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The proposed device, DryTime® for Bladder Control Silent, is a daytime enuresis alarm that may be used by an ambulatory adult to assist the control of incontinence. It is designed and used in a manner consistent with the predicate device (l.e., the emission of bodily fluids is detected when those fluids complete an electrical circuit in a sensor device and thereby set off an electronic alarm).

The proposed device. DryTime® for Bladder Control Silent, is a daytime enuresis alarm that may be used by an ambulatory adult to assist in controlling incontinence. It is designed and used in a manner consistent with the predicate device (i.e., the emission of bodly fluids is detected when those fluids complete an electrical circuit in a sensor device and thereby set off an electronic alarm). DryTime for Bladder Control Silent contains the identical components used in the Health Sense International predicate device, DryTime for Potty Training, except that DryTime® for Bladder Control Silent uses a silent vibrator alarm in place of the audio buzzer alarm of DryTime® for Potty Training.

DryTime for Bladder Control Silent is comprised of a disposable fluid sensor strip unit (Sense'R Strip") attached to a silent vibrator alarm unit, which, in turn, clips via a soft vinyl strap to the front of the undergarment about two inches below the outside of the walstband (fabric is pinched to allow the jaws of clip to attach). The sensor strip unit is the Identical Sense 'R Strip® of the approved DryTime® for Potty Training predicate device, and includes two parallel vertical aluminized mylar sensor strips which are spaced a short distance apart from each other and which are electrically connected to the silent vibrator alarm unit. These aluminized mylar sensor strips are encased inside a disposable soft, absorbent paper sheath; the outer portion of the paper sheath is composed of apertured paper and the inner portion is made of a highly absorbent paper which is in contact with the aluminized mylar sensor strips. When the sensor unit is attached to the undergarment, the sensor strip unlt is extended downward inside the undergarment to lay over the groin. The top side of the paper sheath surrounding the two aluminized mylar sensor strips has an adhesive which secures the strip to the undergarment. The adhesive is exposed by peeling a paper backing from the sensor strip unit.

When the subject urinates or defecates, the released fluid is absorbed by the inner portion of the sensor strip unit through the holes of the outer apertured paper. The absorbed fluid contacts the aluminized mylar sensor strips encased within the paper sheath, and creates a "bridge" between the two conductive strips so that the electrolytes in the fluid complete an electrical circuit with those strips. Once the circuit is completed by the fluid, the alarm is activated to indicate that the person wearing the device has elther urinated or defecated.

At the same time the circuit is completed, a transistor in the alarm unit switches the current to another circuit, thereafter bypassing the aluminized mylar sensor strips. This ensures that the alarm will remain activated once fluld has been detected, regardless of any movements by the subject that might otherwise break the initial circuit created by the fluid bridge between the mylar sensor strips. The activation of the transistor also ensures that current no longer flows through the aluminized mylar sensor strips.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. In fact, it explicitly states the following:

• "Because of the strong similarity between DryTime® for Bladder Control Silent and the predicate device, there has been no nonclinical testing of DryTime® for Bladder Control Silent to demonstrate safety and effectiveness." (Page 4)
• "Because of the strong similarity between DryTime® for Bladder Control Silent and the predicate device, the determination of substantial equivalence does not include an assessment of performance data, and there has been no clinical testing of DryTime for Bladder Control Silent to demonstrate safety and effectiveness." (Page 5)

Therefore, I cannot provide a response with the requested details as they are not present in the given document.

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