The first microneedling 510(k) has been filed following the formal issuance of the Microneedling Classification Order this summer (link to Classification Order here). The FDA Atty firm worked with Esthetic Education LLC to file a microneedling 510(k) for its SkinStylus SteriLock MicroSystem. The SkinStylus is now under a 90-day review.
The SkinStylus Sterilock system is unique as it’s the only device with a removable nose cone that can be reprocessed for added safety, and also features a 12 pin and 36 pin needle configuration.
This 510(k) solidifies previous comments made on this site concerning microneedling devices. In particular, that it is no longer enough simply to register and list as a Class I 510(k) exempt device (previous post with details here). The Final Classification Order is now codified in the Code of Federal Regulations (CFR) and can be used for filing a microneedling 510(k), what is called a predicate.
For those considering a microneedling 510(k), there are two points to consider. First, there is currently only one predicate, the SkinPen Precision by Bellus Medical (DEN 160029). This means any device submitted must demonstrate Substantial Equivalence based on a comparison to SkinPen. Soon that could include the SkinStylus. As with any 510(k), this means matching intended use and technology. There can be differences but those differences cannot raise new questions of safety or efficacy, which may mean submitting additional data. Second, the data requirements are significant. The SkinStylus 510(k) included nearly 500-pages of data reports. That’s at the top-end of a 510(k). Below is a table of tests the FDA has identified as required for a microneedling 510(k).
A 510(k) is not only required but also ensures patient safety. FDA has identified several risks to health associated specifically with this type of device. Whether a device is designed to mitigate those risks rests on a FDA review as part of the 510(k) process.
There are benefits to filing a 510(k)compared to filing a De Novo. In particular, the review time is only 90-120 days. By comparison, the De Novo review can exceed 250-days.
Congratulations to Esthetic Education LLC for taking the first-step and leading the industry by filing the first microneedling 510(k) for its SkinStylus SteriLock MicroSystem. It’s time for others to follow suit.
|Identified risks||Mitigation measures|
|Adverse tissue reaction||Biocompatibility evaluation and Labeling.|
|Cross-contamination and infection||Sterilization validation, Reprocessing validation, Non-clinical performance testing, Shelf life testing, and Labeling.|
|Electrical shock or electromagnetic interference with other devices||Electromagnetic compatibility testing, Electrical safety testing, and Labeling.|
|Damage to underlying tissue including nerves and blood vessels, scarring, and hyper/hypopigmentation due to: • Exceeding safe penetration depth • Mechanical failure • Software malfunction||Non-clinical performance testing, Technological characteristics, Shelf life testing, Labeling, and Software verification, validation, and hazard analysis.|
**Disclaimer: Marc C. Sanchez, Esq. is a FDA attorney in private practice and the above is not intended as legal advice. FDA Atty law firm is hosting this blog solely for educational purposes. Mr. Sanchez also worked with Bellus Medical on its De Novo submission.**
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