[202526]
Rptr cannot accept the irrigator, that was received from surya technologies for use in outpatient facility for the following reasons. The operator's manual indicates that there is a pressure relief valve that limits the pressure within safe limits of 10 to 12 psi. But rptr measured 23 psi. At the nozzle. When rptr called surya in regard to this, rptr was told that the pressure measured was normal. When rptr asked surya if they could provide rptr with a performance verification procedure, they could not. If the manual states that the safe limits of pressure is 10 to 12 psi, then 23 psi, essentially double the pressure, cannot be considered safe. Rptr removed the cover to look inside and found that there is no safety relief valve as the manual had stated. There is, however a pressure regulator that could be used to adjust the pressure at the tip. This regulator could fail over time due to mineral build up and if it does, there is no secondary protection against high pressure. The fda classification regulation name 21 cfr880. 6960 under which the device was submitted, is described in its text as a syringe, irrigating. It then goes on to describe a syringe or a squeeze bulb with integral or detachable tube used to irrigate, withdraw fluid from, or instill fluid into a body cavity or wound. This is a non electrical, manually operated device. The "eaeigator" does not resemble this description physically. The only resemblance to an irrigation syringe is that it is used to clean out ears. It never should have been submitted under this classification and possibly should have been submitted under a new classification. Rptr has talked to someone at the fda and she has referred the matter to the fda office of compliance for further investigation. Rptr cannot pass this unit for use in the facility until these issues have been resolved.
Patient Sequence No: 1, Text Type: D, B5