(58 days)
The Vaginal Stimulation/EMG Probe - Tampon, is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Hollister Incorporated through it's InCare Division currently markets a vaginal 2-electrode Stimulation/EMG probe (K891773 and K930530) and a Small Vaginal Stimulation/EMG probe (K970602) as accessories to it's Pelvic Floor Therapy System product line. Therapy with these currently marketed probes, is normally performed with the patient in the supine position. Requests and comments from physicians and caregivers has indicated the need for a probe that will remain in place and allow the patient to perform normal activities, such as standing or bending during therapy. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - Tampon. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed devices. The proposed probe has a shorter overall length to help it remain in place while a patient is standing, bending, stooping or squatting during therapy.
This document is a 510(k) Summary for a medical device called the "Vaginal Stimulation/EMG Probe - Tampon". It outlines the device's characteristics, intended use, and its substantial equivalence to previously marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide specific acceptance criteria or quantitative performance metrics typically found in a clinical study report (e.g., sensitivity, specificity, accuracy, precision, etc.). Instead, the device's acceptance is based on demonstrating substantial equivalence to existing predicate devices. The "reported device performance" in this context refers to the comparative characteristics, which are implicitly accepted as meeting the required performance since the predicate devices are already cleared.
| Characteristic Category | Acceptance Criteria (Implicit for Substantial Equivalence to Predicate) | Reported Device Performance (Vaginal Stimulation/EMG Probe - Tampon) |
|---|---|---|
| Intended Use | Same as predicate devices | "Intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence." (Identical to predicates) |
| Technological Characteristics | Similar to predicate devices, with justifiable differences | - Number of Electrodes: 2-Stimulation/EMG |
| - Usage Conditions: Reusable - single patient use | ||
| - Electrode Orientation: Circular | ||
| - Body Material: Acrylonitrile-Butadiene-Styrene copolymer (ABS) | ||
| - Probe Length: 2.3 inches nominal (Shorter than predicates, justified for improved patient mobility) | ||
| - Probe Diameter: 0.841 inch nominal (Similar to predicates, but slightly different from 0.750" and 1.0") | ||
| - Electrode Material: Stainless steel | ||
| - Electrode Placement: Vaginal | ||
| - Device Connector: Attached cord with 3.5 mm stereo phono plug | ||
| - 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).