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Performance Testing for a 510k Submission-Case Study-Part 2

Performance Testing for a 510k Submission-Case Study-Part 2 explains the performance testing for a 510k submission in order to obtain clearance from the US FDA for marketing a new medical device. Performance testing is the most important part of new product development, and is usually the last section that you are able to complete before your submission.  510k part 2 Performance Testing for a 510k Submission Case Study Part 2 In my previous 510(k) case study article (http://www.MedicalDeviceAcademy.com/510k-submission-fda-case-study), I showed you how to research the FDA classification database to determine if there is a special controls guidance document to follow in the preparation of your 510k submission. The example I used was for topical adhesives (i.e., MPN). Topical adhesives do not have any Recognized Consensus Standards listed. Instead, all the performance testing requirements are specified in the special controls guidance document.

In this case study article, I selected a different product code that has Recognized Consensus Standards, but it does not have a special controls guidance document. After identifying the device classification and product code, if there is no Special Controls Guidance, you need to plan your performance testing based upon other sources of information. If there is no Special Controls Guidance document, I use three methods for determining what performance testing is needed:

  1. Look for any device-specific standards
  2. Review other 510k summaries
  3. Order previous 510k submissions via FOIA requests

For this case study, the product code selected was a bone fixation screw (i.e., HWC). The number of predicate 510k submissions to choose from for this product code is very large. In fact, there are 29 from Arthrex alone. Some of these 510k submissions include a 510k statement, while others include a 510k summary. A statement is not directly helpful in identifying any of the performance testing that was used for clearance of the potential predicate device. However, 21 CFR 807.93 requires that the company that submitted the 510k shall provide a redacted copy of the 510k submission within 30 days of the request. If this is requested early in your 510k project, you should have a copy of the submission in time to plan your performance testing for verification and validation of the subject device. You can also order predicate 510k submissions through the Freedom of Information Act (FOIA) request process:

(http://www.fda.gov/regulatoryinformation/foi/howtomakeafoiarequest/default.htm).

In the case of a 510k summary, the summary indicates what performance testing was performed in order to demonstrate substantial equivalence. In the case of K103705, the section titled “Substantial Equivalence Summary” states that mechanical testing data for torque and pull-out testing was submitted for the subject device and the predicate device. Other 510k summaries may provide additional data or a more descriptive list of testing that was performed. In the case of this 510k example, there is a second product code listed: HRS, bone fixation plate. The HWC bone fixation screw product code indicates that there are 5 Recognized Consensus Standards:

Only three of the above standards are included in the list of eight Recognized Consensus Standards related to the HWS product code. One of those eight standards should probably be included under the HWC product code, as well:

Now you have a total of six different device-specific standards that can be used for planning the performance testing of your bone screw. This is significantly more helpful than a 510k summary that says torque and pull-out testing was performed. After you have ordered and reviewed each of the standards, you then create a list of performance tests that are applicable to your screw, and create an overall verification and validation plan.

It is important to perform this review each time, because there may be new or revised testing methods established as the Recognized Consensus Standards are updated. If you outsource testing, then you will need to obtain a quotation from a testing lab for each of the applicable tests.

Once you have created a comprehensive testing list, and you have quotations for all the testing required, you need to schedule the testing, and ship samples to the testing lab. Once testing has begun, this is the best time to begin preparation of your 510k submission. Performance testing often takes several months to complete. If you begin preparing the 510k before you have ordered the testing, then you are starting too early, and you may have to change your performance testing summary multiple times.

If you start your 510k preparation after you order your testing, then you can create the entire performance testing summary. The only information that you will be missing is the final report number for each test being performed. For the most part, you do not need the specific results of the testing, because the tests are designed to show that the subject device is “equivalent” or “not worse” in performance. Quantitative comparisons between your subject device and the predicate device is not allowed by the FDA for a 510k submission. Your subject device must be “equivalent” or “not worse than” the predicate device with regard to safety and efficacy.

Additional 510k Training

The new 510k book, “How to Prepare Your 510k in 100 Days,” ships on Monday, February 6th 2017. There is also an on-line 510k course series consisting of 24 webinars. Please visit my webinar page to purchase individual webinars. We also have live 510k workshops

Posted in: 510(k)

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510k Submission to the FDA (Case Study – Part 1)

This article is the first part of a two-part case study providing an overview of the pre-market notification process (i.e., 510k Submission) in order 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.

case study 510K 510k Submission to the FDA (Case Study   Part 1)

For this 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, but 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 information provided by the company

In this case, 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 use the US FDA Registration and Listing Database to identify the product classification simply by 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 a specific product classification. In the case of topical adhesives, the FDA has published a Special Controls document. When there is a Special Controls guidance document available (http://bit.ly/FDA-topical-adhesive), 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 in an ISO Standard recognized by the US FDA. Since all the required performance testing 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. Therefore, the reviewer needs less time, and the FDA performance target for making a decision regarding clearance is 60 days—instead of 90 days.

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 will be some additional testing required that my client may not have anticipated.

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

fig.1 510k 510k Submission to the FDA (Case Study   Part 1)

The risks of adverse tissue reaction, chemical burns, and infection have all been addressed by biocompatibility testing and sterility testing. My client also performed animal testing to identify any problems in a simulated use environment. However, the client did not perform any testing to specifically address unintentional bonding, 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 clearly 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™ (see picture below) is an example of a new applicator for a monomeric, 2-octyl cyanoacrylate.

fig.2 510K 510k Submission to the FDA (Case Study   Part 1)

My client has a similar applicator design to the pictures above, 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 product made by my client. In each of these protocols, the acceptance criteria is performance “not worse than Surgiseal.” 

Additional 510k Training

The new 510k book, “How to Prepare Your 510k in 100 Days,” ships on Monday, February 6th 2017. There is also an on-line 510k course series consisting of 24 webinars. Please visit my webinar page to purchase individual webinars. We also have live 510k workshops

Posted in: 510(k)

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