Indications and Important Safety Information.

Indications for use

The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy 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. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, nerves, tumors, and skin lesions.

In addition, the system is intended for use in the following 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

Neurology

• Freezing of nerve tissue in pain management/cryoanalgesia

Contraindications

There are no specific contraindications for the use of this device.

Intended users

Users are trained in using CT image guidance and performing percutaneous cryoablation procedures. The users of the system must be physicians trained in their respective fields, supported by technologists trained in the operation of the system.

Warnings · Directional Cryoprobe

• The cryosurgical systems produce extreme cold which results in a necrotic effect on tissue. The effects of cryosurgery on tissues of various types must be well understood.
• Visualization must be used at all times during a cryosurgical procedure. If at any point visualization stops or becomes impaired, discontinue treatment immediately.
• Verify the location of the Directional Cryoprobe’s directional or circumferential isotherm prior to beginning treatment.
• Verify the direction and orientation of the Directional Cryoprobe’s directional isotherm prior to beginning treatment.
• Tissue perforation can occur if the Directional Cryoprobe is applied for excessive periods of time.
• Position the Directional Cryoprobe’s ablation zone only in tissue intended for treatment.
• Screen tissues that are in close proximity to known arteries or veins to precisely locate these circulatory structures.
• 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.
• 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.
• The Focused Cryotherapy System is not safe for use in the MR Environment.

Warnings · Console

• Where appropriate, cryoprobe monitoring or other image-based monitoring must be used at all times during a cryosurgical procedure. Do not begin ablation if imaging equipment is not available. Discontinue treatment immediately if image is not satisfactory.
• The Focused Cryotherapy System is only compatible with Argon gas (6000 psi).
• The cryoprobe pre-test must be conducted for each cryoprobe prior to placing them. Discontinue treatment if the pre-test cannot be conducted for any reason.
• Ensure that at least two (2) additional cryoprobes are available for the case in the event that there is a pre-test failure or a failure during the procedure. Otherwise, procedure delay or cancellation may result.
• The Focused Cryotherapy System is not suitable for use in the presence of flammable anesthetics or in an oxygen rich environment.
• DANGER: Risk of explosion if used in the presence of flammable anesthetics.

See the Operator’s Manual for the complete list of console warnings, precautions, and electromagnetic compatibility information.

Precautions

• Carefully read all instructions prior to use. Failure to observe all warnings and precautions may result in complications.
• Federal (USA) law restricts this device to sale by or on the order of a physician.
• Extra Directional Cryoprobes should be available as replacements for pretest failures.
• For single use only. Device may not perform as intended if it is reused. Reuse may lead to material degradation of device and potential risks of cross infection / contamination associated with using inadequately cleaned and sterilized devices.
• Do not resterilize as doing so may damage the Directional Cryoprobe.
• The cryosurgical system should be used only by physicians and staff who have been trained and are thoroughly familiar with the instructions and safety precautions in these Instructions for Use and Focused Cryotherapy System Console’s User Manual.
• All Directional Cryoprobes that are to be used in a procedure must be attached to the Focused Cryotherapy System Console prior to turning on the argon regulator valve. Do not disconnect Directional Cryoprobes during operation.
• All Directional Cryoprobes should be inspected prior to use. Do not use Directional Cryoprobes that are damaged, bent, etc.
• Do not use Directional Cryoprobes that fail the Cryoprobe Test prior to use. If a Directional Cryoprobe fails the Cryoprobe Test, discard it and obtain a new one.
• Directional Cryoprobe are delicate instruments and should be handled with care.
• Frosting may occur over the Directional Cryoprobe handle and tubing during freeze cycle which is normal.
• The Directional Cryoprobe has a very sharp tip and should be handled with care during unpackaging, use and disposal.

Complications

As with all surgical procedures, the possibility of adverse reactions such as pain, fever, chills, sepsis, edema, perforation, ulceration, and hemorrhage may occur.