| Device |
software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment. |
| Definition |
A software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound. The device is intended for prescription use by healthcare providers to provide adjunctive information to be used in conjunction with clinical assessment. It is not for use as a standalone diagnostic device. |
| Physical State |
Portable cart containing a hand-held imaging head (camera), an image processing unit, and a touch-screen display. The hand-held imaging head includes 4 multispectral imaging cameras, a color camera, a distance sensor, a projector, and an LED illumination source. Captured multispectral data is processed using an artificial intelligence (AI) deep learning algorithm that identifies areas of non-healing (deep 2nd and 3rd degree) burn tissue. |
| Technical Method |
Uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns a classification of the skin wound that may include information about severity and healing potential. |
| Target Area |
Skin |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | SHY |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.1840
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
