(89 days)
The Fuji Dynamics Incontinence Stimulation Electrodes 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 Fuji Dynamics Incontinence Stimulation Electrode models Fuji-01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 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 and easy in 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 and drying between uses.
Here's an analysis of the provided text regarding the Fuji Dynamics Incontinence Stimulation Electrode, focusing on acceptance criteria and study details:
This document is a 510(k) summary for a medical device submitted to the FDA. It does not contain a detailed study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or clinical outcomes.
Instead, this 510(k) outlines the device's substantial equivalence to predicate devices based on identical intended use, technological characteristics, and safety testing (biocompatibility). The FDA's 510(k) pathway determines if a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily that it meets specific, predefined performance thresholds through a clinical study.
Therefore, many of your requested points related to performance studies (like sample size for test sets, number of experts, MRMC studies, standalone performance, training set details) will not be present in this type of document because such studies were not required for this specific 510(k) submission.
Here's a breakdown of the information that is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, this document does not present a table of specific quantitative "acceptance criteria" for device performance (e.g., a specific accuracy or sensitivity). The "acceptance" for this 510(k) is based on demonstrating substantial equivalence to the predicate devices. The "reported device performance" is primarily about its physical and functional characteristics matching or being acceptably different from the predicates.
| Feature / Characteristic | Predicate Device Specification (Hollister K971541 / K990456) | Subject Device Specification (Fuji Dynamics ) | Equivalence Assessment |
|---|---|---|---|
| Vaginal Probe (K971541 vs. Fuji-01/02/03/04/05/06/07/14/15) | |||
| Number of Electrodes | 2-Stimulation / EMG | Same | Identical |
| Usage Conditions | Reusable - single patient | Same | Identical |
| Electrode Material | Stainless steel | Same | Identical |
| Electrode Placement | Vaginal | Same | Identical |
| 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).