(90 days)
The Butterfly Toner is indicated for the improvement of abdominal muscle tone, strengthening of the abdominal muscles, and development of a firmer abdomen.
The Butterfly Toner is a single channel, battery operated muscle stimulation system for exercising the abdominal muscles. The Butterfly Toner has two electrodes fixed at a distance of 28 mm.
This 510(k) submission (K093368) for the "Butterfly Toner" muscle stimulator does not include a study with acceptance criteria and device performance results. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Slendertone 512, K010335).
Here's a breakdown of why the requested information cannot be provided from the given document:
- No Clinical Tests: The document explicitly states under "Clinical tests submitted or relied upon:": "None." This means no clinical study was conducted by the applicant for this device to prove it meets specific acceptance criteria.
- Substantial Equivalence: The basis for clearance is "The Butterfly Toner is substantially equivalent to the Slendertone 512 because they use equivalent technology and have the same intended use." In 510(k) submissions, substantial equivalence means demonstrating that the new device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness. This often involves comparing technological characteristics and intended use, rather than conducting new clinical trials with specific performance metrics and acceptance criteria.
- Non-Clinical Tests: Only "Waveforms as provided" are mentioned as non-clinical tests, which are typically electrical performance and safety tests, not outcomes-based clinical performance.
Therefore, the questions regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, adjudication, and MRMC studies cannot be answered as they are not present in this 510(k) submission.
In summary, for medical devices cleared through the 510(k) pathway based on substantial equivalence, especially for devices like muscle stimulators that are well-understood, extensive clinical trials with pre-defined acceptance criteria are often not required if a suitable predicate device exists.
§ 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).