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US FDA : The “Traditional”510(k) 

- Part V

In the last column (See Archives), we discussed the User Fees and continued discussion of the "Traditional" Premarket Notification (510(k)) submission to the FDA. We discussed:

1. Cover Sheet 
2. Table of Contents. 
3. Cover Letter 
4. Truthful and Accurate Statement
5. Indications for Use

In this column, we will continue discussion of the contents of the "Traditional" 510(k). It is important to keep in mind at all times that your 510(k) submission is, in a sense, your real product. Your real customer is the FDA. If you do not satisfy the FDA, you cannot sell your medical device in the U.S. Therefore, you need to make every effort to give the FDA reviewer everything needed in a well-organized, clearly written form. The extra work in anticipating what the reviewer needs will pay off in shorter review times and less chance of extensive reviewer questions, which could lead to more delays.

5. Indications for Use Statement

The importance of the Indications for Use was discussed in the last column (See Archives). Let us continue with that discussion.

The statement should include specific indications and clinical settings. It should also define the target population, anatomical sites, etc. This statement must be consistent with your actual label for the device and any accompanying information, such as instructions for use and promotional materials. For ideas on wording, look at the indications for use statement for your predicate device.

Use the form found on the following link to get the official form that must be put in this section: http://www.fda.gov/cdrh/ode/indicate.html. 

6. General Information

In this brief section, give all the essential device identification information the reviewer needs. This includes:

A. The proprietary name for your device

This is the trade name for your device. You may wish to add the symbol, ®, if you have registered the trademark

B. The common name 

This name is the one commonly used for the device

C. The classification name

This is the named assigned by one FDA's 17 classification panels. (See Archives) These are the names of the individual parts of 21 Code of Federal Regulations (21 CFR, parts 862-892). You device should meet the definition in the appropriate part. An easier way is to do a key word search at the following link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfPCD/classification.cfm


D. The proposed regulatory class

Your device will be Class I, II or III. Most Class II devices require a 510(k). You will find the correct class in the appropriate part of the CFR. Most Class I and some Class II products are 510(k) exempt. If your product is Class I, read carefully any limitations to the exemption that may apply to your product.

E. Device Product Code (Also known as the Classification Code)

Use the link above to enter the Classification Name to get the Product Code (or vice versa).

F. Panel Code

This is simply the name of the one of the 17 classification panels where the classification name for your device is listed.

7. Device Information (or "Device Description")

In this section, you should put everything the FDA reviewer might want to know about your device that could affect its safety and effectiveness. To get a good idea of the level of detail that the reviewer will require, I would first check the FDA website to see if a guidance document has been written for your particular type of device. The link is: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm 
You need to search by key word. This sounds simple but often is frustrating because of the limitations of the search engine and our lack of imagination. For example, I looked for a guidance document for an Anti-Tg Immunoassay used to assess Thyroid autoantibodies. You will not find it if you look up "Anti-Tg" or "Immunoassay" but will find it under "Thyroid". So, keep trying!

You might start with a photograph, picture or schematic of the device and a diagram that clearly shows all the components. By all, I mean all internal and external components, whether assembled or unassembled. A discussion of how these components interact to produce the intended use would be helpful. Similar information, including the function, should be included for all accessories. A discussion of the principles or mechanism of action would ensure the reviewer understands how your device works.

Other useful information that could help the reviewer determine your device's safety and effectiveness could include, depending on the device, such things as:

• The range of sizes, including all applicable dimensions, including length, width, height, diameter, weight, etc.

• reference numbers (codes) and/or models that are included in the 510(k)

• The chemical composition and regulatory status of the device, its accessories and any reagents that are provided. 

• Detailed specifications and standards met. Include data sheets from suppliers or testing laboratories

• Engineering drawings (in English or with an accompanying translation)

• Detailed information about immediate and shipping packaging, including codes and specifications

• Power sources and specifications

• Limitations of the device and reagents, including shelf life

• A list of any single use components

Information supplied in this section should answer such reviewer questions as:

• Are substances in contact with the patient and for how long?

• Are substances delivered to or removed from a patient?

• Is energy delivered to or extracted from the patient?

• Could there be long-term effects from its use?

• Are biological materials processed by the device?

• Is preservation of samples necessary?

• Does the device measure or interpret data?

• Does it contain software?

• Is the device used alone or with other devices or drugs?

• Is the device reusable?

• Which components, if any, are sterile?

• Are there mechanical, environmental or other forces that could affect its operation?

• Are there potential hazards from its use? 

• What is the lifetime of the device and what factors determine it?

You are the expert about your device and know which of the examples above are applicable to your device and what other factors that are special to your device should be added to the list. Concise, clearly written English and large easy-to-read diagrams presented in a logical way will help the reviewer and yourself. 

In the next column, we will continue with the discussion of the contents of the "Traditional" Premarket Notification (510(k)) submission, starting with labeling.

8. Proposed Labeling
9. Performance Testing 
10. Clinical Data
11. Substantial Equivalence Information
12. Information on Sterilization
13. Software
14. Applicable Standards 
15. 510(k) Summary or Statement

Stay safe and healthy!

Norman F. Estrin, Ph.D., RAC
October 30, 2003

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