FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Verruca-Freeze® H cryosurgical system is used for treatment of benign skin lesions. The device consists of:
• Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
• Polyurethane foam swabs
• Detailed instructions including illustrated descriptions

The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion.

The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thaw time is 20-40 seconds.

This treatment methodology is simple and has been an accepted by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.

AI/ML Overview

The provided document is a 510(k) premarket notification letter and summary for a medical device called "Verruca-Freeze H," a cryosurgical unit. It establishes substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, or accuracy), or details of a study that proves the device meets specific performance criteria beyond stability testing for the product's shelf life.

The 510(k) process for this device, a cryosurgical unit, primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through technological characteristics, materials, and intended use. It is not an AI/ML medical device submission, which typically requires rigorous performance studies to demonstrate the algorithm's effectiveness in diagnosis or treatment.

Therefore, I cannot fulfill your request for information on acceptance criteria and study details related to AI/ML device performance from the provided text. The document explicitly states:

"The subject device has the same technological characteristics as the same design, energy source, materials, and other features." (Page 5)
"A stability protocol was developed to ensure that the product is maintained throughout its labeled dating period. Testing conducted under controlled conditions at room temperature and under accelerated conditions." (Page 5)

These statements indicate that the "study" conducted was related to stability and comparison to a predicate device, not an evaluation of an AI algorithm's diagnostic or therapeutic performance using patient data, ground truth, and expert adjudications.

Summary

Regulation Number and Section

§ 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.