§ 878.4371. Irrigating wound retractor device.
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/us/cfr/t21/s§ 878.4371·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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;
(iv)Non-pyrogenic;
(v)Shelf life; and
(vi)Maximum flow rate and suction pressure. [83 FR 24, Jan. 2, 2018]
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§ 878.4371
Irrigating wound retractor device.
Fed. Reg.×1
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