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VISUAL ICE™ MRI Brief Summary

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Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE

The Visual-ICE MRI Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Boston Scientific accessory products are required to perform these procedures. The Visual-ICE MRI Cryoablation System is intended for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology.This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

Patient Groups
The intended population includes patients intended for cryoablative destruction of tissue during surgical procedures.

INDICATIONS FOR USE

The Visual-ICE MRI Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery,dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.
The Visual-ICE MRI Cryoablation System has the following specific indications:

  • Urology - Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)
  • Oncology - Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention
  • Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders.
    • Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthusarea, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
  • Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia
  • General surgery - Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, and ablation of breast fibroadenomas
  • ENT – Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
  • Thoracic surgery - (with the exception of cardiac tissue)
  • Proctology – Ablation of benign or malignant growths of the anus or rectum

CONTRAINDICATIONS

There are no known contraindications specific to the use of the Visual-ICE MRI Cryoablation System.

WARNINGS

General

  • The Visual-ICE MRI Cryoablation System is designed to be operated by medical professionals who have a thorough understanding of the technical principles, clinical applications, and risks associated with cryoablation procedures.
  • Personnel present when making all connections prior to a cryosurgical procedure must be completely familiar with all routine precautions taken in an MRI environment.
  • See Boston Scientific MRI cryoablation needle and accessory product IFUs for Warnings specific for these products.
  • Do not use this device for any purpose other than the stated intended use and indications for use.
  • Do not modify the Visual-ICE MRI Cryoablation System in any way. Only authorized Boston Scientific personnel or Boston Scientific-trained authorized personnel are to service Visual-ICE MRI Cryoablation Systems.
  • The Visual-ICE MRI Cryoablation System should be inspected and serviced periodically according to the system specifications. Service must be performed by authorized service engineers. Reference the Installation, Calibration, and Servicing Section for detailed information.
  • Do not use the Visual-ICE MRI Cryoablation System if the system is visibly damaged, exposing any internalcomponents or sharp edges.
  • The Visual-ICE MRI Cryoablation System Console is MR Unsafe. Never place the Console in the magnet room.
  • All supporting accessory equipment must be MR Safe or MR Conditional. Follow the MR Conditional labeling for all accessory devices.
  • The Visual-ICE MRI Cryoablation System should not be used adjacent to or stacked with other equipment.
  • Lock the wheels on the Visual-ICE MRI Cryoablation System prior to using the system to avoid inadvertent movement of the system during a procedure.
  • To avoid risk of electric shock, this equipment must only be connected to a hospital grade electrical power outlet with a protective earth.
  • Do not start a cryoablation procedure before verifying that the Visual-ICE MRI Cryoablation System and all ancillary equipment are fully operational.
  • Use of cables other than those specified, with the exception of those sold by Boston Scientific for use as replacement parts for internal components, may result in increased emissions or decreased immunity of the Visual ICE MRI Cryoablation System.
  • Only use MRI needles with the Visual-ICE MRI Cryoablation System.
  • Do not use the needle if it is bent or damaged while attempting to unpack or use it. Never use a defective needle for a cryoablation procedure. A defective MRI cryoablation needle that has a gas leak can cause a gas embolism in the patient.
  • Do not kink, pinch, cut or pull excessively on the needle tubing. Damage to needle handle or tubing may cause the needle to become unusable.
  • Have sufficient argon gas available to conduct the planned cryoablation procedure: the number and type of needles, gas cylinder size, pressure and rate of gas flow affect the required gas volume (reference the SYSTEM SPECIFICATIONS Section for gas purity requirements). At least one full spare cylinder should be available for each treatment.
  • High-pressure gas is dangerous if handled improperly. Local laws and safety rules regarding pressurized gas systems, reservoirs and components should always be observed.
  • Ensure that the gas cylinders are chained to a wall or an approved cart to prevent inadvertent tipping of the cylinders.
  • Do not connect the Visual-ICE MRI Cryoablation System to a gas supply exceeding 6000 psi (414 bar, 41.4 MPa) to avoid damage to internal system components.
  • The Visual-ICE MRI Cryoablation System should not be operated in the presence of flammable fumes, e.g., flammable anesthetics or volatile substances.
  • Do not bend or kink the gas supply line. Sharp bends or kinks may compromise the integrity of the gas supply line.
  • Do not roll the Visual-ICE MRI Cryoablation System over the gas supply line; such activity may damage the line.

Procedural

  • Prior to starting a cryoablation procedure, set up the Visual-ICE MRI Cryoablation System (reference the System Setup Section) and then perform Needle Integrity and Functionality Tests. Tests must be successfully completed in order to begin the procedure.
  • Do not use the needle if there is no ice formation during the Freeze phase. Obtain a new needle and repeat the testing procedure.
  • Do not use the needle if bubbles are seen escaping from the needle during Needle Integrity and Functionality Test.
  • Ensure adequate measures are taken to protect organs and structures adjacent to the targeted tissue.
  • Ensure that the MTSs are functioning properly before inserting into the patient by verifying that they are reading a reasonable room temperature.
  • The sterile field and sterility of cryoablation needles should be maintained at all times. Do not contaminate the distal end of the sterile MRI cryoablation needle.
  • Avoid contact with the distal portion of the MRI cryoablation needle to maintain sterility during testing.
  • Continuously monitor needle insertion, needle positioning, iceball formation and removal using image guidance (such as direct visualization or Magnetic Resonance Imaging (MRI)) to ensure adequate tissue coverage and to avoid damage to adjacent structures.
  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the Visual-ICE MRI Cryoablation System, including cables specified for use with the system. Otherwise, degradation of the performance of this equipment could result.
  • Confirm the high-pressure gas connections to the Console and Mobile Connection Panel are securely connected before opening the gas cylinder(s).
  • Secure the safety cable at the end of the gas supply line to the System before connecting the argon gas supply line to the argon gas inlet. The safety cable provides backup protection if the gas supply line becomes inadvertently disconnected from the system. Do not use a gas supply line with a missing safety cable. Doing so could compromise the safety of personnel in the room. Contact Boston Scientific Technical Assistance Center for further instructions.
  • Each needle must be locked into a needle channel before initiating a cryoablation procedure to avoid the risk of forceful ejection of the needles from the Mobile Connection Panel while under gas pressure.
  • Scanning with a high SAR sequence while thawing could result in thermal injury due to needle heating.
  • If the needles are still connected, do not unlock the channels or disconnect the needles from the Needle Interface until all operations in the channel have completed.
  • Do not unlock the locking bar for any needle channel if the GAS Pressure Indicator LED on the Mobile Connection Panel is solid white. Unlocking the locking bars when the channels are under pressure could result in forceful ejection of the needle connectors.
  • Use Freeze and Thaw operations only when the needle is placed in the target tissue.
  • Needle handles and the gas line may frost during freezing. Avoid prolonged contact with frosted portions of a needle handle to avoid unintended thermal tissue damage to the patient or clinician.
  • Needle tubing may become extremely cold when conducting freeze cycles during a cryoablation procedure. It is important that a patient’s skin is protected from direct contact with needle tubing to avoid the potential for thermal injury to the patient. Ensure an appropriate insulating barrier is placed as needed (such as towels) or other method is employed to prevent needle tubing from touching a patient’s skin.
  • MRI Cryoablation Needles may heat up when the scanner RF field is active. Hazards associated with heating canbe minimized by using scan sequences with low SAR and limiting the duration of the scan. It is recommended that the scanner be operated in Normal Operating Mode with a whole body averaged specific absorption rate (SAR) of ≤ 1.5 watts per kilogram (W/kg). It is also recommended that the scan duration be limited to about one minute per scan if the needle is not operating in freezing mode during the scan.
  • The needle handle may become warm during active thawing. Pay attention to the needle handle position. Prolonged contact with warm portions of the needle handle could cause unintended thermal tissue damage/burn to the patient or clinician.
  • Active thawing produces heat along the distal needle shaft. Use care to avoid thermal injury/burn to nontargeted tissues.
  • Ensure adequate thawing or cooling before attempting to remove needles from the patient.
  • Discontinue all needle operation prior to needle removal to minimize risk of thermal injury and/or tissue injury.
  • An electrocautery device should never touch a needle or be in close proximity to them when the needle is connected to the MCP.
  • Do not touch the MCP while touching the patient to avoid the risk of shocking the patient if an inadvertent electrical fault exists.
  • Do not touch the screen if the touch screen monitor goes blank for more than five (5) seconds during a procedure. Immediately turn off power to the system and end the procedure to avoid inadvertent activation of needles.
  • Warn procedure personnel prior to venting the Visual-ICE MRI Cryoablation System to avoid startling them.
  • Warn procedure personnel that gas in the Junction Box Harnesses is vented through the Console at the end of the freeze phase, to avoid startling them. The duration of venting depends on the combined length of the two Junction Box Harnesses. A typical venting duration after freezing is about 10 seconds.
  • Warn procedure personnel that gas in the Junction Box Harnesses is vented through the Console at the end of the thaw phase, to avoid startling them. A typical duration for helium gas venting after thawing is about 3 seconds.
  • Warn procedure personnel that gas in the Junction Box Harnesses is vented through the Console to achieve rapid transitions from helium flush to argon freeze and from freeze to helium thaw, to avoid startling them. The duration of venting depends on the combined length of the two Junction Box Harnesses. A typical venting duration for argon, after freezing, is about 10 seconds. Helium vents more quickly, usually in about 3 seconds.
  • If it is difficult to loosen the pressure gauge connected to the cylinder, or the high-pressure gas supply line(s) cannot be disconnected from the inlet connections, do not apply excessive force to release the gas supply line or to loosen the pressure gauge. The gas line may still be under pressure.
  • Do not apply excessive force to release the Junction Box Harness gas connection hub. The gas lines may still be under pressure.
  • Do not pull on the power cord. Grasp the plug, not the power cord, to disconnect the device from the wall socket.
  • Dispose of device and accessories in accordance with the Disposal Section.

PRECAUTIONS

General

  • Carefully read all instructions prior to use. Failure to observe all warnings and precautions may result in complications.
  • Do not use the Visual-ICE MRI Cryoablation System if any moisture or condensation is present on the surfaces of the system. Allow the system to dry completely for 12 hours prior to powering up the system. Powering up the system containing moisture or condensation could result in permanent damage to the electrical boards, causing the system to be inoperable.
  • Take precautions to avoid potential electrostatic discharge. If an electrostatic discharge occurs after touching the monitor, the screen may flicker for a few seconds. The system will remain functional and the monitor will refresh momentarily.
  • Use care to avoid electrostatic discharge (ESD) events when removing the covers from the Visual-ICE MRI Cryoablation Console and Visual-ICE MRI Cryoablation Mobile Connection Panel. Boston Scientific recommends that the operator touch one or more metal parts on the rear of the system prior to touching anything on the Needle Interface.
  • No data regarding cryoablation in combination with other therapies is available from Boston Scientific.
  • Use the Boston Scientific supplied USB flash drive only to export reports or update software. Other data or software may corrupt the Visual-ICE MRI Cryoablation System.
  • Do not connect any other USB equipment to the Visual-ICE MRI Cryoablation System USB port.
  • Do not use a USB extension cable to connect the USB flash drive to the USB port. Connect USB flash drive directly to the USB port provided on the Visual-ICE MRI Cryoablation System. Use of a USB extension cable may result in electromagnetic emissions exceeding regulatory limits.
  • Select a unique Patient ID that does not reveal the patient’s identity to other system users.

Handling

  • Handle the Visual-ICE MRI Cryoablation System with care. Rough handling may damage the system and cause it to become inoperable. The system should never be tilted.
  • Maneuver the Visual-ICE MRI Cryoablation Console by pulling on the Console using the rear handle.
  • Maneuver the Visual-ICE MRI Mobile Connection Panel using the handles.
  • Do not set food, drinks, or other objects on top of the system. Doing so may damage the system.
  • Do not store liquids in the storage compartment. The storage compartment is not watertight.
  • Do not set heavy objects on the monitor when in the down position or on the monitor storage basin when the monitor is in the up position. The weight limit is 9 kg (20 lb).
  • Prior to lowering the monitor, ensure that no objects are located in the monitor storage basin. Use care when lowering the monitor into the monitor storage basin; do not use excessive force to avoid damaging the monitor.
  • Use care when lowering or swiveling the touch screen monitor to avoid the potential for pinching fingers.
  • Lift the Visual-ICE MRI Cryoablation Console to clear any threshold that is higher than 1 cm. Two people, one on each side, should use the handles to lift the Console.
  • Lift the Mobile Connection Panel using the handles to clear any obstacle, either ascending or descending.
  • Clean the Visual-ICE MRI Cryoablation System by following the instructions in the Handling and Storage Section. Do not use cleaning agents such as Betadine Antiseptic Solution or bleach solution, which may damage the touch screen.
  • Position the argon cylinder close enough to the system to ensure that the gas supply line is not stretched and does not present a trip hazard.
  • Direct the high-pressure gas supply lines toward the floor and secure the lines with the clips located on the rear of the Visual-ICE MRI Cryoablation System to minimize the potential for tripping.
  • Direct the Junction Box Harnesses towards the floor to minimize the potential for tripping.

Procedural

  • The Visual-ICE MRI Cryoablation System should be placed in close proximity for accessible needle connectionand use.
  • Turn the Visual-ICE MRI Cryoablation System ON before connecting the gas cylinders to ensure the properdiagnostic tests are conducted.
  • Confirm that the Manual Vent Valve is closed and Argon Shutoff Valve is in the ON position before connecting the gas line to the Console.
  • If the system produces a continuous hissing sound, verify that the Manual Vent Valve is fully closed. If the Manual Vent Valve is fully closed and the hissing sounds persists, shut OFF the system using the power control knob located on the front of the system. Close the gas supplies using the cylinder valves. Contact Boston Scientific Technical Assistance Center.
  • Failure to operate the Visual-ICE MRI Cryoablation System within the working pressure limits indicated on the user interface may affect the iceball formation.
  • Boston Scientific recommends that only needles of the same type be placed together in a single channel. Additionally, using needles of differing types in a channel may affect the accuracy of the Gas Indicator.
  • During use, avoid damage to the needle from other surgical instruments.
  • While every effort has been made to reduce imaging artifacts while using the needles within the magnet bore, some artifacts may still be present (depending on the imaging resolution and procedure).
  • To minimize heating and image artifacts, position needle tubing such that the tubing runs in the center of the MR system. Avoid routing the tubing along the side of the MR system and keep away from the RF coils. When routing the needle tubing, avoid looping or crossing of the tubing.
  • If a scan with a high SAR level is performed while the needle is not freezing, hazards associated with heating can be mitigated by selecting Stick mode from the Freeze Intensity drop-down menu.
  • Stick mode may be enabled from the Freeze Intensity drop-down menu to actively cool the shaft during a scan. When Stick is selected, argon gas is flowed through the cryoablation needle at a low duty cycle which cools the needle shaft to create a very thin layer of ice around the needle shaft.
  • If a needle appears to be blocked, press the Thaw button to thaw the needle for at least one minute to clear the blockage.
  • When the argon cylinder pressure falls below the lower working pressure limit, the system displays an alert message. To ensure optimal performance, replace an argon cylinder if the pressure falls below the lower working pressure limit.
  • Depressurize the system after the cryoablation procedure is completed (reference the System Shutdown Section).
  • Ice formation during the Flush and Thaw phases indicates that argon gas is connected to the helium inlet. Before proceeding change the cylinders and ensure that each gas supply line is connected to the correct cylinder (reference the Standard Gas Cylinder Setup Section)
  • Visualization of the iceball edge may vary between hard and soft tissues. Exercise caution for bony lesions with decreased visualization.
  • Any interruption of a programmed phase immediately terminates that phase and the programmed cycle.

ADVERSE EVENTS

The potential adverse events associated with the device and/or cryoablation procedure include, but are not limited to:

  • Angina
  • Arrhythmia
  • Atelectasis
  • Bladder spasms
  • Bleeding/hemorrhage
  • Burn/frostbite
  • Cerebrovascular Accident (CVA)/stroke
  • Cryoshock Phenomenon (e.g. multi organ failure, severe coagulopathy, disseminated intravascular coagulation (DIC))
  • Death
  • Distension
  • Edema/swelling
  • Ejaculatory dysfunction
  • Embolism (air, device, thrombus)
  • Erectile dysfunction
  • Fever
  • Fistula
  • Fracture
  • Gastrointestinal symptoms (eg. nausea, vomiting, diarrhea, constipation)
  • Healing, impaired
  • Hematoma
  • Hematuria
  • Hemothorax
  • Hepatic dysfunction/failure
  • Hernia
  • Hypertension
  • Hypotension
  • Hypothermia
  • Ileus
  • Impotence
  • Infection/abscess/sepsis
  • Inflammation
  • Muscle spasm
  • Myocardial infarction
  • Necrosis
  • Need for additional intervention or surgery
  • Nerve Injury
  • Neuropathy
  • Obstruction
  • Pain/discomfort
  • Perforation (including organ and adjacent structures)
  • Pericardial Effusion
  • Perirenal fluid collection
  • Pleural effusion
  • Pneumatosis (air or gas in an abnormal quantity and/or place in the body)
  • Pneumothorax
  • Post ablation syndrome (e.g. fever, pain, nausea, vomiting, malaise, myalgia)
  • Renal insufficiency/failure
  • Renal parenchymal or capsule fracture
  • Respiratory distress/insufficiency/failure
  • Scrotal edema
  • Stenosis/stricture
  • Subcutaneous emphysema
  • Thrombosis/thrombus
  • Tissue damage
  • Transient ischemic attack (TIA)
  • Tumor cell seeding
  • Urethral sloughing
  • Urinary frequency/urgency
  • Urinary incontinence
  • Urinary retention
  • Urinary tract infection
  • Vasovagal response
  • Vessel trauma (e.g. dissection, injury, perforation, pseudoaneurysm, rupture, or other)
  • Wound infection

 

 

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