(342 days)
NatraTone® is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, Urinary Incontinence in women.
NatraTone® is a pelvic floor muscle exerciser. It is a single, reusable device that comes into contact with the vaginal mucosal membrane for a limited (
The provided text is a 510(k) summary for the NatraTone® device, which is a perineometer. This document is a regulatory submission to the FDA for market clearance and does not contain the results of a study designed to prove the device meets specific acceptance criteria.
Instead, the submission focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (GyneFlex Perineometer, K021115). This means the manufacturer is asserting that their device is as safe and effective as the predicate device, primarily based on similarities in intended use, design, materials, and mechanism of action, rather than reporting on new clinical trial data with predefined acceptance criteria.
The document states: "The information in this 510(k) demonstrates that the subject Orelle Corporation NatraTone® is substantially equivalent to the existing GyneFlex device (K021115) with respect to safety and effectiveness."
Therefore, based on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving their fulfillment, as such a study with explicit acceptance criteria is not presented in this 510(k) summary.
In summary, the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).