(235 days)
A114385
No Reference Device(s) K/DEN number was found in the text. This section explicitly states "Not Found".
No
The description details a feedback loop based on sensor readings to control water temperature, 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 like DNNs, training sets, or performance metrics typically associated with AI/ML.
Yes.
The device is used to regulate a patient's body temperature, either raising or lowering it, to maintain a desired temperature. This direct physiological intervention is for therapeutic purposes, such as preventing hypothermia during surgery or managing hyperthermia.
No
The Allon 2000 System is used to actively regulate a patient's body temperature (heating or cooling). Its function is therapeutic/management, maintaining a 'pre-set' or 'desired' temperature, rather than diagnosing a condition. While it uses sensor readings for a feedback loop, these sensors are for control, not for identifying a disease or condition that requires diagnosis.
No
The device description clearly outlines a system that includes hardware components such as a pump, garment, and temperature sensors, which are integral to its function of regulating patient temperature. It is not solely software.
Based on the provided information, the Allon 2000 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Allon 2000 System Function: The Allon 2000 System directly interacts with the patient's body to regulate temperature using a garment and circulating water. It does not analyze any biological specimens.
- Intended Use: The intended use is to maintain body temperature, not to diagnose or monitor a condition based on analyzing samples.
- Device Description: The description focuses on the physical mechanism of temperature exchange with the body.
Therefore, the Allon 2000 System falls under the category of a therapeutic or physiological support device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Allon 2000 System 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.
The Allon 2000 System is indicated primarily 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 (comma separated list FDA assigned to the subject device)
DWI, DWJ
Device Description
The Allon 2000 Hyper-Hypothermia system is used to either lower or raise a patient's temperature and/or maintain a desired patient temperature using a garment, which is wrapped around the body during and after surgery to achieve maximum coverage. This, for example, minimizes the tendency of the body to cool down as a result of anesthesia and exposure. The garment can be configured to cover any surface area of the patient's body and yet not to interfere with areas that must be exposed during surgery. As a flow of cooled or heated water is forced through the garment by the pump of the Allon 2000 System, the heat is exchanged with the body. The water temperature is controlled and maintained at any temperature between 59 and 104.3ºF (15 - 40.2ºC) using a feedback loop based on surface and core thermostat sensor readings.
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)
The electrical and electromagnetic safety of the Allon 2000 as been proven to meet the IEC 60601 and IEC 60602 standard through in-vitro tests. The Allon 2000 software and software applications have been verified and validated. The biological safety of the Allon 2000 garment has been assured through biocompatibility studies. The effective performance of the Allon 2000 System has been established through in vitro, animal and clinical studies.
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.
A114385
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.
Not Found
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
510(k) Summary
M.T.R.E. Advanced Technology Ltd.
Allon 2000 System
510(k) Number K_992386
Submitter's Name:
M.T.R.E. Advanced Technologies Ltd. POB 3582, Caesarea Industrial Park 38900, Israel
Contact Person:
Shoshana Friedman Push-Med Ltd. 117, Ahuza St., Ra'ananna 43373, Israel Tel: 972-9-7718130 Fax: 972-9-7718131
Trade Name:
Allon 2000
Classification Name:
System, Thermal Regulation
Classification:
The FDA has classified these devices under Class II (product code DWI) which are reviewed by the Division of Cardiovascular, Respiratory, and Neurological Devices.
1
Predicate Device:
The Allon 2000 System is substantially equivalent to the Blanketrol II System (Cincinnati Sub-Zero Products, Inc.) Cleared under A114385.
Performance Standards:
No performance standards have been established for such devices under sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the Allon 2000 System complies with the following voluntary standards: IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-35 - Part 2, IEC 68-2-13, MIL-STD-810E, IEC 68-2-6.
Indication for use:
The Allon 2000 System 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.
The Allon 2000 System is indicated primarily 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.
Device Description:
The Allon 2000 Hyper-Hypothermia system is used to either lower or raise a patient's temperature and/or maintain a desired patient temperature using a garment, which is wrapped around the body during and after surgery to achieve maximum coverage. This, for example, minimizes the tendency of the body to cool down as a result of anesthesia and exposure. The garment can be configured to cover any surface area of the patient's body and yet not to interfere with areas that must be exposed during surgery. As a flow of cooled or heated water is forced through the garment by the pump of the Allon 2000 System, the heat is exchanged with the body. The water temperature is controlled and maintained at any temperature between 59 and 104.3ºF (15 - 40.2ºC) using a feedback loop based on surface and core thermostat sensor readings.
2
Safety and Effectiveness:
The electrical and electromagnetic safety of the Allon 2000 as been proven to meet the IEC 60601 and IEC 60602 standard through in-vitro tests. The Allon 2000 software and software applications have been verified and validated. The biological safety of the Allon 2000 garment has been assured through biocompatibility studies. The effective performance of the Allon 2000 System has been established through in vitro, animal and clinical studies.
Substantial Equivalence:
Based on a series of safety and performance testing, including animal and clinical studies, we believe that the Allon 2000 System is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2000
Ms. Shoshana Friedman, RAC MTRE Advanced Technology, LTD. 117 Ahuza Street Ra'ananna 43373 Israel
K992386/S1 Re: Allon 2000 Regulatory Class: II (two) Product Code: DWJ Dated: December 15, 1999 Received: December 16, 1999
Dear Ms. Friedman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Shoshana Friedman, RAC
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Ford Bea L. Campbell
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number
Device Name: Allon 2000 System
Indications for Use:
The Allon 2000 System 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.
The Allon 2000 System is indicated primarily 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.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Bess L. Campbell
(Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_