§878.4371. Irrigating wound retractor device.
21 C.F.R. § 878.4371
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.
Notes, amendments, and revision history
Amendments
[83 FR 24, Jan. 2, 2018]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 23872, June 24, 1988, unless otherwise noted.
Amendments
[83 FR 24, Jan. 2, 2018]