510(k)

510k case study explains the 510k submission process in order to obtain clearance from the US FDA for marketing a new medical device.

This article is the first part of a two-part 510k case study providing an overview of the premarket notification process (i.e., 510k submission) to obtain clearance from the US FDA for marketing a new medical device. This first part of the series focuses on the initial steps of a 510k submission project: 1) identifying product classification, 2) identifying any applicable international standards and special controls guidance documents, and 3) selecting a primary predicate device.

For this 510k case study, I chose the maker of Krazy Glue^® as a hypothetical new client. The company wants to start selling cyanoacrylate as a topical adhesive in the U.S. market. As with the Canadian and European markets, the US FDA considers cyanoacrylate a medical device when it is used as a topical adhesive. The first step toward obtaining FDA clearance for marketing the new product is to determine the device’s classification.

Device Classification

My client was considering asking the FDA to identify the classification of topical adhesives using the 513(g) submission process. Still, I provided the following reasons why the client should not use the 513(g) process:

1. the 513(g) process takes 60 days to get a response from the FDA, while a qualified consultant can make the same determination in less than a day
2. hiring a consultant typically costs less than the 513(g) fee (i.e., $3,387 for large companies and $1,694 for small businesses)
3. the FDA’s classification determination is non-binding, and the accuracy of the FDA’s response is highly dependent upon the quality of the information provided by the company

In this 510k case study, I was able to answer the client’s question about device classification over the phone without any charge. The client indicated that they wanted to launch a product similar to Surgiseal. I was able to use the US FDA Registration and Listing Database to identify the product classification by merely typing “Surgiseal” in the field for “Proprietary Name.” Adhezion Biomedical LLC is registered as the manufacturer of Surgiseal. The three-letter product code “MPN,” and the device is a Class II device requiring premarket notification via a 510k submission.

This product classification also gives my client additional options that are not available to all companies that are trying to achieve 510(k) clearance for the first time. Most new products can only achieve initial 510(k) clearance from the US FDA by submitting a “traditional” 510(k). This process is supposed to take 90 days—assuming there are no significant questions about the submission, and the reviewer has a manageable workload to review. The average time for determination of 510k clearance is currently between 120 and 180 calendar days.

Applicable International Standards & Special Controls Guidance

For some products, there are recognized consensus standards (i.e., ISO Standards) that define the performance requirements for a medical device or a Special Controls document published by the FDA that identifies which performance Standards the FDA requires for specific product classification. In the case of topical adhesives, the FDA has issued a Special Controls document. When there is a Special Controls guidance document available, the company may submit an Abbreviated 510k instead of a Traditional 510k submission.

An Abbreviated 510k submission contains summaries of all the testing results required in the Special Controls document or an ISO Standard recognized by the US FDA. Since all the testing of performance needed to be presented in an Abbreviated 510k submission is in accordance with a previously accepted standard, the FDA reviewer only has to verify that the performance testing identified in the Special Controls document or the ISO Standard has been completed and acceptance criteria have been met. Now that the FDA requires 510k submissions to be submitted with the FDA eSTAR template, the advantages of Abbreviated 510k submissions has disappeared. In the future, this 510k case study may be a rare example where the FDA accepts Abbreviated 510k submissions.

In addition to Special Controls documents, the FDA also has guidance documents related to 510k submissions, such as: “Format for Traditional and Abbreviated 510(k)s.” By following this document verbatim, my client can avoid a lot of time-consuming questions from a reviewer that is having trouble finding the information they are looking for. If a section of the suggested format is not applicable, I still include this section. However, I indicate the reason why this section is not applicable in a brief paragraph (i.e., a one-page section).

As I read through the Special Controls Guidance document, I realized that a specific format for an Abbreviated 510k is described for topical adhesives. Therefore, I need to modify my normal template to match the FDA format for a topical adhesive Abbreviated 510k submission. As I read further, I realized that there would be some additional testing required that my client may not have anticipated. Product-specific testing is quite common and there are many other examples found in FDA special controls requirements in addition to this 510k case study.

In the Special Controls document, there are several risks and recommended mitigation measures identified:

The risks of adverse tissue reaction, chemical burns, and infection have all been addressed by biocompatibility testing and sterility testing. This 510k case study client also performed animal testing to identify any problems in a simulated use environment. However, the client did not perform any testing to address unintentional bonding specifically, wound dehiscence, applicator malfunction or delayed polymerization. The client needs verification protocols and test reports to address these specific risks.

Selection of a Primary Predicate

Another unique requirement from the US FDA for a 510k submission is the concept of a predicate device. A predicate device is a similar product that currently has a valid 510k. In July 2014, the US FDA released a guidance document that clarifies that companies submitting a 510k should identify only one primary predicate–rather than identifying multiple predicates. Ideally, a recent 510k submission should be selected because “old” technology may no longer be considered acceptable from a safety standpoint. In the case of topical adhesives, the applicator is one of the primary differences between legacy products and more recent 510k submissions. The most recent version of Surgiseal™ is an example of a new applicator for a monomeric, 2-octyl cyanoacrylate.

This 510k case study client has a similar applicator design, and therefore Surgiseal™ is selected as the primary predicate device for this 510k submission. For all the testing protocols that need to be created for this 510k submission, comparative testing is performed with a sample of Surgiseal™ and a sample of products made by my client. In each of these protocols, the acceptance criteria are performance “not worse than Surgiseal™.” 

Additional 510k Training

If you enjoyed our 510k case study and you would like more 510k training, please search our website for more articles. We wrote a 510k book in 2017 when we first started hiring consultants to grow Medical Device Academy from an independent consulting business to a consulting firm. The book was called, “How to Prepare Your 510k in 100 Days.” Changes to the FDA 510k process have been rapid over the past 7 years, and the content is no longer relevant, but there is an on-line 510k course series consisting of 33 new FDA eSTAR webinars. You can also purchase our webinars individually.