(87 days)
The Contimed Pressure Biofeedback device is intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.
The Contimed Pressure Biofeedback device is a battery powered machine which registers the force with which a patient contracts their pelvic floor muscles. The force is measured by using an anatomically shaped, inflatable pressure probe that is connected to the Contimed device. The latex probe (anal or vaginal) is inflated with air by using a syringe and is introduced into either the vagina or anus. The voluntary muscle contractions of the exercises compress the air inside the probe and register a reading on the display panel of the Contimed device. The visual display of contraction force gives the patient the ability to see and hear progress in the exercise session. The Contimed has a vertical column of lights. The number of the lights illuminated increases or decreases with an increase of contraction force. To reinforce the effect of the visual signal there is also an audible signal that can be turned on or off. The intensity of the tone increases or decreases in intensity depending on the contraction's force. Over time the exercise program will help the patient to improve the ability to control the pelvic floor muscles.
Three different duty cycles are preset to allow the caregiver the ability to choose a program that will help to strengthen the pelvic floor muscles. They can be set by using the slide switch on the control panel of the device. Three sensitivity levels are available to accommodate different contraction strengths of the pelvic floor muscles. They can be set by using the slide switch on the control panel of the device, there is also a slide switch for zero adjustment.
The provided text does not contain acceptance criteria or a study proving the device meets those criteria.
Instead, the document is a premarket notification (510(k)) summary for the Hollister Contimed Pressure Biofeedback device. This type of document aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, not to prove clinical effectiveness through a study with acceptance criteria.
The document focuses on comparing the technological characteristics of the new device to a predicate device (InCare Contimed II Pressure Biofeedback device, K891774) and a general device type (Perineometer as described in 21 CFR 884.1425).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).