(264 days)
The Intimate Rose Kegel Exercise System 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, low tone in the pelvic floor, which can cause or contribute to health issues including urinary incontinence and sexual dysfunction.
The Intimate Rose Kegel Exercise System is a pelvic floor exercise device for use in strengthening the pelvic floor musculature. It is a reusable, over-the-counter device that is comprised of 6 progressively heavier and color-coded silicone weights. An Intimate Rose Kegel Exercise System weight is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The weight of the Intimate Rose Kegel Exercise System device provides resistance as it is lifted with each contraction of the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.
This document is a 510(k) Summary for a medical device called the "Intimate Rose Kegel Exercise System." It describes the device, its intended use, and compares it to a legally marketed predicate device.
Based on the provided text, the device in question (Intimate Rose Kegel Exercise System) is a physical, non-AI-powered medical device. Therefore, the questions regarding acceptance criteria and studies related to AI/software performance (such as sample size for test sets/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment) are not applicable to this specific device submission.
This document focuses on establishing substantial equivalence for a physical device, primarily through non-clinical performance testing (biocompatibility, reprocessing, mechanical performance), rather than an AI/software-driven diagnostic or therapeutic device.
If the request was intended for an AI-powered device, the provided text does not contain the information necessary to answer the questions.
§ 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).