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Indications for use would be when the patient cannot feed him/herself and cannot be fed by another person. This catheter would be placed Nasogastrically and nutrients supplied through catheter to the patient.

Nasogastric Feeding Tube (4Fr, 6Fr, 10Fr and 12Fr; sterile and non-sterile)

INTENDED USE STATEMENT: The Perineometer (Biofeedback monitor) and vaginal probe are intended to be used to assist the patient in exercising her pelvic muscles (referred to Kegal exercises) which may lead to increased bladder control.

The PERINEOMETER & VAGINAL PROBE , is a passive device which will allow the patient to visually monitor their Kegal exercise progress. The Vaginal probe is a Single patient use only device comprised of a medical grade Silicone shaft with a silicone balloon (Inflatable to enlarge to accomodate various vaginal sizes.) and a oolvurethane connector tube. The silicone balloon is mounted in such a way that when pressure is applied to it, air will be displaced through it's connector tubing. This air displacement is being monitored by the biofeedback monitor will cause the LED lights to turn on in proportion to the pressure exerted. This probe is similar to the legally marketed probe via 510(k) numbers (k902843) and (k913736) except that in this case we are inflating the balloon to provide gentle pressure to the vaginal wall. This will allow the probe to be customized for the patients individual vaqinal size. The Perineometer (Biofeedback Monitor) is powered by rechargeable batteries. To prevent a potential shock hazard this unit will not function while it is being recharged. The Perineometer is identical to the biofeedback monitor which had been 510(k) approved for use in fecal incontinence (k902843). Thus, in the case of this 510(k) submission, we only seek to expand its use for general Kegal exercises. SYSTEM DESCRIPTION: The patient inserts the vaginal probe which is connected to the Perineometer. Once the probe is inflated until it provides gentle pressure to the vaginal wall. As the pelvic muscles expand and contract (Kegal exercises) the pressure in the probe changes and these pressure changes are converted into a visual signal on the Perineometer (biofeedback monitor). The visual signal on the Perineometer is a series of LEDs (lights) which provide the patient with a real time representation of pelvic muscle activity.

The Syringe Flushing/Cleaning Pump is intended to clean the Biosearch Endoscopic Instruments. The Syringe Flushing/Cleaning Pump is a device that helps remove debris that may get trapped inside the Biosearch Endoscopic Instrument.

The Disposable Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments, is a similar design to an existing legally marketed device. It is composed of a variety of medical grade plastics. The threaded connector is especially designed to fit the flushing port of the Biosearch Endoscopic device which impedes water leakage during the cleaning process. The dual check valve is an important feature because it provides an efficient transfer of the water, and/or cleaning fluid. This will provide a sanitary environment for the medical health professional to perform the extensive cleaning of the Biosearch Endoscopic Instruments.