| Device |
negative pressure wound therapy device for reduction of wound complications |
| Regulation Description |
Negative pressure wound therapy device for reduction of wound complications. |
| Definition |
A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds. |
| Physical State |
The device is a portable suction pump that may or may not include a canister for fluid collection. |
| Technical Method |
The device, when used with legally marketed compatible dressings, applies negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. |
| Target Area |
The device, when used with legally marketed compatible dressings, is intended to be applied to closed surgical incisions after surgery. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QFC |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4783
|
|---|
| 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 |
