(71 days)
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.
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.
This information is not provided in a structured format in the document, but can be extracted from the text.
Acceptance Criteria and Device Performance:
The document doesn't explicitly lay out quantitative acceptance criteria in a table format with corresponding performance metrics. However, it states that the device was evaluated against its ability to:
- Produce a pelvic floor muscle contraction equivalent to the current Innova® Vaginal Electrode as demonstrated by the generation of increased urethral pressure.
- Sense voluntary pelvic muscle contraction by an EMG System.
The reported performance states:
- "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."
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produce substantially equivalent pelvic floor muscle contractions (stimulation mode) | The new Innova® ComfortPulse® Vaginal Electrodes (both small and standard sizes) produced contractions "substantially equivalent" to those of the currently marketed Innova® Vaginal Electrodes when stimulation-induced contractions were compared. These contractions were "clinically observable, palpable and measurable." |
| Discriminate between volitional contraction and rest (EMG sensing mode) | All of the electrodes (Innova® ComfortPulse® Vaginal Electrodes, both small and standard sizes, and currently marketed Innova® Vaginal Electrodes) "discriminated between volitional contraction and rest," demonstrating "substantial equivalence" in sensing volitional contraction and rest. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "an acute clinical test" but does not specify the number of participants.
- Data Provenance: Not explicitly stated. It is referred to as "an acute clinical test," implying prospective data collection, likely within a clinical setting. The country of origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The observation that contractions were "clinically observable, palpable and measurable" suggests medical professionals were involved in the assessment, but their number and specific qualifications are not detailed.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document describes a medical device (electrode) and its function, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical electrode and does not involve an algorithm for standalone performance evaluation in the context of AI. The performance discussed is the physical function of the electrode.
7. The type of ground truth used:
- Clinical Observation/Measurement: For muscle contractions, the ground truth was based on "clinically observable, palpable and measurable" muscle contractions and the generation of "increased urethral pressure."
- Volitional Contraction/Rest: For sensing performance, the ground truth was based on the ability to discriminate between "volitional contraction and rest."
8. The sample size for the training set:
- Not applicable. This product is a physical medical device (electrode), not a machine learning model that would typically have a "training set." The development of the device would involve engineering and material testing, not data training.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of a machine learning algorithm. The "ground truth" for the device's design and manufacturing would be based on engineering specifications, material science, and established physiological principles.
{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 RoadSt. Paul, Minnesota 55126-3965 | |
| Contact Person: | Carolyn M. Steele HustenRegulatory Affairs Manager | |
| Classification Name: | Non-implanted Electrical Continence Electrodes(Stimulation Electrodes) 21 CFR Part 876.5320 andPerineometers (EMG Sensing Electrodes) 21 CFR Part 884.1425 | |
| Common or Usual Name: | Vaginal EMG Sensing and Stimulating Electrodes | |
| Proprietary Name: | Innova® ComfortPulse® Vaginal Electrode andInnova® 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 VaginalEMG 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.
§ 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).