Section 878.4680 - Nonpowered, single patient, portable suction apparatus(a)Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9 .53 FR 23872, June 24, 1988, as amended at 65 FR 2318 , Jan. 14, 2000