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XSense Cryoablation System with CryoProbes is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. XSense Cryoablation System with CryoProbes is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including fibroadenomas, prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. XSense Cryoablation System with CryoProbes may be used with an imaging device such as an ultrasound to provide realtime visualization of the cryosurgical procedure. The system has the following specific indications: - · Urology Ablate prostate tissue in cases of prostate cancer and benign prostatic 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. Palliation of the skin. Destruction of warts or lesions. - · Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia. - · ENT (Ear, Nose, and Throat) - Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth. - · General Surgery - Ablation of breast fibroadenomas, leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of the oral cavity, rectum, and skin. - · Thoracic Surgery - Ablation of arrhythmic cardiac tissue and cancerous lesions. - · Proctology - Ablation of benign or malignant growths of the anus and rectum and hemorrhoids.

The XSense Cryoablation System with CryoProbes is operated in conjunction with an imaging system, such as ultrasound, to provide real-time visualization of the cryosurgical procedure, used in a professional healthcare environment for cryotherapy according to IceCure Medical's technology. The device technology is based on the delivery of the lowtemperature cryogen under pressure from the internal dewar to the CryoProbe's tip, enabling it to reach very low temperature, due to the thermal energy transfer principle that occurs as a result of phase transfer from liquid to gas of nitrogen at the tip of the CryoProbe, and thus freeze and destroy the treated tissue that the CryoProbe comes in contact with. The XSense Cryoablation System with CryoProbes is the next generation of its predicatethe already cleared ProSense™ Cryoablation System (K183213) and is part of the IceCure family of cryoablation products. The XSense Cryoablation System with CryoProbes operates in the same manner as the previous design of the ProSense™ Cryoablation System. The XSense Cryoablation System will include the following additional accessories: (1) CryoProbes that are available in two configurations, (2) an external 25 liters dewar with a supporting cart, (3) an Introducer, and (4) a Holder. The system is comprised of three main subsystems: XSense (console), CryoProbes, External dewar. Optional accessories: Introducer, Holder.

The IceCure Family (IceSense™3, ProSense™, and MultiSense™) cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, 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, tumors, skin lesions, and warts. The system has the following specific indications: Urology (ablate prostate tissue in cases of prostate cancer and benign prostatic 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. Palliation of tumors of the skin. Destruction of warts or lesions). Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia). ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth). General Surgery (ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and sebortheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of the oral cavity, rectum, and skin. Ablation of breast fibroadenomas). Thoracic Surgery (ablation of arrhythmic cardiac tissue and cancerous lesions). Proctology (ablation of benign or malignant growths of the anus and rectum and hemorrhoids). The system may be used with imaging device like ultrasound to provide real-time visualization of the cryosurgical procedure. MultiSense™ System is indicated for three probe configuration only.

The IceCure Family of cryotherapy devices includes the IceSense™3 single-probe system (cleared under 510(k) #K102360 and rebranded as ProSense™), and MultiSense™ – a new system that accommodates up to three cryoprobes operating in parallel. The systems are used to destroy unwanted tissue by application of extreme cold to the selected sites. The devices deliver cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable cryoprobe. Various cryoprobes are available. The devices consist of a main chassis for the cooling system, a controller, a touch screen, a foot pedal and a cryohandle that controls the system and holds the probe. Safety measures of the system include alarms, safety valve, emergency button and automatic abortion of the procedure in case of technical malfunction.

The IceSense3 is intended for cryogenic destruction of tissue during surgical procedures. The IceSense3 is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology. The IceSense3 may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.

The IceSense3 device is used to destroy unwanted tissue by application of extreme cold to the selected sites. The device delivers cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable cryoprobe. Various cryoprobes are available. The device consists of a main chassis for the cooling system, a controller, a touch screen, a foot pedal and a cryohandle that controls the system and holds the probe. Safety measures of the system include alarms, safety valve, emergency button and automatic abortion of the procedure in case of technical malfunction.