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Thermogard HO™ Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients. Thermogard XP® Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

The subject of this 510(k) is the new surface feature which makes minor modifications to the existing IVTM Start-Up Kits (SUKs) to enable connection of a Thermogard console to the STx™ Vest provides for circulation of thermally conditioned fluid supplied by the Thermogard console (either Thermogard HQ™ or Thermogard XP®). Transfer of heat between the patient and the circulating fluid results in modification of patient core temperature for the purpose of therapeutic patient temperature modulation. The existing, commercialized Thermogard Systems (Thermogard HQTM and Thermogard XP®) are used in conjunction with catheters placed in the vasculature to support intravascular cooling. The TGHQ-SURF accessory is a modification of the model TGHQ-500D accessory which was verified, validated, and commercialized. The CG-SURF accessory is a modification of the model CG-500D accessory which was verified, validated, and commercialized. These Surface SUK models are identical to their predecessors with the exception of longer inflow and outflow tubing lengths and replacing the Luers for catheters with 0.25inch hose barb valved connectors for the STx™ Vest. The Surface SUK also has a label on the fluid spike to indicate the size of bag of fluid (3000ml) to use and to mark it as non-sterile. The Surface SUKs are otherwise identical to their predecessors in terms of materials that contact the heat exchange fluid (i.e., saline), manufacturing process, and packaging materials. There are no changes to the commercially available Thermogard XP® (K213031) and Thermogard HO™ (K220008) consoles. There are no changes to the commercially available STxTM Vest.

The AutoPulse NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient. The AutoPulse NXT System is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The AutoPulse® NXT Resuscitation System (also referred to as the AutoPulse® Model 200 or AP 200 System) is an automatic, portable, battery-powered chest compressor, which provides chest compressions as an adjunct to performing manual cardiopulmonary resuscitation (CPR). The system can adjust to different patient sizes and can operate in environments with limited space, such as moving vehicles. The system may be a reasonable alternative to conventional CPR in specific settings where the delivery of high-quality manual compressions may be challenging or dangerous for the provider (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR). The AutoPulse® NXT Resuscitation System (hereinafter referred to as AutoPulse® NXT System) consists of four (4) primary components: a reusable platform (AutoPulse® NXT Platform), a single-use chest compression assembly (AutoPulse® NXT Band), a rechargeable battery (AutoPulse® NXT Battery), and a reusable battery charger (AutoPulse® NXT Battery Charger). The AutoPulse® NXT Platform contains the mechanical drive mechanism, control system, software, and electronics necessary to generate and control the motion required to perform mechanical chest compressions. User controls and indicators are contained in two (2) identical User Control Panels provided for ease-of-use. The AutoPulse® NXT Band is a chest compression assembly which consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. Attached to the AutoPulse® NXT Platform, the NXT Band is automatically adjusted to the patient and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. The band is a single-use component that is attached to the AutoPulse® NXT Platform before each use. The Lithium-ion (Li-ion) Battery is a removable component that supplies power for operation of the AutoPulse® NXT Platform. It also includes a printed circuit assembly to provide "smart battery" features including cell balancing, state of charge (SOC) reporting, a history archive, and safety circuits. The AutoPulse® NXT Battery Charger is a reusable, stand-alone unit intended to charge and test-cycle AutoPulse® NXT Batteries. The battery charger has two (2) charging bays, each with its own indicators, and is used to charge and test-cycle up to two (2) AutoPulse® NXT batteries simultaneously. When in use, the battery charger continuously tests itself and any compatible batteries in its ways. The AutoPulse® NXT System comprises the subject devices included in this 510(k).

The Solex 7 Intravascular Heat Exchange Catheter connected to the CoolgardThermal Requlation System is indicated for use: - · In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days) - · To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recoverylintensive care. (Maximum use period: 4 days) - · In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infaction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days) The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use: - · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and - · To induce, maintain and reverse mild hypothermia in neurosurqery and recovery/intensive care. The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use: - · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recoverylintensive care, and - · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.

The ZOLL Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (either the Thermogard HQ™ Console or the Thermogard XP® Console) and intravascular heat exchange catheters connected via a sterile heat exchanger and tubing circuit. These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the Thermogard HQ™ Console (TGHQ) and the Thermogard XP® Console (TGXP) for software changes due to the addition of the TrakLo functionality to both consoles.

The Solex 7 Intravascular Heat Exchange Catheter connected to the Coolgard/Thermogard Thermal Regulation System is indicated for use: · In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days) · To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care. (Maximum use period: 4 days) · In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days) The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy. in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use: • In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and - · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care. The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use: • In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and - · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.

The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQ™ Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the Thermogard HQ™ Console, Thermogard HQ™ Start-Up Kit and Thermogard HQTM Start-Up Kit EX. The Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, and Quattro Intravascular Heat Exchange Catheter are also included as part of the system but are unchanged compared to the predicate device.

The Solex 7 Intravascular Heat Exchange Catheter connected to the Coolgard/Thermogard Thermal Regulation System is indicated for use: · In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days) · To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care. (Maximum use period: 4 days) · In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days) The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy. in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use: • In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and - · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care. The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use: • In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and - · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.

The ZOLL Intravascular Heat Exchange Catheters (Quattro® Intravascular Heat Exchange Catheter Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit, Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter) are sterile, single use heparin coated flexible catheters designed for placement in the femoral, jugular, or subclavian veins. The Solex 78 Intravascular Heat Exchange Catheter Premium Access Kit is a sterile, single use 9.3F flexible catheter designed for placement in the superior vena cava from an insection site in the jugular and subclayian veins. The Cool Line catheter contains two heat exchange balloons, the ICY catheter contains three heat exchange balloons, the Quattro catheter contains four heat exchange balloons and the Solex 7® catheter consists of a serpentine balloon. The ZOLL catheters are connected to a single use, disposable Start-Up Kit (SUK), the Coolgard 3000® Console and Thermogard XP® Console. The catheters connect to the console coolant well via tubing integral to the SUK. The catheter is connected to the SUK by connecting the male outflow Luer of the SUK to the female inflow Luer of the catheter and the female inflow Luer of the SUK to the male outflow Luer of the catheter. Both SUK Luers, in turn, are connected via tubing to a heat exchange coil through which saline circulates. The coil is placed in a coolant well located in the console. The controlled temperature saline is circulated through the closed-loop circuit of the SUK and catheter using the console pump, after which the saline is then returned within the SUK to the console heater and chiller coolant well via the catheter's outflow lumen. The catheters, SUK, the Coolgard 3000® Console and the Thermogard XP® Console are supplied separately. The ZOLL Intravascular Heat Exchange System is also designed for use with an off-the-shelf temperature probe, which is supplied separately and not manufactured by ZOLL.

The Solex 7™ Intravascular Heat Exchange Catheter connected to the CoolGard 3000®/Thermal Regulation System is indicated for use: · In cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care. (Maximum use period = 4 days) · To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care. (Maximum use period = 4 days) · In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infarcerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period = 7 days)

The Solex 7 Intravascular Heat Exchange Catheter (Solex 7 Catheter) is a sterile, single use 9.3F flexible catheter designed for placement in the Superior Vena Cava from an insertion site in the Jugular and Subclavian Veins. The Solex 7 Catheter is connected to a single use, disposable CoolGard 3000 or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 30000 or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are System. supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-theshelf temperature probe. The Solex 7 Catheter is comprised of a polyurethane shaft and a serpentine shaped PET balloon at the distal end. The blood contact surfaces of the catheter incorporate a hydrophilic heparin coating. The catheter has five lumens, two of which when connected to the Start-Up Kit, are used to circulate sterile saline in a closed loop circuit for heat exchange with the blood in the central venous system. Warmed or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the serpentine balloon that interfaces with the patient's blood to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the warmed or chilled saline circulates. The warmed or chilled saline is not infused into the patient. Additional lumens of the Solex 7 Catheter consist of a 0.032" guidewire compatible lumen that can also be used as a primary infusion lumen, and two additional infusion lumens within the catheter shaft.

The Cool Line Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893-A, connected to the ZOLL CoolCard 3000/ Thermogard XP Thermal Regulation System, is indicated for use: - · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and - · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care. The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use: - · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and - · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care. The Start-Up Kit (SUK) is intended to control patient core temperature using heat exchange fluid in conjunction with CoolGard 3000 or Thermogard XP system and ZOLL Heat Exchange Catheters, but does not have a specific independent indications for use.

The ZOLL Intravascular Heat Exchange Catheters (Cool Line, ICY, and Quattro - ZOLL Catheters) are sterile, single use heparin coated flexible catheters designed for placement in the femoral, jugular, or subclavian veins. The Cool Line Catheter contains two heat exchange balloons, the ICY Catheter contains three heat exchange balloons, and the Quattro Catheter contains four heat exchange balloons. The ZOLL Catheters are connected to a single use, disposable Start-Up Kit (SUK) and the CoolGard 3000® or Thermogard XP® Console. The catheters connect to the console coolant well via tubing integral to the SUK. The catheter is connected to the SUK by connecting the male outflow Luer of the SUK to the female inflow Luer of the catheter and the female inflow Luer of the SUK to the male outflow Luer of the catheter. Both SUK Luers, in turn, are connected via tubing to a heat exchange coil through which saline circulates. The coil is placed in a coolant well located in the console. The controlled temperature saline is circulated through the closed-loop circuit of the SUK and catheter using the console pump, after which the saline is then returned within the SUK to the console heater and chiller coolant well via the catheter's outflow lumen. The Catheters. SUK and the CoolGard 3000 or Thermogard XP Console are supplied separately. The ZOLL Intravascular Heat Exchange System is also designed for use with an off-the-shelf temperature probe, which is supplied separately and not manufactured by ZOLL.

The Solex® Intravascular Heat Exchange Catheter connected to the CoolGard 3000®/Thermogard XP® Thermal Regulation System, is indicated for use: - In cardiac surgery patients to achieve and or maintain normothermia during surgery and . recovery/intensive care, and - To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care. Maximum use period: 48 hours

The ZOLL Solex Intravascular Heat Exchange Catheter (Solex Catheter) is a sterile, single use 9.3F flexible catheter designed for placement in the superior vena cava from an insertion site in the jugular vein. The Solex Catheter is connected to a single use, disposable CoolGard 3000" or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 3000" or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange System. The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-the-shelf temperature probe. The Solex Catheter is comprised of a polyurethane shaft and a serpentine shaped PET balloon at the distal end. The blood contact surfaces of the catheter incorporate a hydrophilic heparin coating as an anti-thrombogenic agent. The catheter has five lumens, two of which when connected to the Start-Up Kit, are used to circulate sterile saline in a closed loop circuit for heat exchange with the blood in the central venous system. Heated or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the PET balloon that interfaces with the patient's blood system to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the heated or chilled saline circulates. The heated or chilled saline is not infused into the patient. Additional lumens of the Solex Catheter consist of a 0.032" guidewire compatible lumen that can also be used as a primary infusion lumen, and two additional infusion lumens within the catheter shaft.

The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

The AutoPulse Resuscitation System Model 100 is an automated, portable, batterv powered device that compresses the chest of an adult human as an adjunct to manual CPR. The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger. The AutoPulse Platform contains the mechanical drive mechanism, control system, software and electronics necessary to generate and control the force required to perform mechanical chest compressions. User controls and indicators are contained in the User Control Panel. The AutoPulse Platform and LifeBand are unchanged. A new battery and battery charger are the subject devices of this 510(k).

The Cool Line Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infaccerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. The ZOLL ICY Catheter Model IC-3893A, connected to the ZOLL Thermal Regulation System, is indicated for use: - In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and - To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care. The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use: - In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and - To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recoveryintensive care.

ZOLL IVTM Cool Line. ICY and Quattro catheters are multi lumen intravascular catheters with balloons as heat exchange units. Each of these three catheter models has two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The thermal regulation system chills/warms the saline and pumps it through the inflow lumen of the catheter. The chilled/warmed saline travels to the balloons, whose surface facilitates heat exchange between the patient's circulating blood and the saline returns to the system via the outflow lumen. The chilled/warmed saline is not infused into the patient. Two additional lumens provide infusion channels. The fifth lumen serves as a guide wire lumen which can also be used as an infusion lumen. The basic difference between these three models of catheters is size and number of balloons which provides different heat exchange capacity. The catheters are supplied sterile for single-use only.