(7 days)
The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the MOBLVAC W.C. is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient and also as a pleural and wound drainage device.
The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient.
I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a device called "MOBLVAC W.C." which is a powered suction pump.
The letter grants clearance based on substantial equivalence to a predicate device, but it does not contain information about:
- Specific acceptance criteria for performance (e.g., specific thresholds for suction pressure, flow rate, or durability).
- Study details that would prove the device meets such criteria (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
The letter confirms the device's classification, regulatory requirements, and its stated "Indications for Use" but does not delve into the technical testing or studies conducted to establish its performance.
§ 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.