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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k162606 B. Purpose for Submission: Adding a previously cleared assay on a new

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How to fill out 510k substantial equivalence determination

01

Gather all necessary information about the device being compared and the predicate device.

02

Identify the intended use and technological characteristics of the device.

03

Conduct a thorough analysis to determine if the device is substantially equivalent to the predicate device.

04

Complete all sections of the FDA Form 510(k) and provide supporting documentation.

05

Submit the 510(k) application to the FDA for review and wait for a decision.

Who needs 510k substantial equivalence determination?

01

Any manufacturer seeking to market a new medical device in the United States that is not exempt from the premarket notification requirements.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a process through which the FDA evaluates whether a new medical device is substantially equivalent to a legally marketed device. This determination allows the new device to be marketed without undergoing the more extensive Premarket Approval (PMA) process.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices that are seeking to market a new device that claims substantial equivalence to an existing, legally marketed device must file a 510(k) submission.

How to fill out 510k substantial equivalence determination?

To fill out a 510(k) substantial equivalence determination, manufacturers must complete a standardized form that includes details such as device description, intended use, substantial equivalence claim, and performance data, among other information.

What is the purpose of 510k substantial equivalence determination?

The purpose of the 510(k) substantial equivalence determination is to ensure that new medical devices are as safe and effective as existing devices, thereby allowing them to enter the market without undergoing the full PMA process.

What information must be reported on 510k substantial equivalence determination?

Information required on the 510(k) includes the device's name, classification, description, intended use, performance testing results, labeling, and comparisons to the predicate device.

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