(15 days)
The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids and infectious materials.
The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of suction to wounds and for fluid removal. Disposables for use with the pump include: canister, Tube Attachment Device, Cover and Wound Contact Dressing
This document is a 510(k) summary for the Boehringer Laboratories Suction Pump System. It establishes substantial equivalence to predicate devices and does not describe any specific acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on performance testing against specific acceptance criteria.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.