CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722

{0}------------------------------------------------ K980670 # 510(k) SUMMARY February 20, 1998 ### Submitted by: Cryomedical Sciences, Inc. 1300 Piccard Drive Suite L105 Rockville, Maryland 20850 (301) 417-7070 Fax (310) 417-7077 #### Contact: Richard J. Reinhart, Ph.D. President and CEO or Susan Hayes Requiatory Affairs Proprietary name: CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722 Common name: Cryosurgical units and accessories Cryosurgical units with Liquid Nitrogen, Nitrous Oxide, Carbon Classification: Dioxide. Class II, under CFR § 878.4350. Under CFR § 882.4250 a cryogenic surgical device also is classified in Class II. 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 CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722 are similar in form and function to CMS's own Cryo-lite™ System, and its AccuProbe® 600 Series, as well as Cabot Medical's Cryomedics MT700 and the Erbe Erbokryo CA. For comparisons, please see below. Page 1 of 5 {1}------------------------------------------------ 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. # COMPARISON OF FEATURES BETWEEN THE CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 AND THE CMS CRYO-LITE™ SERIES . | FEATURES | Cryo-liteTM Series<br>(Tab G) | Blizzard 700 Series<br>Models 710, 711, 712,<br>720, 721and 722 | |-------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Cryogens | Choice of liquid nitrogen,<br>carbon dioxide, nitrous oxide<br>and argon which may be<br>used sequentially | Choice of liquid nitrogen,<br>carbon dioxide, nitrous oxide<br>argon or krypton which may<br>be used sequentially | | Number of<br>Cryoprobes | One cryoprobe | Models 710, 711 and 712<br>have a one cryoprobe<br>capacity while models 720,<br>721 and 722 have a two<br>cryoprobe capacity | | Cryogen Containers | Cryogen packet and/or<br>transfer line to larger cryogen<br>source | Cryogen packet and/or<br>transfer line to external<br>cryogen source | | Size | Portable and Hand-held | Portable,- Table-top or<br>wheeled stand | | Cryoprobes Types | Various, interchangeable | Various, interchangeable | Page 2 of 5 {2}------------------------------------------------ # COMPARISON OF FEATURES BETWEEN THE CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND722 AND THE CMS ACCUPROBE® 600 SERIES | FEATURES | AccuProbe® Series<br>(Tab. H) | Blizzard 700 Series<br>Models 710, 711, 712,<br>720, 721and 722 | |-------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Cryogens | Liquid nitrogen | Choice of liquid nitrogen, carbon dioxide, nitrous oxide argon or krypton which may be used sequentially | | Number of<br>Cryoprobes | Depending on the model, from one to eight cryoprobe ports | Models 710, 711 and 712 have a one cryoprobe capacity while models 720, 721 and 722 have a two cryoprobe capacity | | Cryogen Containers | Internal cryogen container | Cryogen packet and/or transfer line to external cryogen source | | Size | Portable | Portable, - Table-top or wheeled stand | | Cryoprobes Types | Various, interchangeable | Various, interchangeable | . Page 3 of 5 {3}------------------------------------------------ # COMPARISON OF FEATURES BETWEEN THE CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720 ,721 AND 722 AND THE CABOT MEDICAL CYROMEDICS MT700 | FEATURES | Cryomedics MT700<br>(Tab I) | Blizzard 700 Series<br>Models 710, 711, 712,<br>720, 721 and 722 | |-------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Cryogens | Choice of nitrous oxide and<br>carbon dioxide | Choice of liquid nitrogen,<br>carbon dioxide, nitrous<br>oxide, argon, or krypton | | Number of<br>Cryoprobes | One probe | Models 710, 711 and 712<br>have a one cryoprobe<br>capacity while models 720,<br>721 and 722 have a two<br>cryoprobe capacity | | Cryogen Containers | Commercial Cryogen<br>Container with Transfer Line<br>to Probe | Cryogen packet and/or<br>Transfer Line to external<br>cryogen source | | Size | Portable - Stand with wheels<br>and hand-held probe | Portable,- Table-top or<br>wheeled stand with hand-<br>held cryoprobe | | Cryoprobes Types | Various, interchangeable | Various, interchangeable | : Page 4 of 5 {4}------------------------------------------------ # COMPARISON OF FEATURES BETWEEN THE CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720 , 721 AND 722 AND THE ERBE ERBOKRYO CA . | FEATURES | Erbokryo CA<br>(Tab J) | Blizzard 700 Series<br>Models 710, 711, 712,<br>720, 721 and 722 | |-------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Cryogens | Choice of nitrous oxide and<br>carbon dioxide | Choice of liquid nitrogen,<br>carbon dioxide, nitrous<br>oxide, argon, or krypton | | Number of<br>Cryoprobes | One probe | Models 710, 711 and 712<br>have a one cryoprobe<br>capacity while models 720,<br>721 and 722 have a two<br>cryoprobe capacity | | Cryogen Containers | Commercial cryogen<br>container with transfer line to<br>probe | Cryogen packet and/or<br>transfer line to larger cryogen<br>source | | Size | Portable - Stand with wheels<br>and hand-held Probe | Portable - Table-top or<br>wheeled stand with and-<br>held cryoprobe | | Cryoprobes Types | Various, Interchangeable | Various, Interchangeable | | Control | Foot switch | Console unit switch or foot<br>pedal | . ・ {5}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest the shape of a bird in flight. The text is in all caps and is evenly spaced around the circle. FEB 2 1 2008 Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850 Cryomedical Sciences Inc. c/o Mr. Richard J. Reinhart, Ph.D. President and CEO 1300 Piccard Drive, Suite L105 Rockville, MD 20850 Re: K980670 Trade Name: CMS Blizzard 700 Series Models 710, 711, 712, 720, 721, 722 Regulatory Class: II (two) Product Code: OCL, GEH Dated: June 2, 1998 Received: June 2, 1998 Dear Dr. Reinhart This letter corrects our substantially equivalent letter of July 17 1998. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {6}------------------------------------------------ Page 2 - Mr. Richard J. Reinhart, Ph.D. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, ell. Mall. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 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; ● **Prescription Use** **(Per 21 CFR 801.109)** pc Division Sian-Off) of General Restorative Device 510(k) Number {8}------------------------------------------------ # Indications for Use (continued) ### 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; **Prescription Use** (Per 21 CFR 801.109) cale (Division Sign-Off) Division of General Restorative Devices 510(k) Number ***_***__ 196067