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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number:
K181464
B. Purpose for Submission:
To obtain a substantial equivalence determination
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How to fill out 510k substantial equivalence determination
How to fill out 510k substantial equivalence determination
01
Gather all necessary information and documentation for the 510(k) submission.
02
Determine the appropriate pathway for submission based on the FDA guidance.
03
Prepare the submission by filling out Form FDA 3514, which is the cover sheet for the 510(k) submission.
04
Clearly state the intended use of the medical device and provide a detailed description of how it operates.
05
Include a comparison to a legally marketed predicate device to demonstrate substantial equivalence.
06
Provide information on the device's performance testing, biocompatibility, risk assessment, and labeling.
07
Prepare a summary of the data and justifications for substantial equivalence.
08
Compile all supporting documents, including clinical trial data, test reports, and labeling documents.
09
Submit the 510(k) application to the FDA for review.
10
Cooperate with the FDA throughout the review process by providing any additional information or clarification as requested.
11
Await the FDA's determination of substantial equivalence and follow any additional requirements or recommendations provided.
Who needs 510k substantial equivalence determination?
01
Any manufacturers or importers who wish to market a medical device in the United States that is not exempt from premarket notification requirements.
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What is 510k substantial equivalence determination?
The 510k substantial equivalence determination is a premarket notification submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a predicate device that is already legally marketed.
Who is required to file 510k substantial equivalence determination?
Medical device manufacturers who intend to market a new device in the United States are required to file a 510k substantial equivalence determination with the FDA.
How to fill out 510k substantial equivalence determination?
To fill out a 510k substantial equivalence determination, the manufacturer must provide detailed information about the new device, compare it to a legally marketed predicate device, and demonstrate that the new device is substantially equivalent.
What is the purpose of 510k substantial equivalence determination?
The purpose of the 510k substantial equivalence determination is to demonstrate that a new medical device is as safe and effective as a legally marketed predicate device, allowing it to be marketed in the United States.
What information must be reported on 510k substantial equivalence determination?
The 510k substantial equivalence determination must include information about the new device, its intended use, performance data, labeling, and a comparison to a legally marketed predicate device.
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