FDA 510(k) Summary or Statement is part of the 510(k) file of a medical device that requires the Premarket notification from the FDA for the marketing authorization in the US market.
510(k) Summary contains the summary of information on the characteristics of the subject device on which the Substantial Equivalence is claimed. 510(k) statement is the declaration of the manufacturer of the medical device that they will provide the information supporting the safety and effectiveness approved by the FDA to Any person within 30 days on the written request.
The manufacturer has to make the choice between the 510k summary or statement that should be made before the 510k is submitted.
Once the Substantial equivalence is determined, they can not change the choice of 510(k) Statement or Summary. The content required to be included in a 510(k) Summary is as per 21 CFR 807.92 and the Statement is as per 21 CFR 807.93. Once the 510(k) file is approved by the FDA the 510(k) Summary or the Statement will be publicly available on the FDA website.
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.
If a 510(k) summary is chosen, sufficient detail should be provided for understanding the basis for determination of substantial equivalence. Summaries or amended summaries are accepted by FDA only until decision regarding substantial equivalence is made.
If a 510(k) Statement is selected, specific statement as per 21 CFR 807.93 should be provided. The statement should be signed by the certifier, not a consultant to the 510(k) submitter and must be clearly identified as “510(k) Statement”.
The following information should not be included in a 510(k) summary:
• Any information that is not covered in the body of the 510(k).
• Any puffery or unsubstantiated labeling claims.
• Raw data
• Trade secret or confidential commercial information.
• Patient identification information.
A premarket notification should include either a summary of the 510(k) which provide safety and effectiveness information to understand the basis for a purpose of substantial equivalence or a statement in which the above information will be made available by the 510(k) applicant to any person within 30 days of a written request
If a 510(k) submitter chooses to provide a 510(k) statement to satisfy the above conditions, that statement must be submitted to FDA for review with the notification. The statement should be on a separate letterhead page, identified clearly as “510(k) Statement,” and signed by the certifier. Only patient identification, trade secrets, and confidential commercial information may be removed from the statement.
The following information not to be included in 510(k) summaries
• the information that is not covered in the body of the 510(k) summary
• the summary shouldn’t contain any raw data or any trade secret or confidential commercial information
• summary should not contain any puffery or unsubstantiated labelling claims
• any information regarding patient identification
Noncompliance with the 510(k) statement will be believed to be a prohibited act under section 301(p) of the FD&C Act and FDA may choose to use its enforcement powers to obtain the same.
I have totally agreed with the above responders, FDA recommends the summary includes only information that is also covered in the body of the 510(k). The FDA recommends not to add any false or exaggerated labelling claims nor the trade secrets or confidential data of the company.