Identification. An irrigating wound retractor device is 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.

Classification. Class II (special controls). The special controls for this device are:

The patient-contacting components of the device must be demonstrated to be biocompatible and evaluated for particulate matter.

Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.

Performance data must support shelf life by demonstrating continued functionality and sterility of the device over the identified shelf life.

Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:

Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;

Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;

Characterize the forces required to deploy the device;

Characterize the device's ranges of operation, including flow rates and maximum suction pressures;

Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and

Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.

The labeling must include or state the following information:

Device size or incision length range;

Method of sterilization;

Flammability classification;

Non-pyrogenic;

Shelf life; and

Maximum flow rate and suction pressure.