Indications, safety, warnings for Visual ICE™ MRI Cryoablation System

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

Intended use / Indications for use

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 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 Visual-ICE MRI Cryoablation System.

Warnings

General

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.
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.
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.
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.
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 can be 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.

Precautions