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The CMS AccuProbe® 800 Series (all models depicted as A) has the same indications for use as its predicate device, the AccuProbe® 600 Series [510(k) number K973190 cleared November 21, 1997]. Urology - The (A) system may be used to ablate prostatic tissue. - . The (A) system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia. Oncology - . system may be used for ablation of cancerous or The (A) malignant tissue. - system may be used for ablation of benign tumors. . The (A) - The . (A) system may be used for palliative intervention. Dermatology - system may be used for the ablation or freezing of The (A) . skin cancers and other cutaneous disorders. Gynecology - system may be used for the ablation of malignant . The (A) neoplasia or benign dysplasia of the female genitalia. General Surgery - (A) system may be used for the ablation of The . leukoplakia of mouth, anaiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses , cavernous hemanaiomas recurrent cancerous lesions. - . The (A) system may be used for the destruction of warts or lesions. - . The (A) system may be used for the palliation of tumors of the oral cavity, rectum, and skin. Thoracic Surgery - The . (A) system may be used for the ablation of arrhythmic cardiac tissue. - . The system may be used for the ablation of cancerous (A) lesions. Proctology - The (A) system may be used for the ablation of benign or malignant growths of the anus and rectum - . systems may be used for the ablation of The (A) hemorrhoids.

The CMS AccuProbe® 800 Series consists of eight models, each of which has two components: i) a console with a pumping mechanism to compress and pressurize the cryogen and ii) one to eight (models 810 through 880) cryoprobes with tips extending from the console. The may include an optional on-board computer which is as redundant display system and archival system to store information about the procedure. The computer does not control or affect the operation of the cryoprobes in any fashion. The cryoprobes consist of interchangeable tips of various materials, sizes and shapes which are used a necessary. The AccuProbe® 800 Series is used to destroy unwanted tissue by the application of extreme cold to the selected site. Liquid nitrogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the used of utlrasound or other imaging device, then becomes cold and freezes the unwanted tissue. The procedure may be monitored in real-time through the use of imaging modes such as ultrasound, Once the freezing is completed (approximately 20 minutes), the cryoprobe will be heated using warming gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue.

Depending on the cryogen used, the following are indications for use: Liquid Nitrogen: For use as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT. - May be used to ablate prostatic tissue. - May be used for the ablation of prostatic tissue in cases of prostate cancer and benign prostatic hyperplasia. - May be used for ablation of cancerous or malignant tissue. - May be used for ablation of benign tumors. - May be used for palliative intervention. - May be used for ablation or freezing of skin cancers and other cutaneous disorders. - May be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia. - May be used for ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts. actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. - May be used for the destruction of warts or lesions. - May be used for the palliation of tumors of the oral cavity, rectum, and skin. - May be used for ablation of arrhythmic cardiac tissue. - May be used for the ablation of benign or malignant growths of the anus and rectum. - May be used for the ablation of hemorrhoids. Nitrous Oxide: For use as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and veterinary medicine. Carbon Dioxide: For used as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery. Argon and Krypton: For use as a cryosurgical tool in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastass, skin lesions, warts and prostate tissue.

The CMS Blizzard 700 Series Models 730, 740, 750, 760, 770, 780 & 790 are made up of two components: 1) a console which holds up to two cryogen packets of varving sizes and 2) depending on the model, can employ from three to nine individually controlled cryoprobes. The consoles includes a power switch, individually controlled cryogen flow switches, thermocouple temperature displays and, depending on the model between three and nine cryoprobe ports. The devices are used to destroy unwanted tissue by the application of cold to the selected site. The cryogen is forced through the cryoprobe under pressure. The cryoprobe, having been placed in the appropriate position, then becomes cold and freezes the tissue.

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721and 722, depending on the cryogen selected, are intended to be used: Liquid Nitrogen: - as a cryosuraical tool for destruction of unwanted tissue in the fields . of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT; - to ablate prostatic tissue; . - for the ablation of prostatic tissue in cases of prostate cancer and . benian prostatic hyperplasia; - for ablation of cancerous or malignant tissue; . - for ablation of benign tumors; . - for palliative intervention; . - for ablation or freezing of skin cancers and other cutaneous . disorders; - for the ablation of malignant neoplasia or benign dysplasia of the . female genitalia; - for ablation of leukoplakia of mouth, angiomas, sebaceous . hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanaiomas, recurrent cancerous lesions; - for the destruction of warts or lesions: ● - for the palliation of tumors of the oral cavity, rectum, and skin;. . - for ablation of arrhythmic cardiac tissue; ● - . for the ablation of benign or malignant growths of the anus and rectum; - for the ablation of hemorrhoids; ● Nitrous Oxide: - as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, general surgery, and urology; Carbon Dioxide: - as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, and general surgery; Argon and Krypton: - as a cryosurgical tool in general surgery, dermatology, neurology, . thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastases, skin lesions, warts and prostate tissue;

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722 are simple, portable cryosurgical devices. All models feature physician-selected cryogen choices as well as a selection of cryoprobes of various sizes and shapes. Models 710, 711 and 712 are single cryoport devices while models 720, 721 and 722 have a two cryoport capacity. Although all models operate in the exact same way, their casings differ to allow desired positioning. The 710 and 720 are wheeled pole type configuration; the 711 and the 721 are tabletop configuration; while the 712 and the 722 are suitcase or attaché type configuration. The devices are used to destroy unwanted tissue by the application of cold to the selected site. The cryogen is forced through the cryoprobe under pressure. The cryoprobe having been placed in the appropriate position, then becomes cold and freezes the tissue.

Each proposed intended use description will have the letter (A ) which represents any of the family of AccuProbe® devices, the AccuProbe® 450, AccuProbe® 550/530 and the AccuProbe® 600 Series inclusive. Urology - system may be used to ablate prostatic tissue. The (A) . - (A) system may be used for the ablation of prostate . The tissue in cases of prostate cancer and benign prostatic hyperplasia. 1 Oncology - system may be used for ablation of cancerous or ● The (A) malignant tissue. - system may be used for ablation of benign tumors. . The (A) - The (A) system may be used for palliative intervention. Dermatology - . The (A) system may be used for the ablation or freezing of skin cancers and other cutaneous disorders. Gynecology - The ● (A) system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia. General Surgery - system may be used for the ablation of ● The (A) leukoplakia of mouth, angiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorthoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and sebortheic keratoses , cavernous hemangiomas, recurrent cancerous lesions. - system may be used for the destruction of warts The (A) . or lesions. - system may be used for the palliation of tumors ● (A) The of the oral cavity, rectum, breast, and skin. Thoracic Surgery - system may be used for the ablation of . The (A) arthythmic cardiac tissue. - system may be used for the ablation of . The (A) cancerous lesions. Proctology - system may be used for the ablation of benign or . The (A) malignant growths of the anus and rectum - systems may be used for the ablation of . (A) The hemorrhoids.

Cryosurgical Units, Cryogenic Surgical Device. Console with multiple ports and spray/closed probes.

The CMS Cryo-lite® System has the same indications for use as its predicate devices, the Frigitronics Model 5900, Frigitronics Cryocare I and the Cryomedics Model MT700 . The Cryo-lite® System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, gynecology general surgery, etc. and veterinary medicine.

The CMS Cryo-lite® System is a completely disposable hand-held cryosurgical device. Both Crvo-lite® System Models 2001 and 2002 consist of hand-helo body, a physician-selected cryogen packet and single cryoprope of varying materials, sizes and shapes. Cryogens available with this system are liquid nitrogen, nitrous oxide, carbon dioxide and argon. The Crvo-lite® System is used to destroy unwanted tissue by application of extreme cold to the selected site. The cryogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound, another imaging device or visual observation then becomes cold and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.

The device is used to destroy unwanted tissue by application of extreme cold to the selected site.

The CMS AccuProbe® 600 series consists of two components including: i) a console which holds three dewars of liguid nitrogen (LN-) (one dewar is filled at a time; one dewar is a receptacle for the circulating LN, and the third dewar contains the supercooling chamber); and ii) one to eight (models 610 through 680) cryoprobes with tips extending from the console. The console includes an optional on-board computer which is used as a redundant display system and an archival system to store information from the procedure. The computer does not control or affect the operation of the cryoprobes in any fashion. The cryoprobes consist of interchangeable tips of various materials, sizes and shapes to be utilized as necessary.