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510(k) Data Aggregation
K Number
K023934Device Name
RAPID THERMAL EXCHANGE SYSTEM
Manufacturer
Date Cleared
2003-01-23
(58 days)
Product Code
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
AVACORE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rapid Thermal Exchange System is designed to noninvasively lower or raise a patient's temperature and/or maintain a desired patient temperature. This is accomplished with local application of negative pressure and heating/cooling to a distal appendage.
Device Description
The Rapid Thermal Exchange (RTX) System consists of three main parts. The 1) Field Controller unit is the vacuum source; it also regulates and pumps the temperaturecontrolled water through the 2) Attachment Hoses that are connected to 3) the Thermal Exchange Chamber (identified in earlier submissions as the Palmo Thermoregulating Accessory).
The patient inserts his/her hand through the arm seal of the Thermal Exchange Chamber. The palm is placed on the temperature-controlled thermal exchange surface. A light vacuum is created by connecting the Thermal Exchange Chamber to the Field Controller Unit's vacuum pump via the inline vacuum control valve. The physician can monitor the adequacy of the vacuum and seal from the dial on the mechanical vacuum gauge mounted to the top of the Thermal Exchange Chamber. A light vacuum (25 inches of water, 47mmHg) is applied to increase the amount of blood available in the appendage.
This combination of light vacuum and a thermal exchange surface provides a rapid and noninvasive mechanism for changing the temperature of the blood flowing through the appendage. This, in turn, changes the temperature of the body core.
The arm seal of the Thermal Exchange Chamber is available in three different sizes (small, medium & large) to accommodate the range of possible hand and wrist sizes of athletes. A variation of the Chamber can be applied to the foot in a similar manner.
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K Number
K014210Device Name
PALMO THERMOREGULATION INTERFACE ACCESSORY
Manufacturer
Date Cleared
2002-08-16
(238 days)
Product Code
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
AVACORE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Palmo Thermoregulation Interface Accessory for the Cincinnati Subzero Blanketrol II is designed to noninvasively lower or raise a patient's temperature and/or maintain a desired patient temperature. This is accomplished with local application of negative pressure and heating/cooling to distal appendage.
Device Description
The Palmo consists of three main parts: 1) a vacuum chamber that contains the 2) thermal exchange surface and an 3) arm seal.
The patient inserts his/her hand through the arm seal and into the vacuum chamber. The palm is placed on the thermal exchange surface. A light vacuum is created by connecting the Palmo to the hospital's regulated vacuum source. The physician can monitor the adequacy of the vacuum and seal from the dial on the mechanical vacuum gauge attached to the top of the Palmo unit. A light vacuum is applied to increase the amount of blood available in the appendage.
The Cincinnati Subzero Blanketrol II (or equivalent) creates the temperature-controlled water that flows through the water channels of the Palmo and heats/cools the thermal exchange plate. The thermal exchange surface is warmed if the patient needs to have the body core temperature increased, and cooled if the body core temperature needs to be decreased.
This combination of light vacuum and a thermal exchange surface provides a rapid and noninvasive mechanism for changing the temperature of the blood flowing through the appendage. This, in turn, changes the temperature of the body core.
The arm seal of the Palmo is available in three different sizes (small, medium & large) to accommodate the range of possible hand and wrist sizes of patients. A variation of the device can also be applied to the foot.
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