(60 days)
The CryoDose H indications for use as follows: CryoDose H is indicated for use in the treatment of actinic keratosis, genital warts, lentigo, mulluscum contagiosum, sebortheic keratosis, skin tags, verruca vulgaris, and verruca plana.
The proposed device, CryoDose H, is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. The device consists of an aerosol-filled canister and parts within the canister. The canister is sold within a kit with accessories including: Directions for Use, swabs, and packaging materials. The aerosol is sprayed onto a foam covered cotton swab that is then placed upon the benign lesion (e.g. wart) for 15-40 seconds.
The provided document describes the acceptance criteria and study for the Nuance Medical, LLC CryoDose H device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured by) | Reported Device Performance and Methodology |
|---|---|
| Biocompatibility: Absence of cytotoxicity, sensitization, and irritation from patient contact materials (foam-tipped swab applicators). (ISO 10993 Part 1) | Biocompatibility testing performed on foam-tipped swab applicators, categorized as external, short-term contact ( |
§ 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.