TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT

K963731 · Enthermics Medical Systems, Inc. · DWJ · Apr 22, 1997 · Cardiovascular

Device Facts

• Record ID: K963731
• Device Name: TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT
• Applicant: Enthermics Medical Systems, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Apr 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The function of the ENTERMICS 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 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.

Device Story

Radiant heating unit for rewarming adult hypothermic patients; consists of fiberglass exterior, semi-cylindrical heating chamber, modified heat-resistant stretcher, dual-probe skin temperature monitoring system, and insulating drapes. Operated by clinical staff in hospital settings. Control panel provides LED readout of chamber temperature, two independent skin temperatures, and setpoint. Heating surface controller factory-preset at 70°C. Includes audible alarm for skin temperature setpoint exceedance and self-diagnostic features. Provides rapid, reproducible external heat to assist recovery from hypothermia; allows quick access to patient for medical intervention.

Clinical Evidence

No clinical data provided; substantial equivalence based on functional similarity to predicate devices and design for safety/effectiveness.

Technological Characteristics

Fiberglass exterior; semi-cylindrical heating chamber; heat-resistant stretcher; dual-probe skin temperature monitoring; audible alarm system. Heating surface controller factory-preset at 70°C. Stand-alone system; no additional power demands. Self-diagnostic features included.

Indications for Use

Indicated for adult patients experiencing surgically- or trauma-induced hypothermia requiring rewarming therapy.

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

• Augustine Medical Bair Hugger™ Convective Warming System (K873745)
• Marquest Temp Marq™ Convective Warming System (K904690)

Submission Summary (Full Text)

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ENTERMICS Medical Systems

CONTACT NAME: Ms. Karen Hansen
DATE: September 10, 1996

K963731
APR 22 1997

TRADE NAME: ENTERMICS 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 ENTERMICS 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 semi-cylindrical 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
Toll Free [phone]
Telephone [phone]
Telex (ITT) 4311070 ALTSHAM
FAX [phone]

Regional Office
115 Evergreen Court
Blue Bell, PA 19422
Telephone [phone]
FAX [phone]

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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.

Ms. Karen Hansen
President
ENTHERMICS Medical Sytems, Inc.

9.10 96
Date

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