Аппарат для радиочастотной коагуляции VNUS Radiofrequency Generator RFG2 Version 4.4.0 Electrosurgical Device

Аппарат для радиочастотной коагуляции

RFG Plus (модель «RFG2»)

VNUS

Radiofrequency Generator RFG2

Electrosurgical Device

Version 4.4.0

Методика VNUS Closure

Эндовенозная радиочастотная облитерация варикозных вен VNUS™
COVIDIEN – это миниинвазивное вмешательство, являющееся
альтернативой классическим операциям и лазеру при варикозной болезни.

Основным свойством метода является точечное приложение
энергии радиочастотного излучения через катетер,
расположенный в просвете варикозной вены, что приводит
к полному склеиванию за счет коагуляции коллагена венозной стенки.

Все катетеры одноразовые и имеют механизм обратной связи с аппаратом VNUS™,
обеспечивают однородный нагрев вены на каждом участке воздействия,
что исключает неравномерность, характерную для технологий постепенного
извлечения, таких как эндовенозная лазерная коагуляция (ЭВЛК).

Управление подачей энергии осуществляется врачом
при помощи кнопки, расположенной в стерильной области.
А гладкая, не прилипающая поверхность нагревательного элемента
облегчает продвижение электрода к следующему сегменту воздействия.
Все это сводит процент осложнений во время
манипуляции и после нее практически к нулю.

Device Description:

The VNUS RF Generator, model RFG2 is a bipolar, high frequency
electronic, microprocessor / software controlled instrument.

It allows the user to set Power, Temperature and Time values, and provides
user displays of Power, Temperature and Time (set-points and measured values)
as well as measured Impedance and user messages.

The RF Generator remains out of the sterile field during use, and is provided non-sterile.
The model RFG2 is compatible only with the disposable RF delivery devices (e.g., catheters)
designed, manufactured and marketed by VNUS Medical Technologies under separate clearance(s).
The instrument cable connects the disposable device to the RF generator.

The Instrument Cable is provided non-sterile, and is user sterilizable by autoclave.

It has been validated to multiple steam sterilization cycles.

Both ends of the cable are identical to eliminate connection errors.
If the VNUS RF delivery device has an integrated cable,

a separate instrument cable is not necessary.
Intended Use:
The VNUS Radiofrequency Generator is intended for use with
VNUS radiofrequency devices intended for vessel and tissue coagulation.

Intended Use of Predicate Devices The specified predicate devices are indicated
for "coagulation of blood vessels in patients with superficial vein reflux" (VNUS Closure System),
and "vessel and tissue coagulation" (VNUS Vessel and Tissue Coagulation System).

Technological Comparison The RF energy is widely used in electrosurgical equipment for many years.
The safety and efficacy of such devices has been well established for a variety of intended uses.
The use of bipolar RF energy delivery has potential advantages over monopolar systems.
No grounding pads are required, and the potential for damage to adjacent tissue is minimized,
as the patient is no longer the return path for electrical current.
The efficiency of bipolar RF energy delivery allows systems such as the
VNUS RF Generator to be used at lower voltage and power settings
 as compared with monopolar systems.

The technological characteristics and principals of operation
of the VNUS RF Generator, model RFG2 are substantially
equivalent to the noted predicate devices.

Test Results:

Performance Results of in-vitro testing will demonstrate that the VNUS
Radiofrequency Generator is safe and effective for its intended use.
Summary of Safety and Effectiveness Based upon the design, materials,
function, intended use, comparison with currently marketed devices and
the non-clinical testing performed by VNUS, it is concluded that the VNUS
Radiofrequency Generator, Model RFG2 (proprietary name: TBD)
is substantially equivalent to the noted predicate devices in safety and effectiveness.