(254 days)
The Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
The Life-Care Vaginal Probe models PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A are the light weight cylinder consisting of two or three independent conductive rings or plates that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in vaginal canal for incontinent treatment as above mentioned and easy for removing after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing for reuse according to the validated cleaning method as recommended in user manual.
The Life-Care Anal Probe models PR-06/06A, PR-12A, PR-13/13A are the light weight cylinder consisting of two or three independent conductive rings that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in rectal canal for incontinent treatment as above mentioned and easy for removing after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing for reuse according to the validated cleaning method.
To fit with different type of device connection, the lead wire of device was provided with two different type of wire connection terminals, the standard female plug terminal and pigtail terminal. For the model with pigtail connection terminal, the letter "A" in the last of model name (e.g. PR-02A ) to separate them from the model with standard female plug terminal.
The provided text describes a 510(k) premarket notification for Everyway Incontinence Stimulation Electrodes, comparing them to predicate devices. The submission focuses on demonstrating substantial equivalence rather than presenting an independent performance study with acceptance criteria.
Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment are not applicable or not provided in this document. The submission argues for equivalence based on similar intended use and technological characteristics, supported by non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific performance acceptance criteria for the Everyway Incontinence Stimulation Electrode. Instead, it relies on demonstrating substantial equivalence to predicate devices (Hollister Vaginal Stimulation/EMG Probe-Tampon K971541 and Anal Stimulation/EMG Probe-w/Stop K990456).
The table provided is a comparison of characteristics between the new device and the predicate devices, not acceptance criteria for a new performance study. The key assertion is that the "new device could maintain the same safety and effectiveness as that of cleared device."
| Electrode Characteristics | Predicate Device (Vaginal) | New Device (Vaginal) | Predicate Device (Anal) | New Device (Anal) |
|---|---|---|---|---|
| Model | Hollister K971541 | Everyway PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A | Hollister K990456 | Everyway PR-06/06A, PR-12A, PR-13/13A |
| Usage Conditions | Reusable-Single Patient | Same | Reusable-Single Patient | Same |
| Electrode Material | Stainless steel | Same | Stainless steel | Same |
| Electrode Placement | Vaginal | Same | Anal | Same |
| Contact Duration | Intermittent mucosal contact |
§ 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).