21 CFR 878.1840 — Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

General, Plastic Surgery (SU) · De Novo Classifications · § 878.1840

Identification

The DeepView AI® System is a prescription device that uses artificial intelligence to analyze images of thermal burn wounds. It detects deep burn tissue (deep partial thickness and full thickness), provides segmentation of areas unlikely to heal within 21 days with conservative treatment alone, and calculates wound area measurement and percent total body surface area (TBSA) burn. It is intended as an aid to physicians in the management of thermal burn wounds in conjunction with clinical assessment and is not a stand-alone diagnostic device.

Classification Rationale

Class II (special controls). FDA determined that the device can be classified in class II with the establishment of special controls to provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes