Search Results

The Minnova Pelvic Floor Stimulation System is indicated for acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflective mechanisms.

The Minnova Pelvic Floor Stimulation System is comprised of a external stimulator and an electrode. The device when used with the Innova® ComfortPulse® Vaginal electrodes (ComfortPulse Electrodes) (K964577 currently under review at the FDA), Innova Vaginal Electrode (K910081), and Innova® Rectal Stimulation Electrode (Innova Rectal Electrode) (K954272), stimulates the muscles of the pelvic floor to achieve and maintain urinary continence. The electrodes are identical to those previously submitted except for the addition of touchproof connectors to comply with "Medical Devices; Performance Standards for Electrode Lead Wires and Banning of Unprotected Electrode Lead Wires; Proposed Rule." There is no adapter required to connect the electrodes to the device. The components of the system are placed in a softsided carrying case.

This document does not contain information about acceptance criteria or a study that proves the device meets those criteria. It primarily describes the device's components, technical specifications, intended use, and the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices. There is no mention of clinical studies, sample sizes, expert involvement, ground truth, or MRMC studies.

Ask a specific question about this device

The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.

The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women. The Microgyn Plus is a battery powered device that delivers a regulated stimulus to the nerves and muscles of the pelvic floor. The stimulus is administered by attaching an anatomically shaped probe to the device and then inserting the probe into the patient's vagina or anus. When stimulation is delivered the body responds by contracting the muscles of the pelvic floor. The Microgyn Plus provides a balanced biphasic stimulation pulse. The pulse has a positive and negative phase such that the net charge applied to the patient is zero. The Microgyn Plus is a current controlled device that provides an output that is adjustable from 0-60 milliamperes. The device also has the ability to select between three frequencies (20, 50, 100 Hz) depending on the frequency selected by the caregiver and the individual needs of the patient.

This document does not contain the information required to answer the request. The provided text describes a medical device, its intended use, and its technological characteristics. It mentions "conclusion" in section 7, but this refers to the conclusion of substantial equivalence to predicate devices, not findings from a study proving acceptance criteria. There is no mention of acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

Ask a specific question about this device