(71 days)
Not Found
No
The summary describes a passive electrode device used for electrical stimulation and EMG sensing, with no mention of AI or ML capabilities in its function or analysis.
Yes
The device is indicated for use in the treatment of urinary incontinence as part of the Innova Pelvic Floor Stimulation (PFS) System, which is a therapeutic application. Additionally, it is used for monitoring and evaluating EMG activity, which can also be part of a therapeutic process.
Yes
Explanation: The device is indicated for "monitoring and evaluating EMG activity of the pelvic floor muscles," which is a diagnostic function.
No
The device description clearly details physical hardware components (electrodes, leadwire cable) made of thermoplastic material and conductive elements, which are integral to its function. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Innova® ComfortPulse® Vaginal Electrodes are used for:
- Pelvic Floor Stimulation (PFS): Applying electrical stimulation to treat urinary incontinence. This is a therapeutic intervention, not a diagnostic test on a specimen.
- EMG Monitoring: Measuring the electrical activity of pelvic floor muscles. While this provides information about the body, it's a direct measurement of physiological activity, not an analysis of a specimen taken from the body.
The device interacts directly with the body (vaginally) and either delivers electrical stimulation or measures electrical signals from the muscles. It does not analyze a sample taken from the patient.
N/A
Intended Use / Indications for Use
The Innova® ComfortPulse® Vaginal Electrodes are a component of the Innova Pelvic Floor Stimulation (PFS) System which is indicated for use in the treatment of urinary incontinence. These electrodes are also a component of the Innova® Clinical EMG System which is indicated for monitoring and evaluating EMG activity of the pelvic floor muscles.
Product codes
Not Found
Device Description
The Innova® ComfortPulse® Vaginal Electrodes, small and standard sizes, have three conductive elements separated by non-conductive elements of thermoplastic material. The small size electrode has a flared cylindrical shape and the standard size electrode has an hourglass shape. The electrodes are designed for repeated intermittent use in the home or clinic for up to one year by a single user. Because it is designed for use by a single user, it does not require sterilization. It does, however, require washing with soap and water and drying between uses. Both small and standard size electrodes have a permanently attached, insulated 40 inch leadwire cable that connects directly to the Stimulation System, but requires an adapter to connect to the EMG System.
The small size electrode is approximately 2.3 inches in length from tip to end, with a maximum diameter of 0.8 inches. The standard size electrode is approximately 2.8 inches in length from tip to end, with a maximum diameter of 1.025 inches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or clinic for up to one year by a single user.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
An acute clinical test was performed to verify that the Innova® ComfortPulse® Vaginal Electrodes produce a pelvic floor muscle contraction equivalent to that produced by the current Innova® Vaginal Electrode as demonstrated by the generation of increased urethral pressure. In addition, both Innova® ComfortPulse® Vaginal Electrodes were assessed for their ability to sense voluntary pelvic muscle contraction by an EMG System.
The electrically stimulated pelvic muscle contractions induced by both new Innova® ComfortPulse® Vaginal Electrodes and the currently marketed Innova® Vaginal Electrodes were clinically observable, palpable and measurable. When stimulation induced pelvic muscle contractions were compared, the new Innova® ComfortPulse® Vaginal Electrodes, both small and standard sizes, produced contractions substantially equivalent to those of the currently marketed Innova® Vaginal Electrodes. All of the electrodes discriminated between volitional contraction and rest, demonstrating that the Innova® ComfortPulse® Vaginal Electrodes, both small and standard sizes, are substantially equivalent to the currently marketed Innova® Vaginal Electrodes in sensing volitional contraction and rest.
Key Metrics
Not Found
Predicate Device(s)
K910081, K940091, K952688, K954272
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
JAN 2 4 1997
Image /page/0/Picture/1 description: The image shows handwritten text and a logo. The text "K964577" and "P173" are written in black ink. To the right of the handwritten text is the word "Empi" in a bold, italicized font, with the registered trademark symbol next to it.
Cost Effective Health Care Solutions
SUMMARY OF SAFETY AND EFFECTIVENESS Empi, Inc. Innova® ComfortPulse® Vaginal Electrode and Innova® ComfortPulse® Small Vaginal Electrode
Empi, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-3965 USA
612-415-9000 FAX 612-415-7305
| A. General Provisions | FAX 612- | |
|---|---|---|
| Submitter's Name: | Empi, Inc. | |
| Submitter's Address: | 599 Cardigan Road | |
| St. Paul, Minnesota 55126-3965 | ||
| Contact Person: | Carolyn M. Steele Husten | |
| Regulatory Affairs Manager | ||
| Classification Name: | Non-implanted Electrical Continence Electrodes | |
| (Stimulation Electrodes) 21 CFR Part 876.5320 and | ||
| Perineometers (EMG Sensing Electrodes) 21 CFR Part 884.1425 | ||
| Common or Usual Name: | Vaginal EMG Sensing and Stimulating Electrodes | |
| Proprietary Name: | Innova® ComfortPulse® Vaginal Electrode and | |
| Innova® ComfortPulse® Small Vaginal Electrode |
B. Name of Predicate Devices
| ◆ Empi, Inc. Innova® Vaginal Stimulation Electrode | K910081 |
|---|---|
| ◆ Empi, Inc. Innova® Vaginal EMG Sensing Electrode | K940091 |
| ◆ Empi, Inc. Innova® Rectal or Small Vaginal | |
| EMG Sensing Electrode | K952688 |
| ◆ Empi, Inc. Innova® Rectal Stimulation Electrode | K954272 |
C. Device Description
The Innova® ComfortPulse® Vaginal Electrodes, small and standard sizes, have three conductive elements separated by non-conductive elements of thermoplastic material. The small size electrode has a flared cylindrical shape and the standard size electrode has an hourglass shape. The electrodes are designed for repeated intermittent use in the home or clinic for up to one year by a single user. Because it is designed for use by a single user, it does not require sterilization. It does, however, require washing with soap and water and drying between uses. Both small and standard size electrodes have a permanently attached, insulated 40 inch leadwire cable that connects directly to the Stimulation System, but requires an adapter to connect to the EMG System.
1
5964077
P2013
SUMMARY OF SAFETY AND EFFECTIVENESS Empi, Inc. Innova® ComfortPulse® Vaginal Electrode and Innova® ComfortPulse® Small Vaginal Electrode Page 2
The small size electrode is approximately 2.3 inches in length from tip to end, with a maximum diameter of 0.8 inches. The standard size electrode is approximately 2.8 inches in length from tip to end, with a maximum diameter of 1.025 inches.
D. Intended Use
The Innova® ComfortPulse® Vaginal Electrodes are a component of the Innova Pelvic Floor Stimulation (PFS) System which is indicated for use in the treatment of urinary incontinence. These electrodes are also a component of the Innova® Clinical EMG System which is indicated for monitoring and evaluating EMG activity of the pelvic floor muscles.
Summary of Technological Characteristics E.
The Innova® ComfortPulse® Vaginal Electrodes use common biocompatible materials which are identical to those of the Empi. Inc. Innova® Rectal or Small Vaginal EMG Sensing Electrode. The electrodes are configured similar to currently marketed Innova® Vaginal and Rectal Electrodes used for the treatment of urinary incontinence. The design allows the electrodes to be used with the currently marketed Innova® Pelvic Floor Stimulation System and Empi's Clinical EMG Sensing Systems.
Non-Clinical and Clinical Test Summary F.
The electrodes have been verified as meeting specifications for internal wire location and integrity, initial impedance, surface inspection, material integrity (mechanical shock) and dimensions. Test results from Innova® Rectal Electrode for material stability and biocompatibility were applied to this device and not repeated because they are comprised of identical material. The results of functional testing were analyzed against product specifications and currently marketed devices. The test results demonstrate that the product meets requirements, is acceptable for its intended use and is equivalent to currently marketed devices.
An acute clinical test was performed to verify that the Innova® ComfortPulse® Vaginal Electrodes produce a pelvic floor muscle contraction equivalent to that produced by the current Innova® Vaginal Electrode as demonstrated by the generation of increased urethral pressure. In addition, both Innova® ComfortPulse® Vaginal Electrodes were assessed for their ability to sense voluntary pelvic muscle contraction by an EMG System.
2
P 3093
SUMMARY OF SAFETY AND EFFECTIVENESS Empi, Inc. Innova® ComfortPulse® Vaginal Electrode and Innova® ComfortPulse® Small Vaginal Electrode Page 3
The electrically stimulated pelvic muscle contractions induced by both new Innova® ComfortPulse® Vaginal Electrodes and the currently marketed Innova® Vaginal Electrodes were clinically observable, palpable and measurable. When stimulation induced pelvic muscle contractions were compared, the new Innova® ComfortPulse® Vaginal Electrodes, both small and standard sizes, produced contractions substantially equivalent to those of the currently marketed Innova® Vaginal Electrodes. All of the electrodes discriminated between volitional contraction and rest, demonstrating that the Innova® ComfortPulse® Vaginal Electrodes, both small and standard sizes, are substantially equivalent to the currently marketed Innova® Vaginal Electrodes in sensing volitional contraction and rest.