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The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications: General Surgery - Destruction of warts or lesions - Palliation of tumors of the oral cavity, rectum and skin - Ablation of leukoplakia of the mouth, 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions Urology - Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology - Ablation of cancerous or malignant tissue - Ablation of benign tumors - Palliative intervention Neurology - Freezing of nerve tissue in pain management/cryoanalgesia Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders Proctology - Ablation of benign or malignant growths of the anus or rectum - Ablation of hemorrhoids Thoracic Surgery - Ablation of arrhythmic cardiac tissue - Ablation of cancerous lesions

The CRYOcare V-probe is a CRYOprobe accessory to be used in conjunction with the CRYOcare CS Surgical System. The indications for use have not changed. The V-Probe delivers cold temperatures via Argon gas utilizing the Joules Thompson principle to targeted tissue. The patient contact V-Probe (an accessory item to the CRYOcare CRYOsurgical CS System) is supplied as a single use Sterile Disposable item.

The Cryocare CN2 System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications: - General Surgery Destruction of warts or lesions Palliation of tumors of the oral cavity, rectum and skin Ablation of leukoplakia of the mouth, 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions - Urology Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia - Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia - Oncology Ablation of cancerous or malignant tissue Ablation of benign tumors Palliative intervention - Neurology Freezing of nerve tissue in pain management/cryoanalgesia - Dermatology Ablation or freezing of skin cancers and other cutaneous disorders - Proctology Ablation of benign or malignant growths of the anus or rectum Ablation of hemorrhoids - Thoracic Surgery Ablation of arrhythmic cardiac tissue Ablation of cancerous lesions

The Cryocare CN2 System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected Cryoprobes) and monitors temperatures in the surrounding tissue (via connected TempProbes). Near Critical Nitrogen (NCN) is utilized as the cryogenic medium. Circulating NCN avoids the 'vapor lock' potential of liquid N2 devices since it is a transition fluid (nitrogen that is neither a liquid, nor a gas). The Cryocare CN2 System has a fold-down LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad. The Cryocare CN2 System can control up to four, single-use, disposable Cryoprobes and monitor up to four independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert liquid nitrogen. An IBM compatible microprocessor serves as the host computer which performs all essential controls and monitoring tasks. Cryoprobe control is achieved via the keypad. Associated accessories include the following: - 1.) Cryoprobes that deliver cold temperatures to targeted tissue. Each Cryoprobe incorporates a thermocouple to measure internal Cryoprobe temperatures. Warm room temperature nitrogen gas is used after the freezing process to thaw tissue. The patient contact Cryoprobe (an accessory item to the Cryocare CN2 System) is supplied as a Single use Sterile Disposable item. This probe attaches to a reusable Cryo-Hose, which in turn attaches to the Cryocare CN2 System. - TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are 2.) standard T-type thermocouples. - 3.) A warming system for use in urological applications.

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications: - General Surgery - Destruction of warts or lesions - Palliation of tumors of the oral cavity, rectum and skin - Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell turnors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions - Urology - Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia - Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia - Oncology - Ablation of cancerous or malignant tissue - Ablation of benign tumors - Palliative intervention - Neurology - Freezing of nerve tissue in pain management/cryoanalgesia - Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders - Proctology - Ablation of benign or malignant growths of the anus or rectum - Ablation of hemorrhoids - Thoracic Surgery - Ablation of arrhythmic cardiac tissue - Ablation of cancerous lesions

The Cryocare CS Surgical System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes). The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad. The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters. Associated accessories include the following: I.) CryoProbes that deliver cold temperatures to targeted tissue. The CryoProbes operate on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal end of the probes. Each CryoProbe incorporates a thermocouple to measure internal CryoProbe temperatures. Helium gas is used after the freezing process to thaw tissue. As the gas passes through the J-T port, there is a significant pressure drop, which conversely results in an increase in the gas temperature. The patient contact CryoProbe (an accessory item to the Cryocare System) is supplied as a Single use Sterile Disposable item. This probe attaches to a reusable Cryo-Hose, which in turn attaches to the Cryocare System. - 2.) TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are standard T-type thermocouples. - 3.) A warming system for use in urological applications.

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications: General Surgery - Destruction of warts or lesions . - Palliation of tumors of the oral cavity, rectum and skin . - . Ablation of leukoplakia of the mouth, 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions Urology - . Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Gynecology - . Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology - Ablation of cancerous or malignant tissue . - . Ablation of benign tumors - Palliative intervention ● Neurology - . Freezing of nerve tissue in pain management/cryoanalgesia Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders . Proctology - . Ablation of benign or malignant growths of the anus or rectum - . Ablation of hemorrhoids Thoracic Surgery - . Ablation of arrhythmic cardiac tissue - Ablation of cancerous lesions . The intended use of the 10LAP4 probe, when used as a part of the Cryocare CS Surgical System, is for diagnostic ultrasound imaging or fluid flow analysis of the human body and is a subset of the uses cleared under K043278, and is documented in Section 4.3 of this submission.

The Cryocare CS Surgical System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes). The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad. The Cryocare CS Surgical system unit integrates the functions of the existing Cryocare surgical system and the CryoGuide system into one console. The CryoGuide software is an optional brachy-like intraoperative real-time guidance and planning system, which identifies and guides CryoProbe placement for prostate procedures. The Cryocare CS Surgical System has an ultrasound system with available a trans-rectal transducer for prostate imaging or a laparoscopic transducer. The transducers operate in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. The Trans-rectal transducer is capable of transverse and sagittal views. Ultrasound images may be obtained either from an external ultrasound (via video connection) or the integrated ultrasound module. The user screen simultaneously displays the real-time ultrasound image along with the treatment screen. For prostate procedures, the treatment screen displays the prostagraph showing the anatomical CryoProbe and TempProbe placements and associated temperature readings. The 10LAP4 Probe is intended for use with Cryocare CS Surgical System's ultrasound imaging system. Technical specifications for the probes is as follows: Frequency: 7.0 MHz # Elements: 128 Array type: Linear Pitch (mm): 0.30 Elevation width (mm): 5.0 Geometric focus (mm): 25 Azimuth radius (mm): N/A Azimuth length (mm): 38.4 The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications: General Surgery - Destruction of warts or lesions . - Palliation of tumors of the oral cavity, rectum and skin . - Ablation of leukoplakia of the mouth, 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions Urology - Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia . Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia . Oncology - Ablation of cancerous or malignant tissue ● - Ablation of benign tumors ● - Palliative intervention ● Neurology - Freezing of nerve tissue in pain management/cryoanalgesia ● Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders . Proctology - Ablation of benign or malignant growths of the anus or rectum . - Ablation of hemorrhoids ● Thoracic Surgery - Ablation of arrhythmic cardiac tissue . - Ablation of cancerous lesions ●

The Cryocare CS (Combo System) Surgical System consists of a compact, easy-to- operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes). The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad. The Cryocare CS unit integrates the functions of the existing Cryocare surgical system and the CryoGuide system into one console. The CryoGuide software is an optional brachy-like intraoperative real-time guidance and planning system, which identifies and guides CryoProbe placement for prostate procedures. An added feature to the Cryocare CS Surgical System is integration of the Terason 2000 ultrasound trans-rectal probe for dedicated prostate imaging. The ultrasound module utilizes the Terason Model 2000 Handheld Ultrasound System using Model 8EC4 Endocavity Smart Probe. It is capable of transverse and sagital views, and operates in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. This use includes ultrasound guidance for placement of needles, cryosurgery, and brachytherapy. Ultrasound images may be obtained either from an external ultrasound (via video connection) or from the integrated Terason 2000 ultrasound module. The user screen simultaneously displays the real-time ultrasound image along with the treatment screen. For prostate procedures, the treatment screen displays the prostagraph showing the anatomical CryoProbe and TempProbe placements and associated temperature readings. The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM-compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.

The Cryocare Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition the system is intended: for use in the following indications: General Surgery - Destruction of warts or lesions - Palliation of tumors of the oral cavity, rectum and skin - Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell turnors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions Urology - Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology - Ablation of cancerous or malignant tissue - Ablation of benign tumors - Palliative intervention Neurology - Freezing of nerve tissue in pain management/cryoanalgesia Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders Proctology - Ablation of benign or malignant growths of the anus or rectum - Ablation of hemorrhoids Thoracic Surgery - Ablation of arrhythmic cardiac tissue - Ablation of cancerous lesions

The Cryocare Surgical System consists of a compact, easy-to-operate console and associated accessories that include CryoProbes to deliver cold temperatures to the targeted tissue and TempProbes to monitor temperatures in the surrounding tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert Argon gas. The console can control up to eight, single-use, disposable CryoProbes. The CryoProbes operate on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal tip of the probes. Each CryoProbe incorporates a thermocouple to monitor probe temperature. Helium gas is used after the freezing process. As the gas passes through the J-T port, there is a significant pressure drop which conversely results in an increase in the gas temperature. The console can also monitor up to eight independent TempProbes. The TempProbes are standard T-type needle thermocouples. An IBM-compatible microprocessor serves as the host computer. System control is accomplished through a remote control keypad. The system can be operated manually or using the AutoFreeze option, which allows users to pre-program specific treatment parameters.

The Cryocare Cardiac Surgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Cryocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis.

The modified Cryocare Cardiac Surgical system consists of a control unit that operates one single use, disposable cryoprobe. The control unit is software controlled and operates off standard 120/230 VAC wall power. System control is accomplished directly through keys on the console itself. The Cryoprobes operate on the Joule-Thompson principle and the refrigerative capacity is limited to the freeze zone of the probe. The cryoprobe incorporates a thermocouple to measure temperature at the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor some operations of the system. The temperature probe is a standard T-type needle thermocouple.

The Classic and Esteem vacuum systems are intended to artificially produce an erection in males suffering from erectile dysfunction (impotence) in order to facilitate sexual intercourse. A vacuum is applied to the penis, causing it to become erect and rigid as blood is drawn into the corpora cavernosa. A constriction ring is then placed on the base of the penis to restrict venous blood flow out of the penis. The device is intended to be used at home or in a doctor's office or clinic.

The silicone Freedom Ring™ was developed as an alternative constriction ring for the ErecAid Classic and Esteem vacuum erection devices. It is similar to the existing polyisoprene Pressure-Point™ Ring (PPR) in that it contains both a urethral notch and dorsal pressure points. It is designed to deliver the same sealing pressure to the penis, thus preventing escape of blood after an erection is achieved. The Freedom Ring makes the vacuum seal against the base of the penis rather than against the groin, thereby reducing the probability of scrotal tissue or pubic hair entrapment.