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The Y2K2 Enteral In-Line Filter is intended for use to filter liquid feeding solutions prior to delivery into a patient's pre-inserted feeding tube, to minimize the risk of tube occusion by macro particulates. This will be applicable to any size or length pediatric or adult feeding tube (e.g., nasogastric, nasoduodenal, nasojejunal, gastrostomy, jejunostomy, transgastric duodenal, or transgastic jejunal).

The proposed and predicate devices are of essentially the same size, construction, and function. They are made of comparable (Re: Pall) or identical (Re: Cobe Cardiovascular) inert biomaterials. The Y2K2 Enteral In-Line Filter differs in having a larger pore size, to remove coarse (but not fine) particulates from enterally delivered fluids.

The Y2K2 Enteral Feeding Manager functions to provide enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. The device will accurately deliver small volumes enterally, and be capable of intermittently measuring residual volumes

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The intended use of the device is to convert regulated continuous suction to "intermittent suction" appropriate for aspiration of gastro-intestinal fluid into two separate chambers that are reversed in on/off phases. This permits gravity "refeeding" of the aspirate during the "off" phases of cach chamber's cycle, while maintaining "continuous suction" on the aspiration tube. The proposed device interrupts externally supplied continuous suction to individually provide "intermittent suction" to one or two aspiration catheters positioned in the patient's gastrointesunal tract.

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