(217 days)
No
The description focuses on hardware components, temperature control, and safety features, with no mention of AI/ML terms or functionalities like learning, adaptation, or data analysis for decision making beyond simple temperature monitoring and alarms.
Yes
The device is described as providing "patient rewarming" for "hypothermic human subjects" and its use is "physician prescribed therapy," directly indicating a therapeutic purpose.
No
The device description indicates its function is "to provide a safe yet effective means of patient rewarming," and it includes features for controlling and monitoring temperature, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a fiberglass exterior, heating chamber, stretcher, temperature probes, and a control panel. It is a physical medical device with integrated controls, not a software-only device.
Based on the provided information, the ENTHERMICS TRU-5000™ Thermal Recovery Radiant Heating Unit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide patient rewarming for adult hypothermic human subjects. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The device is a radiant heating unit designed to warm the patient externally. It includes a heating chamber, stretcher, temperature monitoring system, and control panel. These are all components of a medical device used for patient treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly treat the body itself. The TRU-5000 is a therapeutic device used for patient warming.
N/A
Intended Use / Indications for Use
The function of the ENTHERMICS TRU-5000™ Thermal Recovery Radiant Heating Unit is to provide a safe yet effective means of patient rewarming in the recovery of adult hypothermic human subjects.
Product codes
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Device Description
The TRU-5000 consists of (1) an aesthetically pleasing fiberglass exterior encasing the semicylindrical heating chamber, (2) a modified heat resistant stretcher with a unique lock and key design, (3) a stand-alone, dual-probe, skin temperature audible-alarm system and (4) standard hospital sheets used as insulating drapes. An easy to operate control panel provides quick and easy control of all rewarming operations. The control system includes an LED readout of chamber control temperature, two independent skin temperatures and control setpoint with an audible alarm which sounds whenever the skin temperature setpoint is exceeded. The heating surface temperature controller of the TRU-5000 is factory preset at 70 °C to minimize operator error and provide optimum patient warming. The system requires no additional power demands and includes self diagnostic features to ensure operational accuracy. Quick and easy access to the heating chamber is devised in case of medical intervention.
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
Intended User / Care Setting
physician prescribed therapy for surgically- or trauma-induced hypothermia
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for "Enthermics Medical Systems". The logo consists of a black circle on the left, followed by a design of curved lines. To the right of the curved lines is the text "Enthermics" on the top line and "Medical Systems" on the bottom line.
CONTACT NAME: Ms. Karen Hansen DATE: September 10, 1996
APR
22
1997
TRADE NAME: ENTHERMICS TRU-5000™ Thermal Recovery Radiant Heating Unit COMMON NAME: Thermal Recovery System CLASSIFICATION NAME: Thermal Regulating System
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary of Safety and Effectiveness Information is being submitted in accordance with the requirements of SMDA 1990. This statement serves to certify that the data and information submitted in this application are truthful and accurate and that no material fact has been omitted.
The function of the ENTHERMICS TRU-5000™ Thermal Recovery Radiant Heating Unit is to provide a safe yet effective means of patient rewarming in the recovery of adult hypothermic human subjects. The TRU-5000 consists of (1) an aesthetically pleasing fiberglass exterior encasing the semicylindrical heating chamber, (2) a modified heat resistant stretcher with a unique lock and key design, (3) a stand-alone, dual-probe, skin temperature audible-alarm system and (4) standard hospital sheets used as insulating drapes. An easy to operate control panel provides quick and easy control of all rewarming operations. The control system includes an LED readout of chamber control temperature, two independent skin temperatures and control setpoint with an audible alarm which sounds whenever the skin temperature setpoint is exceeded. The heating surface temperature controller of the TRU-5000 is factory preset at 70 °C to minimize operator error and provide optimum patient warming. The system requires no additional power demands and includes self diagnostic features to ensure operational accuracy. Quick and easy access to the heating chamber is devised in case of medical intervention. The use of the TRU-5000 is a physician prescribed therapy for surgically- or trauma-induced hypothermia, with the ultimate responsibility of the patients overall recovery falling on the physician.
Corporate Headquarters W164N9221 Water Street Menomonee Falls, WI 53051 (800) 862-9276 (414) 251-8356 (ITT) 4311070 ALTSHAM Telex (414) 251-7067 FAX
Regional Office 115 Evergreen Court Blue Bell, PA 19422 Telephone (215) 643-9685 (215) 643-4253
1
The ENTHERMICS TRU-5000 Thermal Recovery Radiant Heating Unit is identical in function to the Augustine Medical Bair Hugger™ Convective Warming System (K873745) and the Marquest Temp Marq™ Convective Warming System (K904690) in that it offers a rapid, accurate, reproducible means of administering external heat to adult hypothermia patients in a clinical environment. The aforementioned predicate devices are two "Thermal Regulating Systems" (21 CFR 870.5900) currently used in the area of clinical hypothermic recovery. Thermal Regulating Systems have been evaluated by the Cardiovascular Device Classification Panel and have been labeled as Class II devices.
The ultimate safety and effectiveness of a recovery aid can only be measured by the successful use or misuse of the device. However, the ENTHERMICS TRU-5000 has been designed to provide maximum control and efficiency of patient heating while minimizing the possibility of thermal injury such that the historical standards of safety and effectiveness setforth by the stated predicate devices can be met or exceeded.
Karth
Ms. Karen Hansen President ENTHERMICS Medical Sytems, Inc.
9-10 96
Date
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