(146 days)
The Histofreezer V indications for use as follows: l, 1,1,2-tetrafluoroethane, pentafluoroethane, and l, 1,1-tri fluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
The Histofreezer V device utilizes extreme cold to facilitate the removal of benign topical lesions. The device utilizes a combination of 1.1.1.2-Tetrafluoroethane. Pentafluoroethane, and 1,1,1-Trifluoroethane delivered from the cannister of gas into a foam bud or cone which acts as a reservoir for the cryogen gas. To perform the treatment the bud or cone facilitates freezing the targeted lesion for up to 40 seconds .. The frozen lesion falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
The provided text is a 510(k) Premarket Notification from the U.S. FDA for the Histofreezer V device. This document does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study that proves a device meets such criteria. Instead, it focuses on demonstrating substantial equivalence of the Histofreezer V, a cryosurgical unit, to a predicate device (CryoDose/McKesson) based on its technological characteristics and performance (specifically temperature attainment).
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance for an AI/ML device, as this information is not present in the provided text.
The text does include:
- A comparison of the Histofreezer V with its predicate device, CryoDose/McKesson (K130995), highlighting similarities in intended use, cryogen, cryogen gas boiling point, cone materials, mode of use, mechanism of action, safety, operation, and defined operators.
- A brief mention of "bench testing" that focused on "demonstrating the equivalency of temperatures over their treatment times while using cone or applicators from the CryoDose/McKesson device and Histofreezer V."
- A statement that the product was tested for biocompatibility according to FDA's guidance and ISO 10993 requirements.
§ 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.