FDA 510k Executive Summary

A 510k Summary provides a brief summary of the device included in the premarket notification and the supporting information. It must be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

The summary should be a separate section for the submission. The summary contains, the 510(k) owner’s name, address, phone and fax numbers, name of contact person, and date the summary was prepared, the name of the device, including the trade or proprietary name, if applicable, the common or usual name, and the classification name. The summary shall prepare on the letterhead of the organization.

The summary shall contain the following information but not limited to.

  • ~ Intended use.
  • ~ Device description
  • ~ General characteristics of the device
  • ~ Performance tests, bench tests, non-clinical/ clinical tests.
  • ~ Comparison table with predicate
  • ~ the determination of substantial equivalence
  • ~ conclusion

Executive Summary / Predicate Comparison is a section of 510(k) which should include,

  • concise description of the device, including the indications for use and technology.
  • device comparison table; and
  • concise summary for any performance testing in the submission.

The information should be sufficient to understand the device. The comparison table shall discuss the similarities and dissimilarities of the device and the predicate device.