Tips for Navigating the FDA 510(k) Approval Process for Alternative Sterilization

  • Posted on: 9 November 2015
  • By: REVOX Steriliza...

Enabling Innovation

Medical and biotech device innovation has surged over the past few years, and these innovations are increasingly limited by industrial sterilization methods that haven’t changed in more than 20 years. Traditional sterilization methods increasingly stifle opportunities for advanced designs and rule out material components that may make the difference between success and failure by virtue of efficacy or economics. REVOX room-temperature vaporized peracetic acid (VPA) sterilization, however, meets the modern demands of innovation. In 2008, the FDA amended its 510(k) approval process to add non-traditional sterilized products. OsteoSymbionics was able to use this new amendment to gain 510(k) approval for their cranial implant sterilized with the REVOX sterilization method.  

The 510(k) Process

Undertaking a 510(k) approval can be a difficult process. “But it doesn’t have to be that way”, says Mason Schwartz, co-inventor and Operations Manager of REVOX® Sterilization Solutions. Schwartz has direct experience in assisting companies toward 510(k) approval of their sterilization process, and he says thorough preparation is the key to a smooth approval process. “As long as your data packet is sufficient, a new sterilization method isn’t going to lengthen your time through the 510(k) process,” Schwartz explains.

To ensure smooth 510(k) approval of your product with the REVOX sterilization method, Schwartz explains a manufacturer’s data packet must include the following items:

  • ISO 14937: This is the FDA’s standard guidance document for novel non-traditional sterilization methods. Use it to explain the process you’ll use, whether you’re using the bioburden validation or overkill validation, and also note what type of packaging evaluation you need to perform to validate sterility.
  • Description of the sterilizing agent: Describe the steriliant’s mode of action. For example, is it lysing infecting organisms’ cell walls or denaturing their proteins?
  • Cycle description: Include an explanation of how the cycle works and provides linear kill.
  • Most Resistant Organism (MRO): Describe the MRO for this process, and define what organisms will be destroyed. Start by doing a literature search on likely organisms to be most resistant to the process, then do a resistance study and provide the results of those tests. AOAC sporicidal activity testing is also recommended.
  • Linearity: Is the process log linear, whereby the reduction of biological indicators can be easily graphed on an X/Y chart? If you’re going to do overkill or bioburden validation, your system needs to be linear so you can demonstrate an extrapolated sterility assurance level of 10-6. Graph the reduction of the MRO against contact time. For vapor systems, this reduction can be measured against the number of injections or blocks.
  • Critical parameters: Include all critical cycle parameters of your product’s necessary sterilization process, including required pressure, time, sterilant concentration, relative humidity, and temperature.

Is a New 510(k) Worth the Switch?

While the prospect of seeking re-approval with a new sterilization method might seem too costly, the manufacturing efficiencies and inventory reductions gained by the REVOX sterilization process can likely offset those costs by a wide margin in the longer term.

Bruce Stoltzfus is Vice President of Operations for MEDIVATORS’ Conroe, TX manufacturing site, where REVOX sterilization will replace all EO contract sterilization. He says improving overall line efficiency is a constant emphasis of his.  “Throughout our organization, we have created Visual Factory tacking and trending charts to identify our areas of waste and process inefficiencies. Often, the inefficiencies are directly related to operational bottlenecks, which include the absence of a JIT (Just-In-Time) manufacturing process to support our sterilization needs,” Stoltzfus notes. “On-site sterilization with REVOX units supports our JIT needs and can be built to scale for specific throughput requirements and will help flatten out that bottlenecks to reduce in-process waste and will in turn, produce the efficiency gains that are quantifiable, even when taking into account the revalidation and 510(k) approval process” He adds, “We’ve done the math—it adds up.”  

For more detailed advice on the 510(k) approval process, check out this video on REVOX’s YouTube channel, or contact a REVOX Solutions Consultant for further advisement at 1-855-473-8690 or email us at