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Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are 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, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families have 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 hemanglomas, mucocele cysts, multiple warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal 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, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - · 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)

Galil Medical's IcePearl 2.1 CX, IceFORCE 2.1 CX, IcePearl 2.1 CX L, and IceFORCE 2.1 CX L Cryoablation Needles (collectively referred to as the 2.1 CX Cryoablation Needles) are sterile, single use, disposable components, when used in conjunction with Galil Medical's commercially available cryoablation systems, to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The 2.1 CX Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. Both the IcePearl and IceFORCE needle families offer handles configured as straight and in a 90-degree angled configuration (to aid positioning of the needle within the CT imaging system gantry). Additionally, both needle families offer a long version of the needle that contains a longer needle shaft and a 90-degree angled handle configuration (IcePearl 2.1 CX L and IceFORCE 2.1 CX L). The change presented in this Special 510(k) is an internal component change. There are no changes to the intended use, indications for use, or technological characteristics.

The HEATfx Microwave Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings. The HEATfx Microwave Ablation System is not intended for use in cardiac procedures.

The HEATfx Microwave Ablation System is a mobile system intended to deliver microwave energy for thermal tissue ablation using a minimally invasive procedure. The HEATfx Microwave Ablation System is comprised of a console with optional cart, microwave ablation needles with cooling water manifold, optional thermal sensor, and related accessories. The HEATfx console is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The HEATfx System utilizes three 2450 MHz, 145W generators to deliver microwave energy to up to three HEATfx Needles. The HEATfx Microwave Ablation Needles are inserted into the target lesion under ultrasound or CT image guidance during laparoscopic procedures, or using direct visualization during surgical procedures, and operated using the console. The needles incorporate an antenna that transmits the microwave energy uniformly around the needle shaft. When connected to the HEATfx console, the console's internal pump and a disposable water manifold circulate sterile water through the needle for needle cooling and facilitating a uniform ablation zone. The optional Multi-Point Thermal Sensor allows the user to monitor tissue temperatures near critical structures during an ablation procedure. The system must be used with an irrigation baq of sterile water (not provided with the system).

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, 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 - . 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

The ICEfx™ Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The ICEfx System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by the use of Galil Medical CX technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

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, 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

The Visual-ICE™ MRI Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE MRI Cryoablation System has been designed to permit the delivery of cryoablation treatments under visual guidance in an MR environment. The Visual-ICE MRI System is comprised of a Console, Mobile Connection Panel (MCP) and a Junction Box Assembly. The system is computercontrolled with a touch screen user interface that allows the user to control and monitor the procedure. The console is located in the control room, while the Mobile Connection Panel is located in the magnet room. Junction boxes mounted in the two rooms, and connection of the gas and signal lines between the junction boxes occurs via a penetration panel. The Mobile Connection Panel is constructed of non-ferromagnetic materials to allow for placement within the magnet room close to the scanner. The Visual-ICE MRI Cryoablation System was designed for compatibility with Galil Medical's previously cleared IceRod MRI and IceSeed MRI cryoablation needles (K051052).

The Visual-ICE Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures. The Visual-ICE 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, 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 the rectum, hemorrhoids, 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: Ablation of arrhythmic cardiac tissue cancerous lesions - · Proctology: Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

The Visual-ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw® technology in which a heating element inside the cryoablation needle can be energized to cause thawing. This Special 510(k) is being submitted to modify the software with a variety of changes to enhance usability of the system. The functions of the system that users use to deliver the cryoablation treatment remain unchanged.

The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE System 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 Visual-ICE 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 hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) - . General surgery (palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) - Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions) . - . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemomhoids)

The Visual-ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating. helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing. This Special 510(k) is being submitted to modify the software with a variety of changes to enhance usability of the system. These changes are primary being made to the user interface and the service and maintenance screens. Basic functionality of the system remains unchanged, however, the following functional modifications have been made: - . Organ map display has been modified to allow users to place MTS needles on the Organ Мар, - When all channels are locked and linked together the Test All button icon state identifies the . state for all channels. - The software defaults all needles to the first 1-wire needle that was attached. . - User interface can display up to three large timers instead of two. . - Freeze-thaw cycles can now be programmed for all channels using the All button, . - The software wams the user of low gas when the remaining gas time reaches 10 minutes . instead of 5 minutes, - "Stick" intensity has been changed from 20% to 5%, . - Helium low-pressure warning was reduced to 1800 PSI from 2100 PSI. .

The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE System 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, lesions, and warts. The Visual-ICE 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, hemorrhoids, 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 Ablation of arrhythmic cardiac tissue cancerous lesions • Proctology Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

The Visual-ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or alternatively, by the use of Galil Medical i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems are 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 systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. Galil Medical Cryoablation Systems have 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 hemanglomas, mucccele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) - . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) - t General surgery (palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) - . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) - . Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions) - t Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

The IceEDGE 2.4 Cryoablation Needle is a sterile, single use, disposable component used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. It is intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The disposable cryoablation needle has a sharp cutting tip, a 2.4 mm shaft, a color-coded handle, gas tubing, and a connector. Additionally, the needle shaft exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceEDGE needle differs from the predicate devices in that it contains modified heat exchanger and a larger shaft diameter to enable the needle to produce a larger iceball size.