(88 days)
The Histofreezer® device is indicated for use in the treatment of the following: Genital Warts Molluscum Contagiosum Seborrhoeic Keratosis Skin Tags Verruca Plantaris Verruca Vulgaris Verruca Plana
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Histofreezer Device." It primarily discusses the substantial equivalence of this device to a legally marketed predicate device and grants permission to market it.
Crucially, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results (like MRMC or standalone performance). It lists the "Indications For Use" for the device, but this is not equivalent to performance data or acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about the study that proves the device meets those criteria, as this information 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.