(56 days)
No
The description details a feedback loop system based on temperature sensors and a thermo-electric device, which is a standard control mechanism and does not indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is intended to maintain pre-set body temperature as determined by the physician, which is a therapeutic function.
No
Explanation: The device is described as a system to maintain pre-set body temperature and control patient temperature. It measures temperature but primarily uses the gathered information to regulate temperature, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components including a temperature controlled disposable garment, body sensors, connecting flexible water pipes, and a heating/cooling unit. It describes the physical operation of circulating water and using a solid-state thermo-electric device.
Based on the provided information, the Allon 2001 version 5 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to maintain pre-set body temperature and normal body temperature during surgical procedures. This is a therapeutic function, not a diagnostic one.
- Device Description: The device works by circulating water through a garment to heat or cool the patient's body. It uses body sensors to measure temperature, but this measurement is used for feedback control of the heating/cooling system, not for diagnosing a condition.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing information used for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Allon 2001 version 5 does not fit this description. It is a device used for temperature management of the patient's body.
N/A
Intended Use / Indications for Use
The Allon 2001 version 5 is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients.
Product codes
DWJ
Device Description
The Allon 2001 version 5 system consists of the following elements:
- Temperature controlled disposable 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 worn by the patient. The water circulates through the heating/cooling unit. Temperature (body) sensors are placed on the patient and in the rectum, nasopharynx or esophageal to measure core temperature. The operator selects the desired patient core temperature and the unit operates in an automatic mode. Patient temperature is controlled and maintained at any set point between 30-40°C using a feedback loop and sensors placed on the patient's body. The heating/cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump. The system is intrinsically safe, due to the characteristics of the thermo-electric device, heating capacity drops off as the Thermo Electro Cooler (TEC) temperature rises. Hence, if for any reason, flow of coolant is interrupted, the TEC will overheat and the power output will fall, thus limiting water temperature rise. The disposable garment is provided in a variety of shapes and sizes, which are manufactured of the same materials and by the same process as those already cleared under K001546, K992386 and K003349.
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
adult and pediatric patients.
Intended User / Care Setting
Hospital, invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors
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)
K003349, preamendment
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
Section 2 - Certification and Summaries
Allon 2001 version 5 PG 1 Of 4
M.T.R.E. Advanced Technology, Ltd. POB 26, Or Akiva Industrial Park Or Akiva, Israel 30600 Tel - [972] 4-6108000 Fax - |972| 4-6108001
FEB 1 0 2003
Summary of Safety and Effectiveness 2.1
| Non-Confidential Summary of Safety and Effectiveness |
|---|
| page 1 of 4 |
| 11-Dec-02 |
| M.T.R.E. Advanced Technology, Ltd.
POB 26, Or Akiva Industrial Park
Or Akiva, Israel 30600 | Tel - 011-972-4-6108000
Fax - 011-972-4-6108001 |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Official Contact : | Shlomi Deler, QA/RA Manager |
| Proprietary or Trade Name: | Allon 2001 version 5 |
| Common/Usual Name: | Thermal Regulating System |
| Classification Name: | Thermal Regulating System |
| Device: | Allon 2001 version 5 |
| Predicate Devices: | M.T.R.E. - Allon 2001 - K003349
Cincinnati Subzero - Blanketrol II - preamendment |
Device Description:
The Allon 2001 vesion 5 system consists of the following elements:
- Temperature controlled disposable 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 worn by the patient. The water circulates through the heating/ cooling unit. Temperature (body) sensors are placed on the patient and in the rectum, nasopharynx or esophageal to measure core temperature. The operator selects the desired patient core temperature and the unit operates in an automatic mode. Patient temperature is controlled and maintained at any set point between 30-40°C using a feedback loop and sensors placed on the patient's body.
1
K∅24128
Allon 2001 version 5 HG 200 y
Section 2 - Certification and Summaries
Non-Confidential Summary of Safety and Effectiveness page 2 of 4 11-Dec-02
The heating/cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump. The system is intrinsically safe, due to the characteristics of the thermo-electric device, heating capacity drops off as the Thermo Electro Cooler (TEC) temperature rises. Hence, if for any reason, flow of coolant is interrupted, the TEC will overheat and the power output will fall, thus limiting water temperature rise.
The disposable garment is provided in a variety of shapes and sizes, which are manufactured of the same materials and by the same process as those already cleared under K001546, K992386 and K003349.
| Intended Use: | |
|---|---|
| Indication for use-- | The Allon 2001 version 5 is intended to maintain pre-set body |
| temperature as determined by the physician. It can also be utilized | |
| to maintain normal body temperature during surgical procedures. | |
| This system can be used with adult and pediatric patients. | |
| Environment of Use -- | Hospital, invasive and coronary care units, in operating, recovery |
| and emergency rooms, in burn units, and on medical / surgical | |
| floors | |
| Contraindications-- | The Allon 2001 version 5 system should not be in direct contact |
| with open, widespread skin lesions such as burns or dermatitis. The | |
| safety and effectiveness of use of the Allon2001 version 5 | |
| on patients with multiple traumas has not been established. |
Comparison to Predicate Devices:
| | Allon 2001 / CSZ - Blanketrol
K003349 Preamendment | Allon 2001 version 5 |
|---------------------------------|----------------------------------------------------------|-------------------------------------------------------------------|
| Equipment Design | | |
| Dimensions | 26cm X 53cm X 52cm | 26cm W X 62.5cm D
X 94cm H |
| Weight | 33 Kg (without water in the
reservoir) | The same |
| Mobility | Mobile with four wheels. | The same |
| Power max. | 500 W max. | The same |
| Input power | 120/230 V ac with isolation
transformer | The same |
| Water tank | 6 liter | The same |
| page 3 of 4
11-Dec-02 | | |
| | Allon 2001 / CSZ - Blanketrol
K003349
Preamendment | Allon 2001 version 5 |
| HCU | Thermo Electro Cooler based on
Peltier effect. | The same |
| Control System | | |
| Water out temp' | 13-40.8 °C | The same |
| Set Point temp' | 30-40 °C | The same |
| Flow rate | 0.2-1.25Lpm | The same |
| Pressure rate | 0.1-1.3 bar | The same |
| Safety System | | |
| High primary | 41°C / CSZ - 45 °C | 42 °C |
| High secondary | 42°C / CSZ - 46 °C | 44 °C |
| High third | 44°C / CSZ - N/A | N/A |
| Low primary | 10 °C | The same |
| Pressure valve | Yes | The same |
| Safety Alert / Alarms | | |
| Dislodged sensor | Yes | The same |
| Incorrect Patient temp' setting | Yes | The same |
| High/Low patient temp' limit. | Yes | The same |
| Out of normothermia | Yes | The same |
| High/Low water temp' limit | Yes | The same |
| Low water | Yes | The same |
| Low water flow | Yes | The same |
| Water blocking | Yes | The same |
| Non - Operating Pump | Yes | The same |
| Monitoring/indicators | | |
| Water out temp' | Yes | The same |
| Not enough water in tank | Yes | The same |
| Water in temp' | Yes | The same |
| Patient Surface Temp. | Yes | The same |
| Patient core Temp. | Yes | The same |
| Water pressure | Yes | The same |
| Graphic presentation. | Yes | Modified , after changing
machine interface lay-out
display |
| Patient temp During treatment | | |
| | Allon 2001 / CSZ - Blanketrol | Allon 2001- modified |
| | K003349
Preamendment | |
| Operating Buttons | | |
| Set Point temp' | Yes | The same |
| Silence Alarm | Yes | The same |
2
Section 2 - Certification and Summaries
K024128 Allon 2001 version 5 PG 3 of Y
Non-Confidential Summary of Safety and Effectiveness
t d
3
Section 2 - Certification and Summaries
K024128 Allon 2001 version 5
PG-YOF Y
Non-Confidential Summary of Safety and Effectiveness
page 4 of 4 11-Dec-02
Discussion of Substantial Equivalence to Legally Marketed Predicate Devices
The Allon 2001 version 5 system is viewed as substantially equivalent to the following predicate devices - Allon 2001 system cleared under K003349, and Cincinnati Subzero - Blanketrol preamendment.
There are no significant differences between the Allon 2001 version 5 and the Allon 2001 and Cincinnati Subzero - Blanketrol, the predicate devices, that affect the safety or effectiveness of the intended device as compared to the predicate devices. Allon 2001 version 5 is viewed as substantially equivalent to the predicate devices since they:
- Have the same intended use
- Maintain pre-set body temperature as determined by the physician. 1.1
- 1.2 Maintain normal body temperature during surgical procedures.
- Have the same environment for use
- Are used in hospitals, invasive and coronary care units, in operating, recovery and 2.1 emergency rooms, in burn units, and on medical / surgical floors,
- 2.2 Have been designed for stationary and intra-institution transport only.
-
- Are similar in design
-
- Employ the same technology
-
- Are made of identical materials
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2003
M.T.R.E. Advanced Technology, Ltd. c/o Mr. Douglas Rash President M.T.R.E. North America, Inc. 6052 Wilmington Pick #225 Centerville, OH 45459
Re: K024128
Trade Name: Allon 2001 Version 5 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulation System Regulatory Class: Class II (two) Product Code: DWJ Dated: January 20, 2003 Received: January 27, 2003
Dear Mr. Rash:
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.
5
Page 2 – Mr. Douglas Rash
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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
[signature]
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
2.3 Indications for Use
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number: | KΦ24128 (To be assigned) |
|---|---|
| Device Name: | Allon 2001 version 5 |
| Intended Use | The Allon 2001 version 5 is intended to maintain pre- set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. De La Torre
510(k) Number K024128
Prescription Use
(Per CFR 801.109) X
or
Over-the-counter use _