(106 days)
No
The description details a feedback loop based on temperature sensors and a solid-state thermo-electric device, which is a standard control system and does not indicate the use of AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is used for "monitoring and controlling patient temperature," which is a therapeutic intervention as it directly impacts and manages a physiological state to restore health or alleviate symptoms.
No
This device is a thermal regulating system designed to control patient temperature, not to diagnose a condition or disease. While it monitors temperature, this monitoring is for the purpose of controlling temperature rather than diagnosing an illness.
No
The device description explicitly lists multiple hardware components including a temperature controlled garment, body sensors, water pipes, and a heating/cooling unit.
Based on the provided information, the CritiCool device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "monitoring and controlling patient temperature." This is a therapeutic and monitoring function performed directly on the patient's body.
- Device Description: The description details a system that physically interacts with the patient (garment, sensors, water circulation) to regulate their temperature. It does not involve analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CritiCool's function falls outside of this definition.
N/A
Intended Use / Indications for Use
The CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Product codes
DWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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:
-
- 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
- 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
K071341 August 3, 2007 K024128 - February 10, 2003 K003349 - November 13, 2000
1
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.
2
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
No. | Maximum Garment
Height, m | Maximum Garment
Width, m | Garment
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
Version 5 | CritiCool |
|-------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------|
| FDA approval | K071341 | K024128 | This application |
| Specifications | ArcticSun | Allon 2001
Version 5 | CritiCool |
| Control Modes | Automatic, Manual,
Purge, Stop | Automatic | Automatic |
| Heater Capability | 750 W | 500W | 500W |
| Circulating Fluid | Distilled or Sterile
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
compatible | YSI 400 Series
compatible | YSI 400 Series
compatible |
| Patient Temperature Inputs | 2 | 2 – Core
temperature
Surface
temperature | 2 – Core
temperature
Surface
temperature |
| Patient Temperature Display
Range | 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 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 | ±0.4°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 Control
Range - Automatic Mode | 32°C to 38.5°C
(89.6° F to 101.3°F)
in 0.1°C/F
increments | 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 | 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 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 |
| Water Temperature Control
Range Manual Mode | 4°C to 42°C | N/A | N/A |
| Specifications | ArcticSun | Allon 2001
Version 5 | CritiCool |
| | (39.2°F to 107.6°F)
in 0.1°C/F
increments | | |
| Maximum Water
Temperature (Automatic
Mode) | 36°C to 42°C
96.8°F to 107.6°F
in 1°C/F increments | 40.8°C (105.4°F) | 40.8°C
(105.4°F) |
| Minimum Water
Temperature (Automatic
Mode) | 4°C to 25°C
39.2°F to 77°F
in 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 VAC
500W 50/60 Hz
6.3 amp | 230/115 VAC
500W 50/60 Hz
6.3 amp |
| Current Leakage | 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
9
.
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