(231 days)
ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence in adult women.
ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women.
The ApexMV device is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women for Over-the-Counter use. The ApexMV device is to be distributed as a kit that contains the following items:
- · 1 ApexMV device
- 1 4 pack of AA batteries
- · 1 2 oz. tube of InControl Medical Electrode Gel**
- 1 ApexMV IFU/ User Manual
- · 1 ApexMV Quick Reference Card
- 1 Screw driver
- 1 Travel Bag
- 1 Animation Video
The ApexMV device consists of a hand held control unit with bio-feedback and inflation pump attached to a customizable inflatable probe via flexible tubing. The customizable inflatable probe is inserted vaginally or rectally and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is also used to improve the ability of the muscles to hold a contraction for an extended period of time for the treatment of stress, urge, or mixed urinary and/or fecal incontinence in adult women. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
This document describes the regulatory submission for the ApexMV device, which is a non-implantable muscle stimulator for treating urinary and/or fecal incontinence in adult women.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for performance metrics. Instead, the "acceptance criteria" are implied by the successful completion of various tests and the determination of substantial equivalence to previously cleared predicate devices. The reported "device performance" is primarily qualitative, stating that the device "successfully passed all of this testing" and is "safe and effective."
Below is a table summarizing the tests performed and the reported outcomes, which implicitly serve as the device meeting the acceptance criteria for regulatory clearance:
| Acceptance Criteria (Implied by Test Completion) | Reported Device Performance (Qualitative) |
|---|---|
| Software Verification and Validation Testing | |
| (Adherence to FDA Guidance for Software in Medical Devices for "moderate" level of concern) | Documentation was provided as recommended. |
| The software met the requirements for a "moderate" level of concern. | |
| Testing data found in Appendix 4 – Risk Management File. | |
| Electrical Safety and Electromagnetic Compatibility (EMC) Testing | |
| (Compliance with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, and IEC 60601-1-2 standards) | The ApexMV device complies with all specified IEC standards for safety and EMC. |
| Testing data found in Appendix 7 – SGS EMC and Electrical Safety. | |
| Biocompatibility Testing | |
| (Compliance with ISO 10993-1 for tissue-contacting parts |
§ 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).