| Device |
wound retraction and protection system |
| Regulation Description |
Irrigating wound retractor device. |
| Definition |
A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound. |
| Physical State |
The device is comprised of a flexible, double-walled sheath with an impermeable inner layer. The retraction component is formed by attaching the sheath to a fixed-diameter ring at the bottom of the device. The sheath also includes an integrated fluid delivery and removal component. |
| Technical Method |
The device is sterile, single-use surgical wound retraction that integrates surgical retraction, wound barrier protection, and fluid delivery and removal. Fluid is delivered via gravitational feed from an external sterile irrigation solution bag into the device and delivered to the wound edges through the permeable outer layer of the sheath. Excess fluid is removed through a separate chamber within the sheath via a connection with the hospital’s standard vacuum suction mechanism. |
| Target Area |
Abdomen |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | PQI |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4371
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
