(311 days)
The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.
MYOTouch is a hand-held device designed to be used for surgical correction of neonatal anorectal malformations. MYOTouch is intended for prescription use. The device is a 9V battery-powered, one-channel muscle stimulator. The device is supplied with a Sterile Stylus, which connects to the control unit by cable and plug. The MYOTouch muscle stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Pena, "Pull-through", or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique. A trained professional or pediatric surgeon must use the MYOTouch device. The pediatric surgeon uses manual, push-button controls to control the electrical stimulation level. The unit is intended for prescription use and is designed with simplicity and ease of use. It has two preset modes available.
I am sorry, but the provided text is a 510(k) premarket notification for a medical device called the MYOTouch Muscle Stimulator. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.
However, the document explicitly states in Section VIII, "No clinical tests were submitted to support this 510(k)."
Therefore, based on the information provided, I cannot answer your request regarding the acceptance criteria and the study that proves the device meets those criteria, as no such study is presented in this document. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device through technical comparisons and compliance with recognized standards, rather than direct performance studies against acceptance criteria.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).