/F<br>increments | 30°C to 40°C<br>(86°F to 104°F)<br>in 0.1°C/F<br>increments | 30°C to 40°C<br>(86°F to 104°F)<br>in 0.1°C/F<br>increments |
| Water Temperature Display<br>Range | 3°C to 45°C<br>(37.4°F to 113.0°F )<br>in 0.1°C/F | 9°C to 44°C<br>(48.2°F to<br>111.2°F)<br>in 0.1°C/F | 9°C to 44°C<br>(48.2°F to<br>111.2°F)<br>in 0.1°C/F |
| Water Temperature Control<br>Range Manual Mode | 4°C to 42°C | N/A | N/A |
| Specifications | ArcticSun | Allon 2001<br>Version 5 | CritiCool |
| | (39.2°F to 107.6°F)<br>in 0.1°C/F<br>increments | | |
| Maximum Water<br>Temperature (Automatic<br>Mode) | 36°C to 42°C<br>96.8°F to 107.6°F<br>in 1°C/F increments | 40.8°C (105.4°F) | 40.8°C<br>(105.4°F) |
| Minimum Water<br>Temperature (Automatic<br>Mode) | 4°C to 25°C<br>39.2°F to 77°F<br>in 1°C/F increments | 13°C (55.4°F) | 13°C (55.4°F) |
| Mains Input* | 115VAC, 60 Hz,<br>11.0 A (nominal)<br>230VAC, 50 Hz,<br>5.5 A | 230/115 VAC<br>500W 50/60 Hz<br>6.3 amp | 230/115 VAC<br>500W 50/60 Hz<br>6.3 amp |
| Current Leakage | < 300uA | < 150uA | < 150uA |
| Circuit Breaker | 12.0 Amp | 2 X 6.3 Amp fuse | 2 X 6.3 Amp<br>fuse |
| Data output | Yes | Yes | Yes |
| Operating relative humidity<br>range | 5 - 70% | 10%-100% | 10%-100% |
| Storage relative humidity<br>range | 5 - 95% non-<br>condensing | 10%-100% | 10%-100% |
| Operating temperature range | 10°C to 27°C<br>(50°F to 80°F) | 30°C to 40°C (50-<br>104°F) | 30°C to 40°C<br>(50-104°F) |
| Storage temperature range | -30°C to - 50°C<br>(20°F to 120°F) | -40°C to 70°C<br>( 40°F to 158°F) | -40°C to 70°C<br>( 40°F to<br>158°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 2001<br>Version 5 | CritiCool |
| Alarm | (108.5° F / 111.2°F) | | |
| Water Temperature Low<br>Alarm | 3.5°C (38.3°F) | 10°C | 10°C |
| System Patient Temperature<br>High 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) or<br>2°C above set<br>point |
| System Patient Temperature<br>Low Alarm | 31.0°C (87.8°F) | 35.5°C (95.9°F) or<br>0.5°C below set<br>point | 35.5°C (95.9°F) or 0.5°C below set point |
| Adjustable Patient<br>Temperature High Alert | 10.1°C to 44°C<br>(50.1°F to 111.2°F) | N/A | N/A |
| Adjustable Patient<br>Temperature Low Alert | 10.0°C to<br>41.9°C to<br>107.5°F | N/A | N/A |
| Patient Probe Fault Alarm<br>Short or Open | Yes | Yes | Yes |
| Water flow Alert 50% of<br>case maximum | Yes | Yes | Yes |
| System Water Temperature<br>High Alarm | 43.0°C/ 44°C | 42°C | 42°C |
| | (109.4°F/ 111.2°F) | | |
| System Water Temperature<br>Low Alarm | 3.0°C (37.4°F) | 10°C | 10°C |
| Reservoir level Alert then<br>Alarm Low then Empty | Yes | Yes | Yes |
| System Self Test Alarm<br>At 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

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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 .

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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. [phone] ext. 213 Tel: [phone] Fax: E-mail: Ifat [e-mail]

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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.

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## 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 [phone]. 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 [phone] or [phone] 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