| Device |
semi-automated autologous skin graft harvesting and application device |
| Definition |
A semi- automated autologous skin graft harvesting and application device is a handheld electromechanical surgical instrument that extracts autologous skin graft tissue from a healthy donor skin site and deposits it to a recipient site. The device extraction and deposition functions are automated and are activated by the user. The device is not intended for treatment of third degree burns. |
| Physical State |
The device consists of (1) a handheld electronically controlled unit with built in software and user interface and (2) a tissue collection/deposition accessory that engages with the handheld unit and is used to acquire, transfer, and deposit skin tissue. The device may also consist of accessory components, e.g., a protective sleeve. |
| Technical Method |
The essential components of the device are (1) a handheld unit that allows the user to control the device’s function via software and a user interface on the device, (2) a tissue collection/deposition accessory, e.g., a needle cartridge containing an array of coring needles and plungers that is used to collect, transfer, and deposit the hull thickness skin grafts from the donor site to the recipient site, respectively. The device may also include optional accessories, e.g., a protective sleeve that is used to lessen the potential for soilage of the handheld unit during use. The user places the collection/deposition accessory onto the donor site and, upon activating the collection f |
| Target Area |
Skin |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QYK |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4795
|
|---|
| 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 |
