CRYOCARE CN2 SYSTEM

{0}------------------------------------------------ # AUG 2 8 2006 Cryocare CN2 System K062175 # 510(k) SPECIAL PREMARKET NOTIFICATION SUMMARY | • Device Trade or Proprietary Name: | Cryocare CN2 System | |-------------------------------------|-----------------------------------| | • Common / Classification Name: | Cryosurgical unit and accessories | | • Class: | Class II | | • Regulation Number: | 878.4350 | | • Product Code: | GEH | #### · Labeling: Federal (United States) Law restricts this device to sale by or on the order of a physician or licensed healthcare professional. #### · Predicate Device for Substantial Equivalence Comparison: The Cryocare CN2 System Cryoprobe accessory is claimed to be substantially equivalent to the following Predicate Devices: | Manufacturer | Device Name | 510-K Number | Decision Date | |----------------------------|----------------|--------------|----------------| | Cryomedical Sciences, Inc. | CMS Accuprobe® | K0982055 | Sept. 08, 1998 | | Cryomedical Sciences, Inc. | CMS Accuprobe® | K0973190 | Nov. 21, 1997 | | Cryomedical Sciences, Inc. | CMS Accuprobe® | K0964336 | Mar. 20, 1997 | #### · Device Description: 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 {1}------------------------------------------------ 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. ## · Indications for Use Statement: The Cryocare CN2 System has the same intended use as previously cleared for the predicate devices. 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 deep greed to freeze/ablate tissue by the application of extreme cold temperatures including protate 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 - 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 {2}------------------------------------------------ - . Ablation of cancerous lesions #### Contraindications for Use . - There are no specific contraindications for the use of this device. � - · Rationale for Substantial Equivalence - The Cryocare CN2 System patient interface accessory Cryoprobe and Cryo-Hose 】. design is very similar to the predicate device [CMS Accuprobe accessory item already approved by the FDA1. - The INTENDED USES and the OPERATING PRINCIPLES (i.e. Effectiveness) of 2. the Cryocare CN2 System, Cryoprobe and Cryo-Hose accessory items are the SAME as the predicate device. - The OPERATIONAL FEATURES of the Cryocare CN2 System, Cryoprobe and 3. Cryo-Hose accessory items are the SAME to those offered by the predicated avice - The SAFETY FEATURES of the Cryocare CN2 System, Cryoprobe and Cryo-4. Hose accessory items are the SAME to those offered by the predicate device, Therefore, in summary, the Cryocare CN2 System, Cryoprobe and Cryo-Hose accessory items are substantially equivalent to the identified predicate device accessory items that have previously been allowed for commercial distribution in the United States. ## · Safety and Effectiveness The Cryocare CN2 System complies with the ASTM "Standard Performance and Safety Specification for Cryosurgical Medical Instruments" [Designation: F 882-84 and Davy 2002)] which reasonably assures the device is safe when used as directed for its prescribed intended use. The Cryocare CN2 System does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device. ## · Conclusions The data submitted in this 510(k) Premarket Notification, for the Cryocare CN2 System demonstrates that this device and Cryoprobe and Cryo-Hose accessory item is substantially equivalent with respect to the indications for use, operating principles, operational features, and safety features to the identified legally marketed predicate device. With the information provided, the safety and effectiveness of the product can be reasonably assured, and we believe that this device clearly meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper portion of the circle. FEB 2 1 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Endocare. Inc. c/o Mr. Alden Kay Senior Director Regulatory & Quality 201 Technology Drive Irvine, CA 92618-2400 Re: K062175 Trade/Device Name: Cryocare CN2 System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: July 31, 2006 Received: July 31, 2006 Dear Mr. Kay: This letter corrects our substantially equivalent letter of August 28, 2006. 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. {4}------------------------------------------------ Page 2 - Mr. Alden Kay 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, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number: K062175 Device Name: Cryocare CN2 System ## Indications for Use (Page 1 of 2): 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 Prescription Use X X (Per 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) P.M (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K062775 {6}------------------------------------------------ ## Indications for Use ## 510(k) Number: u « ## K062175 CryoCare CN2 System Device Name: ## Indications for Use (Page 2 of 2) - . 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 ## Prescription Use _____ (Per 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Deb (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(a) Number K062175