(68 days)
No
The description focuses on electrical stimulation parameters (current, frequency, pulse type) and does not mention any adaptive or learning capabilities, data analysis, or AI/ML terminology.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women," which is a therapeutic purpose.
No
The device is described as providing electrical stimulation for the rehabilitation of weak pelvic floor muscles, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "battery powered device that delivers a regulated stimulus" and uses an "anatomically shaped probe," indicating it is a hardware device, not software-only.
Based on the provided information, the Microgyn Plus Stimulation Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves blood, urine, tissue, or other bodily fluids.
- The Microgyn Plus Stimulation Device directly interacts with the patient's body. It delivers electrical stimulation to the pelvic floor muscles via a probe inserted into the vagina or anus.
- The intended use is for rehabilitation and treatment of a physical condition (urinary incontinence). This is a therapeutic purpose, not a diagnostic one based on analyzing biological samples.
The description clearly indicates a device for physical therapy and treatment, not for analyzing biological samples to diagnose a condition.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvic floor muscles, vagina or anus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Caregiver
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
InCare Microgyn II Stimulation Device, K891773, InCare PRS9300 Pelvic Floor Therapy System, K930530C, Empi Innova Stimulation device, K910081/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the Hollister logo. The logo consists of a stylized cross-like symbol on the left and the word "Hollister" in a serif font on the right. The logo is black and white.
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
1
Image /page/1/Picture/0 description: The image shows the Hollister brand logo. To the left of the brand name is a geometric design that looks like a plus sign made of rectangles. To the right of the geometric design is the brand name "Hollister."
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.
36 - 2
-11-
1'2 / L
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.