(148 days)
The CryoPro® Mini and CryoPro Maxi units are intended to be used within the fields of dermatology and plastic surgery for the treatment of cryoresponsive benign, premalignant and malignant tumors such as skin tags, verrucae, actinic keratoses and basal cell carcinoma.
The CryoPro® Mini consists of a 0.35 L stainless steel vacuum insulated, stainless steel flask equipped with a stainless steel top which holds a pressure relief valve and a dispensing valve for dispensing liquid nitrogen. The dispensing valve body is made of stainless steel with a brass valve stem and sealed with a Teflon gasket.
The dispensing valve may be mounted with spray nozzles or closed contact probes of varying sizes depending on the size and nature of the area to be treated.
The CryoPro® Maxi provides a 0.5 L stainless steel vacuum insulated flask and is otherwise identical to the CryoPro® Mini unit.
The provided text describes a 510(k) submission for the CryoPro® Mini and CryoPro® Maxi cryosurgical units. It details the device, its intended use, and its technological characteristics compared to a predicate device. However, this document does not contain information regarding detailed acceptance criteria, specific performance studies, sample sizes, expert qualifications, or ground truth establishment.
The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (CryoGun® liquid nitrogen cryosurgical system). The FDA's letter confirms this substantial equivalence based on the provided information, allowing the device to be marketed.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and study details. The information required for those points is not present in the provided text.
§ 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.