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RT300 vs. the MyoCycle, Part 1 – Introduction
Mar 31
2017

RT300 vs. the MyoCycle, Part 1 – Introduction

Posted by Myolyn

Considering buying an FES bike and exploring your options? This post is the first part of a four part guide that provides a detailed comparison between the MyoCycle and the most common alternative, the RT300.

The MyoCycle Home and MyoCycle Pro are new medical devices that use functional electrical stimulation (FES) to help people with muscle weakness or paralysis to exercise by pedaling a stationary bike. Such devices are commonly known as FES bikes. Though the MyoCycle is new, the idea of an FES bike is not. In fact, there have been several FES bikes on the market since the 1980’s, and the benefits of FES-cycling are clear. So, what’s different about the MyoCycle? This article answers that question, beginning with an explanation of how new medical devices in the US are regulated by the FDA based on the idea of substantial equivalence. From there, the article explores three key aspects of an FES bike – therapy, ease of use, and affordability – and compares the MyoCycle to the RT300, the most prevalent FES bike on the market today. If you’re interested in purchasing an FES bike and are exploring your options, or if you just want to know more about FES bikes, then this article is for you.

FDA Review: Substantial Equivalence

The FDA is currently reviewing the MyoCycle before clearing it for sale in the United States. The review is part of the FDA’s 510(k) Premarket Notification process, since the MyoCycle is a Class II medical device with similar devices already on the market (predicate devices). This means that the FDA is reviewing MYOLYN’s claim that the MyoCycle is “substantially equivalent” to a predicate device in terms of safety and effectiveness. The FDA reviews information about the product and either agrees that the product is substantially equivalent or asks for more information before making a decision. If all goes well, the FDA will issue a letter indicating that the device has been cleared and the company can begin marketing the product.

The FDA’s 510(k) process is important and necessary for ensuring that new medical devices are safe and do what they claim to do. The process hinges on the determination of substantial equivalence, but what does that really mean? According to the FDA:

“A device is substantially equivalent if, in comparison to a predicate, it:

  • has the same intended use as the predicate; and
  • has the same technological characteristics as the predicate;

or

  • has the same intended use as the predicate; and
  • has different technological characteristics and the information submitted to FDA;
    • does not raise new questions of safety and effectiveness; and
    • demonstrates that the device is at least as safe and effective as the legally marketed device.

 

Let’s break that down. This definition says that there are two ways a device can be substantially equivalent to a predicate. One way – the obvious way – is that the two devices are pretty much the same in every way (they have the same intended use and features). The other way is a bit more complicated. A new device must have the same intended use as a predicate, but it doesn’t need to be technologically the same. While the new device can have different features, these differences can’t negatively impact safety or effectiveness. In the end, the new device must be at least as safe and effective as the predicate.

To summarize, if a medical device has 510(k) clearance from the FDA, it has been proven to be at least as safe and effective as a predicate device.

The MyoCycle 510(k) follows the second path to demonstrating substantial equivalence. While there are other devices like the MyoCycle that have the same intended use, nothing on the market has the same technological characteristics. MYOLYN chose the RT300 as the predicate device for the MyoCycle 510(k), because the MyoCycle is most similar to the RT300, as opposed to the MOTOmed viva2 with FES or the ERGYS.

The upcoming parts of this article will focus on the features of the MyoCycle that differentiate it from the RT300. Some of these features relate to safety and efficacy, while others relate to usability and affordability.

 Continue to RT300 vs. the MyoCycle, Part 2 – Therapy

Can’t wait to learn more about the MyoCycle? Click here to request more information now.

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