(205 days)
Apex is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support.
Apex is a hand-held, home-use device designed to treat female stress urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina 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 used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
The provided text describes the 510(k) premarket notification for the Apex device, a non-implanted muscle stimulator for treating female stress urinary incontinence. The acceptance criteria and the study proving the device meets these criteria are primarily focused on demonstrating substantial equivalence to a predicate device (InTone K110179) and ensuring safety for over-the-counter use.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in a quantitative performance table (e.g., Sensitivity X%, Specificity Y%). Instead, it focuses on demonstrating substantial equivalence to a predicate device and confirming safety and intended performance through various tests for its over-the-counter use.
The "Acceptance Criteria" implicitly stem from comparability to the predicate and compliance with relevant standards and usability requirements for an OTC device. "Reported Device Performance" is presented in terms of compliance with these standards and successful completion of the studies.
| Acceptance Criteria (Implicitly based on Predicate Equivalence and OTC Safety) | Reported Device Performance (Apex) |
|---|---|
| Intended Use Equivalence: Treat female stress urinary incontinence by applying stimulation to pelvic floor muscles. | Substantially equivalent to InTone (K110179). Both apply electrical stimulation to strengthen pelvic floor muscles. Apex specifically designed for female stress urinary incontinence. |
| Primary Function Equivalence: Delivery of electrical stimulation. | Identical to InTone (K110179). |
| Warnings/Precautions Equivalence & Clarity: Improve end-user understanding for OTC use. | Substantially equivalent to InTone (K110179). Reworded for Apex to improve end-user understanding for OTC use. Validated through Human Factors and Usability Testing. |
| Contraindications Equivalence & Clarity: Improve end-user understanding for OTC use and ensure proper self-limitation. | Substantially equivalent to InTone (K110179). Reworded and reordered for Apex to improve end-user understanding for OTC use. Validated through collaboration with the supervising physician from the Human Factors and Usability Testing. |
| Labeling Summary Clarity: Improve end-user understanding. | Substantially equivalent to InTone (K110179). User manual reworded for Apex to improve end-user understanding for OTC use. Manual validated through collaboration with the supervising physician from Human Factors and Usability Testing. Enhanced labeling includes educational consumer-focused box, detailed IFU, quick reference guide, and instructional video. |
| Electrical Safety Standards Compliance: Meet IEC 60601-1 and IEC 60601-2-10 standards. | The device complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety. |
| Electromagnetic Compatibility (EMC) Standards Compliance: Meet IEC 60601-1-2 standard. | The device complies with the IEC 60601-1-2 standard for EMC. |
| Biocompatibility: Meet ISO 10993-1 for tissue contact. | Biocompatibility evaluation conducted per ISO 10993-1. Insertion Unit is tissue contacting for |
§ 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).