(68 days)
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.
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K9632222
Plor2
Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781
Hollister Incorporated Microgyn Plus Stimulation Device, K963222 Additional Information
510(k) Summary
1. Submitter's name, Address and Contact Person
Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048
Contact Person Joseph S. Tokarz Manager, Regulatory Affairs (847)680-2849 Ph (847)918-3860 Fax
Date Summary Prepared - August 14, 1996
2. Name of Device:
Hollister Microgyn Plus Stimulation Device
3. Name of Predicate Device(s)
- . InCare Microgyn II Stimulation Device, K891773
- . InCare PRS9300 Pelvic Floor Therapy System, K930530C
- . Empi Innova Stimulation device, K910081/A
4. Description of 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 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.
5. Statement of Intended Use
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.
6. Statement of Technological Characteristics of the Device
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Hollister Incorporated Microgyn Plus Stimulation Device
anatomically shaped probe to the device and then inserting the probe into the patients vagina or anus. 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.
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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.
7. Conclusion
Based upon the information presented above it is concluded that the proposed Microgyn Plus Stimulation Device is safe and effective for its intended use and is substantially equivalent to the predicate device.
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).