(216 days)
The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for the treatment of unnary incominence.
The Innova Rectal Stimmlation Electrode assembly is a light-weight cylinder consisting of two conductive rings that are paired and isolated, physically. The cylinder is shaped with a waist and a handle for confort, positioning and ease in removing, It is watertight to allow for washing with socop and water between uses. The electrode is designed for repeated intermittent use in the home or clinic for up to one year by a single user. It does not require sterilization, but does require washing with soap and water and drying between uses.
The provided text describes the "Innova Rectal Stimulation Electrode" and its performance in comparison to a predicate device, the "InCare Rectal Electrode."
Here's an analysis of the acceptance criteria and study data based on the provided input:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Innova Rectal Electrode's Performance |
|---|---|
| I. Product Verification and Validation: | |
| Leadwire placement and integrity | "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met) |
| Impedance | "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met) |
| Tensile strength | "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met) |
| Connection strength | "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met) |
| Flexion | "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met) |
| Label durability | "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met) |
| Surface integrity | "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met) |
| Material integrity (mechanical stability) | "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met) |
| Dimensions | "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met) |
| Material biocompatibility | "Meets ISO 10993 and USP class VI" |
| II. Clinical Performance (vs. InCare Rectal Electrode): | |
| Produce pelvic floor contraction equal to or greater than InCare Rectal Electrode | All subjects had pelvic muscle contractions using both electrodes that were of sufficient amplitude to produce an observable and measurable response at maximum comfortable intensity. |
| Maximum comfortable current intensity | Innova rectal electrode achieved significantly higher maximum comfortable current intensity (p |
§ 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).