(11 days)
The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
The ClariFix Device is a handheld, single patient-use, disposable cryosurgical device used for the destruction of tissue during surgical procedures, including with chronic rhinitis. The device consists of a Handle attached to a Cannula with a Cryoprobe at the distal end. The ClariFix Device is provided sterile to the user. The device is provided with a 10mL nitrous oxide Canister.
To perform cryosurgery, the ClariFix Device is removed from the sterile packaging and a nitrous oxide Canister is inserted into the Handle. A Canister Cap is then tightened onto the Handle, which pierces the Canister. The cryogen is held in the Handle until the user opens a mechanical valve that allows cryogen to flow down the Cannula into the Cryoprobe.
The Cryoprobe is placed into contact with the target tissue via direct visualization. The Cannula can be rotated to ensure proper positioning. Once the Cryoprobe is in the desired position, cryosurgery can start.
The Cryoprobe is held in contact with the target location during cryosurgery. As cryogen flows into the Cryoprobe, the liquid partially evaporates and the inside of the Cryoprobe cools to
This FDA 510(k) summary document for the ClariFix Device (K190356) does not describe an AI/ML medical device. It pertains to a cryosurgical unit and accessories. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for training and testing, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI performance cannot be extracted from this document, as these concepts are not applicable to the device described.
The document focuses on demonstrating substantial equivalence to a predicate device (Arrinex, Inc., ClariFix Device K162608) by showing similar intended use, indications for use, and technological characteristics. The performance data mentioned are related to device functionality and safety (e.g., temperature reproducibility, leakage, mechanical integrity, shelf-life, sterilization) rather than the performance of an AI algorithm in diagnosis or prediction.
§ 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.