ICEFX™ Brief Summary

INTENDED USE

The ICEfx 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 ICEfx 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 ICEfx 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 ICEfx 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. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.
• 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 canthus area, 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, 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 ICEfx Cryoablation System.

WARNINGS

General

• The ICEfx 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.
• See Boston Scientific 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 ICEfx Cryoablation System in any way. Only authorized Boston Scientific personnel or Boston Scientific-trained authorized personnel are to service an ICEfx Cryoablation System.
• The ICEfx 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 ICEfx Cryoablation System if the system is visibly damaged, exposing any internal components or sharp edges.
• Do not use an ICEfx Cryoablation System near magnetic resonance imaging (MRI) equipment.
• The ICEfx Cryoablation System should not be used adjacent to or stacked with other equipment.
• If the ICEfx Cryoablation Console is mounted on a cart, lock the wheels on the cart 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 ICEfx 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 ICEfx Cryoablation System.
• Only use non-MRI needles with the ICEfx Cryoablation System.
• Boston Scientific recommends using the Boston Scientific MTS to monitor the freeze / thaw temperatures for theintended treatment protocol and to monitor temperatures in the adjacent organs and structures.
• 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 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 argon gas cylinder is chained to a wall or an approved cart to prevent inadvertent tipping of the cylinder.
• Do not connect the ICEfx Cryoablation System to a gas supply exceeding 6000 psi (414 bar, 41.4 MPa) to avoid damage to internal system components.
• The ICEfx 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 ICEfx Cryoablation System over the gas supply line; such activity may damage the line.

Procedural

• Prior to starting a cryoablation procedure, set up the ICEfx 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 cryoablation needle.
• Avoid contact with the distal portion of the cryoablation needle to maintain sterility during testing.
• Continuously monitor needle insertion, needle positioning, iceball formation and removal using image guidance (such as direct visualization, ultrasound, or Computed Tomography (CT)) 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 ICEfx Cryoablation System, including cables specified for use with the system. Otherwise, degradation of the performance of this equipment could result.
• Confirm the high-pressure argon gas supply is securely connected before opening the gas cylinder.
• Secure the safety cable at the end of the gas supply line to the Console 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 offorceful ejection of the needles while under gas pressure.
• If the needles are still connected, do not unlock the channels or disconnect the needles from the needle connection panel until all operations in the channel have completed.
• Use Freeze and Thaw operations only when the needle is placed in the target tissue.
• If a needle needs to be added during a procedure, connect the needle to an open channel. If there is no open channel available, reference the Adding a CX Needle During a Cryoablation Procedure Section for the instructions for adding a CX needle to a channel with an open port.
• Needle handles and the gas line may frost during freezing. Avoid prolonged contact with frosted portions of aneedle 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.
• 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.
• When conducting FastThaw Function or when conducting cautery function for Track Ablation, be alert for the Active Zone Indicator as the needle is withdrawn to prevent unintended tissue damage from the hot needle.
• If a needle without CX functionality is connected to the ICEfx Cryoablation System, active thawing is not possible. Needle release from an iceball will only be achievable with passive thaw. Use image guidance to ensure adequate thawing.
• Do not touch the ICEfx Cryoablation Console 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 ICEfx Cryoablation System to avoid startling them.
• If it is difficult to loosen the pressure gauge connected to the cylinder, or the argon gas supply line cannot be disconnected from the argon inlet connection, 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 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 ICEfx 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 and MTS temperature readings may be inaccurate for a few seconds. The system will remain functional and the monitor will refresh momentarily.
• 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 ICEfx Cryoablation System.
• Do not connect any other USB equipment to the ICEfx Cryoablation System USB port.
• Do not use a USB extension cable to connect the USB flash drive to the USB port. Connect the USB flash drivedirectly to the USB port provided on the ICEfx Cryoablation System. Use of a USB extension cable may result inelectromagnetic emissions exceeding regulatory limits.
• Select a unique Patient ID that does not reveal the patient’s identity to other system users. Do not include any patient identifiable information or health care provider physician information in Patient ID, Physician Name, Hospital Name, Hospital Address, Notes, Custom fields, or any other field.

Handling

• Handle the ICEfx Cryoablation System with care. Rough handling may damage the system and cause it to become inoperable. The Console should never be tilted. If the Console is not attached to a cart, ensure that the Console is placed on a flat, stable surface.
• Do not set food, drinks, or other objects on top of the Console. Doing so may damage the system.
• Do not set heavy objects on the monitor when in the down position or on the monitor storage basin when themonitor is in the up position.
• 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.
• If the Console is attached to the ICEfx Cryoablation Cart, use the cart handles to lift the system to clear anythreshold that is higher than 2 cm. Two people, one on each side, should use the handles to lift the system.
• Clean the ICEfx Cryoablation System by following the instructions in the Cleaning the ICEfx Cryoablation System Section. Do not use cleaning agents such as Betadine Antiseptic Solution or bleach solution, which may damage the touch screen.
• When placing the ICEfx Cryoablation Console on or removing the ICEfx Cryoablation Console from the ICEfx Cryoablation Cart, lift the Console using the handles on the underside of the base. Refer to the Removing the Console from the Cart Section for instructions on how to place or remove the Console from the ICEfx Cryoablation Cart.
• Position the argon cylinder close enough to the Console to ensure that the gas supply line is not stretched and does not present a trip hazard.
• Direct the high-pressure argon gas supply line towards the floor and secure the line with the clip located on the rear of the Console to minimize the potential for tripping.

Procedural

• The ICEfx Cryoablation System should be placed in close proximity for accessible needle connection and use.
• Turn the ICEfx Cryoablation Console ON before connecting the argon cylinder to ensure the proper diagnostic tests are conducted.
• Confirm that the Vent Valve is closed and Argon Shutoff Valve is in the ON position before connecting the gasline to the Console.
• If the Console produces a continuous hissing sound, verify that the Vent Valve is fully closed. If the Vent Valve is fully closed and the hissing sounds persists, shut OFF the system using the power switch located on the rear of the Console. Close the gas supply using the cylinder valve. Contact Boston Scientific Technical Assistance Center.
• Failure to operate the ICEfx Cryoablation System within the working pressure limits indicated on the user interface may affect iceball formation.
• Boston Scientific recommends that only needles of the same type be placed together in a single channel. Usingneedles 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.
• Do not allow the MTS to touch the cryoablation needle during use; erratic temperature measurements may be displayed.
• Needles without CX functionality do not support i-Thaw Function or FastThaw Function. Needle release from an iceball will only be achievable with passive thaw.
• Needles without CX functionality do not support cautery function for the purposes of track ablation.
• The cautery function should not be initiated if the Active Zone Indicator is visible outside the patient’s skin.
• If a needle appears to be blocked, press the Thaw button to thaw the needle for at least one minute to clear the blockage.
• If a needle without CX functionality appears to be blocked, wait for any formed ice to passively thaw. Do not use the needle. Use a new needle to continue the procedure.
• 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 Shutting Down the System Section).
• Visualization of the iceball edge may vary between hard and soft tissues. Exercise caution for bony lesions with decreased visualization.

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

Additional Safety Information on Bone Cryoablation Procedures:

Refer to the cryoablation needle IFU for the isotherm data of the selected needle type.

• When performing bone cryoablation procedures, the peripheral margin of the ice ball on imaging corresponds to 0 °C. Continue imaging when cryoablating tumors in close proximity to vital structures (e.g.,spine, nerves) as cryoablation may result in temporary or permanent injury to adjacent nerves.
  
• Ensure unintended targets, such as critical structures, are not within the outer edge of the iceball. Any tissue or structures within the 0 °C isotherm may be damaged, including bone cortex tissue.
• Patients with evidence of impending fracture or high risk of fracture should be given careful consideration

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