(84 days)
The ENDOcare CRYOcare™ Cryotherapy System is designed for use 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 removal of prostate tissue.
The current ENDOcare CRYOcare™ Cryosurgical System is a cryosurgical system that consists of a control unit and eight cryoprobes. The Cryosurgical System also incorporates independent thermocouple inputs to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power. The control units for the 2 and 5-probe models will have the same performance characteristics as the 8-probe model. The only difference will be in the outer case which will be smaller and more cost effective to meet the needs of different customers.
At the heart of the ENDOcare CRYOcare™ Cryosurgical System is the Cryoprobe. The Cryoprobes limit the extreme cold zone to a small active area at the tip, which results in an overall more efficient surgical tool. The probes are supplied sterile and individually packaged. The probes used for the 2-probe and 5-probe output configurations are exactly the same as those for the 8-probe output configuration. The ENDOcare Cryoprobe is a single use cryostat. Cryostats have been used as refrigerant devices for the past one hundred years. The Cryoprobe has no moving parts and is made of standard surgical stainless steel. The ENDOcare Cryoprobe is small enough in diameter to used medically, yet generates enough cooling capacity to effectively ablate tissue
This document describes a cryosurgical system, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics like ground truth, training sets, MRMC studies, and stand-alone performance are not applicable. The provided text focuses on the device description, substantial equivalence to a previously cleared device, and sterilization methodology for its cryoprobes.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.