Section 878.4371 - Irrigating wound retractor device(a)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.(b)Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible and evaluated for particulate matter.(2) Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.(3) Performance data must support shelf life by demonstrating continued functionality and sterility of the device over the identified shelf life.(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:(i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;(ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;(iii) Characterize the forces required to deploy the device;(iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures;(v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and(vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.(5) The labeling must include or state the following information:(i) Device size or incision length range;(ii) Method of sterilization;(iii) Flammability classification;(vi) Maximum flow rate and suction pressure.