(226 days)
The Rusch Emergency Mask is designed to assist in providing immediate life support to health emergency victims requiring oxygen support(inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The device is intended for mouth to mask ventilation by trained individuals trained in the use of the device and qualified to use the device. The device is intended to be used on adult,child and infant population.
The Rusch Emergency Mask is one-piece, single use, full-sized light weight PVC mask system which includes a universal breathing tube, one way filtered valve, head straps and oxygen port. The design of the ER mask permits it to fold into a convenient pocket sized case for portability yet deploy instantly for use as a CPR Mask when removed from its package. The mask can be supplied with or without examination gloves. The soft PVC cushion promotes a seal to the face allowing ventilation through both the mouth and nose simultaneously. The transparent structure permits visual identification. The mouth piece and the one way valve with 3M Filtrate TM filter provide the rescuer protection when using "mouth-tomouth" rescue techniques. The proximal end of the breathing tube can be attached to a universal resuscitation bag port while the integral oxygen tube allows for connection to an emergency oxygen system.
The provided document for the Rusch Emergency Mask (K993528) does not contain information regarding
acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a
predicate device (Laerdal Pocket Mask™ K933048). It describes the device's intended use and
technological characteristics, but does not present any performance study data, clinical trials, or
metrics that would allow for the construction of a table of acceptance criteria and reported device
performance.
Therefore, I cannot provide the requested information. The document merely confirms that the FDA
reviewed the 510(k) notification and determined the device to be substantially equivalent to a
legally marketed predicate device, allowing it to proceed to market. This determination is based on
the device's design, intended use, and technological characteristics being comparable to the
predicate, rather than on specific performance acceptance criteria met through a dedicated study.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).