(56 days)
1P-16 infiltration/suction pump is indicated for fluid infiltration and aspiration
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Peristaltic Infiltration/Suction Pump" (also referred to as IP-16 Infiltration/Suction Pump).
This document does not contain any information about acceptance criteria for device performance, a study to prove meeting those criteria, or details regarding the methodologies of such a study.
The FDA letter confirms that the device is "substantially equivalent" to predicate devices already on the market, signifying its regulatory clearance based on that comparison, not necessarily on a direct performance study detailed within this letter.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.